Low price ventolin

At that time, this drug benefit was "carved into" the Medicaid managed care low price ventolin benefit package. Before that date, people enrolled in a Medicaid managed care plan obtained all of their health care through the plan, but used their regular Medicaid card to access any drug available on the state formulary on a "fee for service" basis without needing to utilize a restricted pharmacy network or comply with managed care plan rules. COMING IN April 2021 - In the NYS Budget enacted in April 2020, the pharmacy benefit was "carved out" of "mainstream" Medicaid managed care plans. That means that members of managed care plans will access their drugs outside low price ventolin their plan, unlike the rest of their medical care, which is accessed from in-network providers. How Prescription Drugs are Obtained through Managed Care plans No - Until April 2020 HOW DO MANAGED CARE PLANS DEFINE THE PHARMACY BENEFIT FOR CONSUMERS?.

The Medicaid pharmacy benefit includes all FDA approved prescription drugs, as well as some over-the-counter drugs and medical supplies. Under Medicaid managed care low price ventolin. Plan formularies will be comparable to but not the same as the Medicaid formulary. Managed care plans are required to have drug formularies that are “comparable” to the Medicaid fee for service formulary. Plan formularies do not have to include all drugs low price ventolin covered listed on the fee for service formulary, but they must include generic or therapeutic equivalents of all Medicaid covered drugs.

The Pharmacy Benefit will vary by plan. Each plan will have its own formulary and drug coverage policies like prior authorization and step therapy. Pharmacy networks low price ventolin can also differ from plan to plan. Prescriber Prevails applies in certain drug classes. Prescriber prevails applys to medically necessary precription drugs in the following classes.

atypical antipsychotics, anti-depressants, anti-retrovirals, anti-rejection, seizure, low price ventolin epilepsy, endocrine, hemotologic and immunologic therapeutics. Prescribers will need to demonstrate reasonable profession judgment and supply plans witht requested information and/or clinical documentation. Pharmacy Benefit Information Website -- http://mmcdruginformation.nysdoh.suny.edu/-- This website provides very helpful information on a plan by plan basis regarding pharmacy networks and drug formularies. The Department of Health plans to build capacity for interactive searches allowing for comparison of coverage low price ventolin across plans in the near future. Standardized Prior Autorization (PA) Form -- The Department of Health worked with managed care plans, provider organizations and other state agencies to develop a standard prior authorization form for the pharmacy benefit in Medicaid managed care.

The form will be posted on the Pharmacy Information Website in July of 2013. Mail Order Drugs -- Medicaid managed low price ventolin care members can obtain mail order/specialty drugs at any retail network pharmacy, as long as that retail network pharmacy agrees to a price that is comparable to the mail order/specialty pharmacy price. CAN CONSUMERS SWITCH PLANS IN ORDER TO GAIN ACCESS TO DRUGS?. Changing plans is often an effective strategy for consumers eligible for both Medicaid and Medicare (dual eligibles) who receive their pharmacy service through Medicare Part D, because dual eligibles are allowed to switch plans at any time. Medicaid consumers will have this option only in the limited circumstances during the first year of enrollment in managed care low price ventolin.

Medicaid managed care enrollees can only leave and join another plan within the first 90 days of joining a health plan. After the 90 days has expired, enrollees are “locked in” to the plan for the rest of the year. Consumers can switch plans during the “lock in” period only for good cause low price ventolin. The pharmacy benefit changes are not considered good cause. After the first 12 months of enrollment, Medicaid managed care enrollees can switch plans at any time.

STEPS CONSUMERS CAN TAKE WHEN A MANAGED CARE PLAM DENIES ACCESS TO A NECESSARY DRUG As a first step, consumers should try to work with their providers to satisfy plan low price ventolin requirements for prior authorization or step therapy or any other utilization control requirements. If the plan still denies access, consumers can pursue review processes specific to managed care while at the same time pursuing a fair hearing. All plans are required to maintain an internal and external review process for complaints and appeals of service denials. Some plans low price ventolin may develop special procedures for drug denials. Information on these procedures should be provided in member handbooks.

Beginning April 1, 2018, Medicaid managed care enrollees whose plan denies prior approval of a prescription drug, or discontinues a drug that had been approved, will receive an Initial Adverse Determination notice from the plan - See Model Denial IAD Notice and IAD Notice to Reduce, Suspend or Stop Services The enrollee must first request an internal Plan Appeal and wait for the Plan's decision. An adverse decision is called a 'FInal Adverse low price ventolin Determination" or FAD. See model Denial FAD Notice and FAD Notice to Reduce, Suspend or Stop Services. The enroll has the right to request a fair hearing to appeal an FAD. The enrollee may only request a fair hearing BEFORE receiving the FAD if the plan fails to send the FAD in the required time low price ventolin limit, which is 30 calendar days in standard appeals, and 72 hours in expedited appeals.

The plan may extend the time to decide both standard and expedited appeals by up to 14 days if more information is needed and it is in the enrollee's interest. AID CONTINUING -- If an enrollee requests a Plan Appeal and then a fair hearing because access to a drug has been reduced or terminated, the enrollee has the right to aid continuing (continued access to the drug in question) while waiting for the Plan Appeal and then the fair hearing. The enrollee must request the Plan Appeal and then the Fair Hearing before the effective date of the IAD and FAD low price ventolin notices, which is a very short time - only 10 days including mailing time. See more about the changes in Managed Care appeals here. Even though that article is focused on Managed Long Term Care, the new appeals requirements also apply to Mainstream Medicaid managed care.

Enrollees who are in the first 90 days of enrollment, or past the first 12 months of enrollment low price ventolin also have the option of switching plans to improve access to their medications. Consumers who experience problems with access to prescription drugs should always file a complaint with the State Department of Health’s Managed Care Hotline, number listed below. ACCESSING MEDICAID'S PHARMACY BENEFIT IN FEE FOR SERVICE MEDICAID For those Medicaid recipients who are not yet in a Medicaid Managed Care program, and who do not have Medicare Part D, the Medicaid Pharmacy program covers most of their prescription drugs and select non-prescription drugs and medical supplies for Family Health Plus enrollees. Certain drugs/drug categories require the prescribers low price ventolin to obtain prior authorization. These include brand name drugs that have a generic alternative under New York's mandatory generic drug program or prescribed drugs that are not on New York's preferred drug list.

The full Medicaid formulary can be searched on the eMedNY website. Even in low price ventolin fee for service Medicaid, prescribers must obtain prior authorization before prescribing non-preferred drugs unless otherwise indicated. Prior authorization is required for original prescriptions, not refills. A prior authorization is effective for the original dispensing and up to five refills of that prescription within the next six months. Click here for more information on NY's low price ventolin prior authorization process.

The New York State Board of Pharmacy publishes an annual list of the 150 most frequently prescribed drugs, in the most common quantities. The State Department of Health collects retail price information on these drugs from pharmacies that participate in the Medicaid program. Click here to search for a low price ventolin specific drug from the most frequently prescribed drug list and this site can also provide you with the locations of pharmacies that provide this drug as well as their costs. Click here to view New York State Medicaid’s Pharmacy Provider Manual. WHO YOU CAN CALL FOR HELP Community Health Advocates Hotline.

1-888-614-5400 NY low price ventolin State Department of Health's Managed Care Hotline. 1-800-206-8125 (Mon. - Fri. 8:30 am low price ventolin - 4:30 pm) NY State Department of Insurance. 1-800-400-8882 NY State Attorney General's Health Care Bureau.

1-800-771-7755Haitian individuals and immigrants from some other countries who have applied for Temporary Protected Status (TPS) may be eligible for public health insurance in New York State. 2019 updates - The Trump administration has taken steps to end TPS status low price ventolin. Two courts have temporarily enjoined the termination of TPS, one in New York State in April 2019 and one in California in October 2018. The California case was argued in an appeals court on August 14, 2019, which the LA Times reported looked likely to uphold the federal action ending TPS. See US Immigration Website on TPS - General TPS website low price ventolin with links to status in all countries, including HAITI.

See also Pew Research March 2019 article. Courts Block Changes in Public charge rule- See updates on the Public Charge rule here, blocked by federal court injunctions in October 2019. Read more about this low price ventolin change in public charge rules here. What is Temporary Protected Status?. TPS is a temporary immigration status granted to eligible individuals of a certain country designated by the Department of Homeland Security because serious temporary conditions in that country, such as armed conflict or environmental disaster, prevents people from that country to return safely.

On January 21, 2010 the United States determined that individuals from Haiti warranted TPS because of low price ventolin the devastating earthquake that occurred there on January 12. TPS gives undocumented Haitian residents, who were living in the U.S. On January 12, 2010, protection from forcible deportation and allows them to work legally. It is important low price ventolin to note that the U.S. Grants TPS to individuals from other countries, as well, including individuals from El Salvador, Honduras, Nicaragua, Somalia and Sudan.

TPS and Public Health Insurance TPS applicants residing in New York are eligible for Medicaid and Family Health Plus as long as they also meet the income requirements for these programs. In New York, applicants for TPS are considered PRUCOL immigrants (Permanently Residing Under low price ventolin Color of Law) for purposes of medical assistance eligibility and thus meet the immigration status requirements for Medicaid, Family Health Plus, and the Family Planning Benefit Program. Nearly all children in New York remain eligible for Child Health Plus including TPS applicants and children who lack immigration status. For more information on immigrant eligibility for public health insurance in New York see 08 GIS MA/009 and the attached chart. Where to Apply What to BringIndividuals who have applied for TPS will need to bring several documents to prove their eligibility for public low price ventolin health insurance.

Individuals will need to bring. 1) Proof of identity. 2) low price ventolin Proof of residence in New York. 3) Proof of income. 4) Proof of application for TPS.

5) Proof that U.S low price ventolin. Citizenship and Immigration Services (USCIS) has received the application for TPS. Free Communication Assistance All applicants for public health insurance, including Haitian Creole speakers, have a right to get help in a language they can understand. All Medicaid offices and enrollers are required to offer free translation and interpretation services to anyone low price ventolin who cannot communicate effectively in English. A bilingual worker or an interpreter, whether in-person or over the telephone, must be provided in all interactions with the office.

Important documents, such as Medicaid applications, should be translated either orally or in writing. Interpreter services must be offered free of charge, and applicants requiring interpreter services must not be made to wait unreasonably longer than English speaking applicants. An applicant must never be asked to bring their own interpreter. Related Resources on TPS and Public Health Insurance o The New York Immigration Coalition (NYIC) has compiled a list of agencies, law firms, and law schools responding to the tragedy in Haiti and the designation of Haiti for Temporary Protected Status. A copy of the list is posted at the NYIC’s website at http://www.thenyic.org.

o USCIS TPS website with links to status in all countries, including HAITI. O For information on eligibility for public health insurance programs call The Legal Aid Society’s Benefits Hotline 1-888-663-6880 Tuesdays, Wednesdays and Thursdays. 9:30 am - 12:30 pm FOR IMMIGRATION HELP. CONTACT THE New York State New Americans Hotline for a referral to an organization to advise you. 212-419-3737 Monday-Friday, from 9:00 a.m.

To 8:00 p.m.Saturday-Sunday, from 9:00 a.m. To 5:00 p.m. Or call toll-free in New York State at 1-800-566-7636 Please see these fact sheets and web sites of national organizations for more information about the new PUBLIC CHARGE rules.

Is ventolin hfa the same as albuterol

Ventolin
Advair
Long term side effects
Yes
No
Discount price
Yes
No
Where to buy
Muscle pain
Memory problems

Most of the American Rescue Plan’s (ARP) is ventolin hfa the same as albuterol additional premium subsidies have been available since April, and an estimated 1.65 million people have enrolled in health plans through the exchange (marketplace) https://seifenkiste.nato-leipzig.de/canadian-online-pharmacy-for-cialis/ during the asthma treatment-related special enrollment period that’s been ongoing since February. But a major provision of the law will take effect on July 1, when HealthCare.gov makes additional subsidies available to people who have received unemployment compensation this year. DC and is ventolin hfa the same as albuterol 14 states run their own exchanges, and some of them had already activated the additional unemployment-based subsidies in May or June. But in the 36 states that use HealthCare.gov, as well as some of the state-based exchanges, the additional subsidies will become available this Thursday, July 1. Here’s what you need to know about these additional unemployment-based subsidies.

The subsidies is ventolin hfa the same as albuterol apply to both premiums and out-of-pocket costs The unemployment-based subsidies are two-fold. They provide full premium subsidies, which means they fully cover the cost of the benchmark plan (second-lowest-cost Silver plan) in your area. They provide the most robust level of cost-sharing reductions, which means they’ll boost the benefits of any Silver-level plan so that it’s better than a Platinum plan. Who is eligible for unemployment-based subsidies? is ventolin hfa the same as albuterol. The unemployment-based subsidies are available to anyone who has received or been approved to receive unemployment compensation at any time this year.

(If you’re eligible to receive unemployment compensation but haven’t applied or haven’t been approved to receive it, you’re not eligible for the additional health insurance subsidies.) Eligibility for the unemployment-based subsidies includes people whose income is under the federal poverty level, as long as they’re not eligible for Medicaid. (If a person is eligible for Medicaid or CHIP, they aren’t eligible for subsidies in the is ventolin hfa the same as albuterol exchange. Nothing has changed about that.) People with income under the poverty level are normally not eligible for subsidies, which means there’s a coverage gap in the states that have refused to accept federal funding to expand Medicaid. But a person who would otherwise be in the coverage gap can receive a full premium subsidy and full cost-sharing reductions in 2021, if they receive unemployment compensation at any time during the year. CMS has confirmed that the full is ventolin hfa the same as albuterol premium subsidies are only available if it’s a taxpayer who is receiving the unemployment compensation.

If it’s a dependent who is receiving it, the household is eligible for the cost-sharing reductions (assuming the household is otherwise also eligible for premium tax credits), but not the full premium subsidies. Even if you only received unemployment compensation for one week of 2021, you’re potentially eligible for the enhanced subsidies for the entire year. But subsidy eligibility would end if and when you become eligible for employer-sponsored health coverage (that’s considered affordable and provides minimum value), or is ventolin hfa the same as albuterol premium-free Medicare Part A. The ARP has not fixed the family glitch, so family members would also lose access to any subsidies in the exchange if they become eligible for employer-sponsored coverage that’s considered affordable for the employee. How to claim the extra subsidies HealthCare.gov will not be able to automatically update these subsidies (although that’s something that may become available later on), so you’ll need to log back into your account and update your application to activate the subsidies.

You can do this through HealthCare.gov, or through an enhanced direct is ventolin hfa the same as albuterol enrollment entity if you use one. Some of the state-run exchanges are automatically applying the additional subsidies to accounts where applicants indicated that they’re receiving unemployment compensation this year. But if you’re in a state that runs its own exchange, it’s in your best interest to log back into your account to confirm that you’re receiving all of the benefits for which you’re eligible. If you enroll or update your account between July is ventolin hfa the same as albuterol 1 and July 31, your new subsidies will take effect August 1. The asthma treatment-related special enrollment period continues through August 15 in most states, but enrollments or updates completed in August won’t take effect until September.

If you’ve already got coverage through the exchange but you don’t update your application to start receiving the additional unemployment-based subsidies, you’ll be able to claim the premium subsidy on your 2021 tax return. However, there is no is ventolin hfa the same as albuterol way to claim cost-sharing reductions after the fact. So it’s important to make sure you’re enrolled in a Silver plan as soon as possible, if you want to take advantage of that benefit. You might need to switch plans to get the full benefit You can get the additional premium subsidies applied to any metal-level plan, although your subsidy can never be more than the cost of your plan. So if is ventolin hfa the same as albuterol you’re enrolled in a plan that’s less expensive than the benchmark plan, you might find that you’re able to upgrade to a better plan without paying any additional premium.

But you can only get the enhanced cost-sharing reductions if you’re enrolled in a Silver plan. So if you currently have a Bronze or Gold plan, you might choose to switch to a Silver plan to get the full benefits available under the ARP. Although switching to a new plan mid-year usually means starting over with a new deductible and out-of-pocket maximum, many states and insurers are allowing enrollees to keep their accumulated out-of-pocket is ventolin hfa the same as albuterol costs, as long as they switch to a new plan from the same insurer. What you’ll pay each month The unemployment-based subsidies will cover the full cost of the benchmark plan. So you’ll have access to two Silver plans that have no premium, and you’ll likely have access to a variety of Bronze plans — and possibly some Gold plans — that have no premium.

If you pick a plan that’s more expensive than the benchmark plan, including the is ventolin hfa the same as albuterol higher-cost Silver plans, you’ll pay at least some premium each month. If you’re in a state that has additional state-mandated benefits that aren’t covered by premium subsidies, you may find that you have to pay at least a dollar or two each month in premiums, regardless of which plan you select. What you’ll pay when you need medical care If you enroll in a Silver plan, you’ll get the full benefits of the unemployment-based subsidies, meaning that you’ll have fairly low out-of-pocket costs if you need medical care later this year. Any Silver plan you choose will have a maximum out-of-pocket of no more than $2,850 in 2021, and it’s common to see these plans is ventolin hfa the same as albuterol with deductibles that range from $0 to $500. Copays for office visits and many prescriptions also tend to be fairly low.

If you choose a non-Silver plan, the normal cost-sharing will apply. No matter what plan you select, your out-of-pocket maximum for in-network care won’t exceed $8,550 this year, but the specifics of the coverage will vary considerably from one is ventolin hfa the same as albuterol plan to another. How big will your subsidy be?. You can use our subsidy calculator to see the subsidy amount that will be available to you. For people receiving unemployment compensation, the exchange will disregard any income above 139% is ventolin hfa the same as albuterol of the poverty level for 2021.

The 2020 poverty level numbers are used to determine subsidy eligibility for 2021, so you can find the poverty level for your household size, multiply it by 1.39, and enter that number into the subsidy calculator. And if you need help finding a plan, our direct enrollment entity can provide assistance. Louise Norris is an individual health insurance broker who has been is ventolin hfa the same as albuterol writing about health insurance and health reform since 2006. She has written dozens of opinions and educational pieces about the Affordable Care Act for healthinsurance.org. Her state health exchange updates are is ventolin hfa the same as albuterol regularly cited by media who cover health reform and by other health insurance experts.The Supreme Court upheld the Affordable Care Act today in a 7-2 ruling.

The court dismissed a challenge to the law, noting that the states and individuals who were trying to overturn the ACA did not have standing. This is the third time the ACA has survived challenges in the Supreme Court. In 2012, is ventolin hfa the same as albuterol the ruling was 5-4, and in 2015, the ruling was 6-3. These cases have all had varying arguments and merits, but it’s noteworthy that although the court has become more conservative over the last decade, the justices have increasingly favored the ACA. In this year’s case, some legal analysts had speculated that the court might overturn the ACA’s individual mandate but allow it to be severed from the rest of the ACA.

That approach would have upheld the ACA as well, but the court is ventolin hfa the same as albuterol simply dismissed the whole case. (This thread from Nicholas Bagley is a great summary, if you’re interested in the specifics.) So nothing has changed. The ACA remains intact, and the general consensus is that it’s here to stay. Is this decision is ventolin hfa the same as albuterol the end of legal challenges to the ACA?. That doesn’t mean the Affordable Care Act won’t continue to face legal challenges — a case that’s currently under consideration in Texas takes aim at the ACA’s requirement that health plans fully cover the cost of certain preventive care.

But that case does not seek to overturn the ACA itself, and it appears unlikely that the Supreme Court would take up any other case that might aim to do so. What does is ventolin hfa the same as albuterol this decision mean for consumers?. There was a collective sigh of relief this morning among people who are enrolled in Medicaid under the ACA’s expanded eligibility guidelines, as well as those who purchase their own individual/family health insurance and rely on the ACA’s premium tax credits, cost-sharing reductions, guaranteed-issue rules and coverage for pre-existing conditions, and essential health benefits. According to a recent analysis by Charles Gaba, more than 10% of all Americans are covered under Medicaid expansion, ACA-compliant individual/family health plans, and Basic Health Programs, all of which stem directly from the ACA. As we’ve explained during prior legal and legislative challenges to the ACA, the law provides a vast array of additional consumer protections that is ventolin hfa the same as albuterol extend to most Americans in one way or another.

But the people who are most likely to feel a sense of relief today are those enrolled in coverage that either wouldn’t exist or wouldn’t be accessible to them without the ACA. The anxiety about losing health coverage is no longer hanging over these Americans. Premium subsidies will continue to be available, and the subsidy enhancements provided by is ventolin hfa the same as albuterol the American Rescue Plan will continue to be in effect throughout 2022 – and possibly longer, if Congress acts to extend them. If you’ve been on the fence about enrolling in individual/family coverage during the special enrollment period that’s currently ongoing in nearly every state, you can now enroll with confidence. And the same is true about signing up for 2022 coverage when open enrollment starts in November.

And although is ventolin hfa the same as albuterol today’s ruling was on a lawsuit that hinged around the individual mandate and penalty, nothing has changed about the ACA’s requirement that most people maintain health insurance. There continues to be no federal penalty for not having health insurance, as has been the case since 2019. (If you’re in California, Massachusetts, New Jersey, Rhode Island, or the District of Columbia, there’s still a penalty for going without health insurance.) What does the decision mean for health insurers?. Insurers that offer individual/family health insurance have been displaying increasing confidence in the ACA for the last few years is ventolin hfa the same as albuterol. After fleeing the marketplaces/exchanges in 2017 and 2018, insurers started to join or rejoin the marketplaces in 2019.

That trend continued in 2020 and 2021, and we’re already seeing more insurer participation in the initial 2022 rate proposals that have been submitted by insurers in several states. The case that the Supreme Court dismissed today was initially filed in early 2018, so the legal threat to the ACA has been in the background throughout those three years of increasing insurer participation in the ACA-compliant insurance is ventolin hfa the same as albuterol market. Although insurance companies — and the actuaries who set premiums — tend to be quite averse to uncertainty, the individual market has proven to be profitable for insurers in recent years (after being unprofitable in the early years of ACA implementation). Insurers’ increasing willingness to offer plans in the marketplace is testament to that, despite the uncertainty that the lawsuit created over the last few years. Now that there’s no longer a pending legal threat to the ACA, we might see even more insurers opting to join the marketplaces or expand their existing coverage is ventolin hfa the same as albuterol areas.

What does the decision mean for states?. Although many states have enacted laws designed to protect consumers in case the ACA had been overturned, there’s no getting around the fact that they rely heavily on federal funding that’s provided under the ACA. Without that funding, most states would is ventolin hfa the same as albuterol not have been able to maintain the ACA’s Medicaid expansion or affordability provisions for self-purchased health insurance. There’s no longer a threat to the funding, which might make states more likely to push forward with additional consumer protections tied to the ACA. Among the most obvious is Medicaid expansion in the 13 states that have not yet accepted federal funding to expand Medicaid eligibility under the ACA.

The American Rescue Plan provides two years of additional is ventolin hfa the same as albuterol federal funding to states that newly expand Medicaid. So far, Oklahoma is the only state making use of that provision, and the state had already planned to expand Medicaid this year as a result of a ballot measure that Oklahoma voters passed last year. To be fair, the other 13 states have rejected Medicaid expansion year after year, including during the 2020 and 2021 legislative sessions that took place during a global ventolin. Without a change to the makeup of their legislatures, most are likely to continue to do so is ventolin hfa the same as albuterol. But now that the Supreme Court has upheld the ACA yet again, states that newly expand Medicaid can do so without a lingering worry that the federal funding might be eliminated.

It’s also possible that more states might consider reinsurance programs that make use of the ACA’s 1332 waiver provisions. But that is ventolin hfa the same as albuterol would also depend on whether the American Rescue Plan’s subsidy enhancements are extended beyond 2022. Reinsurance programs make coverage more affordable for people who don’t receive premium subsidies. Before the ARP eliminated the “subsidy cliff” for 2021 and 2022, the lack of affordability for households earning a little more than 400% of the poverty level was a very real problem. But that’s not currently an issue, as is ventolin hfa the same as albuterol those households qualify for subsidies if the benchmark plan would otherwise cost them more than 8.5% of their income.

If Congress extends that provision, reinsurance programs would help very few enrollees (and they can also harm subsidized enrollees in some areas, since they reduce the size of premium subsidies). State legislatures will need to keep an eye on how this plays out at the federal level, but without an extension of the ARP’s subsidy structure, we can expect to see more states pursuing 1332 waivers for reinsurance programs in the next few years. Louise Norris is an individual health insurance broker who has been writing about health insurance and health reform is ventolin hfa the same as albuterol since 2006. She has written dozens of opinions and educational pieces about the Affordable Care Act for healthinsurance.org. Her state health exchange updates are regularly cited by media who cover health reform and by other health insurance experts..

Most of the American Rescue Plan’s (ARP) additional premium subsidies have been available since April, and an estimated 1.65 million people have enrolled low price ventolin in health plans through the exchange (marketplace) during the asthma treatment-related special enrollment period Canadian online pharmacy for cialis that’s been ongoing since February. But a major provision of the law will take effect on July 1, when HealthCare.gov makes additional subsidies available to people who have received unemployment compensation this year. DC and 14 states run their own exchanges, and some of them had already activated the additional unemployment-based low price ventolin subsidies in May or June.

But in the 36 states that use HealthCare.gov, as well as some of the state-based exchanges, the additional subsidies will become available this Thursday, July 1. Here’s what you need to know about these additional unemployment-based subsidies. The subsidies apply to both premiums and out-of-pocket costs The unemployment-based subsidies low price ventolin are two-fold.

They provide full premium subsidies, which means they fully cover the cost of the benchmark plan (second-lowest-cost Silver plan) in your area. They provide the most robust level of cost-sharing reductions, which means they’ll boost the benefits of any Silver-level plan so that it’s better than a Platinum plan. Who is low price ventolin eligible for unemployment-based subsidies?.

The unemployment-based subsidies are available to anyone who has received or been approved to receive unemployment compensation at any time this year. (If you’re eligible to receive unemployment compensation but haven’t applied or haven’t been approved to receive it, you’re not eligible for the additional health insurance subsidies.) Eligibility for the unemployment-based subsidies includes people whose income is under the federal poverty level, as long as they’re not eligible for Medicaid. (If a low price ventolin person is eligible for Medicaid or CHIP, they aren’t eligible for subsidies in the exchange.

Nothing has changed about that.) People with income under the poverty level are normally not eligible for subsidies, which means there’s a coverage gap in the states that have refused to accept federal funding to expand Medicaid. But a person who would otherwise be in the coverage gap can receive a full premium subsidy and full cost-sharing reductions in 2021, if they receive unemployment compensation at any time during the year. CMS has confirmed that the full premium subsidies are only available if it’s low price ventolin a taxpayer who is receiving the unemployment compensation.

If it’s a dependent who is receiving it, the household is eligible for the cost-sharing reductions (assuming the household is otherwise also eligible for premium tax credits), but not the full premium subsidies. Even if you only received unemployment compensation for one week of 2021, you’re potentially eligible for the enhanced subsidies for the entire year. But subsidy eligibility would end if and when you become eligible for employer-sponsored health coverage (that’s low price ventolin considered affordable and provides minimum value), or premium-free Medicare Part A.

The ARP has not fixed the family glitch, so family members would also lose access to any subsidies in the exchange if they become eligible for employer-sponsored coverage that’s considered affordable for the employee. How to claim the extra subsidies HealthCare.gov will not be able to automatically update these subsidies (although that’s something that may become available later on), so you’ll need to log back into your account and update your application to activate the subsidies. You can do this through HealthCare.gov, or through an enhanced direct enrollment low price ventolin entity if you use one.

Some of the state-run exchanges are automatically applying the additional subsidies to accounts where applicants indicated that they’re receiving unemployment compensation this year. But if you’re in a state that runs its own exchange, it’s in your best interest to log back into your account to confirm that you’re receiving all of the benefits for which you’re eligible. If you enroll or update low price ventolin your account between July 1 and July 31, your new subsidies will take effect August 1.

The asthma treatment-related special enrollment period continues through August 15 in most states, but enrollments or updates completed in August won’t take effect until September. If you’ve already got coverage through the exchange but you don’t update your application to start receiving the additional unemployment-based subsidies, you’ll be able to claim the premium subsidy on your 2021 tax return. However, there is no way to claim cost-sharing reductions after the fact low price ventolin.

So it’s important to make sure you’re enrolled in a Silver plan as soon as possible, if you want to take advantage of that benefit. You might need to switch plans to get the full benefit You can get the additional premium subsidies applied to any metal-level plan, although your subsidy can never be more than the cost of your plan. So if you’re enrolled in a plan that’s less expensive than the benchmark plan, you might find that you’re able to upgrade to a better plan without paying any low price ventolin additional premium.

But you can only get the enhanced cost-sharing reductions if you’re enrolled in a Silver plan. So if you currently have a Bronze or Gold plan, you might choose to switch to a Silver plan to get the full benefits available under the ARP. Although switching to low price ventolin a new plan mid-year usually means starting over with a new deductible and out-of-pocket maximum, many states and insurers are allowing enrollees to keep their accumulated out-of-pocket costs, as long as they switch to a new plan from the same insurer.

What you’ll pay each month The unemployment-based subsidies will cover the full cost of the benchmark plan. So you’ll have access to two Silver plans that have no premium, and you’ll likely have access to a variety of Bronze plans — and possibly some Gold plans — that have no premium. If you pick a plan that’s more expensive than the benchmark plan, including the higher-cost low price ventolin Silver plans, you’ll pay at least some premium each month.

If you’re in a state that has additional state-mandated benefits that aren’t covered by premium subsidies, you may find that you have to pay at least a dollar or two each month in premiums, regardless of which plan you select. What you’ll pay when you need medical care If you enroll in a Silver plan, you’ll get the full benefits of the unemployment-based subsidies, meaning that you’ll have fairly low out-of-pocket costs if you need medical care later this year. Any Silver plan you choose low price ventolin will have a maximum out-of-pocket of no more than $2,850 in 2021, and it’s common to see these plans with deductibles that range from $0 to $500.

Copays for office visits and many prescriptions also tend to be fairly low. If you choose a non-Silver plan, the normal cost-sharing will apply. No matter what plan you select, your out-of-pocket maximum for in-network care won’t exceed $8,550 this year, but the specifics of the coverage will vary considerably from one plan low price ventolin to another.

How big will your subsidy be?. You can use our subsidy calculator to see the subsidy amount that will be available to you. For people receiving low price ventolin unemployment compensation, the exchange will disregard any income above 139% of the poverty level for 2021.

The 2020 poverty level numbers are used to determine subsidy eligibility for 2021, so you can find the poverty level for your household size, multiply it by 1.39, and enter that number into the subsidy calculator. And if you need help finding a plan, our direct enrollment entity can provide assistance. Louise Norris is an individual health insurance broker low price ventolin who has been writing about health insurance and health reform since 2006.

She has written dozens of opinions and educational pieces about the Affordable Care Act for healthinsurance.org. Her state health exchange updates are regularly cited by low price ventolin media who cover health reform and by other health insurance experts.The Supreme Court upheld the Affordable Care Act today in a 7-2 ruling. The court dismissed a challenge to the law, noting that the states and individuals who were trying to overturn the ACA did not have standing.

This is the third time the ACA has survived challenges in the Supreme Court. In 2012, the ruling was 5-4, and in 2015, the ruling was low price ventolin 6-3. These cases have all had varying arguments and merits, but it’s noteworthy that although the court has become more conservative over the last decade, the justices have increasingly favored the ACA.

In this year’s case, some legal analysts had speculated that the court might overturn the ACA’s individual mandate but allow it to be severed from the rest of the ACA. That approach would have upheld the ACA as well, but low price ventolin the court simply dismissed the whole case. (This thread from Nicholas Bagley is a great summary, if you’re interested in the specifics.) So nothing has changed.

The ACA remains intact, and the general consensus is that it’s here to stay. Is this decision the end of legal challenges low price ventolin to the ACA?. That doesn’t mean the Affordable Care Act won’t continue to face legal challenges — a case that’s currently under consideration in Texas takes aim at the ACA’s requirement that health plans fully cover the cost of certain preventive care.

But that case does not seek to overturn the ACA itself, and it appears unlikely that the Supreme Court would take up any other case that might aim to do so. What does this low price ventolin decision mean for consumers?. There was a collective sigh of relief this morning among people who are enrolled in Medicaid under the ACA’s expanded eligibility guidelines, as well as those who purchase their own individual/family health insurance and rely on the ACA’s premium tax credits, cost-sharing reductions, guaranteed-issue rules and coverage for pre-existing conditions, and essential health benefits.

According to a recent analysis by Charles Gaba, more than 10% of all Americans are covered under Medicaid expansion, ACA-compliant individual/family health plans, and Basic Health Programs, all of which stem directly from the ACA. As we’ve explained during prior legal and legislative challenges to the ACA, the law provides a vast array of additional consumer protections that extend to most Americans in one way or another low price ventolin. But the people who are most likely to feel a sense of relief today are those enrolled in coverage that either wouldn’t exist or wouldn’t be accessible to them without the ACA.

The anxiety about losing health coverage is no longer hanging over these Americans. Premium subsidies will low price ventolin continue to be available, and the subsidy enhancements provided by the American Rescue Plan will continue to be in effect throughout 2022 – and possibly longer, if Congress acts to extend them. If you’ve been on the fence about enrolling in individual/family coverage during the special enrollment period that’s currently ongoing in nearly every state, you can now enroll with confidence.

And the same is true about signing up for 2022 coverage when open enrollment starts in November. And although today’s ruling was on low price ventolin a lawsuit that hinged around the individual mandate and penalty, nothing has changed about the ACA’s requirement that most people maintain health insurance. There continues to be no federal penalty for not having health insurance, as has been the case since 2019.

(If you’re in California, Massachusetts, New Jersey, Rhode Island, or the District of Columbia, there’s still a penalty for going without health insurance.) What does the decision mean for health insurers?. Insurers that offer individual/family health insurance have been displaying increasing confidence in the ACA for low price ventolin the last few years. After fleeing the marketplaces/exchanges in 2017 and 2018, insurers started to join or rejoin the marketplaces in 2019.

That trend continued in 2020 and 2021, and we’re already seeing more insurer participation in the initial 2022 rate proposals that have been submitted by insurers in several states. The case that the Supreme Court dismissed today was initially filed in early 2018, so the legal threat to the ACA has been in the background throughout those three years of increasing insurer participation low price ventolin in the ACA-compliant insurance market. Although insurance companies — and the actuaries who set premiums — tend to be quite averse to uncertainty, the individual market has proven to be profitable for insurers in recent years (after being unprofitable in the early years of ACA implementation).

Insurers’ increasing willingness to offer plans in the marketplace is testament to that, despite the uncertainty that the lawsuit created over the last few years. Now that there’s no longer a pending legal threat to the ACA, we might see even more insurers opting to join the marketplaces or low price ventolin expand their existing coverage areas. What does the decision mean for states?.

Although many states have enacted laws designed to protect consumers in case the ACA had been overturned, there’s no getting around the fact that they rely heavily on federal funding that’s provided under the ACA. Without that funding, low price ventolin most states would not have been able to maintain the ACA’s Medicaid expansion or affordability provisions for self-purchased health insurance. There’s no longer a threat to the funding, which might make states more likely to push forward with additional consumer protections tied to the ACA.

Among the most obvious is Medicaid expansion in the 13 states that have not yet accepted federal funding to expand Medicaid eligibility under the ACA. The American low price ventolin Rescue Plan provides two years of additional federal funding to states that newly expand Medicaid. So far, Oklahoma is the only state making use of that provision, and the state had already planned to expand Medicaid this year as a result of a ballot measure that Oklahoma voters passed last year.

To be fair, the other 13 states have rejected Medicaid expansion year after year, including during the 2020 and 2021 legislative sessions that took place during a global ventolin. Without a change to the makeup of their legislatures, most are likely to continue low price ventolin to do so. But now that the Supreme Court has upheld the ACA yet again, states that newly expand Medicaid can do so without a lingering worry that the federal funding might be eliminated.

It’s also possible that more states might consider reinsurance programs that make use of the ACA’s 1332 waiver provisions. But that would also low price ventolin depend on whether the American Rescue Plan’s subsidy enhancements are extended beyond 2022. Reinsurance programs make coverage more affordable for people who don’t receive premium subsidies.

Before the ARP eliminated the “subsidy cliff” for 2021 and 2022, the lack of affordability for households earning a little more than 400% of the poverty level was a very real problem. But that’s not currently an issue, as those households qualify for subsidies if the benchmark plan would low price ventolin otherwise cost them more than 8.5% of their income. If Congress extends that provision, reinsurance programs would help very few enrollees (and they can also harm subsidized enrollees in some areas, since they reduce the size of premium subsidies).

State legislatures will need to keep an eye on how this plays out at the federal level, but without an extension of the ARP’s subsidy structure, we can expect to see more states pursuing 1332 waivers for reinsurance programs in the next few years. Louise Norris is low price ventolin an individual health insurance broker who has been writing about health insurance and health reform since 2006. She has written dozens of opinions and educational pieces about the Affordable Care Act for healthinsurance.org.

Her state health exchange updates are regularly cited by media who cover health reform and by other health insurance experts..

How should I use Ventolin?

Take Ventolin by mouth. If Ventolin upsets your stomach, take it with food or milk. Do not take more often than directed. Talk to your pediatrician regarding the use of Ventolin in children. Special care may be needed. Overdosage: If you think you have taken too much of Ventolin contact a poison control center or emergency room at once. Note: Ventolin is only for you. Do not share Ventolin with others.

How often to use ventolin hfa

Patients Figure how often to use ventolin hfa 1 http://facummings.com/?p=1. Figure 1. Enrollment and how often to use ventolin hfa Randomization.

Of the 1107 patients who were assessed for eligibility, 1063 underwent randomization. 541 were assigned to the remdesivir group and 522 to the placebo how often to use ventolin hfa group (Figure 1). Of those assigned to receive remdesivir, 531 patients (98.2%) received the treatment as assigned.

Forty-nine patients had remdesivir treatment discontinued before day 10 because of an adverse event or a serious adverse event other than death (36 patients) or because the patient withdrew consent (13). Of those assigned to receive placebo, 518 patients (99.2%) received placebo as how often to use ventolin hfa assigned. Fifty-three patients discontinued placebo before day 10 because of an adverse event or a serious adverse event other than death (36 patients), because the patient withdrew consent (15), or because the patient was found to be ineligible for trial enrollment (2).

As of April 28, 2020, a total of 391 patients in the remdesivir group and 340 in the placebo how often to use ventolin hfa group had completed the trial through day 29, recovered, or died. Eight patients who received remdesivir and 9 who received placebo terminated their participation in the trial before day 29. There were 132 patients in the remdesivir group and how often to use ventolin hfa 169 in the placebo group who had not recovered and had not completed the day 29 follow-up visit.

The analysis population included 1059 patients for whom we have at least some postbaseline data available (538 in the remdesivir group and 521 in the placebo group). Four of the 1063 patients were not included in the primary analysis because no postbaseline data were available at the time of the database freeze. Table 1 how often to use ventolin hfa.

Table 1. Demographic and Clinical Characteristics how often to use ventolin hfa at Baseline. The mean age of patients was 58.9 years, and 64.3% were male (Table 1).

On the basis of the evolving epidemiology of asthma treatment during the trial, 79.8% of patients were enrolled at sites in North how often to use ventolin hfa America, 15.3% in Europe, and 4.9% in Asia (Table S1). Overall, 53.2% of the patients were white, 20.6% were black, 12.6% were Asian, and 13.6% were designated as other or not reported. 249 (23.4%) were Hispanic or Latino.

Most patients had either one (27.0%) or two or more (52.1%) of the prespecified coexisting conditions at enrollment, how often to use ventolin hfa most commonly hypertension (49.6%), obesity (37.0%), and type 2 diabetes mellitus (29.7%). The median number of days between symptom onset and randomization was 9 (interquartile range, 6 to 12). Nine hundred forty-three (88.7%) patients how often to use ventolin hfa had severe disease at enrollment as defined in the Supplementary Appendix.

272 (25.6%) patients met category 7 criteria on the ordinal scale, 197 (18.5%) category 6, 421 (39.6%) category 5, and 127 (11.9%) category 4. There were 46 (4.3%) patients who had missing ordinal scale data at how often to use ventolin hfa enrollment. No substantial imbalances in baseline characteristics were observed between the remdesivir group and the placebo group.

Primary Outcome Figure 2. Figure 2 how often to use ventolin hfa. Kaplan–Meier Estimates of Cumulative Recoveries.

Cumulative recovery estimates are shown in the overall population (Panel A), in patients how often to use ventolin hfa with a baseline score of 4 on the ordinal scale (not receiving oxygen. Panel B), in those with a baseline score of 5 (receiving oxygen. Panel C), in those how often to use ventolin hfa with a baseline score of 6 (receiving high-flow oxygen or noninvasive mechanical ventilation.

Panel D), and in those with a baseline score of 7 (receiving mechanical ventilation or ECMO. Panel E). Table 2 how often to use ventolin hfa.

Table 2. Outcomes Overall and According how often to use ventolin hfa to Score on the Ordinal Scale in the Intention-to-Treat Population. Figure 3.

Figure 3 how often to use ventolin hfa. Time to Recovery According to Subgroup. The widths of the confidence intervals have not been adjusted for multiplicity and therefore cannot be used to infer treatment effects.

Race and how often to use ventolin hfa ethnic group were reported by the patients. Patients in the remdesivir group had a shorter time to recovery than patients in the placebo group (median, 11 days, as compared with 15 days. Rate ratio for recovery, 1.32 how often to use ventolin hfa.

95% confidence interval [CI], 1.12 to 1.55. P<0.001. 1059 patients (Figure 2 and Table 2).

Among patients with a baseline ordinal score of 5 (421 patients), the rate ratio for recovery was 1.47 (95% CI, 1.17 to 1.84). Among patients with a baseline score of 4 (127 patients) and those with a baseline score of 6 (197 patients), the rate ratio estimates for recovery were 1.38 (95% CI, 0.94 to 2.03) and 1.20 (95% CI, 0.79 to 1.81), respectively. For those receiving mechanical ventilation or ECMO at enrollment (baseline ordinal scores of 7.

272 patients), the rate ratio for recovery was 0.95 (95% CI, 0.64 to 1.42). A test of interaction of treatment with baseline score on the ordinal scale was not significant. An analysis adjusting for baseline ordinal score as a stratification variable was conducted to evaluate the overall effect (of the percentage of patients in each ordinal score category at baseline) on the primary outcome.

This adjusted analysis produced a similar treatment-effect estimate (rate ratio for recovery, 1.31. 95% CI, 1.12 to 1.54. 1017 patients).

Table S2 in the Supplementary Appendix shows results according to the baseline severity stratum of mild-to-moderate as compared with severe. Patients who underwent randomization during the first 10 days after the onset of symptoms had a rate ratio for recovery of 1.28 (95% CI, 1.05 to 1.57. 664 patients), whereas patients who underwent randomization more than 10 days after the onset of symptoms had a rate ratio for recovery of 1.38 (95% CI, 1.05 to 1.81.

380 patients) (Figure 3). Key Secondary Outcome The odds of improvement in the ordinal scale score were higher in the remdesivir group, as determined by a proportional odds model at the day 15 visit, than in the placebo group (odds ratio for improvement, 1.50. 95% CI, 1.18 to 1.91.

P=0.001. 844 patients) (Table 2 and Fig. S5).

Mortality was numerically lower in the remdesivir group than in the placebo group, but the difference was not significant (hazard ratio for death, 0.70. 95% CI, 0.47 to 1.04. 1059 patients).

The Kaplan–Meier estimates of mortality by 14 days were 7.1% and 11.9% in the remdesivir and placebo groups, respectively (Table 2). The Kaplan–Meier estimates of mortality by 28 days are not reported in this preliminary analysis, given the large number of patients that had yet to complete day 29 visits. An analysis with adjustment for baseline ordinal score as a stratification variable showed a hazard ratio for death of 0.74 (95% CI, 0.50 to 1.10).

Safety Outcomes Serious adverse events occurred in 114 patients (21.1%) in the remdesivir group and 141 patients (27.0%) in the placebo group (Table S3). 4 events (2 in each group) were judged by site investigators to be related to remdesivir or placebo. There were 28 serious respiratory failure adverse events in the remdesivir group (5.2% of patients) and 42 in the placebo group (8.0% of patients).

Acute respiratory failure, hypotension, viral pneumonia, and acute kidney injury were slightly more common among patients in the placebo group. No deaths were considered to be related to treatment assignment, as judged by the site investigators. Grade 3 or 4 adverse events occurred in 156 patients (28.8%) in the remdesivir group and in 172 in the placebo group (33.0%) (Table S4).

The most common adverse events in the remdesivir group were anemia or decreased hemoglobin (43 events [7.9%], as compared with 47 [9.0%] in the placebo group). Acute kidney injury, decreased estimated glomerular filtration rate or creatinine clearance, or increased blood creatinine (40 events [7.4%], as compared with 38 [7.3%]). Pyrexia (27 events [5.0%], as compared with 17 [3.3%]).

Hyperglycemia or increased blood glucose level (22 events [4.1%], as compared with 17 [3.3%]). And increased aminotransferase levels including alanine aminotransferase, aspartate aminotransferase, or both (22 events [4.1%], as compared with 31 [5.9%]). Otherwise, the incidence of adverse events was not found to be significantly different between the remdesivir group and the placebo group.Trial Design and Oversight The RECOVERY trial was designed to evaluate the effects of potential treatments in patients hospitalized with asthma treatment at 176 National Health Service organizations in the United Kingdom and was supported by the National Institute for Health Research Clinical Research Network.

(Details regarding this trial are provided in the Supplementary Appendix, available with the full text of this article at NEJM.org.) The trial is being coordinated by the Nuffield Department of Population Health at the University of Oxford, the trial sponsor. Although the randomization of patients to receive dexamethasone, hydroxychloroquine, or lopinavir–ritonavir has now been stopped, the trial continues randomization to groups receiving azithromycin, tocilizumab, or convalescent plasma. Hospitalized patients were eligible for the trial if they had clinically suspected or laboratory-confirmed asthma and no medical history that might, in the opinion of the attending clinician, put patients at substantial risk if they were to participate in the trial.

Initially, recruitment was limited to patients who were at least 18 years of age, but the age limit was removed starting on May 9, 2020. Pregnant or breast-feeding women were eligible. Written informed consent was obtained from all the patients or from a legal representative if they were unable to provide consent.

The trial was conducted in accordance with the principles of the Good Clinical Practice guidelines of the International Conference on Harmonisation and was approved by the U.K. Medicines and Healthcare Products Regulatory Agency and the Cambridge East Research Ethics Committee. The protocol with its statistical analysis plan is available at NEJM.org and on the trial website at www.recoverytrial.net.

The initial version of the manuscript was drafted by the first and last authors, developed by the writing committee, and approved by all members of the trial steering committee. The funders had no role in the analysis of the data, in the preparation or approval of the manuscript, or in the decision to submit the manuscript for publication. The first and last members of the writing committee vouch for the completeness and accuracy of the data and for the fidelity of the trial to the protocol and statistical analysis plan.

Randomization We collected baseline data using a Web-based case-report form that included demographic data, the level of respiratory support, major coexisting illnesses, suitability of the trial treatment for a particular patient, and treatment availability at the trial site. Randomization was performed with the use of a Web-based system with concealment of the trial-group assignment. Eligible and consenting patients were assigned in a 2:1 ratio to receive either the usual standard of care alone or the usual standard of care plus oral or intravenous dexamethasone (at a dose of 6 mg once daily) for up to 10 days (or until hospital discharge if sooner) or to receive one of the other suitable and available treatments that were being evaluated in the trial.

For some patients, dexamethasone was unavailable at the hospital at the time of enrollment or was considered by the managing physician to be either definitely indicated or definitely contraindicated. These patients were excluded from entry in the randomized comparison between dexamethasone and usual care and hence were not included in this report. The randomly assigned treatment was prescribed by the treating clinician.

Patients and local members of the trial staff were aware of the assigned treatments. Procedures A single online follow-up form was to be completed when the patients were discharged or had died or at 28 days after randomization, whichever occurred first. Information was recorded regarding the patients’ adherence to the assigned treatment, receipt of other trial treatments, duration of admission, receipt of respiratory support (with duration and type), receipt of renal support, and vital status (including the cause of death).

In addition, we obtained routine health care and registry data, including information on vital status (with date and cause of death), discharge from the hospital, and respiratory and renal support therapy. Outcome Measures The primary outcome was all-cause mortality within 28 days after randomization. Further analyses were specified at 6 months.

Secondary outcomes were the time until discharge from the hospital and, among patients not receiving invasive mechanical ventilation at the time of randomization, subsequent receipt of invasive mechanical ventilation (including extracorporeal membrane oxygenation) or death. Other prespecified clinical outcomes included cause-specific mortality, receipt of renal hemodialysis or hemofiltration, major cardiac arrhythmia (recorded in a subgroup), and receipt and duration of ventilation. Statistical Analysis As stated in the protocol, appropriate sample sizes could not be estimated when the trial was being planned at the start of the asthma treatment ventolin.

As the trial progressed, the trial steering committee, whose members were unaware of the results of the trial comparisons, determined that if 28-day mortality was 20%, then the enrollment of at least 2000 patients in the dexamethasone group and 4000 in the usual care group would provide a power of at least 90% at a two-sided P value of 0.01 to detect a clinically relevant proportional reduction of 20% (an absolute difference of 4 percentage points) between the two groups. Consequently, on June 8, 2020, the steering committee closed recruitment to the dexamethasone group, since enrollment had exceeded 2000 patients. For the primary outcome of 28-day mortality, the hazard ratio from Cox regression was used to estimate the mortality rate ratio.

Among the few patients (0.1%) who had not been followed for 28 days by the time of the data cutoff on July 6, 2020, data were censored either on that date or on day 29 if the patient had already been discharged. That is, in the absence of any information to the contrary, these patients were assumed to have survived for 28 days. Kaplan–Meier survival curves were constructed to show cumulative mortality over the 28-day period.

Cox regression was used to analyze the secondary outcome of hospital discharge within 28 days, with censoring of data on day 29 for patients who had died during hospitalization. For the prespecified composite secondary outcome of invasive mechanical ventilation or death within 28 days (among patients who were not receiving invasive mechanical ventilation at randomization), the precise date of invasive mechanical ventilation was not available, so a log-binomial regression model was used to estimate the risk ratio. Table 1.

Table 1. Characteristics of the Patients at Baseline, According to Treatment Assignment and Level of Respiratory Support. Through the play of chance in the unstratified randomization, the mean age was 1.1 years older among patients in the dexamethasone group than among those in the usual care group (Table 1).

To account for this imbalance in an important prognostic factor, estimates of rate ratios were adjusted for the baseline age in three categories (<70 years, 70 to 79 years, and ≥80 years). This adjustment was not specified in the first version of the statistical analysis plan but was added once the imbalance in age became apparent. Results without age adjustment (corresponding to the first version of the analysis plan) are provided in the Supplementary Appendix.

Prespecified analyses of the primary outcome were performed in five subgroups, as defined by characteristics at randomization. Age, sex, level of respiratory support, days since symptom onset, and predicted 28-day mortality risk. (One further prespecified subgroup analysis regarding race will be conducted once the data collection has been completed.) In prespecified subgroups, we estimated rate ratios (or risk ratios in some analyses) and their confidence intervals using regression models that included an interaction term between the treatment assignment and the subgroup of interest.

Chi-square tests for linear trend across the subgroup-specific log estimates were then performed in accordance with the prespecified plan. All P values are two-sided and are shown without adjustment for multiple testing. All analyses were performed according to the intention-to-treat principle.

The full database is held by the trial team, which collected the data from trial sites and performed the analyses at the Nuffield Department of Population Health, University of Oxford.Trial Population Table 1. Table 1. Characteristics of the Participants in the mRNA-1273 Trial at Enrollment.

The 45 enrolled participants received their first vaccination between March 16 and April 14, 2020 (Fig. S1). Three participants did not receive the second vaccination, including one in the 25-μg group who had urticaria on both legs, with onset 5 days after the first vaccination, and two (one in the 25-μg group and one in the 250-μg group) who missed the second vaccination window owing to isolation for suspected asthma treatment while the test results, ultimately negative, were pending.

All continued to attend scheduled trial visits. The demographic characteristics of participants at enrollment are provided in Table 1. treatment Safety No serious adverse events were noted, and no prespecified trial halting rules were met.

As noted above, one participant in the 25-μg group was withdrawn because of an unsolicited adverse event, transient urticaria, judged to be related to the first vaccination. Figure 1. Figure 1.

Systemic and Local Adverse Events. The severity of solicited adverse events was graded as mild, moderate, or severe (see Table S1).After the first vaccination, solicited systemic adverse events were reported by 5 participants (33%) in the 25-μg group, 10 (67%) in the 100-μg group, and 8 (53%) in the 250-μg group. All were mild or moderate in severity (Figure 1 and Table S2).

Solicited systemic adverse events were more common after the second vaccination and occurred in 7 of 13 participants (54%) in the 25-μg group, all 15 in the 100-μg group, and all 14 in the 250-μg group, with 3 of those participants (21%) reporting one or more severe events. None of the participants had fever after the first vaccination. After the second vaccination, no participants in the 25-μg group, 6 (40%) in the 100-μg group, and 8 (57%) in the 250-μg group reported fever.

One of the events (maximum temperature, 39.6°C) in the 250-μg group was graded severe. (Additional details regarding adverse events for that participant are provided in the Supplementary Appendix.) Local adverse events, when present, were nearly all mild or moderate, and pain at the injection site was common. Across both vaccinations, solicited systemic and local adverse events that occurred in more than half the participants included fatigue, chills, headache, myalgia, and pain at the injection site.

Evaluation of safety clinical laboratory values of grade 2 or higher and unsolicited adverse events revealed no patterns of concern (Supplementary Appendix and Table S3). asthma Binding Antibody Responses Table 2. Table 2.

Geometric Mean Humoral Immunogenicity Assay Responses to mRNA-1273 in Participants and in Convalescent Serum Specimens. Figure 2. Figure 2.

asthma Antibody and Neutralization Responses. Shown are geometric mean reciprocal end-point enzyme-linked immunosorbent assay (ELISA) IgG titers to S-2P (Panel A) and receptor-binding domain (Panel B), PsVNA ID50 responses (Panel C), and live ventolin PRNT80 responses (Panel D). In Panel A and Panel B, boxes and horizontal bars denote interquartile range (IQR) and median area under the curve (AUC), respectively.

Whisker endpoints are equal to the maximum and minimum values below or above the median ±1.5 times the IQR. The convalescent serum panel includes specimens from 41 participants. Red dots indicate the 3 specimens that were also tested in the PRNT assay.

The other 38 specimens were used to calculate summary statistics for the box plot in the convalescent serum panel. In Panel C, boxes and horizontal bars denote IQR and median ID50, respectively. Whisker end points are equal to the maximum and minimum values below or above the median ±1.5 times the IQR.

In the convalescent serum panel, red dots indicate the 3 specimens that were also tested in the PRNT assay. The other 38 specimens were used to calculate summary statistics for the box plot in the convalescent panel. In Panel D, boxes and horizontal bars denote IQR and median PRNT80, respectively.

Whisker end points are equal to the maximum and minimum values below or above the median ±1.5 times the IQR. The three convalescent serum specimens were also tested in ELISA and PsVNA assays. Because of the time-intensive nature of the PRNT assay, for this preliminary report, PRNT results were available only for the 25-μg and 100-μg dose groups.Binding antibody IgG geometric mean titers (GMTs) to S-2P increased rapidly after the first vaccination, with seroconversion in all participants by day 15 (Table 2 and Figure 2A).

Dose-dependent responses to the first and second vaccinations were evident. Receptor-binding domain–specific antibody responses were similar in pattern and magnitude (Figure 2B). For both assays, the median magnitude of antibody responses after the first vaccination in the 100-μg and 250-μg dose groups was similar to the median magnitude in convalescent serum specimens, and in all dose groups the median magnitude after the second vaccination was in the upper quartile of values in the convalescent serum specimens.

The S-2P ELISA GMTs at day 57 (299,751 [95% confidence interval {CI}, 206,071 to 436,020] in the 25-μg group, 782,719 [95% CI, 619,310 to 989,244] in the 100-μg group, and 1,192,154 [95% CI, 924,878 to 1,536,669] in the 250-μg group) exceeded that in the convalescent serum specimens (142,140 [95% CI, 81,543 to 247,768]). asthma Neutralization Responses No participant had detectable PsVNA responses before vaccination. After the first vaccination, PsVNA responses were detected in less than half the participants, and a dose effect was seen (50% inhibitory dilution [ID50].

Figure 2C, Fig. S8, and Table 2. 80% inhibitory dilution [ID80].

Fig. S2 and Table S6). However, after the second vaccination, PsVNA responses were identified in serum samples from all participants.

The lowest responses were in the 25-μg dose group, with a geometric mean ID50 of 112.3 (95% CI, 71.2 to 177.1) at day 43. The higher responses in the 100-μg and 250-μg groups were similar in magnitude (geometric mean ID50, 343.8 [95% CI, 261.2 to 452.7] and 332.2 [95% CI, 266.3 to 414.5], respectively, at day 43). These responses were similar to values in the upper half of the distribution of values for convalescent serum specimens.

Before vaccination, no participant had detectable 80% live-ventolin neutralization at the highest serum concentration tested (1:8 dilution) in the PRNT assay. At day 43, wild-type ventolin–neutralizing activity capable of reducing asthma infectivity by 80% or more (PRNT80) was detected in all participants, with geometric mean PRNT80 responses of 339.7 (95% CI, 184.0 to 627.1) in the 25-μg group and 654.3 (95% CI, 460.1 to 930.5) in the 100-μg group (Figure 2D). Neutralizing PRNT80 average responses were generally at or above the values of the three convalescent serum specimens tested in this assay.

Good agreement was noted within and between the values from binding assays for S-2P and receptor-binding domain and neutralizing activity measured by PsVNA and PRNT (Figs. S3 through S7), which provides orthogonal support for each assay in characterizing the humoral response induced by mRNA-1273. asthma T-Cell Responses The 25-μg and 100-μg doses elicited CD4 T-cell responses (Figs.

S9 and S10) that on stimulation by S-specific peptide pools were strongly biased toward expression of Th1 cytokines (tumor necrosis factor α >. Interleukin 2 >. Interferon γ), with minimal type 2 helper T-cell (Th2) cytokine expression (interleukin 4 and interleukin 13).

CD8 T-cell responses to S-2P were detected at low levels after the second vaccination in the 100-μg dose group (Fig. S11).Trial Design and Oversight We conducted this three-group trial at 55 hospitals in Brazil. The trial was designed by the executive committee (see the Supplementary Appendix, available with the full text of this article at NEJM.org) and approved by the Brazilian National Commission for Research Ethics, the Brazilian Health Regulatory Agency (ANVISA), and ethics committees at the participating sites.

The trial was funded by the hospitals and research institutes participating in Coalition asthma treatment Brazil (see the Supplementary Appendix). EMS Pharma provided additional funding and logistic support for the trial and also donated and supplied the trial drugs. EMS Pharma had no role in the conduct of the trial, the analysis, or the decision to submit the manuscript for publication.

The trial was overseen by an independent international data and safety monitoring committee. The executive committee vouches for the completeness and accuracy of the data and for the fidelity of the trial to the protocol (available at NEJM.org). Participants The trial included consecutive patients who were 18 years of age or older and who had been hospitalized with suspected or confirmed asthma treatment with 14 or fewer days since symptom onset.

Among the reasons for exclusion from the trial were the use of supplemental oxygen at a rate of more than 4 liters per minute as administered by a nasal cannula or at a level of at least 40% as administered by a Venturi mask. The use of supplemental oxygen administered by a high-flow nasal cannula or invasive or noninvasive ventilation. Previous use of chloroquine, hydroxychloroquine, azithromycin, or any other macrolide for more than 24 hours before enrollment (and since the onset of symptoms).

And a history of severe ventricular tachycardia or electrocardiographic findings with a corrected QT interval (QTc) of at least 480 msec. Complete information on the inclusion and exclusion criteria is provided in the Supplementary Appendix. All the patients provided written or electronic informed consent before randomization.

Randomization, Interventions, and Follow-up Patients were randomly assigned in a 1:1:1 ratio to receive standard care (control group), standard care plus hydroxychloroquine at a dose of 400 mg twice daily for 7 days (hydroxychloroquine-alone group), or standard care plus hydroxychloroquine at a dose of 400 mg twice daily plus azithromycin at a dose of 500 mg once a day for 7 days. Randomization was performed in blocks of six and was stratified according to the use or nonuse of supplemental oxygen at the time of randomization. Randomization was performed centrally by means of an electronic case-report form system (RedCap) as described in the Supplementary Appendix.12 The current standard care for asthma treatment was at the discretion of the treating physicians.

The use of glucocorticoids, other immunomodulators, antibiotic agents, and antiviral agents was allowed (see the Supplementary Appendix). The administration of hydroxychloroquine or chloroquine was not allowed in the control group, and the use of macrolides was not allowed in the control group or the hydroxychloroquine-alone group. Guidance was provided to the investigators about how to adjust or interrupt treatment according to side effects and laboratory abnormalities.

Data were collected daily, from randomization until day 15, in the electronic case-report form. For patients who were discharged before day 15, a structured telephone call to the patient or the patient’s family was conducted on or after day 15 by an interviewer who was unaware of the assigned trial group in order to assess vital status and return to routine activities. Outcomes The primary outcome was clinical status at 15 days, evaluated with the use of a seven-level ordinal scale.

Scores on the scale were defined as follows. A score of 1 indicated not hospitalized with no limitations on activities. 2, not hospitalized but with limitations on activities.

3, hospitalized and not receiving supplemental oxygen. 4, hospitalized and receiving supplemental oxygen. 5, hospitalized and receiving oxygen supplementation administered by a high-flow nasal cannula or noninvasive ventilation.

6, hospitalized and receiving mechanical ventilation. And 7, death. Secondary outcomes included clinical status at 7 days, evaluated with the use of a six-level ordinal scale (see below and see the Supplementary Appendix).

An indication for intubation within 15 days. The receipt of supplemental oxygen administered by a high-flow nasal cannula or noninvasive ventilation between randomization and 15 days. Duration of hospital stay.

In-hospital death. Thromboembolic complications. Acute kidney injury.

And the number of days alive and free from respiratory support up to 15 days. A day alive and free from respiratory support was defined as any day in which the patient did not receive supplemental oxygen or invasive or noninvasive mechanical ventilation, from randomization to day 15. Patients who died during the 15-day window were assigned a value of 0 days alive and free from respiratory support in this assessment.

Safety outcomes are listed in the Supplementary Appendix. All the trial outcomes were assessed by the site investigators, who were aware of the trial-group assignments (except as noted above for patients who had been discharged before day 15 and who were assessed for the primary outcome by means of a blinded telephone interview). No formal adjudication of trial outcomes was performed.

Sample-Size Calculation and Protocol Changes We had originally planned for the trial to include 630 patients, using the intention-to-treat analysis population, with a six-level ordinal outcome as the primary outcome, as described in the Supplementary Appendix. However, before the first interim analysis was conducted, we changed the primary-outcome assessment to the seven-level ordinal scale and the main analysis population from the intention-to-treat population to a modified intention-to-treat population that included only patients with a diagnosis of asthma treatment that had been confirmed by reverse-transcriptase–polymerase-chain-reaction (RT-PCR) testing (using the test available at each site). The change to the use of the seven-level ordinal scale was adopted because on April 10, 2020 (before the first enrolled patient had reached 15 days of follow-up), we established the capability to obtain 15-day information on limitations on activities with the use of blinded telephone interviews.

We therefore added another level to the six-level ordinal outcome, dividing the first level (not hospitalized) into two levels (level 1, not hospitalized and with no limitations on activities. And level 2, not hospitalized but with limitations on activities). The change to the modified intention-to-treat population was adopted because, under the hypothesis that treatment would have beneficial effects on the primary outcome only for patients who had a confirmed diagnosis, the inclusion of unconfirmed cases would decrease the estimated effect size and power.

As a related change, we added external adjudication of unconfirmed cases, which were classified as probable, possible, or probably not asthma treatment (see the Supplementary Appendix). The sample size was revised with the use of the overall distribution of the seven-level ordinal outcome at day 15 observed among the first 120 patients, with the levels 1 through 7 having the following proportions of patients. 60%, 19%, 7%, 1%, 1%, 5%, and 7%, respectively.

With 630 patients who had undergone randomization and 510 patients included in the modified intention-to-treat analysis, we calculated that the trial would have 80% power to detect an odds ratio of 0.5 between groups (two-by-two comparisons), at a significance level of 5% and with Bonferroni adjustment for multiple comparisons (α=5%, divided by 3 for each comparison).13 Statistical Analysis The primary outcome was analyzed by mixed ordinal logistic regression with random intercept according to site, assuming proportional odds. We report all two-by-two comparisons. Binary outcomes were assessed with the use of a mixed logistic-regression model, except for in-hospital mortality, which was assessed with a Cox proportional-hazards model.

Continuous outcomes were evaluated by means of generalized linear regression or mixed models for repeated variables, as appropriate. All models were adjusted for age and the use of supplemental oxygen at admission. We also performed sensitivity analyses that included all the patients who had undergone randomization (intention-to-treat population) and sensitivity analyses for the primary outcome for the following groups.

Patients with definitive, probable, or possible asthma treatment. And patients with definitive or probable asthma treatment. Two additional populations were considered.

An efficacy population included patients with a confirmed diagnosis who received at least one dose of the assigned trial drug. The safety population included patients according to the medications received, regardless of the assigned trial group or the result of asthma treatment testing. We planned three interim analyses, to be conducted when 120 patients, 315 patients, and 504 patients had completed 15 days of follow-up.

However, only the first interim analysis was conducted. Owing to faster-than-expected enrollment, primary-outcome data for the second and third interim analyses were available only after trial recruitment was finished. After discussion with the data and safety monitoring committee, the second and third interim analyses were cancelled.

The data and safety monitoring committee used Haybittle–Peto14 stopping boundaries, with a P-value threshold of less than 0.001 to interrupt the trial for safety and a P-value threshold of less than 0.0001 to interrupt the trial for efficacy. We did not adjust the final values of the hypothesis test for sequential analyses. Analyses were performed with the use of R software (R Core Team).15 P values for the primary outcome were adjusted with the use of Bonferroni correction.

No P values are reported for secondary outcomes. The widths of the confidence intervals for the secondary outcomes have not been adjusted for multiple comparisons, so the intervals should not be used to infer definitive treatment effects. P values for the safety analyses were not adjusted given the importance of identifying potential signals of harm.

Additional details about the statistical analyses are provided in the Supplementary Appendix.Interactive GraphicThere is broad consensus that widespread asthma testing is essential to safely reopening the United States. A big concern has been test availability, but test accuracy may prove a larger long-term problem.While debate has focused on the accuracy of antibody tests, which identify prior , diagnostic testing, which identifies current , has received less attention. But inaccurate diagnostic tests undermine efforts at containment of the ventolin.Diagnostic tests (typically involving a nasopharyngeal swab) can be inaccurate in two ways.

A false positive result erroneously labels a person infected, with consequences including unnecessary quarantine and contact tracing. False negative results are more consequential, because infected persons — who might be asymptomatic — may not be isolated and can infect others.Given the need to know how well diagnostic tests rule out , it’s important to review assessment of test accuracy by the Food and Drug Administration (FDA) and clinical researchers, as well as interpretation of test results in a ventolin.The FDA has granted Emergency Use Authorizations (EUAs) to commercial test manufacturers and issued guidance on test validation.1 The agency requires measurement of analytic and clinical test performance. Analytic sensitivity indicates the likelihood that the test will be positive for material containing any ventolin strains and the minimum concentration the test can detect.

Analytic specificity indicates the likelihood that the test will be negative for material containing pathogens other than the target ventolin.Clinical evaluations, assessing performance of a test on patient specimens, vary among manufacturers. The FDA prefers the use of “natural clinical specimens” but has permitted the use of “contrived specimens” produced by adding viral RNA or inactivated ventolin to leftover clinical material. Ordinarily, test-performance studies entail having patients undergo an index test and a “reference standard” test determining their true state.

Clinical sensitivity is the proportion of positive index tests in patients who in fact have the disease in question. Sensitivity, and its measurement, may vary with the clinical setting. For a sick person, the reference-standard test is likely to be a clinical diagnosis, ideally established by an independent adjudication panel whose members are unaware of the index-test results.

For asthma, it is unclear whether the sensitivity of any FDA-authorized commercial test has been assessed in this way. Under the EUAs, the FDA does allow companies to demonstrate clinical test performance by establishing the new test’s agreement with an authorized reverse-transcriptase–polymerase-chain-reaction (RT-PCR) test in known positive material from symptomatic people or contrived specimens. Use of either known positive or contrived samples may lead to overestimates of test sensitivity, since swabs may miss infected material in practice.1Designing a reference standard for measuring the sensitivity of asthma tests in asymptomatic people is an unsolved problem that needs urgent attention to increase confidence in test results for contact-tracing or screening purposes.

Simply following people for the subsequent development of symptoms may be inadequate, since they may remain asymptomatic yet be infectious. Assessment of clinical sensitivity in asymptomatic people had not been reported for any commercial test as of June 1, 2020.Two studies from Wuhan, China, arouse concern about false negative RT-PCR tests in patients with apparent asthma treatment illness. In a preprint, Yang et al.

Described 213 patients hospitalized with asthma treatment, of whom 37 were critically ill.2 They collected 205 throat swabs, 490 nasal swabs, and 142 sputum samples (median, 3 per patient) and used an RT-PCR test approved by the Chinese regulator. In days 1 through 7 after onset of illness, 11% of sputum, 27% of nasal, and 40% of throat samples were deemed falsely negative. Zhao et al.

Studied 173 hospitalized patients with acute respiratory symptoms and a chest CT “typical” of asthma treatment, or asthma detected in at least one respiratory specimen. Antibody seroconversion was observed in 93%.3 RT-PCR testing of respiratory samples taken on days 1 through 7 of hospitalization were asthma–positive in at least one sample from 67% of patients. Neither study reported using an independent panel, unaware of index-test results, to establish a final diagnosis of asthma treatment illness, which may have biased the researchers toward overestimating sensitivity.In a preprint systematic review of five studies (not including the Yang and Zhao studies), involving 957 patients (“under suspicion of asthma treatment” or with “confirmed cases”), false negatives ranged from 2 to 29%.4 However, the certainty of the evidence was considered very low because of the heterogeneity of sensitivity estimates among the studies, lack of blinding to index-test results in establishing diagnoses, and failure to report key RT-PCR characteristics.4 Taken as a whole, the evidence, while limited, raises concern about frequent false negative RT-PCR results.If asthma diagnostic tests were perfect, a positive test would mean that someone carries the ventolin and a negative test that they do not.

With imperfect tests, a negative result means only that a person is less likely to be infected. To calculate how likely, one can use Bayes’ theorem, which incorporates information about both the person and the accuracy of the test (recently reviewed5). For a negative test, there are two key inputs.

Pretest probability — an estimate, before testing, of the person’s chance of being infected — and test sensitivity. Pretest probability might depend on local asthma treatment prevalence, asthma exposure history, and symptoms. Ideally, clinical sensitivity and specificity of each test would be measured in various clinically relevant real-life situations (e.g., varied specimen sources, timing, and illness severity).Assume that an RT-PCR test was perfectly specific (always negative in people not infected with asthma) and that the pretest probability for someone who, say, was feeling sick after close contact with someone with asthma treatment was 20%.

If the test sensitivity were 95% (95% of infected people test positive), the post-test probability of with a negative test would be 1%, which might be low enough to consider someone uninfected and may provide them assurance in visiting high-risk relatives. The post-test probability would remain below 5% even if the pretest probability were as high as 50%, a more reasonable estimate for someone with recent exposure and early symptoms in a “hot spot” area.But sensitivity for many available tests appears to be substantially lower. The studies cited above suggest that 70% is probably a reasonable estimate.

At this sensitivity level, with a pretest probability of 50%, the post-test probability with a negative test would be 23% — far too high to safely assume someone is uninfected.Chance of asthma , Given a Negative Test Result, According to Pretest Probability. The blue line represents a test with sensitivity of 70% and specificity of 95%. The green line represents a test with sensitivity of 90% and specificity of 95%.

The shading is the threshold for considering a person not to be infected (asserted to be 5%). Arrow A indicates that with the lower-sensitivity test, this threshold cannot be reached if the pretest probability exceeds about 15%. Arrow B indicates that for the higher-sensitivity test, the threshold can be reached up to a pretest probability of about 33%.

An of this graph is available at NEJM.org.The graph shows how the post-test probability of varies with the pretest probability for tests with low (70%) and high (95%) sensitivity. The horizontal line indicates a probability threshold below which it would be reasonable to act as if the person were uninfected (e.g., allowing the person to visit an elderly grandmother). Where this threshold should be set — here, 5% — is a value judgment and will vary with context (e.g., lower for people visiting a high-risk relative).

The threshold highlights why very sensitive diagnostic tests are needed. With a negative result on the low-sensitivity test, the threshold is exceeded when the pretest probability exceeds 15%, but with a high-sensitivity test, one can have a pretest probability of up to 33% and still, assuming the 5% threshold, be considered safe to be in contact with others.The graph also highlights why efforts to reduce pretest probability (e.g., by social distancing, possibly wearing masks) matter. If the pretest probability gets too high (above 50%, for example), testing loses its value because negative results cannot lower the probability of enough to reach the threshold.We draw several conclusions.

First, diagnostic testing will help in safely opening the country, but only if the tests are highly sensitive and validated under realistic conditions against a clinically meaningful reference standard. Second, the FDA should ensure that manufacturers provide details of tests’ clinical sensitivity and specificity at the time of market authorization. Tests without such information will have less relevance to patient care.Third, measuring test sensitivity in asymptomatic people is an urgent priority.

It will also be important to develop methods (e.g., prediction rules) for estimating the pretest probability of (for asymptomatic and symptomatic people) to allow calculation of post-test probabilities after positive or negative results. Fourth, negative results even on a highly sensitive test cannot rule out if the pretest probability is high, so clinicians should not trust unexpected negative results (i.e., assume a negative result is a “false negative” in a person with typical symptoms and known exposure). It’s possible that performing several simultaneous or repeated tests could overcome an individual test’s limited sensitivity.

However, such strategies need validation.Finally, thresholds for ruling out need to be developed for a variety of clinical situations. Since defining these thresholds is a value judgement, public input will be crucial..

Patients Figure low price ventolin 1. Figure 1. Enrollment and low price ventolin Randomization. Of the 1107 patients who were assessed for eligibility, 1063 underwent randomization.

541 were assigned to the remdesivir group and 522 to low price ventolin the placebo group (Figure 1). Of those assigned to receive remdesivir, 531 patients (98.2%) received the treatment as assigned. Forty-nine patients had remdesivir treatment discontinued before day 10 because of an adverse event or a serious adverse event other than death (36 patients) or because the patient withdrew consent (13). Of those assigned to receive low price ventolin placebo, 518 patients (99.2%) received placebo as assigned.

Fifty-three patients discontinued placebo before day 10 because of an adverse event or a serious adverse event other than death (36 patients), because the patient withdrew consent (15), or because the patient was found to be ineligible for trial enrollment (2). As of April 28, 2020, a total of 391 patients in the remdesivir group and 340 in the placebo group had completed the trial low price ventolin through day 29, recovered, or died. Eight patients who received remdesivir and 9 who received placebo terminated their participation in the trial before day 29. There were 132 patients in the remdesivir group low price ventolin and 169 in the placebo group who had not recovered and had not completed the day 29 follow-up visit.

The analysis population included 1059 patients for whom we have at least some postbaseline data available (538 in the remdesivir group and 521 in the placebo group). Four of the 1063 patients were not included in the primary analysis because no postbaseline data were available at the time of the database freeze. Table 1 low price ventolin. Table 1.

Demographic and low price ventolin Clinical Characteristics at Baseline. The mean age of patients was 58.9 years, and 64.3% were male (Table 1). On the basis of the evolving low price ventolin epidemiology of asthma treatment during the trial, 79.8% of patients were enrolled at sites in North America, 15.3% in Europe, and 4.9% in Asia (Table S1). Overall, 53.2% of the patients were white, 20.6% were black, 12.6% were Asian, and 13.6% were designated as other or not reported.

249 (23.4%) were Hispanic or Latino. Most patients had either one (27.0%) or two or more (52.1%) of the prespecified coexisting conditions at enrollment, most commonly hypertension (49.6%), obesity (37.0%), and type low price ventolin 2 diabetes mellitus (29.7%). The median number of days between symptom onset and randomization was 9 (interquartile range, 6 to 12). Nine hundred forty-three (88.7%) patients had severe disease at enrollment as defined low price ventolin in the Supplementary Appendix.

272 (25.6%) patients met category 7 criteria on the ordinal scale, 197 (18.5%) category 6, 421 (39.6%) category 5, and 127 (11.9%) category 4. There were low price ventolin 46 (4.3%) patients who had missing ordinal scale data at enrollment. No substantial imbalances in baseline characteristics were observed between the remdesivir group and the placebo group. Primary Outcome Figure 2.

Figure 2 low price ventolin. Kaplan–Meier Estimates of Cumulative Recoveries. Cumulative recovery estimates are shown in the overall population (Panel A), in patients with a low price ventolin baseline score of 4 on the ordinal scale (not receiving oxygen. Panel B), in those with a baseline score of 5 (receiving oxygen.

Panel C), in those with a baseline score of 6 (receiving high-flow oxygen or noninvasive low price ventolin mechanical ventilation. Panel D), and in those with a baseline score of 7 (receiving mechanical ventilation or ECMO. Panel E). Table 2 low price ventolin.

Table 2. Outcomes Overall and According to Score low price ventolin on the Ordinal Scale in the Intention-to-Treat Population. Figure 3. Figure 3 low price ventolin.

Time to Recovery According to Subgroup. The widths of the confidence intervals have not been adjusted for multiplicity and therefore cannot be used to infer treatment effects. Race and ethnic group were reported by the patients low price ventolin. Patients in the remdesivir group had a shorter time to recovery than patients in the placebo group (median, 11 days, as compared with 15 days.

Rate ratio for recovery, low price ventolin 1.32. 95% confidence interval [CI], 1.12 to 1.55. P<0.001. 1059 patients (Figure 2 and Table 2).

Among patients with a baseline ordinal score of 5 (421 patients), the rate ratio for recovery was 1.47 (95% CI, 1.17 to 1.84). Among patients with a baseline score of 4 (127 patients) and those with a baseline score of 6 (197 patients), the rate ratio estimates for recovery were 1.38 (95% CI, 0.94 to 2.03) and 1.20 (95% CI, 0.79 to 1.81), respectively. For those receiving mechanical ventilation or ECMO at enrollment (baseline ordinal scores of 7. 272 patients), the rate ratio for recovery was 0.95 (95% CI, 0.64 to 1.42).

A test of interaction of treatment with baseline score on the ordinal scale was not significant. An analysis adjusting for baseline ordinal score as a stratification variable was conducted to evaluate the overall effect (of the percentage of patients in each ordinal score category at baseline) on the primary outcome. This adjusted analysis produced a similar treatment-effect estimate (rate ratio for recovery, 1.31. 95% CI, 1.12 to 1.54.

1017 patients). Table S2 in the Supplementary Appendix shows results according to the baseline severity stratum of mild-to-moderate as compared with severe. Patients who underwent randomization during the first 10 days after the onset of symptoms had a rate ratio for recovery of 1.28 (95% CI, 1.05 to 1.57. 664 patients), whereas patients who underwent randomization more than 10 days after the onset of symptoms had a rate ratio for recovery of 1.38 (95% CI, 1.05 to 1.81.

380 patients) (Figure 3). Key Secondary Outcome The odds of improvement in the ordinal scale score were higher in the remdesivir group, as determined by a proportional odds model at the day 15 visit, than in the placebo group (odds ratio for improvement, 1.50. 95% CI, 1.18 to 1.91. P=0.001.

844 patients) (Table 2 and Fig. S5). Mortality was numerically lower in the remdesivir group than in the placebo group, but the difference was not significant (hazard ratio for death, 0.70. 95% CI, 0.47 to 1.04.

1059 patients). The Kaplan–Meier estimates of mortality by 14 days were 7.1% and 11.9% in the remdesivir and placebo groups, respectively (Table 2). The Kaplan–Meier estimates of mortality by 28 days are not reported in this preliminary analysis, given the large number of patients that had yet to complete day 29 visits. An analysis with adjustment for baseline ordinal score as a stratification variable showed a hazard ratio for death of 0.74 (95% CI, 0.50 to 1.10).

Safety Outcomes Serious adverse events occurred in 114 patients (21.1%) in the remdesivir group and 141 patients (27.0%) in the placebo group (Table S3). 4 events (2 in each group) were judged by site investigators to be related to remdesivir or placebo. There were 28 serious respiratory failure adverse events in the remdesivir group (5.2% of patients) and 42 in the placebo group (8.0% of patients). Acute respiratory failure, hypotension, viral pneumonia, and acute kidney injury were slightly more common among patients in the placebo group.

No deaths were considered to be related to treatment assignment, as judged by the site investigators. Grade 3 or 4 adverse events occurred in 156 patients (28.8%) in the remdesivir group and in 172 in the placebo group (33.0%) (Table S4). The most common adverse events in the remdesivir group were anemia or decreased hemoglobin (43 events [7.9%], as compared with 47 [9.0%] in the placebo group). Acute kidney injury, decreased estimated glomerular filtration rate or creatinine clearance, or increased blood creatinine (40 events [7.4%], as compared with 38 [7.3%]).

Pyrexia (27 events [5.0%], as compared with 17 [3.3%]). Hyperglycemia or increased blood glucose level (22 events [4.1%], as compared with 17 [3.3%]). And increased aminotransferase levels including alanine aminotransferase, aspartate aminotransferase, or both (22 events [4.1%], as compared with 31 [5.9%]). Otherwise, the incidence of adverse events was not found to be significantly different between the remdesivir group and the placebo group.Trial Design and Oversight The RECOVERY trial was designed to evaluate the effects of potential treatments in patients hospitalized with asthma treatment at 176 National Health Service organizations in the United Kingdom and was supported by the National Institute for Health Research Clinical Research Network.

(Details regarding this trial are provided in the Supplementary Appendix, available with the full text of this article at NEJM.org.) The trial is being coordinated by the Nuffield Department of Population Health at the University of Oxford, the trial sponsor. Although the randomization of patients to receive dexamethasone, hydroxychloroquine, or lopinavir–ritonavir has now been stopped, the trial continues randomization to groups receiving azithromycin, tocilizumab, or convalescent plasma. Hospitalized patients were eligible for the trial if they had clinically suspected or laboratory-confirmed asthma and no medical history that might, in the opinion of the attending clinician, put patients at substantial risk if they were to participate in the trial. Initially, recruitment was limited to patients who were at least 18 years of age, but the age limit was removed starting on May 9, 2020.

Pregnant or breast-feeding women were eligible. Written informed consent was obtained from all the patients or from a legal representative if they were unable to provide consent. The trial was conducted in accordance with the principles of the Good Clinical Practice guidelines of the International Conference on Harmonisation and was approved by the U.K. Medicines and Healthcare Products Regulatory Agency and the Cambridge East Research Ethics Committee.

The protocol with its statistical analysis plan is available at NEJM.org and on the trial website at www.recoverytrial.net. The initial version of the manuscript was drafted by the first and last authors, developed by the writing committee, and approved by all members of the trial steering committee. The funders had no role in the analysis of the data, in the preparation or approval of the manuscript, or in the decision to submit the manuscript for publication. The first and last members of the writing committee vouch for the completeness and accuracy of the data and for the fidelity of the trial to the protocol and statistical analysis plan.

Randomization We collected baseline data using a Web-based case-report form that included demographic data, the level of respiratory support, major coexisting illnesses, suitability of the trial treatment for a particular patient, and treatment availability at the trial site. Randomization was performed with the use of a Web-based system with concealment of the trial-group assignment. Eligible and consenting patients were assigned in a 2:1 ratio to receive either the usual standard of care alone or the usual standard of care plus oral or intravenous dexamethasone (at a dose of 6 mg once daily) for up to 10 days (or until hospital discharge if sooner) or to receive one of the other suitable and available treatments that were being evaluated in the trial. For some patients, dexamethasone was unavailable at the hospital at the time of enrollment or was considered by the managing physician to be either definitely indicated or definitely contraindicated.

These patients were excluded from entry in the randomized comparison between dexamethasone and usual care and hence were not included in this report. The randomly assigned treatment was prescribed by the treating clinician. Patients and local members of the trial staff were aware of the assigned treatments. Procedures A single online follow-up form was to be completed when the patients were discharged or had died or at 28 days after randomization, whichever occurred first.

Information was recorded regarding the patients’ adherence to the assigned treatment, receipt of other trial treatments, duration of admission, receipt of respiratory support (with duration and type), receipt of renal support, and vital status (including the cause of death). In addition, we obtained routine health care and registry data, including information on vital status (with date and cause of death), discharge from the hospital, and respiratory and renal support therapy. Outcome Measures The primary outcome was all-cause mortality within 28 days after randomization. Further analyses were specified at 6 months.

Secondary outcomes were the time until discharge from the hospital and, among patients not receiving invasive mechanical ventilation at the time of randomization, subsequent receipt of invasive mechanical ventilation (including extracorporeal membrane oxygenation) or death. Other prespecified clinical outcomes included cause-specific mortality, receipt of renal hemodialysis or hemofiltration, major cardiac arrhythmia (recorded in a subgroup), and receipt and duration of ventilation. Statistical Analysis As stated in the protocol, appropriate sample sizes could not be estimated when the trial was being planned at the start of the asthma treatment ventolin. As the trial progressed, the trial steering committee, whose members were unaware of the results of the trial comparisons, determined that if 28-day mortality was 20%, then the enrollment of at least 2000 patients in the dexamethasone group and 4000 in the usual care group would provide a power of at least 90% at a two-sided P value of 0.01 to detect a clinically relevant proportional reduction of 20% (an absolute difference of 4 percentage points) between the two groups.

Consequently, on June 8, 2020, the steering committee closed recruitment to the dexamethasone group, since enrollment had exceeded 2000 patients. For the primary outcome of 28-day mortality, the hazard ratio from Cox regression was used to estimate the mortality rate ratio. Among the few patients (0.1%) who had not been followed for 28 days by the time of the data cutoff on July 6, 2020, data were censored either on that date or on day 29 if the patient had already been discharged. That is, in the absence of any information to the contrary, these patients were assumed to have survived for 28 days.

Kaplan–Meier survival curves were constructed to show cumulative mortality over the 28-day period. Cox regression was used to analyze the secondary outcome of hospital discharge within 28 days, with censoring of data on day 29 for patients who had died during hospitalization. For the prespecified composite secondary outcome of invasive mechanical ventilation or death within 28 days (among patients who were not receiving invasive mechanical ventilation at randomization), the precise date of invasive mechanical ventilation was not available, so a log-binomial regression model was used to estimate the risk ratio. Table 1.

Table 1. Characteristics of the Patients at Baseline, According to Treatment Assignment and Level of Respiratory Support. Through the play of chance in the unstratified randomization, the mean age was 1.1 years older among patients in the dexamethasone group than among those in the usual care group (Table 1). To account for this imbalance in an important prognostic factor, estimates of rate ratios were adjusted for the baseline age in three categories (<70 years, 70 to 79 years, and ≥80 years).

This adjustment was not specified in the first version of the statistical analysis plan but was added once the imbalance in age became apparent. Results without age adjustment (corresponding to the first version of the analysis plan) are provided in the Supplementary Appendix. Prespecified analyses of the primary outcome were performed in five subgroups, as defined by characteristics at randomization. Age, sex, level of respiratory support, days since symptom onset, and predicted 28-day mortality risk.

(One further prespecified subgroup analysis regarding race will be conducted once the data collection has been completed.) In prespecified subgroups, we estimated rate ratios (or risk ratios in some analyses) and their confidence intervals using regression models that included an interaction term between the treatment assignment and the subgroup of interest. Chi-square tests for linear trend across the subgroup-specific log estimates were then performed in accordance with the prespecified plan. All P values are two-sided and are shown without adjustment for multiple testing. All analyses were performed according to the intention-to-treat principle.

The full database is held by the trial team, which collected the data from trial sites and performed the analyses at the Nuffield Department of Population Health, University of Oxford.Trial Population Table 1. Table 1. Characteristics of the Participants in the mRNA-1273 Trial at Enrollment. The 45 enrolled participants received their first vaccination between March 16 and April 14, 2020 (Fig.

S1). Three participants did not receive the second vaccination, including one in the 25-μg group who had urticaria on both legs, with onset 5 days after the first vaccination, and two (one in the 25-μg group and one in the 250-μg group) who missed the second vaccination window owing to isolation for suspected asthma treatment while the test results, ultimately negative, were pending. All continued to attend scheduled trial visits. The demographic characteristics of participants at enrollment are provided in Table 1.

treatment Safety No serious adverse events were noted, and no prespecified trial halting rules were met. As noted above, one participant in the 25-μg group was withdrawn because of an unsolicited adverse event, transient urticaria, judged to be related to the first vaccination. Figure 1. Figure 1.

Systemic and Local Adverse Events. The severity of solicited adverse events was graded as mild, moderate, or severe (see Table S1).After the first vaccination, solicited systemic adverse events were reported by 5 participants (33%) in the 25-μg group, 10 (67%) in the 100-μg group, and 8 (53%) in the 250-μg group. All were mild or moderate in severity (Figure 1 and Table S2). Solicited systemic adverse events were more common after the second vaccination and occurred in 7 of 13 participants (54%) in the 25-μg group, all 15 in the 100-μg group, and all 14 in the 250-μg group, with 3 of those participants (21%) reporting one or more severe events.

None of the participants had fever after the first vaccination. After the second vaccination, no participants in the 25-μg group, 6 (40%) in the 100-μg group, and 8 (57%) in the 250-μg group reported fever. One of the events (maximum temperature, 39.6°C) in the 250-μg group was graded severe. (Additional details regarding adverse events for that participant are provided in the Supplementary Appendix.) Local adverse events, when present, were nearly all mild or moderate, and pain at the injection site was common.

Across both vaccinations, solicited systemic and local adverse events that occurred in more than half the participants included fatigue, chills, headache, myalgia, and pain at the injection site. Evaluation of safety clinical laboratory values of grade 2 or higher and unsolicited adverse events revealed no patterns of concern (Supplementary Appendix and Table S3). asthma Binding Antibody Responses Table 2. Table 2.

Geometric Mean Humoral Immunogenicity Assay Responses to mRNA-1273 in Participants and in Convalescent Serum Specimens. Figure 2. Figure 2. asthma Antibody and Neutralization Responses.

Shown are geometric mean reciprocal end-point enzyme-linked immunosorbent assay (ELISA) IgG titers to S-2P (Panel A) and receptor-binding domain (Panel B), PsVNA ID50 responses (Panel C), and live ventolin PRNT80 responses (Panel D). In Panel A and Panel B, boxes and horizontal bars denote interquartile range (IQR) and median area under the curve (AUC), respectively. Whisker endpoints are equal to the maximum and minimum values below or above the median ±1.5 times the IQR. The convalescent serum panel includes specimens from 41 participants.

Red dots indicate the 3 specimens that were also tested in the PRNT assay. The other 38 specimens were used to calculate summary statistics for the box plot in the convalescent serum panel. In Panel C, boxes and horizontal bars denote IQR and median ID50, respectively. Whisker end points are equal to the maximum and minimum values below or above the median ±1.5 times the IQR.

In the convalescent serum panel, red dots indicate the 3 specimens that were also tested in the PRNT assay. The other 38 specimens were used to calculate summary statistics for the box plot in the convalescent panel. In Panel D, boxes and horizontal bars denote IQR and median PRNT80, respectively. Whisker end points are equal to the maximum and minimum values below or above the median ±1.5 times the IQR.

The three convalescent serum specimens were also tested in ELISA and PsVNA assays. Because of the time-intensive nature of the PRNT assay, for this preliminary report, PRNT results were available only for the 25-μg and 100-μg dose groups.Binding antibody IgG geometric mean titers (GMTs) to S-2P increased rapidly after the first vaccination, with seroconversion in all participants by day 15 (Table 2 and Figure 2A). Dose-dependent responses to the first and second vaccinations were evident. Receptor-binding domain–specific antibody responses were similar in pattern and magnitude (Figure 2B).

For both assays, the median magnitude of antibody responses after the first vaccination in the 100-μg and 250-μg dose groups was similar to the median magnitude in convalescent serum specimens, and in all dose groups the median magnitude after the second vaccination was in the upper quartile of values in the convalescent serum specimens. The S-2P ELISA GMTs at day 57 (299,751 [95% confidence interval {CI}, 206,071 to 436,020] in the 25-μg group, 782,719 [95% CI, 619,310 to 989,244] in the 100-μg group, and 1,192,154 [95% CI, 924,878 to 1,536,669] in the 250-μg group) exceeded that in the convalescent serum specimens (142,140 [95% CI, 81,543 to 247,768]). asthma Neutralization Responses No participant had detectable PsVNA responses before vaccination. After the first vaccination, PsVNA responses were detected in less than half the participants, and a dose effect was seen (50% inhibitory dilution [ID50].

Figure 2C, Fig. S8, and Table 2. 80% inhibitory dilution [ID80]. Fig.

S2 and Table S6). However, after the second vaccination, PsVNA responses were identified in serum samples from all participants. The lowest responses were in the 25-μg dose group, with a geometric mean ID50 of 112.3 (95% CI, 71.2 to 177.1) at day 43. The higher responses in the 100-μg and 250-μg groups were similar in magnitude (geometric mean ID50, 343.8 [95% CI, 261.2 to 452.7] and 332.2 [95% CI, 266.3 to 414.5], respectively, at day 43).

These responses were similar to values in the upper half of the distribution of values for convalescent serum specimens. Before vaccination, no participant had detectable 80% live-ventolin neutralization at the highest serum concentration tested (1:8 dilution) in the PRNT assay. At day 43, wild-type ventolin–neutralizing activity capable of reducing asthma infectivity by 80% or more (PRNT80) was detected in all participants, with geometric mean PRNT80 responses of 339.7 (95% CI, 184.0 to 627.1) in the 25-μg group and 654.3 (95% CI, 460.1 to 930.5) in the 100-μg group (Figure 2D). Neutralizing PRNT80 average responses were generally at or above the values of the three convalescent serum specimens tested in this assay.

Good agreement was noted within and between the values from binding assays for S-2P and receptor-binding domain and neutralizing activity measured by PsVNA and PRNT (Figs. S3 through S7), which provides orthogonal support for each assay in characterizing the humoral response induced by mRNA-1273. asthma T-Cell Responses The 25-μg and 100-μg doses elicited CD4 T-cell responses (Figs. S9 and S10) that on stimulation by S-specific peptide pools were strongly biased toward expression of Th1 cytokines (tumor necrosis factor α >.

Interleukin 2 >. Interferon γ), with minimal type 2 helper T-cell (Th2) cytokine expression (interleukin 4 and interleukin 13). CD8 T-cell responses to S-2P were detected at low levels after the second vaccination in the 100-μg dose group (Fig. S11).Trial Design and Oversight We conducted this three-group trial at 55 hospitals in Brazil.

The trial was designed by the executive committee (see the Supplementary Appendix, available with the full text of this article at NEJM.org) and approved by the Brazilian National Commission for Research Ethics, the Brazilian Health Regulatory Agency (ANVISA), and ethics committees at the participating sites. The trial was funded by the hospitals and research institutes participating in Coalition asthma treatment Brazil (see the Supplementary Appendix). EMS Pharma provided additional funding and logistic support for the trial and also donated and supplied the trial drugs. EMS Pharma had no role in the conduct of the trial, the analysis, or the decision to submit the manuscript for publication.

The trial was overseen by an independent international data and safety monitoring committee. The executive committee vouches for the completeness and accuracy of the data and for the fidelity of the trial to the protocol (available at NEJM.org). Participants The trial included consecutive patients who were 18 years of age or older and who had been hospitalized with suspected or confirmed asthma treatment with 14 or fewer days since symptom onset. Among the reasons for exclusion from the trial were the use of supplemental oxygen at a rate of more than 4 liters per minute as administered by a nasal cannula or at a level of at least 40% as administered by a Venturi mask.

The use of supplemental oxygen administered by a high-flow nasal cannula or invasive or noninvasive ventilation. Previous use of chloroquine, hydroxychloroquine, azithromycin, or any other macrolide for more than 24 hours before enrollment (and since the onset of symptoms). And a history of severe ventricular tachycardia or electrocardiographic findings with a corrected QT interval (QTc) of at least 480 msec. Complete information on the inclusion and exclusion criteria is provided in the Supplementary Appendix.

All the patients provided written or electronic informed consent before randomization. Randomization, Interventions, and Follow-up Patients were randomly assigned in a 1:1:1 ratio to receive standard care (control group), standard care plus hydroxychloroquine at a dose of 400 mg twice daily for 7 days (hydroxychloroquine-alone group), or standard care plus hydroxychloroquine at a dose of 400 mg twice daily plus azithromycin at a dose of 500 mg once a day for 7 days. Randomization was performed in blocks of six and was stratified according to the use or nonuse of supplemental oxygen at the time of randomization. Randomization was performed centrally by means of an electronic case-report form system (RedCap) as described in the Supplementary Appendix.12 The current standard care for asthma treatment was at the discretion of the treating physicians.

The use of glucocorticoids, other immunomodulators, antibiotic agents, and antiviral agents was allowed (see the Supplementary Appendix). The administration of hydroxychloroquine or chloroquine was not allowed in the control group, and the use of macrolides was not allowed in the control group or the hydroxychloroquine-alone group. Guidance was provided to the investigators about how to adjust or interrupt treatment according to side effects and laboratory abnormalities. Data were collected daily, from randomization until day 15, in the electronic case-report form.

For patients who were discharged before day 15, a structured telephone call to the patient or the patient’s family was conducted on or after day 15 by an interviewer who was unaware of the assigned trial group in order to assess vital status and return to routine activities. Outcomes The primary outcome was clinical status at 15 days, evaluated with the use of a seven-level ordinal scale. Scores on the scale were defined as follows. A score of 1 indicated not hospitalized with no limitations on activities.

2, not hospitalized but with limitations on activities. 3, hospitalized and not receiving supplemental oxygen. 4, hospitalized and receiving supplemental oxygen. 5, hospitalized and receiving oxygen supplementation administered by a high-flow nasal cannula or noninvasive ventilation.

6, hospitalized and receiving mechanical ventilation. And 7, death. Secondary outcomes included clinical status at 7 days, evaluated with the use of a six-level ordinal scale (see below and see the Supplementary Appendix). An indication for intubation within 15 days.

The receipt of supplemental oxygen administered by a high-flow nasal cannula or noninvasive ventilation between randomization and 15 days. Duration of hospital stay. In-hospital death. Thromboembolic complications.

Acute kidney injury. And the number of days alive and free from respiratory support up to 15 days. A day alive and free from respiratory support was defined as any day in which the patient did not receive supplemental oxygen or invasive or noninvasive mechanical ventilation, from randomization to day 15. Patients who died during the 15-day window were assigned a value of 0 days alive and free from respiratory support in this assessment.

Safety outcomes are listed in the Supplementary Appendix. All the trial outcomes were assessed by the site investigators, who were aware of the trial-group assignments (except as noted above for patients who had been discharged before day 15 and who were assessed for the primary outcome by means of a blinded telephone interview). No formal adjudication of trial outcomes was performed. Sample-Size Calculation and Protocol Changes We had originally planned for the trial to include 630 patients, using the intention-to-treat analysis population, with a six-level ordinal outcome as the primary outcome, as described in the Supplementary Appendix.

However, before the first interim analysis was conducted, we changed the primary-outcome assessment to the seven-level ordinal scale and the main analysis population from the intention-to-treat population to a modified intention-to-treat population that included only patients with a diagnosis of asthma treatment that had been confirmed by reverse-transcriptase–polymerase-chain-reaction (RT-PCR) testing (using the test available at each site). The change to the use of the seven-level ordinal scale was adopted because on April 10, 2020 (before the first enrolled patient had reached 15 days of follow-up), we established the capability to obtain 15-day information on limitations on activities with the use of blinded telephone interviews. We therefore added another level to the six-level ordinal outcome, dividing the first level (not hospitalized) into two levels (level 1, not hospitalized and with no limitations on activities. And level 2, not hospitalized but with limitations on activities).

The change to the modified intention-to-treat population was adopted because, under the hypothesis that treatment would have beneficial effects on the primary outcome only for patients who had a confirmed diagnosis, the inclusion of unconfirmed cases would decrease the estimated effect size and power. As a related change, we added external adjudication of unconfirmed cases, which were classified as probable, possible, or probably not asthma treatment (see the Supplementary Appendix). The sample size was revised with the use of the overall distribution of the seven-level ordinal outcome at day 15 observed among the first 120 patients, with the levels 1 through 7 having the following proportions of patients. 60%, 19%, 7%, 1%, 1%, 5%, and 7%, respectively.

With 630 patients who had undergone randomization and 510 patients included in the modified intention-to-treat analysis, we calculated that the trial would have 80% power to detect an odds ratio of 0.5 between groups (two-by-two comparisons), at a significance level of 5% and with Bonferroni adjustment for multiple comparisons (α=5%, divided by 3 for each comparison).13 Statistical Analysis The primary outcome was analyzed by mixed ordinal logistic regression with random intercept according to site, assuming proportional odds. We report all two-by-two comparisons. Binary outcomes were assessed with the use of a mixed logistic-regression model, except for in-hospital mortality, which was assessed with a Cox proportional-hazards model. Continuous outcomes were evaluated by means of generalized linear regression or mixed models for repeated variables, as appropriate.

All models were adjusted for age and the use of supplemental oxygen at admission. We also performed sensitivity analyses that included all the patients who had undergone randomization (intention-to-treat population) and sensitivity analyses for the primary outcome for the following groups. Patients with definitive, probable, or possible asthma treatment. And patients with definitive or probable asthma treatment.

Two additional populations were considered. An efficacy population included patients with a confirmed diagnosis who received at least one dose of the assigned trial drug. The safety population included patients according to the medications received, regardless of the assigned trial group or the result of asthma treatment testing. We planned three interim analyses, to be conducted when 120 patients, 315 patients, and 504 patients had completed 15 days of follow-up.

However, only the first interim analysis was conducted. Owing to faster-than-expected enrollment, primary-outcome data for the second and third interim analyses were available only after trial recruitment was finished. After discussion with the data and safety monitoring committee, the second and third interim analyses were cancelled. The data and safety monitoring committee used Haybittle–Peto14 stopping boundaries, with a P-value threshold of less than 0.001 to interrupt the trial for safety and a P-value threshold of less than 0.0001 to interrupt the trial for efficacy.

We did not adjust the final values of the hypothesis test for sequential analyses. Analyses were performed with the use of R software (R Core Team).15 P values for the primary outcome were adjusted with the use of Bonferroni correction. No P values are reported for secondary outcomes. The widths of the confidence intervals for the secondary outcomes have not been adjusted for multiple comparisons, so the intervals should not be used to infer definitive treatment effects.

P values for the safety analyses were not adjusted given the importance of identifying potential signals of harm. Additional details about the statistical analyses are provided in the Supplementary Appendix.Interactive GraphicThere is broad consensus that widespread asthma testing is essential to safely reopening the United States. A big concern has been test availability, but test accuracy may prove a larger long-term problem.While debate has focused on the accuracy of antibody tests, which identify prior , diagnostic testing, which identifies current , has received less attention. But inaccurate diagnostic tests undermine efforts at containment of the ventolin.Diagnostic tests (typically involving a nasopharyngeal swab) can be inaccurate in two ways.

A false positive result erroneously labels a person infected, with consequences including unnecessary quarantine and contact tracing. False negative results are more consequential, because infected persons — who might be asymptomatic — may not be isolated and can infect others.Given the need to know how well diagnostic tests rule out , it’s important to review assessment of test accuracy by the Food and Drug Administration (FDA) and clinical researchers, as well as interpretation of test results in a ventolin.The FDA has granted Emergency Use Authorizations (EUAs) to commercial test manufacturers and issued guidance on test validation.1 The agency requires measurement of analytic and clinical test performance. Analytic sensitivity indicates the likelihood that the test will be positive for material containing any ventolin strains and the minimum concentration the test can detect. Analytic specificity indicates the likelihood that the test will be negative for material containing pathogens other than the target ventolin.Clinical evaluations, assessing performance of a test on patient specimens, vary among manufacturers.

The FDA prefers the use of “natural clinical specimens” but has permitted the use of “contrived specimens” produced by adding viral RNA or inactivated ventolin to leftover clinical material. Ordinarily, test-performance studies entail having patients undergo an index test and a “reference standard” test determining their true state. Clinical sensitivity is the proportion of positive index tests in patients who in fact have the disease in question. Sensitivity, and its measurement, may vary with the clinical setting.

For a sick person, the reference-standard test is likely to be a clinical diagnosis, ideally established by an independent adjudication panel whose members are unaware of the index-test results. For asthma, it is unclear whether the sensitivity of any FDA-authorized commercial test has been assessed in this way. Under the EUAs, the FDA does allow companies to demonstrate clinical test performance by establishing the new test’s agreement with an authorized reverse-transcriptase–polymerase-chain-reaction (RT-PCR) test in known positive material from symptomatic people or contrived specimens. Use of either known positive or contrived samples may lead to overestimates of test sensitivity, since swabs may miss infected material in practice.1Designing a reference standard for measuring the sensitivity of asthma tests in asymptomatic people is an unsolved problem that needs urgent attention to increase confidence in test results for contact-tracing or screening purposes.

Simply following people for the subsequent development of symptoms may be inadequate, since they may remain asymptomatic yet be infectious. Assessment of clinical sensitivity in asymptomatic people had not been reported for any commercial test as of June 1, 2020.Two studies from Wuhan, China, arouse concern about false negative RT-PCR tests in patients with apparent asthma treatment illness. In a preprint, Yang et al. Described 213 patients hospitalized with asthma treatment, of whom 37 were critically ill.2 They collected 205 throat swabs, 490 nasal swabs, and 142 sputum samples (median, 3 per patient) and used an RT-PCR test approved by the Chinese regulator.

In days 1 through 7 after onset of illness, 11% of sputum, 27% of nasal, and 40% of throat samples were deemed falsely negative. Zhao et al. Studied 173 hospitalized patients with acute respiratory symptoms and a chest CT “typical” of asthma treatment, or asthma detected in at least one respiratory specimen. Antibody seroconversion was observed in 93%.3 RT-PCR testing of respiratory samples taken on days 1 through 7 of hospitalization were asthma–positive in at least one sample from 67% of patients.

Neither study reported using an independent panel, unaware of index-test results, to establish a final diagnosis of asthma treatment illness, which may have biased the researchers toward overestimating sensitivity.In a preprint systematic review of five studies (not including the Yang and Zhao studies), involving 957 patients (“under suspicion of asthma treatment” or with “confirmed cases”), false negatives ranged from 2 to 29%.4 However, the certainty of the evidence was considered very low because of the heterogeneity of sensitivity estimates among the studies, lack of blinding to index-test results in establishing diagnoses, and failure to report key RT-PCR characteristics.4 Taken as a whole, the evidence, while limited, raises concern about frequent false negative RT-PCR results.If asthma diagnostic tests were perfect, a positive test would mean that someone carries the ventolin and a negative test that they do not. With imperfect tests, a negative result means only that a person is less likely to be infected. To calculate how likely, one can use Bayes’ theorem, which incorporates information about both the person and the accuracy of the test (recently reviewed5). For a negative test, there are two key inputs.

Pretest probability — an estimate, before testing, of the person’s chance of being infected — and test sensitivity. Pretest probability might depend on local asthma treatment prevalence, asthma exposure history, and symptoms. Ideally, clinical sensitivity and specificity of each test would be measured in various clinically relevant real-life situations (e.g., varied specimen sources, timing, and illness severity).Assume that an RT-PCR test was perfectly specific (always negative in people not infected with asthma) and that the pretest probability for someone who, say, was feeling sick after close contact with someone with asthma treatment was 20%. If the test sensitivity were 95% (95% of infected people test positive), the post-test probability of with a negative test would be 1%, which might be low enough to consider someone uninfected and may provide them assurance in visiting high-risk relatives.

The post-test probability would remain below 5% even if the pretest probability were as high as 50%, a more reasonable estimate for someone with recent exposure and early symptoms in a “hot spot” area.But sensitivity for many available tests appears to be substantially lower. The studies cited above suggest that 70% is probably a reasonable estimate. At this sensitivity level, with a pretest probability of 50%, the post-test probability with a negative test would be 23% — far too high to safely assume someone is uninfected.Chance of asthma , Given a Negative Test Result, According to Pretest Probability. The blue line represents a test with sensitivity of 70% and specificity of 95%.

The green line represents a test with sensitivity of 90% and specificity of 95%. The shading is the threshold for considering a person not to be infected (asserted to be 5%). Arrow A indicates that with the lower-sensitivity test, this threshold cannot be reached if the pretest probability exceeds about 15%. Arrow B indicates that for the higher-sensitivity test, the threshold can be reached up to a pretest probability of about 33%.

An of this graph is available at NEJM.org.The graph shows how the post-test probability of varies with the pretest probability for tests with low (70%) and high (95%) sensitivity. The horizontal line indicates a probability threshold below which it would be reasonable to act as if the person were uninfected (e.g., allowing the person to visit an elderly grandmother). Where this threshold should be set — here, 5% — is a value judgment and will vary with context (e.g., lower for people visiting a high-risk relative). The threshold highlights why very sensitive diagnostic tests are needed.

With a negative result on the low-sensitivity test, the threshold is exceeded when the pretest probability exceeds 15%, but with a high-sensitivity test, one can have a pretest probability of up to 33% and still, assuming the 5% threshold, be considered safe to be in contact with others.The graph also highlights why efforts to reduce pretest probability (e.g., by social distancing, possibly wearing masks) matter. If the pretest probability gets too high (above 50%, for example), testing loses its value because negative results cannot lower the probability of enough to reach the threshold.We draw several conclusions. First, diagnostic testing will help in safely opening the country, but only if the tests are highly sensitive and validated under realistic conditions against a clinically meaningful reference standard. Second, the FDA should ensure that manufacturers provide details of tests’ clinical sensitivity and specificity at the time of market authorization.

Tests without such information will have less relevance to patient care.Third, measuring test sensitivity in asymptomatic people is an urgent priority. It will also be important to develop methods (e.g., prediction rules) for estimating the pretest probability of (for asymptomatic and symptomatic people) to allow calculation of post-test probabilities after positive or negative results. Fourth, negative results even on a highly sensitive test cannot rule out if the pretest probability is high, so clinicians should not trust unexpected negative results (i.e., assume a negative result is a “false negative” in a person with typical symptoms and known exposure). It’s possible that performing several simultaneous or repeated tests could overcome an individual test’s limited sensitivity.

However, such strategies need validation.Finally, thresholds for ruling out need to be developed for a variety of clinical situations. Since defining these thresholds is a value judgement, public input will be crucial..

How often use ventolin

Start Preamble Census Bureau, how often use ventolin Commerce. Notice of information collection. Request for how often use ventolin comment. The Department of Commerce, in accordance with the Paperwork Reduction Act (PRA) of 1995, invites the general public and other Federal agencies to comment on proposed, and continuing information collections, which helps us assess the impact of our information collection requirements and minimize the public's reporting burden.

The purpose of this notice is to allow for an additional 60 days of public comment on a proposed new information collection, the Management and how often use ventolin Organizational Practices Survey—Hospitals (MOPS-HP). An information collection request (ICR) for the MOPS-HP was submitted to OMB for approval on July 7, 2020 and is currently pending OMB review. To ensure consideration, comments regarding this proposed information collection must be received on or before January 19, 2021. Interested persons how often use ventolin are invited to submit written comments by email to Thomas.J.Smith@census.gov.

Please reference Management and Organizational Practices Survey—Hospitals (MOPS-HP) in the subject line of your comments. You may also submit comments, identified by Docket Number USBC-2020-0029, to the how often use ventolin Federal e-Rulemaking Portal. Http://www.regulations.gov. All comments received are part of the public record.

No comments will be posted to http://www.regulations.gov for public viewing until after the how often use ventolin comment period has closed. Comments will generally be posted without change. All Personally Identifiable Information (for example, name and address) voluntarily how often use ventolin submitted by the commenter may be publicly accessible. Do not submit Confidential Business Information or otherwise sensitive or protected information.

You may submit attachments to electronic comments in Microsoft Word, Excel, or Adobe PDF file formats. Start Further Info Requests for additional information or specific questions related to collection activities should be how often use ventolin directed to Edward Watkins at edward.e.watkins.iii@census.gov or 301-763-4750. End Further Info End Preamble Start Supplemental Information I. Abstract The how often use ventolin U.S.

Census Bureau plans to conduct the Management and Organizational Practices Survey-Hospitals (MOPS-HP) for survey year 2020 as a joint project with Harvard Business School. The MOPS-HP will utilize a subset of the Service Annual Survey mail-out sample and will collect data on management practices from Chief Nursing Officers (CNOs) at how often use ventolin general medical and surgical hospitals to assist in studying their relationship to clinical and financial performance. A notice seeking public comment on our plans to conduct this survey was previously published in the Federal Register on February 12, 2020, on pages 4623-4624. That notice proposed collecting data for survey years 2019 and 2014, but collection has been adjusted due to the ongoing asthma ventolin.

The ventolin has further highlighted the relevance of hospital management practices, especially as they relate to hospitals' abilities to respond to shocks to how often use ventolin their organization and the health care system. In light of this, the Census Bureau has modified the survey proposal to collect data for reference years 2020 and 2019. This change seeks to directly measure management practices and protocols before and during the ventolin to obtain a better understanding of how hospitals how often use ventolin have had to adjust and pivot operations during this public health emergency. The Census Bureau also plans to include two additional questions in the MOPS-HP content to help improve measurement of hospital preparedness.

These questions will provide information on two elements of responsiveness, hospitals' coordinated deployment of frontline clinical workers and hospitals' ability to quickly respond to needed changes in standardized clinical protocols. In an effort to limit respondent burden while adding this content, adjustments were made how often use ventolin to keep the total number of questions and estimated burden per response unchanged. The project plan, schedule, and collection strategy are being actively monitored, and adjustments will be made as necessary, as the Census Bureau is cognizant and respectful of the time, resources, and burden placed on CNOs during the ventolin. After the close of this second comment period, the Census Bureau will submit these planned changes as an amendment to the ICR, how often use ventolin which is currently pending review at OMB.

Any comments received by the close of the comment period will be summarized and included in the amendment. Currently, no official statistics on management practices in hospitals exist. Past research shows these practices are related to health care providers' how often use ventolin clinical and financial outcomes. This suggests that providing measures on management practices may potentially help the United States health care system, which is challenged by rising health care costs, increased demand from an aging society, and quality objectives.

These data would permit users to examine relationships between how often use ventolin management practices and financial outcomes using Census Bureau data (e.g., revenues) and relationships with clinical outcomes using external data sources. Additionally, these data would provide hospital administrators and managers information to evaluate their practices in comparison to other hospitals at an aggregate level. The MOPS-HP content was proposed by external researchers with past experience in surveying hospitals on how often use ventolin management practices. Some questions are adapted from the Management and Organizational Practices Survey (MOPS), conducted in the manufacturing sector, allowing for inter-sectoral comparisons.

Content for the MOPS-HP includes performance monitoring, financial and clinical targets, and incentives. The 39 questions are grouped into the following sections how often use ventolin. Tenure, Management Practices, Management Training, Management of Team Interactions, Staffing and Allocation of Human Resources, Standardized Clinical Protocols, Documentation of Patients' Medical Records, and Organizational Characteristics.Start Printed Page 73674 II. Method of Collection The MOPS-HP sample will consist of approximately 3,200 hospital locations for enterprises classified under General Medical and Surgical Hospitals (NAICS how often use ventolin 6221) and sampled in the Service Annual Survey (SAS).

The survey will be mailed separately from the 2020 SAS and collected electronically through the Census Bureau's Centurion online reporting system. Respondents will be sent an initial letter with instructions detailing how to log into the instrument and report their information. These letters will be addressed to the how often use ventolin location's CNO. In instances where the CNO is not identifiable, the letter will be addressed to the hospital's administrative office with attention to the CNO.

Collection is scheduled to how often use ventolin begin in the initial months of 2021. III. Data OMB Control Number. 0607-XXXX.

Form Number(s). MP-2000. Type of Review. Regular submission, New Information Collection Request.

Affected Public. General medical and surgical hospitals. Estimated Number of Respondents. Approximately 3,200.

Estimated Time per Response. 45 minutes. Estimated Total Annual Burden Hours. 2,400.

Estimated Total Annual Cost to Public. $0. (This is not the cost of respondents' time, but the indirect costs respondents may incur for such things as purchases of specialized software or hardware needed to report, or expenditures for accounting or records maintenance services required specifically by the collection.) Respondent's Obligation. Mandatory.

Legal Authority. Title 13 U.S.C., Sections 131 and 182. IV. Request for Comments We are soliciting public comments to permit the Department/Bureau to.

(a) Evaluate whether the proposed information collection is necessary for the proper functions of the Department, including whether the information will have practical utility. (b) Evaluate the accuracy of our estimate of the time and cost burden for this proposed collection, including the validity of the methodology and assumptions used. (c) Evaluate ways to enhance the quality, utility, and clarity of the information to be collected. And (d) Minimize the reporting burden on those who are to respond, including the use of automated collection techniques or other forms of information technology.

Comments that you submit in response to this notice are a matter of public record. We will include, or summarize, each comment in our request to OMB to approve this ICR. Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you may ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.

Start Signature Sheleen Dumas, Department PRA Clearance Officer, Office of the Chief Information Officer, Commerce Department. End Signature End Supplemental Information [FR Doc. 2020-25580 Filed 11-18-20. 8:45 am]BILLING CODE 3510-07-PStart Preamble Department of Veterans Affairs.

Interim final rule. The Department of Veterans Affairs (VA) is issuing this interim final rule to confirm that its health care professionals may practice their health care profession consistent with the scope and requirements of their VA employment, notwithstanding any State license, registration, certification, or other requirements that unduly interfere with their practice. Specifically, this rulemaking confirms VA's current practice of allowing VA health care professionals to deliver health care services in a State other than the health care professional's State of licensure, registration, certification, or other State requirement, thereby enhancing beneficiaries' access to critical VA health care services. This rulemaking also confirms VA's authority to establish national standards of practice for health care professionals which will standardize a health care professional's practice in all VA medical facilities.

Effective Date. This rule is effective on November 12, 2020. Comments. Comments must be received on or before January 11, 2021.

Comments may be submitted through www.Regulations.gov or mailed to, Beth Taylor, 10A1, 810 Vermont Avenue NW, Washington, DC 20420. Comments should indicate that they are submitted in response to [“RIN 2900-AQ94—Authority of VA Professionals to Practice Health Care.”] Comments received will be available at regulations.gov for public viewing, inspection, or copies. Start Further Info Beth Taylor, Chief Nursing Officer, Veterans Health Administration. 810 Vermont Avenue NW, Washington, DC 20420, (202) 461-7250.

(This is not a toll-free number.) End Further Info End Preamble Start Supplemental Information On January 30, 2020, the World Health Organization (WHO) declared the asthma treatment outbreak to be a Public Health Emergency of International Concern. On January 31, 2020, the Secretary of the Department of Health and Human Services declared a Public Health Emergency pursuant to 42 United States Code (U.S.C.) 247d, for the entire United States to aid in the nation's health care community response to the asthma treatment outbreak. On March 11, 2020, in light of new data and the rapid spread in Europe, WHO declared asthma treatment to be a ventolin. On March 13, 2020, the President declared a National Emergency due to asthma treatment under sections 201 and 301 of the National Emergencies Act (50 U.S.C.

1601 et seq.) and consistent with section 1135 of the Social Security Act (SSA), as amended (42 U.S.C. 1320b-5). As a result of responding to the needs of our veteran population and other non-veteran beneficiaries during the asthma treatment National Emergency, where VA has had to shift health care Start Printed Page 71839professionals to other locations or duties to assist in the care of those affected by this ventolin, VA has become acutely aware of the need to promulgate this rule to clarify the policies governing VA's provision of health care. This rule is intended to confirm that VA health care professionals may practice their health care profession consistent with the scope and requirements of their VA employment, notwithstanding any State license, registration, certification, or other requirements that unduly interfere with their practice.

In particular, it will confirm (1) VA's continuing practice of authorizing VA health care professionals to deliver health care services in a State other than the health care professional's State of licensure, registration, certification, or other requirement. And (2) VA's authority to establish national standards of practice for health care professions via policy, which will govern their employment, subject only to State laws where the health care professional is licensed, credentialed, registered, or subject to some other State requirements that do not unduly interfere with those duties. We note that the term State as it applies to this rule means each of the several States, Territories, and possessions of the United States, the District of Columbia, and the Commonwealth of Puerto Rico, or a political subdivision of such State. This definition is consistent with the term State as it is defined in 38 U.S.C.

101(20). A conflicting State law is one that would unduly interfere with the fulfillment of a VA health care professional's Federal duties. We note that the policies and practices confirmed in this rule only apply to VA health care professionals appointed under 38 U.S.C. 7306, 7401, 7405, 7406, or 7408 or title 5 of the U.S.

Code, which does not include contractors working in VA medical facilities or those working in the community. VA has long understood its governing statutory authorities to permit VA to engage in these practices. Section 7301(b) of title 38 the U.S. Code establishes that the primary function of the Veterans Health Administration (VHA) within VA is to provide a complete medical and hospital service for the medical care and treatment of veterans.

To allow VHA to carry out its medical care mission, Congress established a comprehensive personnel system for certain VA health care professionals, independent of the civil service rules. See Chapters 73-74 of title 38 of the U.S. Code. Congress granted the Secretary express statutory authority to establish the qualifications for VA's health care professionals, determine the hours and conditions of employment, take disciplinary action against employees, and otherwise regulate the professional activities of those individuals.

38 U.S.C. 7401-7464. Section 7402 of 38 U.S.C. Establishes the qualifications of appointees.

To be eligible for appointment as a VA employee in a health care profession covered by section 7402(b) (other than a medical facility Director appointed under section 7402(b)(4)), most individuals, after appointment, must, among other requirements, be licensed, registered, or certified to practice their profession in a State, or satisfy some other State requirement. However, the standards prescribed in section 7402(b) establish only the basic qualifications for VA health care professionals and do not limit the Secretary from establishing other qualifications or rules for health care professionals. In addition, the Secretary is responsible for the control, direction, and management of the Department, including agency personnel and management matters. See 38 U.S.C.

303. Such authorities permit the Secretary to further regulate the health care professions to make certain that VA's health care system provides safe and effective health care by qualified health care professionals to ensure the well-being of those veterans who have borne the battle. In this rulemaking, VA is detailing its authority to manage its health care professionals by stating that they may practice their health care profession consistent with the scope and requirements of their VA employment, notwithstanding any State license, registration, certification, or other State requirements that unduly interfere with their practice. VA believes that this is necessary in order to provide additional protection for VA health care professionals against adverse State actions proposed or taken against them when they are practicing within the scope of their VA employment, particularly when they are practicing across State lines or when they are performing duties consistent with a VA national standard of practice for their health care profession.

Practice Across State Lines Historically, VA has operated as a national health care system that authorizes VA health care professionals to practice in any State as long as they have a valid license, registration, certification, or fulfill other State requirements in at least one State. In doing so, VA health care professionals have been practicing within the scope of their VA employment regardless of any unduly burdensome State requirements that would restrict practice across State lines. We note, however, that VA may only hire health care professionals who are licensed, registered, certified, or satisfy some other requirement in a State, unless the statute requires or provides otherwise (e.g., 38 U.S.C. 7402(b)(14)).

The asthma treatment ventolin has highlighted VA's acute need to exercise its statutory authority of allowing VA health care professionals to practice across State lines. In response to the ventolin, VA needed to and continues to need to move health care professionals quickly across the country to care for veterans and other beneficiaries and not have State licensure, registration, certification, or other State requirements hinder such actions. Put simply, it is crucial for VA to be able to determine the location and practice of its VA health care professionals to carry out its mission without any unduly burdensome restrictions imposed by State licensure, registration, certification, or other requirements. This rulemaking will support VA's authority to do so and will provide an increased level of protection against any adverse State action being proposed or taken against VA health care professionals who practice within the scope of their VA employment.

Since the start of the ventolin, in furtherance of VA's Fourth Mission, VA has rapidly utilized its resources to assist parts of the country that are undergoing serious and critical shortages of health care resources. VA's Fourth Mission is to improve the Nation's preparedness for response to war, terrorism, national emergencies, and natural disasters by developing plans and taking actions to ensure continued service to veterans, as well as to support national, State, and local emergency management, public health, safety and homeland security efforts. VA has deployed personnel to support other VA medical facilities that have been impacted by asthma treatment as well as provided support to State and community nursing homes. As of July 2020, VA has deployed personnel to more than 45 States.

VA utilized the Disaster Emergency Medical Personnel System (DEMPS), VA's main deployment program, for VA health care professionals to travel to locations deemed as national emergency or disaster areas, to help provide health care services in places such as New Orleans, Louisiana, and New York City, New York. As of June 2020, a total of 1,893 staff have been mobilized to meet the needs of our facilities and Fourth Start Printed Page 71840Mission requests during the ventolin. VA deployed 877 staff to meet Federal Emergency Management Agency (FEMA) Mission requests, 420 health care professionals were deployed as DEMPS response, 414 employees were mobilized to cross level staffing needs within their Veterans Integrated Service Networks (VISN), 69 employees were mobilized to support needs in another VISN, and 113 Travel Nurse Corps staff responded specifically for asthma treatment staffing support. In light of the rapidly changing landscape of the ventolin, it is crucial for VA to be able to move its health care professionals quickly across the country to assist when a new hot spot emerges without fear of any adverse action from a State be proposed or taken against a VA health care professional.

We note that, in addition to providing in person health care across State lines during the ventolin, VA also provides telehealth across State lines. VA's video to home services have been heavily leveraged during the ventolin to deliver safe, quality VA health care while adhering to Centers for Disease Control and Prevention (CDC) physical distancing guidelines. Video visits to veterans' homes or other offsite location have increased from 41,425 in February 2020 to 657,423 in July of 2020. This represents a 1,478 percent utilization increase.

VA has specific statutory authority under 38 U.S.C. 1730C to allow health care professionals to practice telehealth in any State regardless of where they are licensed, registered, certified, or satisfy some other State requirement. This rulemaking is consistent with Congressional intent under Public Law 115-185, sec. 151, June 6, 2018, codified at 38 U.S.C.

1730C for all VA health care professionals to practice across State lines regardless of the location of where they provide health care. This rulemaking will ensure that VA professionals are protected regardless of how they provide health care, whether it be via telehealth or in-person. Beyond the current need to mobilize health care resources quickly to different parts of the country, this practice of allowing VA health care professionals to practice across State lines optimizes the VA health care workforce to meet the needs of all VA beneficiaries year-round. It is common practice within the VA health care system to have primary and specialty health care professionals routinely travel to smaller VA medical facilities or rural locations in nearby States to provide care that may be difficult to obtain or unavailable in that community.

As of January 14, 2020, out of 182,100 licensed health care professionals who are employed by VA, 25,313 or 14 percent do not hold a State license, registration, or certification in the same State as their main VA medical facility. This number does not include the VA health care professionals who practice at a main VA medical facility in one State where they are licensed, registered, certified, or hold some other State requirement, but also practice at a nearby Community Based Outpatient Clinic (CBOC) in a neighboring State where they do not hold such credentials. Indeed, 49 out of the 140 VA medical facilities nationwide have one or more sites of care in a different State than the main VA medical facility. Also, VA has rural mobile health units that provide health care services to veterans who have difficulty accessing VA health care facilities.

These mobile units are a vital source of health care to veterans who live in rural and medically underserved communities. Some of the services provided by the mobile units include, but are not limited to, health care screening, mental health outreach, influenza and pneumonia vaccinations, and routine primary care. The rural mobile health units are an integral part of VA's goal of encouraging healthier communities and support VA's preventative health programs. Health care professionals who provide health care in these mobile units may provide services in various States where they may not hold a license, registration, or certification, or satisfy some other State requirement.

It is critical that these health care professionals are protected from any adverse State action proposed or taken when performing these crucial services. In addition, the practice of health care professionals of providing health care across State lines also gives VA the flexibility to hire qualified health care professionals from any State to meet the staffing needs of a VA health care facility where recruitment or retention is difficult. As of December 31, 2019, VA had approximately 13,000 vacancies for health care professions across the country. As a national health care system, it is imperative for VA to be able to recruit and retain health care professionals, where recruitment and retention is difficult, to ensure there is access to health care regardless of where the VA beneficiary resides.

Permitting VA health care professionals to practice across State lines is an important incentive when trying to recruit for these vacancies, particularly during a ventolin, where private health care facilities have greater flexibility to offer more competitive pay and benefits. This is also especially beneficial in recruiting spouses of active service members who frequently move across the country. National Standard of Practice This rulemaking also confirms VA's authority to establish national standards of practice for health care professions. We note that this rulemaking does not create any such national standards.

All national standards of practice will be created via policy. For the purposes of this rulemaking, a national standard of practice describes the tasks and duties that a VA health care professional practicing in the health care profession may perform and may be permitted to undertake. Having a national standard of practice means that individuals from the same VA health care profession may provide the same type of tasks and duties regardless of the VA medical facility where they are located or the State license, registration, certification, or other State requirement they hold. We emphasize that VA will determine, on an individual basis, that a health care professional has the necessary education, training, and skills to perform the tasks and duties detailed in the national standard of practice.

The need for national standards of practice have been highlighted by VA's large-scale initiative regarding the new electronic health record (EHR). VA's health care system is currently undergoing a transformational initiative to modernize the system by replacing its current EHR with a joint EHR with Department of Defense (DoD) to promote interoperability of medical data between VA and DoD. VA's new EHR system will provide VA and DoD health care professionals with quick and efficient access to the complete picture of a veteran's health information, improving VA's delivery of health care to our nation's veterans. For this endeavor, DoD and VA established a joint governance over the EHR system.

In order to be successful, VA must standardize clinical processes with DoD. This means that all health care professionals in DoD and VA who practice in a certain health care profession must be able to carry out the same duties and tasks irrespective of State requirements. The reason why this is important is because each health care profession is designated a role in the EHR system that sets forth specific privileges within the EHR that dictate allowed tasks for such profession. These tasks include, but are not limited to, dispensing and administrating medications.

Prescriptive practices. Ordering of procedures and diagnostic imaging. And required level of oversight. VA has the ability to modify these privileges within EHR, however, VA Start Printed Page 71841cannot do so on an individual user level, but rather at the role level for each health care profession.

In other words, VA cannot modify the privileges for all health care professionals in one State to be consistent with that State's requirements. Instead, the privileges can only be modified for every health care professional in that role across all States. Therefore, the privileges established within EHR cannot be made facility or State specific. In order to achieve standardized clinical processes, VA and DoD must create the uniform standards of practice for each health care specialty.

Currently, DoD has specific authority from Congress to create national standards of practice for their health care professionals under 10 U.S.C. 1094. While VA lacks a similarly specific statute, VA has the general statutory authority, as explained above, to regulate its health care professionals and authorize health care practices that preempt conflicting State law. This regulation will confirm VA's authority to do so.

Absent such standardized practices, it will be incredibly difficult for VA to achieve its goal of being an active participant in EHR modernization because either some VA health care professionals would fear potential adverse State actions or DoD and VA would need to agree upon roles that are consistent with the most restrictive States' requirements to ensure that all health care professionals are acting within the scope of their State requirements. VA believes that agreement upon roles that are consistent with the most restrictive State is not an acceptable option because it will lead to delayed care and consequently decreased access and level of health care for VA beneficiaries. One example that impacts multiple health care professions throughout the VA system is the ability to administer medication without a provider (physician or advanced practice nurse practitioner) co-signature. As it pertains to nursing, almost all States permit nurses to follow a protocol.

However, some States, such as New York, North Carolina, and South Carolina, do not permit nurses to follow a protocol without a provider co-signature. A protocol is a standing order that has been approved by medical and clinical leadership if a certain sequence of health care events occur. For instance, if a patient is exhibiting certain signs of a heart attack, there is a protocol in place to administer potentially life-saving medication. If the nurse is the first person to see the signs, the nurse will follow the approved protocol and immediately administer the medication.

However, if the nurse cannot follow the protocol and requires a provider co-signature, administration of the medication will be delayed until a provider is able to co-sign the order, which may lead to the deterioration of the patient's condition. This also increases the provider's workload and decreases the amount of time the provider can spend with patients. Historically, VA physical therapists (PTs), occupational therapists, and speech therapists were routinely able to determine the need to administer topical medications during therapy sessions and were able to administer the topical without a provider co-signature. However, in order to accommodate the new EHR system and variance in State requirements, these therapists would need to place an order for all medications, including topicals, which would leave these therapists waiting for a provider co-signature in the middle of a therapy session, thus delaying care.

Furthermore, these therapists also routinely ordered imaging to better assess the clinical needs of the patient, but would also have to wait for a provider co-signature, which will further delay care and increase provider workload. In addition to requiring provider co-signatures, there will also be a significant decrease in access to care due to other variances in State requirements. For instance, direct access to PTs will be limited in order to ensure that the role is consistent with all State requirements. Direct access means that a beneficiary may request PT services without a provider's referral.

However, while almost half of the States allow unrestricted direct access to PTs, over half of the States have some limitations on requesting PT services. For instance, in Alabama, a licensed PT may perform an initial evaluation and may only provide other services as delineated in specific subdivisions of the Alabama Physical Therapy Practice Act. Furthermore, in New York, PT treatment may be rendered by a licensed PT for 10 visits or 30 days, whichever shall occur first, without a referral from a physician, dentist, podiatrist, nurse practitioner, or licensed midwife. This is problematic as VA will not be able to allow for direct access due to these variances and direct access has been shown to be beneficial for patient care.

Currently, VISN 23 is completing a two-year strategic initiative to implement direct access and have PTs embedded into patient aligned care teams (PACT). Outcomes thus far include decreased wait times, improved veteran satisfaction, improved provider satisfaction, and improved functional outcomes. Therefore, VA will confirm its authority to ensure that health care professionals are protected against State action when they adhere to VA's national standards of practice. We reiterate that this rulemaking does not establish national standards of practice for each health care profession, but merely confirms VA's authority to do so, thereby preempting any State restrictions that unduly interfere with those practices.

The actual national standards of practice will be developed in subregulatory policy for each health care profession. As such, VA will make a concerted effort to engage appropriate stakeholders when developing the national standards of practice. Preemption As previously explained, in this rulemaking, VA is confirming its authority to manage its health care professionals. Specifically, this rulemaking will confirm VA's long-standing practice of allowing its health care professionals to practice in a State where they do not hold a license, registration, certification, or satisfy some other State requirement.

The rule will also confirm that VA health care professionals must adhere to VA's national standards of practice, as determined by VA policy, irrespective of conflicting State licensing, registration, certification, or other State requirements that unduly burden that practice. We do note that VA health care professionals will only be required to perform tasks and duties to the extent of their education, skill, and training. For instance, VA would not require a registered nurse to perform a task that the individual nurse was not trained to perform. Currently, practice in accordance with VA employment, including practice across State lines or adhering to a VA standard of practice, may jeopardize VA health care professionals' credentials or result in fines and imprisonment for unauthorized health care practice.

This is because most States have restrictions that limit health care professionals' practice or have rules that prohibit health care professionals from furnishing health care services within that State without a license, registration, certification, or other requirement from that State. We note that, some States, for example Rhode Island, Utah, and Michigan, have enacted legislation or regulations that specifically allow certain VA health care professionals to practice in those States when they do not hold a State license. Several VA health care professionals have already had actions proposed or taken against them by various States Start Printed Page 71842while practicing health care within the scope of their VA employment, while they either practiced in a State where they do not hold a license, registration, certification, or other State requirement that unduly interfered with their VA employment. In one instance, a VA psychologist was licensed in California but was employed and providing supervision of a trainee at the VA Medical Center (VAMC) in Nashville, Tennessee.

California psychology licensing laws require supervisors to hold a license from the State where they are practicing and do not allow for California licensed psychologists to provide supervision to trainees or unlicensed psychologists outside the State of California. The California State Psychology Licensing Board proposed sanctions and fines of $1,000 for violating section 1387.4(a) of the CA Code of Regulations (CCR). The VA system did not qualify for the exemption of out of State supervision requirements listed in CCR section 1387.4. In addition, a VA physician who was licensed in Oregon, but was practicing at a VAMC in Biloxi, Mississippi had the status of their license changed from active to inactive because the Oregon Medical Board determined the professional did not reside in Oregon, in violation of Oregon's requirement that a physician physically reside in the State in order to maintain an active license.

This rulemaking serves to preempt State requirements, such as the ones discussed above, that were or can be used to take an action against VA health care professionals for practicing within the scope of their VA employment. State licensure, registration, certification, and other State requirements are preempted to the extent such State laws unduly interfere with the ability of VA health care professionals to practice health care while acting within the scope of their VA employment. As explained above, Congress provided general statutory provisions that permit the VA Secretary to authorize health care practices by health care professionals at VA, which serve to preempt conflicting State laws that unduly interfere with the exercise of health care by VA health care professionals pursuant to that authorization. Although some VA health care professionals are required by Federal statute to have a State license, see, e.g., 38 U.S.C.

7402(b)(1)(C) (providing that, to be eligible to be appointed to a physician position at the VA, a physician must be licensed to practice medicine, surgery, or osteopathy in a State), a State may not attach a condition to the license that is unduly burdensome to or unduly interferes with the practice of health care within the scope of VA employment. Under well-established interpretations of the Supremacy Clause, Federal laws and policies authorizing VA health care professionals to practice according to VA standards preempt conflicting State law. That is, a State law that prevents or unreasonably interferes with the performance of VA duties. See, e.g., Hancock v.

Train, 426 U.S. 167, 178-81 (1976). Sperry v. Florida, 373 U.S.

379, 385 (1963). Miller v. Arkansas, 352 U.S. 187 (1956).

Ohio v. Thomas, 173 U.S. 276, 282-84 (1899). State Bar Disciplinary Rules as Applied to Federal Government Attorneys, 9 Op.

O.L.C. 71, 72-73 (1985). When a State law does not conflict with the performance of Federal duties in these ways, VA health care professionals are required to abide by the State law. Therefore, VA's policies and regulations will preempt State licensure, registration, and certification laws, rules, or other requirements only to the extent they conflict with the ability of VA health care professionals to practice health care while acting within the scope of their VA employment.

We emphasize that, in instances where there is no conflict with State requirements, VA health care professionals should abide by the State requirement. For example, if a State license requires a health care professional to have a certain number of hours of continuing professional education per year to maintain their license, the health care professional must adhere to this State requirement if it does not prevent or unduly interfere with the exercise of VA employment. To determine whether a State requirement is conflicting, VA would assess whether the State law unduly interferes on a case-by-case basis. For instance, if Oregon requires all licensed physicians to reside in Oregon, VA would likely find that it unduly interferes with already licensed VA physicians who reside and work for VA in the State of Mississippi.

We emphasize that the intent of the regulation is to only preempt State requirements that are unduly burdensome and interfere with a VA health care professionals' practice for the VA. For instance, it would not require a State to issue a license to an individual who does not meet the education requirements to receive a license in that State. We note that this rulemaking also does not affect VA's existing requirement that all VA health care professionals adhere to restrictions imposed by the Controlled Substances Act, 21 U.S.C. 801 et seq.

And implementing regulations at 21 CFR 1300, et seq., to prescribe or administer controlled substances. Any preemption of conflicting State requirements will be the minimum necessary for VA to effectively furnish health care services. It would be costly and time-consuming for VA to lobby each State board for each health care profession specialty to remove restrictions that impair VA's ability to furnish health care services to beneficiaries and then wait for the State to implement appropriate changes. Doing so would not guarantee a successful result.

Regulation For these reasons, VA is establishing a new regulation titled Health care professionals' practice in VA, which will be located at 38 CFR 17.419. This rule will confirm the ability of VA health care professionals to practice their health care profession consistent with the scope and requirements of their VA employment, notwithstanding any State license, registration, certification, or other requirements that unduly interfere with their practice. Subsection (a) of § 17.419 contains the definitions that will apply to the new section. Subsection (a)(1) contains the definition for beneficiary.

We are defining the term beneficiary to mean a veteran or any other individual receiving health care under title 38 of the U.S. Code. We are using this definition because VA provides health care to veterans, certain family members of veterans, servicemembers, and others. This is VA's standard use of this term.

Subsection (a)(2) contains the definition for health care professional. We are defining the term health care professional to be an individual who meets specific criteria that is listed below. Subsection (a)(2)(i) will require that a health care professional be appointed to an occupation in VHA that is listed or authorized under 38 U.S.C. 7306, 7401, 7405, 7406, or 7408 or title 5 of the U.S.

Code. Subsection (a)(2)(ii) requires that the individual is not a VA-contracted health care professional. A health care professional does not include a contractor or a community health care professional because they are not considered VA employees nor appointed under 38 U.S.C. 7306, 7401, 7405, 7406, or 7408 or title 5 of the U.S.

Code. Subsection (a)(2)(iii) lists the required qualifications for a health care professional. We note that these qualifications do not include all general Start Printed Page 71843qualifications for appointment, such as to hold a degree of doctor of medicine. These qualifications are related to licensure, registration, certification, or other State requirements.

Subsection (a)(2)(iii)(A) states that the health care professional must have an active, current, full, and unrestricted license, registration, certification, or satisfies another State requirement in a State to practice the health care specialty identified under 38 U.S.C. 7402(b). This standard ensures that VA health care professionals are qualified to practice their individual health care specialty if the specialty requires such credential. Subsection (a)(2)(iii)(B) states that the individual has other qualifications as prescribed by the Secretary for one of the health care professions listed under 38 U.S.C.

7402(b). Some health care professionals appointed under 38 U.S.C. 7401(3) whose qualifications are listed in 38 U.S.C. 7402(b) are not required to meet State license, registration, certification, or other requirements and rely on the qualifications prescribed by the Secretary.

Therefore, these individuals would be included in this subsection and required to have the qualifications prescribed by the Secretary for their health care profession. Subsection (a)(2)(iii)(C) states that the individual is otherwise authorized by the Secretary to provide health care services. This would include those individuals who practice a health care profession that does not require a State license, registration, certification, or other requirement and is also not listed in 38 U.S.C. 7402(b), but is authorized by the Secretary to provide health care services.

Subsection (a)(2)(iii)(D) includes individuals who are trainees or may have a time limited appointment to finish clinicals or other requirements prior to being fully licensed. Therefore, the regulation will state that the individual is under the clinical supervision of a health care professional that meets the requirements listed in subsection (a)(2)(iii)(A)-(C) and the individual must meet the requirements in subsection (a)(2)(iii)(D)(i) or (a)(2)(iii)(D)(ii). Subsection (a)(2)(iii)(D)(i) states that the individual is a health professions trainee appointed under 38 U.S.C. 7405 or 7406 participating in clinical or research training under supervision to satisfy program or degree requirements.

Subsection (a)(2)(iii)(D)(ii) states that the individual is a health care employee, appointed under title 5 of the U.S. Code, 38 U.S.C. 7401(1) or (3), or 38 U.S.C. 7405 for any category of personnel described in 38 U.S.C.

7401(1) or (3) who must obtain an active, current, full and unrestricted licensure, registration, or certification or meet the qualification standards as defined by the Secretary within the specified time frame. These individuals have a time-limited appointment to obtain credentials. For example, marriage and family therapists require a certain number of supervised clinical post-graduate hours prior to receiving their license. Lastly, as we previously discussed in this rulemaking, we are defining the term State in subsection (a)(3) as the term is defined in 38 U.S.C.

101(20), and also including political subdivisions of such States. This is consistent with the definition of State in 38 U.S.C. 1730C(f) which is VA's statutory authority to preempt State law when the covered health care professional is using telehealth to provide treatment to an individual under this title. We believe that it is important to define the term in the same way as it is defined for health care professionals practicing via telehealth so that way it is consistent regardless of whether the health care professional is practicing in-person or via telehealth.

Moreover, as subdivisions of a State are granted legal authority from the State itself, it makes sense to subject entities created by a State, or authorized by a State to create themselves, to be subject to the same limitations and restrictions as the State itself. Section 17.419(b) details that VA health care professionals must practice within the scope of their Federal employment irrespective of conflicting State requirements that would prevent or unduly interfere with the exercise of Federal duties. This provision confirms that VA health care professionals may furnish health care consistent with their VA employment obligations without fear of adverse action proposed or taken by any State. In order to clarify and make transparent how VA utilizes or intends to utilize our current statutory authority, we are providing a non-exhaustive list of examples.

The first example is listed in subsection (b)(1)(i). It states that a health care professional may practice their VA health care profession in any State irrespective of the State where they hold a valid license, registration, certification, or other qualification. The second example is listed in subsection (b)(1)(ii). It states that a health care professional may practice their VA health care profession consistent with the VA national standard of practice as determined by VA.

As previously explained, VA intends to establish national standards of practice via VA policy. A health care professional's practice within VA will continue to be subject to the limitations imposed by the Controlled Substances Act, 21 U.S.C. 801, et seq. And implementing regulations at 21 CFR 1300, et seq., on the authority to prescribe or administer controlled substances, as well as any other limitations on the provision of VA care set forth in applicable Federal law and policy.

This will ensure that professionals are still in compliance with critical laws concerning the prescribing and administering of controlled substances. This requirement is stated in subsection (b)(2). Subsection (c) expressly states the intended preemptive effect of § 17.419, to ensure that conflicting State and local laws, rules, regulations, and requirements related to health care professionals' practice will have no force or effect when such professionals are practicing health care while working within the scope of their VA employment. In circumstances where there is a conflict between Federal and State law, Federal law would prevail in accordance with Article VI, clause 2, of the U.S.

Constitution. Executive Order 13132 establishes principles for preemption of State law when it is implicated in rulemaking or proposed legislation. Where a Federal statute does not expressly preempt State law, agencies shall construe any authorization in the statute for the issuance of regulations as authorizing preemption of State law by rulemaking only when the exercise of State authority directly conflicts with the exercise of Federal authority or there is clear evidence to conclude that the Congress intended the agency to have the authority to preempt State law. In this situation, the Federal statutes do not expressly preempt State laws.

However, VA construes the authorization established in 38 U.S.C. 303, 501, and 7401-7464 as authorizing preemption because the exercise of State authority directly conflicts with the exercise of Federal authority under these statutes. Congress granted the Secretary express statutory authority to establish the qualifications for VA's health care professionals, determine the hours and conditions of employment, take disciplinary action against employees, and otherwise regulate the professional activities of those individuals. 38 U.S.C.

7401-7464. Specifically, section 7402(b) states that most health care professionals, after appointment by VA, must, among other Start Printed Page 71844requirements, be licensed, registered, or certified to practice their profession in a State. To that end, VA's regulations and policies will preempt any State law or action that conflicts with the exercise of Federal duties in providing health care at VA. In addition, any regulatory preemption of State law must be restricted to the minimum level necessary to achieve the objectives of the statute pursuant to the regulations that are promulgated.

In this rulemaking, State licensure, registration, and certification laws, rules, regulations, or other requirements are preempted only to the extent such State laws unduly interfere with the ability of VA health care professionals to practice health care while acting within the scope of their VA employment. Therefore, VA believes that the rulemaking is restricted to the minimum level necessary to achieve the objectives of the Federal statutes. The Executive Order also requires an agency that is publishing a regulation that preempts State law to follow certain procedures. These procedures include.

The agency consult with, to the extent practicable, the appropriate State and local officials in an effort to avoid conflicts between State law and Federally protected interests. And the agency provide all affected State and local officials notice and an opportunity for appropriate participation in the proceedings. For the reasons below, VA believes that it is not practicable to consult with the appropriate State and local officials prior to the publication of this rulemaking. The National Emergency caused by asthma treatment has highlighted VA's acute need to quickly shift health care professionals across the country.

As both private and VA medical facilities in different parts of the country reach or exceed capacity, VA must be able to mobilize its health care professionals across State lines to provide critical care for those in need. As explained in the Supplementary Information above, as of June 2020, a total of 1,893 staff have been mobilized to meet the needs of our facilities and Fourth Mission requests during the ventolin. VA deployed 877 staff to meet Federal Emergency Management Agency (FEMA) Mission requests, 420 health care professionals were deployed as DEMPS response, 414 employees were mobilized to cross level staffing needs within their Veterans Integrated Service Networks (VISN), 69 employees were mobilized to support needs in another VISN, and 113 Travel Nurse Corps staff responded specifically for asthma treatment staffing support. Given the speed in which it is required for our health care professionals to go to these facilities and provide health care, it is also essential that the health care professionals can follow the same standards of practice irrespective of the location of the facility or the requirements of their individual State license.

This is important because if multiple health care professionals, such as multiple registered nurses, licensed in different States are all sent to one VA medical facility to assist when there is a shortage of professionals, it would be difficult and cumbersome if they could not all perform the same duties and each supervising provider had to be briefed on the tasks each registered nurse could perform. In addition, not having a uniform national scope of practice could limit the tasks that the registered nurses could provide. This rulemaking will provide health care professionals an increased level of protection against adverse State actions while VA strives to increase access to high quality health care across the VA health care system during this National Emergency. It would be time consuming and contrary to the public health and safety to delay implementing this rulemaking until we consulted with State and local officials.

For these reasons, it would be impractical to consult with State and local officials prior to the publication of this rulemaking. We note that this rulemaking does not establish any national standards of practice. Instead, VA will establish the national standards of practice via subregulatory guidance. VA will, to the extent practicable, make all efforts to engage with State and local officials when establishing the national standards of practice via subregulatory guidance.

Also, this interim final rule will have a 60-day comment period that will allow State and local officials the opportunity to provide their input on the rule. Administrative Procedures Act An Agency may forgo notice and comment required under the Administrative Procedures Act (APA), 5 U.S.C. 553, if the agency for good cause finds that compliance would be impracticable, unnecessary, or contrary to the public interest. An agency may also bypass the APA's 30-day publication requirement if good cause exists.

The Secretary of Veterans Affairs finds that there is good cause under the provisions of 5 U.S.C. 553(b)(B) to publish this rule without prior opportunity for public comment because it would be impracticable and contrary to the public interest and finds that there is good cause under 5 U.S.C. 553(d)(3) to bypass its 30-day publication requirement for the same reasons as outlined above in the Federalism section, above. In short, this rulemaking will provide health care professionals protection against adverse State actions while VA strives to increase access to high quality health care across the VA health care system during this National Emergency.

In addition to the needs discussed above regarding the National Emergency, it is also imperative that VA move its health care professionals across State lines in order to facilitate the implementation of the new EHR system immediately. VA implemented EHR at the first VA facility in October 2020 and additional sites are scheduled to have EHR implemented over the course of the next eight years. The next site is scheduled for implementation in Quarter 2 of Fiscal Year 2021 (i.e., between January to March 2021). Due to the implementation of the new EHR system, VA expects decreased productivity and reduced clinical staffing during training and other events surrounding EHR enactment.

VA expects a productivity decrease of up to 30 percent for the 60 days before implementation and the 120 days after at each site. Any decrease in productivity could result in decreased access to health care for our Nation's veterans. In order to support this anticipated productivity decrease, VA is engaging in a “national supplement,” where health care professionals from other VA medical facilities will be deployed to those VA medical facilities and VISNs that are undergoing EHR implementation. The national supplement would mitigate reduced access during EHR deployment activities, such as staff training, cutover, and other EHR implementation activities.

Over the eight-year deployment timeline, the national supplement is estimated to have full time employee equivalents of approximately 60 nurses, 3 pharmacy technicians, 5 mental health and primary care providers, and other VA health care professionals. We note that the actual number of VA health care professionals deployed to each site will vary based on need. The national supplement will require VA health care professionals on a national level to practice health care in States where they do not hold a State license, registration, certification, or other requirement. In addition, VISNs will be providing local cross-leveling and intra-VISN staff deployments to support EHRM implementation activities.

Put simply, in order to mitigate the decreased Start Printed Page 71845productivity as a result of EHR implementation, VA must transfer VA health care professionals across the country to States where they do not hold a license, registration, certification, or other requirement to assist in training on the new system as well as to support patient care. Therefore, it would be impracticable and contrary to the public health and safety to delay implementing this rulemaking until a full public notice-and-comment process is completed. This rulemaking will be effective upon publication in the Federal Register. As noted above, this interim final rule will have a 60-day comment period that will allow State and local officials the opportunity to provide their input on the rule, and VA will take those comments into consideration when deciding whether any modifications to this rule are warranted.

Paperwork Reduction Act This final rule contains no provisions constituting a collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). Regulatory Flexibility Act The Regulatory Flexibility Act, 5 U.S.C. 601-612, is not applicable to this rulemaking because a notice of proposed rulemaking is not required under 5 U.S.C.

553. 5 U.S.C. 601(2), 603(a), 604(a). Executive Orders 12866, 13563, and 13771 Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, and other advantages.

Distributive impacts. And equity). Executive Order 13563 (Improving Regulation and Regulatory Review) emphasizes the importance of quantifying both costs and benefits, reducing costs, harmonizing rules, and promoting flexibility. The Office of Information and Regulatory Affairs has determined that this rule is a significant regulatory action under Executive Order 12866.

VA's impact analysis can be found as a supporting document at http://www.regulations.gov, usually within 48 hours after the rulemaking document is published. Additionally, a copy of the rulemaking and its impact analysis are available on VA's website at http://www.va.gov/​orpm/​, by following the link for “VA Regulations Published From FY 2004 Through Fiscal Year to Date.” This interim final rule is not subject to the requirements of E.O. 13771 because this rule results in no more than de minimis costs. Unfunded Mandates The Unfunded Mandates Reform Act of 1995 requires, at 2 U.S.C.

1532, that agencies prepare an assessment of anticipated costs and benefits before issuing any rule that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more (adjusted annually for inflation) in any one year. This interim final rule will have no such effect on State, local, and tribal governments, or on the private sector. Congressional Review Act Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), the Office of Information and Regulatory Affairs designated this rule as not a major rule, as defined by 5 U.S.C.

804(2). Catalog of Federal Domestic Assistance The Catalog of Federal Domestic Assistance numbers and titles for the programs affected by this document are. 64.007, Blind Rehabilitation Centers. 64.008, Veterans Domiciliary Care.

64.009, Veterans Medical Care Benefits. 64.010, Veterans Nursing Home Care. 64.011, Veterans Dental Care. 64.012, Veterans Prescription Service.

64.013, Veterans Prosthetic Appliances. 64.018, Sharing Specialized Medical Resources. 64.019, Veterans Rehabilitation Alcohol and Drug Dependence. 64.022, Veterans Home Based Primary Care.

64.039 CHAMPVA. 64.040 VHA Inpatient Medicine. 64.041 VHA Outpatient Specialty Care. 64.042 VHA Inpatient Surgery.

64.043 VHA Mental Health Residential. 64.044 VHA Home Care. 64.045 VHA Outpatient Ancillary Services. 64.046 VHA Inpatient Psychiatry.

64.047 VHA Primary Care. 64.048 VHA Mental Health Clinics. 64.049 VHA Community Living Center. And 64.050 VHA Diagnostic Care.

Start List of Subjects Administrative practice and procedureAlcohol abuseAlcoholismClaimsDay careDental healthDrug abuseForeign relationsGovernment contractsGrant programs-healthGrant programs-veteransHealth careHealth facilitiesHealth professionsHealth recordsHomelessMedical and dental schoolsMedical devicesMedical researchMental health programsNursing homesReporting and recordkeeping requirementsScholarships and fellowshipsTravel and transportation expensesVeterans End List of Subjects Signing Authority The Secretary of Veterans Affairs, or designee, approved this document and authorized the undersigned to sign and submit the document to the Office of the Federal Register for publication electronically as an official document of the Department of Veterans Affairs. Brooks D. Tucker, Assistant Secretary for Congressional and Legislative Affairs, Performing the Delegable Duties of the Chief of Staff, Department of Veterans Affairs, approved this document on October 19, 2020, for publication. Start Signature Consuela Benjamin, Regulations Development Coordinator, Office of Regulation Policy &.

Management, Office of the Secretary, Department of Veterans Affairs. End Signature For the reasons stated in the preamble, the Department of Veterans Affairs is amending 38 CFR part 17 as set forth below. Start Part End Part Start Amendment Part1. The authority citation for part 17 is amended by adding an entry for § 17.419 in numerical order to read in part as follows.

End Amendment Part Start Authority 38 U.S.C. 501, and as noted in specific sections. End Authority * * * * * Section 17.419 also issued under 38 U.S.C. 1701 (note), 7301, 7306, 7330A, 7401-7403, 7405, 7406, 7408).

* * * * * Start Amendment Part2. Add § 17.419 to read as follows. End Amendment Part Health care professionals' practice in VA. (a) Definitions.

The following definitions apply to this section. (1) Beneficiary. The term beneficiary means a veteran or any other individual receiving health care under title 38 of the United States Code. (2) Health care professional.

The term health care professional is an individual who. (i) Is appointed to an occupation in the Veterans Health Administration that is listed in or authorized under 38 U.S.C. 7306, 7401, 7405, 7406, or 7408 or title 5 of the U.S. Code.

(ii) Is not a VA-contracted health care professional. And (iii) Is qualified to provide health care as follows. (A) Has an active, current, full, and unrestricted license, registration, certification, or satisfies another State requirement in a State. (B) Has other qualifications as prescribed by the Secretary for one of Start Printed Page 71846the health care professions listed under 38 U.S.C.

7402(b). (C) Is an employee otherwise authorized by the Secretary to provide health care services. Or (D) Is under the clinical supervision of a health care professional that meets the requirements of subsection (a)(2)(iii)(A)-(C) of this section and is either. (i) A health professions trainee appointed under 38 U.S.C.

7405 or 7406 participating in clinical or research training under supervision to satisfy program or degree requirements. Or (ii) A health care employee, appointed under title 5 of the U.S. Code, 38 U.S.C. 7401(1) or (3), or 38 U.S.C.

7405 for any category of personnel described in 38 U.S.C. 7401(1) or (3) who must obtain an active, current, full and unrestricted licensure, registration, certification, or meet the qualification standards as defined by the Secretary within the specified time frame. (3) State. The term State means a State as defined in 38 U.S.C.

101(20), or a political subdivision of such a State. (b) Health care professional's practice. (1) When a State law or license, registration, certification, or other requirement prevents or unduly interferes with a health care professional's practice within the scope of their VA employment, the health care professional is required to abide by their Federal duties, which includes, but is not limited to, the following situations. (i) A health care professional may practice their VA health care profession in any State irrespective of the State where they hold a valid license, registration, certification, or other State qualification.

Or (ii) A health care professional may practice their VA health care profession within the scope of the VA national standard of practice as determined by VA. (2) VA health care professional's practice is subject to the limitations imposed by the Controlled Substances Act, 21 U.S.C. 801 et seq. And implementing regulations at 21 CFR 1300 et seq., on the authority to prescribe or administer controlled substances, as well as any other limitations on the provision of VA care set forth in applicable Federal law and policy.

(c) Preemption of State law. Pursuant to the Supremacy Clause, U.S. Const. Art.

IV, cl. 2, and in order to achieve important Federal interests, including, but not limited to, the ability to provide the same complete health care and hospital service to beneficiaries in all States as required by 38 U.S.C. 7301, conflicting State laws, rules, regulations or requirements pursuant to such laws are without any force or effect, and State governments have no legal authority to enforce them in relation to actions by health care professionals within the scope of their VA employment. End Supplemental Information [FR Doc.

2020-24817 Filed 11-10-20. 8:45 am]BILLING CODE 8320-01-P.

Start Preamble low price ventolin Census Bureau, Commerce. Notice of information collection. Request for comment low price ventolin.

The Department of Commerce, in accordance with the Paperwork Reduction Act (PRA) of 1995, invites the general public and other Federal agencies to comment on proposed, and continuing information collections, which helps us assess the impact of our information collection requirements and minimize the public's reporting burden. The purpose low price ventolin of this notice is to allow for an additional 60 days of public comment on a proposed new information collection, the Management and Organizational Practices Survey—Hospitals (MOPS-HP). An information collection request (ICR) for the MOPS-HP was submitted to OMB for approval on July 7, 2020 and is currently pending OMB review.

To ensure consideration, comments regarding this proposed information collection must be received on or before January 19, 2021. Interested persons low price ventolin are invited to submit written comments by email to Thomas.J.Smith@census.gov. Please reference Management and Organizational Practices Survey—Hospitals (MOPS-HP) in the subject line of your comments.

You may also submit comments, identified by Docket Number low price ventolin USBC-2020-0029, to the Federal e-Rulemaking Portal. Http://www.regulations.gov. All comments received are part of the public record.

No comments will be low price ventolin posted to http://www.regulations.gov for public viewing until after the comment period has closed. Comments will generally be posted without change. All Personally low price ventolin Identifiable Information (for example, name and address) voluntarily submitted by the commenter may be publicly accessible.

Do not submit Confidential Business Information or otherwise sensitive or protected information. You may submit attachments to electronic comments in Microsoft Word, Excel, or Adobe PDF file formats. Start Further Info Requests for additional information or specific questions related to collection activities should be directed to low price ventolin Edward Watkins at edward.e.watkins.iii@census.gov or 301-763-4750.

End Further Info End Preamble Start Supplemental Information I. Abstract The low price ventolin U.S. Census Bureau plans to conduct the Management and Organizational Practices Survey-Hospitals (MOPS-HP) for survey year 2020 as a joint project with Harvard Business School.

The MOPS-HP will utilize a subset of the Service Annual Survey mail-out sample and will collect data on management practices from Chief Nursing Officers (CNOs) at general medical and surgical hospitals to assist in studying their relationship to clinical and financial performance low price ventolin. A notice seeking public comment on our plans to conduct this survey was previously published in the Federal Register on February 12, 2020, on pages 4623-4624. That notice proposed collecting data for survey years 2019 and 2014, but collection has been adjusted due to the ongoing asthma ventolin.

The ventolin low price ventolin has further highlighted the relevance of hospital management practices, especially as they relate to hospitals' abilities to respond to shocks to their organization and the health care system. In light of this, the Census Bureau has modified the survey proposal to collect data for reference years 2020 and 2019. This change seeks to directly measure management practices and protocols before and during the ventolin to obtain a better understanding of how hospitals have had to adjust and pivot low price ventolin operations during this public health emergency.

The Census Bureau also plans to include two additional questions in the MOPS-HP content to help improve measurement of hospital preparedness. These questions will provide information on two elements of responsiveness, hospitals' coordinated deployment of frontline clinical workers and hospitals' ability to quickly respond to needed changes in standardized clinical protocols. In an low price ventolin effort to limit respondent burden while adding this content, adjustments were made to keep the total number of questions and estimated burden per response unchanged.

The project plan, schedule, and collection strategy are being actively monitored, and adjustments will be made as necessary, as the Census Bureau is cognizant and respectful of the time, resources, and burden placed on CNOs during the ventolin. After the close of this second comment period, the low price ventolin Census Bureau will submit these planned changes as an amendment to the ICR, which is currently pending review at OMB. Any comments received by the close of the comment period will be summarized and included in the amendment.

Currently, no official statistics on management practices in hospitals exist. Past research shows low price ventolin these practices are related to health care providers' clinical and financial outcomes. This suggests that providing measures on management practices may potentially help the United States health care system, which is challenged by rising health care costs, increased demand from an aging society, and quality objectives.

These data would permit users to examine relationships between low price ventolin management practices and financial outcomes using Census Bureau data (e.g., revenues) and relationships with clinical outcomes using external data sources. Additionally, these data would provide hospital administrators and managers information to evaluate their practices in comparison to other hospitals at an aggregate level. The MOPS-HP content was proposed by external low price ventolin researchers with past experience in surveying hospitals on management practices.

Some questions are adapted from the Management and Organizational Practices Survey (MOPS), conducted in the manufacturing sector, allowing for inter-sectoral comparisons. Content for the MOPS-HP includes performance monitoring, financial and clinical targets, and incentives. The 39 questions are grouped low price ventolin into the following sections.

Tenure, Management Practices, Management Training, Management of Team Interactions, Staffing and Allocation of Human Resources, Standardized Clinical Protocols, Documentation of Patients' Medical Records, and Organizational Characteristics.Start Printed Page 73674 II. Method of Collection The MOPS-HP sample will consist of approximately 3,200 hospital locations for enterprises classified under General Medical and Surgical Hospitals (NAICS 6221) and sampled in low price ventolin the Service Annual Survey (SAS). The survey will be mailed separately from the 2020 SAS and collected electronically through the Census Bureau's Centurion online reporting system.

Respondents will be sent an initial letter with instructions detailing how to log into the instrument and report their information. These letters will be addressed to the low price ventolin location's CNO. In instances where the CNO is not identifiable, the letter will be addressed to the hospital's administrative office with attention to the CNO.

Collection is low price ventolin scheduled to begin in the initial months of 2021. III. Data OMB Control Number.

Type of Review. Regular submission, New Information Collection Request. Affected Public.

General medical and surgical hospitals. Estimated Number of Respondents. Approximately 3,200.

Estimated Time per Response. 45 minutes. Estimated Total Annual Burden Hours.

2,400. Estimated Total Annual Cost to Public. $0.

(This is not the cost of respondents' time, but the indirect costs respondents may incur for such things as purchases of specialized software or hardware needed to report, or expenditures for accounting or records maintenance services required specifically by the collection.) Respondent's Obligation. Mandatory. Legal Authority.

Title 13 U.S.C., Sections 131 and 182. IV. Request for Comments We are soliciting public comments to permit the Department/Bureau to.

(a) Evaluate whether the proposed information collection is necessary for the proper functions of the Department, including whether the information will have practical utility. (b) Evaluate the accuracy of our estimate of the time and cost burden for this proposed collection, including the validity of the methodology and assumptions used. (c) Evaluate ways to enhance the quality, utility, and clarity of the information to be collected.

And (d) Minimize the reporting burden on those who are to respond, including the use of automated collection techniques or other forms of information technology. Comments that you submit in response to this notice are a matter of public record. We will include, or summarize, each comment in our request to OMB to approve this ICR.

Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you may ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so. Start Signature Sheleen Dumas, Department PRA Clearance Officer, Office of the Chief Information Officer, Commerce Department.

End Signature End Supplemental Information [FR Doc. 2020-25580 Filed 11-18-20. 8:45 am]BILLING CODE 3510-07-PStart Preamble Department of Veterans Affairs.

Interim final rule. The Department of Veterans Affairs (VA) is issuing this interim final rule to confirm that its health care professionals may practice their health care profession consistent with the scope and requirements of their VA employment, notwithstanding any State license, registration, certification, or other requirements that unduly interfere with their practice. Specifically, this rulemaking confirms VA's current practice of allowing VA health care professionals to deliver health care services in a State other than the health care professional's State of licensure, registration, certification, or other State requirement, thereby enhancing beneficiaries' access to critical VA health care services.

This rulemaking also confirms VA's authority to establish national standards of practice for health care professionals which will standardize a health care professional's practice in all VA medical facilities. Effective Date. This rule is effective on November 12, 2020.

Comments. Comments must be received on or before January 11, 2021. Comments may be submitted through www.Regulations.gov or mailed to, Beth Taylor, 10A1, 810 Vermont Avenue NW, Washington, DC 20420.

Comments should indicate that they are submitted in response to [“RIN 2900-AQ94—Authority of VA Professionals to Practice Health Care.”] Comments received will be available at regulations.gov for public viewing, inspection, or copies. Start Further Info Beth Taylor, Chief Nursing Officer, Veterans Health Administration. 810 Vermont Avenue NW, Washington, DC 20420, (202) 461-7250.

(This is not a toll-free number.) End Further Info End Preamble Start Supplemental Information On January 30, 2020, the World Health Organization (WHO) declared the asthma treatment outbreak to be a Public Health Emergency of International Concern. On January 31, 2020, the Secretary of the Department of Health and Human Services declared a Public Health Emergency pursuant to 42 United States Code (U.S.C.) 247d, for the entire United States to aid in the nation's health care community response to the asthma treatment outbreak. On March 11, 2020, in light of new data and the rapid spread in Europe, WHO declared asthma treatment to be a ventolin.

On March 13, 2020, the President declared a National Emergency due to asthma treatment under sections 201 and 301 of the National Emergencies Act (50 U.S.C. 1601 et seq.) and consistent with section 1135 of the Social Security Act (SSA), as amended (42 U.S.C. 1320b-5).

As a result of responding to the needs of our veteran population and other non-veteran beneficiaries during the asthma treatment National Emergency, where VA has had to shift health care Start Printed Page 71839professionals to other locations or duties to assist in the care of those affected by this ventolin, VA has become acutely aware of the need to promulgate this rule to clarify the policies governing VA's provision of health care. This rule is intended to confirm that VA health care professionals may practice their health care profession consistent with the scope and requirements of their VA employment, notwithstanding any State license, registration, certification, or other requirements that unduly interfere with their practice. In particular, it will confirm (1) VA's continuing practice of authorizing VA health care professionals to deliver health care services in a State other than the health care professional's State of licensure, registration, certification, or other requirement.

And (2) VA's authority to establish national standards of practice for health care professions via policy, which will govern their employment, subject only to State laws where the health care professional is licensed, credentialed, registered, or subject to some other State requirements that do not unduly interfere with those duties. We note that the term State as it applies to this rule means each of the several States, Territories, and possessions of the United States, the District of Columbia, and the Commonwealth of Puerto Rico, or a political subdivision of such State. This definition is consistent with the term State as it is defined in 38 U.S.C.

101(20). A conflicting State law is one that would unduly interfere with the fulfillment of a VA health care professional's Federal duties. We note that the policies and practices confirmed in this rule only apply to VA health care professionals appointed under 38 U.S.C.

7306, 7401, 7405, 7406, or 7408 or title 5 of the U.S. Code, which does not include contractors working in VA medical facilities or those working in the community. VA has long understood its governing statutory authorities to permit VA to engage in these practices.

Section 7301(b) of title 38 the U.S. Code establishes that the primary function of the Veterans Health Administration (VHA) within VA is to provide a complete medical and hospital service for the medical care and treatment of veterans. To allow VHA to carry out its medical care mission, Congress established a comprehensive personnel system for certain VA health care professionals, independent of the civil service rules.

See Chapters 73-74 of title 38 of the U.S. Code. Congress granted the Secretary express statutory authority to establish the qualifications for VA's health care professionals, determine the hours and conditions of employment, take disciplinary action against employees, and otherwise regulate the professional activities of those individuals.

38 U.S.C. 7401-7464. Section 7402 of 38 U.S.C.

Establishes the qualifications of appointees. To be eligible for appointment as a VA employee in a health care profession covered by section 7402(b) (other than a medical facility Director appointed under section 7402(b)(4)), most individuals, after appointment, must, among other requirements, be licensed, registered, or certified to practice their profession in a State, or satisfy some other State requirement. However, the standards prescribed in section 7402(b) establish only the basic qualifications for VA health care professionals and do not limit the Secretary from establishing other qualifications or rules for health care professionals.

In addition, the Secretary is responsible for the control, direction, and management of the Department, including agency personnel and management matters. See 38 U.S.C. 303.

Such authorities permit the Secretary to further regulate the health care professions to make certain that VA's health care system provides safe and effective health care by qualified health care professionals to ensure the well-being of those veterans who have borne the battle. In this rulemaking, VA is detailing its authority to manage its health care professionals by stating that they may practice their health care profession consistent with the scope and requirements of their VA employment, notwithstanding any State license, registration, certification, or other State requirements that unduly interfere with their practice. VA believes that this is necessary in order to provide additional protection for VA health care professionals against adverse State actions proposed or taken against them when they are practicing within the scope of their VA employment, particularly when they are practicing across State lines or when they are performing duties consistent with a VA national standard of practice for their health care profession.

Practice Across State Lines Historically, VA has operated as a national health care system that authorizes VA health care professionals to practice in any State as long as they have a valid license, registration, certification, or fulfill other State requirements in at least one State. In doing so, VA health care professionals have been practicing within the scope of their VA employment regardless of any unduly burdensome State requirements that would restrict practice across State lines. We note, however, that VA may only hire health care professionals who are licensed, registered, certified, or satisfy some other requirement in a State, unless the statute requires or provides otherwise (e.g., 38 U.S.C.

7402(b)(14)). The asthma treatment ventolin has highlighted VA's acute need to exercise its statutory authority of allowing VA health care professionals to practice across State lines. In response to the ventolin, VA needed to and continues to need to move health care professionals quickly across the country to care for veterans and other beneficiaries and not have State licensure, registration, certification, or other State requirements hinder such actions.

Put simply, it is crucial for VA to be able to determine the location and practice of its VA health care professionals to carry out its mission without any unduly burdensome restrictions imposed by State licensure, registration, certification, or other requirements. This rulemaking will support VA's authority to do so and will provide an increased level of protection against any adverse State action being proposed or taken against VA health care professionals who practice within the scope of their VA employment. Since the start of the ventolin, in furtherance of VA's Fourth Mission, VA has rapidly utilized its resources to assist parts of the country that are undergoing serious and critical shortages of health care resources.

VA's Fourth Mission is to improve the Nation's preparedness for response to war, terrorism, national emergencies, and natural disasters by developing plans and taking actions to ensure continued service to veterans, as well as to support national, State, and local emergency management, public health, safety and homeland security efforts. VA has deployed personnel to support other VA medical facilities that have been impacted by asthma treatment as well as provided support to State and community nursing homes. As of July 2020, VA has deployed personnel to more than 45 States.

VA utilized the Disaster Emergency Medical Personnel System (DEMPS), VA's main deployment program, for VA health care professionals to travel to locations deemed as national emergency or disaster areas, to help provide health care services in places such as New Orleans, Louisiana, and New York City, New York. As of June 2020, a total of 1,893 staff have been mobilized to meet the needs of our facilities and Fourth Start Printed Page 71840Mission requests during the ventolin. VA deployed 877 staff to meet Federal Emergency Management Agency (FEMA) Mission requests, 420 health care professionals were deployed as DEMPS response, 414 employees were mobilized to cross level staffing needs within their Veterans Integrated Service Networks (VISN), 69 employees were mobilized to support needs in another VISN, and 113 Travel Nurse Corps staff responded specifically for asthma treatment staffing support.

In light of the rapidly changing landscape of the ventolin, it is crucial for VA to be able to move its health care professionals quickly across the country to assist when a new hot spot emerges without fear of any adverse action from a State be proposed or taken against a VA health care professional. We note that, in addition to providing in person health care across State lines during the ventolin, VA also provides telehealth across State lines. VA's video to home services have been heavily leveraged during the ventolin to deliver safe, quality VA health care while adhering to Centers for Disease Control and Prevention (CDC) physical distancing guidelines.

Video visits to veterans' homes or other offsite location have increased from 41,425 in February 2020 to 657,423 in July of 2020. This represents a 1,478 percent utilization increase. VA has specific statutory authority under 38 U.S.C.

1730C to allow health care professionals to practice telehealth in any State regardless of where they are licensed, registered, certified, or satisfy some other State requirement. This rulemaking is consistent with Congressional intent under Public Law 115-185, sec. 151, June 6, 2018, codified at 38 U.S.C.

1730C for all VA health care professionals to practice across State lines regardless of the location of where they provide health care. This rulemaking will ensure that VA professionals are protected regardless of how they provide health care, whether it be via telehealth or in-person. Beyond the current need to mobilize health care resources quickly to different parts of the country, this practice of allowing VA health care professionals to practice across State lines optimizes the VA health care workforce to meet the needs of all VA beneficiaries year-round.

It is common practice within the VA health care system to have primary and specialty health care professionals routinely travel to smaller VA medical facilities or rural locations in nearby States to provide care that may be difficult to obtain or unavailable in that community. As of January 14, 2020, out of 182,100 licensed health care professionals who are employed by VA, 25,313 or 14 percent do not hold a State license, registration, or certification in the same State as their main VA medical facility. This number does not include the VA health care professionals who practice at a main VA medical facility in one State where they are licensed, registered, certified, or hold some other State requirement, but also practice at a nearby Community Based Outpatient Clinic (CBOC) in a neighboring State where they do not hold such credentials.

Indeed, 49 out of the 140 VA medical facilities nationwide have one or more sites of care in a different State than the main VA medical facility. Also, VA has rural mobile health units that provide health care services to veterans who have difficulty accessing VA health care facilities. These mobile units are a vital source of health care to veterans who live in rural and medically underserved communities.

Some of the services provided by the mobile units include, but are not limited to, health care screening, mental health outreach, influenza and pneumonia vaccinations, and routine primary care. The rural mobile health units are an integral part of VA's goal of encouraging healthier communities and support VA's preventative health programs. Health care professionals who provide health care in these mobile units may provide services in various States where they may not hold a license, registration, or certification, or satisfy some other State requirement.

It is critical that these health care professionals are protected from any adverse State action proposed or taken when performing these crucial services. In addition, the practice of health care professionals of providing health care across State lines also gives VA the flexibility to hire qualified health care professionals from any State to meet the staffing needs of a VA health care facility where recruitment or retention is difficult. As of December 31, 2019, VA had approximately 13,000 vacancies for health care professions across the country.

As a national health care system, it is imperative for VA to be able to recruit and retain health care professionals, where recruitment and retention is difficult, to ensure there is access to health care regardless of where the VA beneficiary resides. Permitting VA health care professionals to practice across State lines is an important incentive when trying to recruit for these vacancies, particularly during a ventolin, where private health care facilities have greater flexibility to offer more competitive pay and benefits. This is also especially beneficial in recruiting spouses of active service members who frequently move across the country.

National Standard of Practice This rulemaking also confirms VA's authority to establish national standards of practice for health care professions. We note that this rulemaking does not create any such national standards. All national standards of practice will be created via policy.

For the purposes of this rulemaking, a national standard of practice describes the tasks and duties that a VA health care professional practicing in the health care profession may perform and may be permitted to undertake. Having a national standard of practice means that individuals from the same VA health care profession may provide the same type of tasks and duties regardless of the VA medical facility where they are located or the State license, registration, certification, or other State requirement they hold. We emphasize that VA will determine, on an individual basis, that a health care professional has the necessary education, training, and skills to perform the tasks and duties detailed in the national standard of practice.

The need for national standards of practice have been highlighted by VA's large-scale initiative regarding the new electronic health record (EHR). VA's health care system is currently undergoing a transformational initiative to modernize the system by replacing its current EHR with a joint EHR with Department of Defense (DoD) to promote interoperability of medical data between VA and DoD. VA's new EHR system will provide VA and DoD health care professionals with quick and efficient access to the complete picture of a veteran's health information, improving VA's delivery of health care to our nation's veterans.

For this endeavor, DoD and VA established a joint governance over the EHR system. In order to be successful, VA must standardize clinical processes with DoD. This means that all health care professionals in DoD and VA who practice in a certain health care profession must be able to carry out the same duties and tasks irrespective of State requirements.

The reason why this is important is because each health care profession is designated a role in the EHR system that sets forth specific privileges within the EHR that dictate allowed tasks for such profession. These tasks include, but are not limited to, dispensing and administrating medications. Prescriptive practices.

Ordering of procedures and diagnostic imaging. And required level of oversight. VA has the ability to modify these privileges within EHR, however, VA Start Printed Page 71841cannot do so on an individual user level, but rather at the role level for each health care profession.

In other words, VA cannot modify the privileges for all health care professionals in one State to be consistent with that State's requirements. Instead, the privileges can only be modified for every health care professional in that role across all States. Therefore, the privileges established within EHR cannot be made facility or State specific.

In order to achieve standardized clinical processes, VA and DoD must create the uniform standards of practice for each health care specialty. Currently, DoD has specific authority from Congress to create national standards of practice for their health care professionals under 10 U.S.C. 1094.

While VA lacks a similarly specific statute, VA has the general statutory authority, as explained above, to regulate its health care professionals and authorize health care practices that preempt conflicting State law. This regulation will confirm VA's authority to do so. Absent such standardized practices, it will be incredibly difficult for VA to achieve its goal of being an active participant in EHR modernization because either some VA health care professionals would fear potential adverse State actions or DoD and VA would need to agree upon roles that are consistent with the most restrictive States' requirements to ensure that all health care professionals are acting within the scope of their State requirements.

VA believes that agreement upon roles that are consistent with the most restrictive State is not an acceptable option because it will lead to delayed care and consequently decreased access and level of health care for VA beneficiaries. One example that impacts multiple health care professions throughout the VA system is the ability to administer medication without a provider (physician or advanced practice nurse practitioner) co-signature. As it pertains to nursing, almost all States permit nurses to follow a protocol.

However, some States, such as New York, North Carolina, and South Carolina, do not permit nurses to follow a protocol without a provider co-signature. A protocol is a standing order that has been approved by medical and clinical leadership if a certain sequence of health care events occur. For instance, if a patient is exhibiting certain signs of a heart attack, there is a protocol in place to administer potentially life-saving medication.

If the nurse is the first person to see the signs, the nurse will follow the approved protocol and immediately administer the medication. However, if the nurse cannot follow the protocol and requires a provider co-signature, administration of the medication will be delayed until a provider is able to co-sign the order, which may lead to the deterioration of the patient's condition. This also increases the provider's workload and decreases the amount of time the provider can spend with patients.

Historically, VA physical therapists (PTs), occupational therapists, and speech therapists were routinely able to determine the need to administer topical medications during therapy sessions and were able to administer the topical without a provider co-signature. However, in order to accommodate the new EHR system and variance in State requirements, these therapists would need to place an order for all medications, including topicals, which would leave these therapists waiting for a provider co-signature in the middle of a therapy session, thus delaying care. Furthermore, these therapists also routinely ordered imaging to better assess the clinical needs of the patient, but would also have to wait for a provider co-signature, which will further delay care and increase provider workload.

In addition to requiring provider co-signatures, there will also be a significant decrease in access to care due to other variances in State requirements. For instance, direct access to PTs will be limited in order to ensure that the role is consistent with all State requirements. Direct access means that a beneficiary may request PT services without a provider's referral.

However, while almost half of the States allow unrestricted direct access to PTs, over half of the States have some limitations on requesting PT services. For instance, in Alabama, a licensed PT may perform an initial evaluation and may only provide other services as delineated in specific subdivisions of the Alabama Physical Therapy Practice Act. Furthermore, in New York, PT treatment may be rendered by a licensed PT for 10 visits or 30 days, whichever shall occur first, without a referral from a physician, dentist, podiatrist, nurse practitioner, or licensed midwife.

This is problematic as VA will not be able to allow for direct access due to these variances and direct access has been shown to be beneficial for patient care. Currently, VISN 23 is completing a two-year strategic initiative to implement direct access and have PTs embedded into patient aligned care teams (PACT). Outcomes thus far include decreased wait times, improved veteran satisfaction, improved provider satisfaction, and improved functional outcomes.

Therefore, VA will confirm its authority to ensure that health care professionals are protected against State action when they adhere to VA's national standards of practice. We reiterate that this rulemaking does not establish national standards of practice for each health care profession, but merely confirms VA's authority to do so, thereby preempting any State restrictions that unduly interfere with those practices. The actual national standards of practice will be developed in subregulatory policy for each health care profession.

As such, VA will make a concerted effort to engage appropriate stakeholders when developing the national standards of practice. Preemption As previously explained, in this rulemaking, VA is confirming its authority to manage its health care professionals. Specifically, this rulemaking will confirm VA's long-standing practice of allowing its health care professionals to practice in a State where they do not hold a license, registration, certification, or satisfy some other State requirement.

The rule will also confirm that VA health care professionals must adhere to VA's national standards of practice, as determined by VA policy, irrespective of conflicting State licensing, registration, certification, or other State requirements that unduly burden that practice. We do note that VA health care professionals will only be required to perform tasks and duties to the extent of their education, skill, and training. For instance, VA would not require a registered nurse to perform a task that the individual nurse was not trained to perform.

Currently, practice in accordance with VA employment, including practice across State lines or adhering to a VA standard of practice, may jeopardize VA health care professionals' credentials or result in fines and imprisonment for unauthorized health care practice. This is because most States have restrictions that limit health care professionals' practice or have rules that prohibit health care professionals from furnishing health care services within that State without a license, registration, certification, or other requirement from that State. We note that, some States, for example Rhode Island, Utah, and Michigan, have enacted legislation or regulations that specifically allow certain VA health care professionals to practice in those States when they do not hold a State license.

Several VA health care professionals have already had actions proposed or taken against them by various States Start Printed Page 71842while practicing health care within the scope of their VA employment, while they either practiced in a State where they do not hold a license, registration, certification, or other State requirement that unduly interfered with their VA employment. In one instance, a VA psychologist was licensed in California but was employed and providing supervision of a trainee at the VA Medical Center (VAMC) in Nashville, Tennessee. California psychology licensing laws require supervisors to hold a license from the State where they are practicing and do not allow for California licensed psychologists to provide supervision to trainees or unlicensed psychologists outside the State of California.

The California State Psychology Licensing Board proposed sanctions and fines of $1,000 for violating section 1387.4(a) of the CA Code of Regulations (CCR). The VA system did not qualify for the exemption of out of State supervision requirements listed in CCR section 1387.4. In addition, a VA physician who was licensed in Oregon, but was practicing at a VAMC in Biloxi, Mississippi had the status of their license changed from active to inactive because the Oregon Medical Board determined the professional did not reside in Oregon, in violation of Oregon's requirement that a physician physically reside in the State in order to maintain an active license.

This rulemaking serves to preempt State requirements, such as the ones discussed above, that were or can be used to take an action against VA health care professionals for practicing within the scope of their VA employment. State licensure, registration, certification, and other State requirements are preempted to the extent such State laws unduly interfere with the ability of VA health care professionals to practice health care while acting within the scope of their VA employment. As explained above, Congress provided general statutory provisions that permit the VA Secretary to authorize health care practices by health care professionals at VA, which serve to preempt conflicting State laws that unduly interfere with the exercise of health care by VA health care professionals pursuant to that authorization.

Although some VA health care professionals are required by Federal statute to have a State license, see, e.g., 38 U.S.C. 7402(b)(1)(C) (providing that, to be eligible to be appointed to a physician position at the VA, a physician must be licensed to practice medicine, surgery, or osteopathy in a State), a State may not attach a condition to the license that is unduly burdensome to or unduly interferes with the practice of health care within the scope of VA employment. Under well-established interpretations of the Supremacy Clause, Federal laws and policies authorizing VA health care professionals to practice according to VA standards preempt conflicting State law.

That is, a State law that prevents or unreasonably interferes with the performance of VA duties. See, e.g., Hancock v. Train, 426 U.S.

167, 178-81 (1976). Sperry v. Florida, 373 U.S.

379, 385 (1963). Miller v. Arkansas, 352 U.S.

276, 282-84 (1899). State Bar Disciplinary Rules as Applied to Federal Government Attorneys, 9 Op. O.L.C.

71, 72-73 (1985). When a State law does not conflict with the performance of Federal duties in these ways, VA health care professionals are required to abide by the State law. Therefore, VA's policies and regulations will preempt State licensure, registration, and certification laws, rules, or other requirements only to the extent they conflict with the ability of VA health care professionals to practice health care while acting within the scope of their VA employment.

We emphasize that, in instances where there is no conflict with State requirements, VA health care professionals should abide by the State requirement. For example, if a State license requires a health care professional to have a certain number of hours of continuing professional education per year to maintain their license, the health care professional must adhere to this State requirement if it does not prevent or unduly interfere with the exercise of VA employment. To determine whether a State requirement is conflicting, VA would assess whether the State law unduly interferes on a case-by-case basis.

For instance, if Oregon requires all licensed physicians to reside in Oregon, VA would likely find that it unduly interferes with already licensed VA physicians who reside and work for VA in the State of Mississippi. We emphasize that the intent of the regulation is to only preempt State requirements that are unduly burdensome and interfere with a VA health care professionals' practice for the VA. For instance, it would not require a State to issue a license to an individual who does not meet the education requirements to receive a license in that State.

We note that this rulemaking also does not affect VA's existing requirement that all VA health care professionals adhere to restrictions imposed by the Controlled Substances Act, 21 U.S.C. 801 et seq. And implementing regulations at 21 CFR 1300, et seq., to prescribe or administer controlled substances.

Any preemption of conflicting State requirements will be the minimum necessary for VA to effectively furnish health care services. It would be costly and time-consuming for VA to lobby each State board for each health care profession specialty to remove restrictions that impair VA's ability to furnish health care services to beneficiaries and then wait for the State to implement appropriate changes. Doing so would not guarantee a successful result.

Regulation For these reasons, VA is establishing a new regulation titled Health care professionals' practice in VA, which will be located at 38 CFR 17.419. This rule will confirm the ability of VA health care professionals to practice their health care profession consistent with the scope and requirements of their VA employment, notwithstanding any State license, registration, certification, or other requirements that unduly interfere with their practice. Subsection (a) of § 17.419 contains the definitions that will apply to the new section.

Subsection (a)(1) contains the definition for beneficiary. We are defining the term beneficiary to mean a veteran or any other individual receiving health care under title 38 of the U.S. Code.

We are using this definition because VA provides health care to veterans, certain family members of veterans, servicemembers, and others. This is VA's standard use of this term. Subsection (a)(2) contains the definition for health care professional.

We are defining the term health care professional to be an individual who meets specific criteria that is listed below. Subsection (a)(2)(i) will require that a health care professional be appointed to an occupation in VHA that is listed or authorized under 38 U.S.C. 7306, 7401, 7405, 7406, or 7408 or title 5 of the U.S.

Code. Subsection (a)(2)(ii) requires that the individual is not a VA-contracted health care professional. A health care professional does not include a contractor or a community health care professional because they are not considered VA employees nor appointed under 38 U.S.C.

7306, 7401, 7405, 7406, or 7408 or title 5 of the U.S. Code. Subsection (a)(2)(iii) lists the required qualifications for a health care professional.

We note that these qualifications do not include all general Start Printed Page 71843qualifications for appointment, such as to hold a degree of doctor of medicine. These qualifications are related to licensure, registration, certification, or other State requirements. Subsection (a)(2)(iii)(A) states that the health care professional must have an active, current, full, and unrestricted license, registration, certification, or satisfies another State requirement in a State to practice the health care specialty identified under 38 U.S.C.

7402(b). This standard ensures that VA health care professionals are qualified to practice their individual health care specialty if the specialty requires such credential. Subsection (a)(2)(iii)(B) states that the individual has other qualifications as prescribed by the Secretary for one of the health care professions listed under 38 U.S.C.

7402(b). Some health care professionals appointed under 38 U.S.C. 7401(3) whose qualifications are listed in 38 U.S.C.

7402(b) are not required to meet State license, registration, certification, or other requirements and rely on the qualifications prescribed by the Secretary. Therefore, these individuals would be included in this subsection and required to have the qualifications prescribed by the Secretary for their health care profession. Subsection (a)(2)(iii)(C) states that the individual is otherwise authorized by the Secretary to provide health care services.

This would include those individuals who practice a health care profession that does not require a State license, registration, certification, or other requirement and is also not listed in 38 U.S.C. 7402(b), but is authorized by the Secretary to provide health care services. Subsection (a)(2)(iii)(D) includes individuals who are trainees or may have a time limited appointment to finish clinicals or other requirements prior to being fully licensed.

Therefore, the regulation will state that the individual is under the clinical supervision of a health care professional that meets the requirements listed in subsection (a)(2)(iii)(A)-(C) and the individual must meet the requirements in subsection (a)(2)(iii)(D)(i) or (a)(2)(iii)(D)(ii). Subsection (a)(2)(iii)(D)(i) states that the individual is a health professions trainee appointed under 38 U.S.C. 7405 or 7406 participating in clinical or research training under supervision to satisfy program or degree requirements.

Subsection (a)(2)(iii)(D)(ii) states that the individual is a health care employee, appointed under title 5 of the U.S. Code, 38 U.S.C. 7401(1) or (3), or 38 U.S.C.

7405 for any category of personnel described in 38 U.S.C. 7401(1) or (3) who must obtain an active, current, full and unrestricted licensure, registration, or certification or meet the qualification standards as defined by the Secretary within the specified time frame. These individuals have a time-limited appointment to obtain credentials.

For example, marriage and family therapists require a certain number of supervised clinical post-graduate hours prior to receiving their license. Lastly, as we previously discussed in this rulemaking, we are defining the term State in subsection (a)(3) as the term is defined in 38 U.S.C. 101(20), and also including political subdivisions of such States.

This is consistent with the definition of State in 38 U.S.C. 1730C(f) which is VA's statutory authority to preempt State law when the covered health care professional is using telehealth to provide treatment to an individual under this title. We believe that it is important to define the term in the same way as it is defined for health care professionals practicing via telehealth so that way it is consistent regardless of whether the health care professional is practicing in-person or via telehealth.

Moreover, as subdivisions of a State are granted legal authority from the State itself, it makes sense to subject entities created by a State, or authorized by a State to create themselves, to be subject to the same limitations and restrictions as the State itself. Section 17.419(b) details that VA health care professionals must practice within the scope of their Federal employment irrespective of conflicting State requirements that would prevent or unduly interfere with the exercise of Federal duties. This provision confirms that VA health care professionals may furnish health care consistent with their VA employment obligations without fear of adverse action proposed or taken by any State.

In order to clarify and make transparent how VA utilizes or intends to utilize our current statutory authority, we are providing a non-exhaustive list of examples. The first example is listed in subsection (b)(1)(i). It states that a health care professional may practice their VA health care profession in any State irrespective of the State where they hold a valid license, registration, certification, or other qualification.

The second example is listed in subsection (b)(1)(ii). It states that a health care professional may practice their VA health care profession consistent with the VA national standard of practice as determined by VA. As previously explained, VA intends to establish national standards of practice via VA policy.

A health care professional's practice within VA will continue to be subject to the limitations imposed by the Controlled Substances Act, 21 U.S.C. 801, et seq. And implementing regulations at 21 CFR 1300, et seq., on the authority to prescribe or administer controlled substances, as well as any other limitations on the provision of VA care set forth in applicable Federal law and policy.

This will ensure that professionals are still in compliance with critical laws concerning the prescribing and administering of controlled substances. This requirement is stated in subsection (b)(2). Subsection (c) expressly states the intended preemptive effect of § 17.419, to ensure that conflicting State and local laws, rules, regulations, and requirements related to health care professionals' practice will have no force or effect when such professionals are practicing health care while working within the scope of their VA employment.

In circumstances where there is a conflict between Federal and State law, Federal law would prevail in accordance with Article VI, clause 2, of the U.S. Constitution. Executive Order 13132 establishes principles for preemption of State law when it is implicated in rulemaking or proposed legislation.

Where a Federal statute does not expressly preempt State law, agencies shall construe any authorization in the statute for the issuance of regulations as authorizing preemption of State law by rulemaking only when the exercise of State authority directly conflicts with the exercise of Federal authority or there is clear evidence to conclude that the Congress intended the agency to have the authority to preempt State law. In this situation, the Federal statutes do not expressly preempt State laws. However, VA construes the authorization established in 38 U.S.C.

303, 501, and 7401-7464 as authorizing preemption because the exercise of State authority directly conflicts with the exercise of Federal authority under these statutes. Congress granted the Secretary express statutory authority to establish the qualifications for VA's health care professionals, determine the hours and conditions of employment, take disciplinary action against employees, and otherwise regulate the professional activities of those individuals. 38 U.S.C.

7401-7464. Specifically, section 7402(b) states that most health care professionals, after appointment by VA, must, among other Start Printed Page 71844requirements, be licensed, registered, or certified to practice their profession in a State. To that end, VA's regulations and policies will preempt any State law or action that conflicts with the exercise of Federal duties in providing health care at VA.

In addition, any regulatory preemption of State law must be restricted to the minimum level necessary to achieve the objectives of the statute pursuant to the regulations that are promulgated. In this rulemaking, State licensure, registration, and certification laws, rules, regulations, or other requirements are preempted only to the extent such State laws unduly interfere with the ability of VA health care professionals to practice health care while acting within the scope of their VA employment. Therefore, VA believes that the rulemaking is restricted to the minimum level necessary to achieve the objectives of the Federal statutes.

The Executive Order also requires an agency that is publishing a regulation that preempts State law to follow certain procedures. These procedures include. The agency consult with, to the extent practicable, the appropriate State and local officials in an effort to avoid conflicts between State law and Federally protected interests.

And the agency provide all affected State and local officials notice and an opportunity for appropriate participation in the proceedings. For the reasons below, VA believes that it is not practicable to consult with the appropriate State and local officials prior to the publication of this rulemaking. The National Emergency caused by asthma treatment has highlighted VA's acute need to quickly shift health care professionals across the country.

As both private and VA medical facilities in different parts of the country reach or exceed capacity, VA must be able to mobilize its health care professionals across State lines to provide critical care for those in need. As explained in the Supplementary Information above, as of June 2020, a total of 1,893 staff have been mobilized to meet the needs of our facilities and Fourth Mission requests during the ventolin. VA deployed 877 staff to meet Federal Emergency Management Agency (FEMA) Mission requests, 420 health care professionals were deployed as DEMPS response, 414 employees were mobilized to cross level staffing needs within their Veterans Integrated Service Networks (VISN), 69 employees were mobilized to support needs in another VISN, and 113 Travel Nurse Corps staff responded specifically for asthma treatment staffing support.

Given the speed in which it is required for our health care professionals to go to these facilities and provide health care, it is also essential that the health care professionals can follow the same standards of practice irrespective of the location of the facility or the requirements of their individual State license. This is important because if multiple health care professionals, such as multiple registered nurses, licensed in different States are all sent to one VA medical facility to assist when there is a shortage of professionals, it would be difficult and cumbersome if they could not all perform the same duties and each supervising provider had to be briefed on the tasks each registered nurse could perform. In addition, not having a uniform national scope of practice could limit the tasks that the registered nurses could provide.

This rulemaking will provide health care professionals an increased level of protection against adverse State actions while VA strives to increase access to high quality health care across the VA health care system during this National Emergency. It would be time consuming and contrary to the public health and safety to delay implementing this rulemaking until we consulted with State and local officials. For these reasons, it would be impractical to consult with State and local officials prior to the publication of this rulemaking.

We note that this rulemaking does not establish any national standards of practice. Instead, VA will establish the national standards of practice via subregulatory guidance. VA will, to the extent practicable, make all efforts to engage with State and local officials when establishing the national standards of practice via subregulatory guidance.

Also, this interim final rule will have a 60-day comment period that will allow State and local officials the opportunity to provide their input on the rule. Administrative Procedures Act An Agency may forgo notice and comment required under the Administrative Procedures Act (APA), 5 U.S.C. 553, if the agency for good cause finds that compliance would be impracticable, unnecessary, or contrary to the public interest.

An agency may also bypass the APA's 30-day publication requirement if good cause exists. The Secretary of Veterans Affairs finds that there is good cause under the provisions of 5 U.S.C. 553(b)(B) to publish this rule without prior opportunity for public comment because it would be impracticable and contrary to the public interest and finds that there is good cause under 5 U.S.C.

553(d)(3) to bypass its 30-day publication requirement for the same reasons as outlined above in the Federalism section, above. In short, this rulemaking will provide health care professionals protection against adverse State actions while VA strives to increase access to high quality health care across the VA health care system during this National Emergency. In addition to the needs discussed above regarding the National Emergency, it is also imperative that VA move its health care professionals across State lines in order to facilitate the implementation of the new EHR system immediately.

VA implemented EHR at the first VA facility in October 2020 and additional sites are scheduled to have EHR implemented over the course of the next eight years. The next site is scheduled for implementation in Quarter 2 of Fiscal Year 2021 (i.e., between January to March 2021). Due to the implementation of the new EHR system, VA expects decreased productivity and reduced clinical staffing during training and other events surrounding EHR enactment.

VA expects a productivity decrease of up to 30 percent for the 60 days before implementation and the 120 days after at each site. Any decrease in productivity could result in decreased access to health care for our Nation's veterans. In order to support this anticipated productivity decrease, VA is engaging in a “national supplement,” where health care professionals from other VA medical facilities will be deployed to those VA medical facilities and VISNs that are undergoing EHR implementation.

The national supplement would mitigate reduced access during EHR deployment activities, such as staff training, cutover, and other EHR implementation activities. Over the eight-year deployment timeline, the national supplement is estimated to have full time employee equivalents of approximately 60 nurses, 3 pharmacy technicians, 5 mental health and primary care providers, and other VA health care professionals. We note that the actual number of VA health care professionals deployed to each site will vary based on need.

The national supplement will require VA health care professionals on a national level to practice health care in States where they do not hold a State license, registration, certification, or other requirement. In addition, VISNs will be providing local cross-leveling and intra-VISN staff deployments to support EHRM implementation activities. Put simply, in order to mitigate the decreased Start Printed Page 71845productivity as a result of EHR implementation, VA must transfer VA health care professionals across the country to States where they do not hold a license, registration, certification, or other requirement to assist in training on the new system as well as to support patient care.

Therefore, it would be impracticable and contrary to the public health and safety to delay implementing this rulemaking until a full public notice-and-comment process is completed. This rulemaking will be effective upon publication in the Federal Register. As noted above, this interim final rule will have a 60-day comment period that will allow State and local officials the opportunity to provide their input on the rule, and VA will take those comments into consideration when deciding whether any modifications to this rule are warranted.

Paperwork Reduction Act This final rule contains no provisions constituting a collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). Regulatory Flexibility Act The Regulatory Flexibility Act, 5 U.S.C.

601-612, is not applicable to this rulemaking because a notice of proposed rulemaking is not required under 5 U.S.C. 553. 5 U.S.C.

601(2), 603(a), 604(a). Executive Orders 12866, 13563, and 13771 Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, and other advantages. Distributive impacts.

And equity). Executive Order 13563 (Improving Regulation and Regulatory Review) emphasizes the importance of quantifying both costs and benefits, reducing costs, harmonizing rules, and promoting flexibility. The Office of Information and Regulatory Affairs has determined that this rule is a significant regulatory action under Executive Order 12866.

VA's impact analysis can be found as a supporting document at http://www.regulations.gov, usually within 48 hours after the rulemaking document is published. Additionally, a copy of the rulemaking and its impact analysis are available on VA's website at http://www.va.gov/​orpm/​, by following the link for “VA Regulations Published From FY 2004 Through Fiscal Year to Date.” This interim final rule is not subject to the requirements of E.O. 13771 because this rule results in no more than de minimis costs.

Unfunded Mandates The Unfunded Mandates Reform Act of 1995 requires, at 2 U.S.C. 1532, that agencies prepare an assessment of anticipated costs and benefits before issuing any rule that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more (adjusted annually for inflation) in any one year. This interim final rule will have no such effect on State, local, and tribal governments, or on the private sector.

Congressional Review Act Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), the Office of Information and Regulatory Affairs designated this rule as not a major rule, as defined by 5 U.S.C. 804(2).

Catalog of Federal Domestic Assistance The Catalog of Federal Domestic Assistance numbers and titles for the programs affected by this document are. 64.007, Blind Rehabilitation Centers. 64.008, Veterans Domiciliary Care.

64.009, Veterans Medical Care Benefits. 64.010, Veterans Nursing Home Care. 64.011, Veterans Dental Care.

64.012, Veterans Prescription Service. 64.013, Veterans Prosthetic Appliances. 64.018, Sharing Specialized Medical Resources.

64.019, Veterans Rehabilitation Alcohol and Drug Dependence. 64.022, Veterans Home Based Primary Care. 64.039 CHAMPVA.

64.040 VHA Inpatient Medicine. 64.041 VHA Outpatient Specialty Care. 64.042 VHA Inpatient Surgery.

64.043 VHA Mental Health Residential. 64.044 VHA Home Care. 64.045 VHA Outpatient Ancillary Services.

64.046 VHA Inpatient Psychiatry. 64.047 VHA Primary Care. 64.048 VHA Mental Health Clinics.

64.049 VHA Community Living Center. And 64.050 VHA Diagnostic Care. Start List of Subjects Administrative practice and procedureAlcohol abuseAlcoholismClaimsDay careDental healthDrug abuseForeign relationsGovernment contractsGrant programs-healthGrant programs-veteransHealth careHealth facilitiesHealth professionsHealth recordsHomelessMedical and dental schoolsMedical devicesMedical researchMental health programsNursing homesReporting and recordkeeping requirementsScholarships and fellowshipsTravel and transportation expensesVeterans End List of Subjects Signing Authority The Secretary of Veterans Affairs, or designee, approved this document and authorized the undersigned to sign and submit the document to the Office of the Federal Register for publication electronically as an official document of the Department of Veterans Affairs.

Brooks D. Tucker, Assistant Secretary for Congressional and Legislative Affairs, Performing the Delegable Duties of the Chief of Staff, Department of Veterans Affairs, approved this document on October 19, 2020, for publication. Start Signature Consuela Benjamin, Regulations Development Coordinator, Office of Regulation Policy &.

Management, Office of the Secretary, Department of Veterans Affairs. End Signature For the reasons stated in the preamble, the Department of Veterans Affairs is amending 38 CFR part 17 as set forth below. Start Part End Part Start Amendment Part1.

The authority citation for part 17 is amended by adding an entry for § 17.419 in numerical order to read in part as follows. End Amendment Part Start Authority 38 U.S.C. 501, and as noted in specific sections.

End Authority * * * * * Section 17.419 also issued under 38 U.S.C. 1701 (note), 7301, 7306, 7330A, 7401-7403, 7405, 7406, 7408). * * * * * Start Amendment Part2.

Add § 17.419 to read as follows. End Amendment Part Health care professionals' practice in VA. (a) Definitions.

The following definitions apply to this section. (1) Beneficiary. The term beneficiary means a veteran or any other individual receiving health care under title 38 of the United States Code.

(2) Health care professional. The term health care professional is an individual who. (i) Is appointed to an occupation in the Veterans Health Administration that is listed in or authorized under 38 U.S.C.

7306, 7401, 7405, 7406, or 7408 or title 5 of the U.S. Code. (ii) Is not a VA-contracted health care professional.

And (iii) Is qualified to provide health care as follows. (A) Has an active, current, full, and unrestricted license, registration, certification, or satisfies another State requirement in a State. (B) Has other qualifications as prescribed by the Secretary for one of Start Printed Page 71846the health care professions listed under 38 U.S.C.

7402(b). (C) Is an employee otherwise authorized by the Secretary to provide health care services. Or (D) Is under the clinical supervision of a health care professional that meets the requirements of subsection (a)(2)(iii)(A)-(C) of this section and is either.

(i) A health professions trainee appointed under 38 U.S.C. 7405 or 7406 participating in clinical or research training under supervision to satisfy program or degree requirements. Or (ii) A health care employee, appointed under title 5 of the U.S.

Code, 38 U.S.C. 7401(1) or (3), or 38 U.S.C. 7405 for any category of personnel described in 38 U.S.C.

7401(1) or (3) who must obtain an active, current, full and unrestricted licensure, registration, certification, or meet the qualification standards as defined by the Secretary within the specified time frame. (3) State. The term State means a State as defined in 38 U.S.C.

101(20), or a political subdivision of such a State. (b) Health care professional's practice. (1) When a State law or license, registration, certification, or other requirement prevents or unduly interferes with a health care professional's practice within the scope of their VA employment, the health care professional is required to abide by their Federal duties, which includes, but is not limited to, the following situations.

(i) A health care professional may practice their VA health care profession in any State irrespective of the State where they hold a valid license, registration, certification, or other State qualification. Or (ii) A health care professional may practice their VA health care profession within the scope of the VA national standard of practice as determined by VA. (2) VA health care professional's practice is subject to the limitations imposed by the Controlled Substances Act, 21 U.S.C.

801 et seq. And implementing regulations at 21 CFR 1300 et seq., on the authority to prescribe or administer controlled substances, as well as any other limitations on the provision of VA care set forth in applicable Federal law and policy. (c) Preemption of State law.

Pursuant to the Supremacy Clause, U.S. Const. Art.

IV, cl. 2, and in order to achieve important Federal interests, including, but not limited to, the ability to provide the same complete health care and hospital service to beneficiaries in all States as required by 38 U.S.C. 7301, conflicting State laws, rules, regulations or requirements pursuant to such laws are without any force or effect, and State governments have no legal authority to enforce them in relation to actions by health care professionals within the scope of their VA employment.

End Supplemental Information [FR Doc. 2020-24817 Filed 11-10-20. 8:45 am]BILLING CODE 8320-01-P.