The US Drug Enforcement Administration (DEA) and the Substance Abuse and Mental Health Services Administration (SAMHSA) are extending telehealth flexibilities that allow providers to prescribe controlled substances. While the extension is in place, the DEA indicated that it will be further evaluating its recently proposed rules for post-COVID-19 public health emergency telemedicine prescription of controlled substances.
Members of Congress could call for more transparency about how hospitals use their federal drug discount program savings. According to this Bloomberg Law article, a study found that the Health Resources and Services Administration’s oversight of the 340B program could be improved. McDermott Partner Emily Jane Cook said there is interest in Congress overseeing aspects of hospitals, including the 340B program.
“I wouldn’t be surprised to see a bill being introduced that imposes more explicit oversight requirements,” Cook said.
Reproduced with permission. Published May 15, 2023. Copyright 2023 by Bloomberg Industry Group, Inc. (800-372-1033) http://www.bloombergindustry.com.
Medicare Advantage (MA) plans are facing both regulatory and business risks following the conclusion of the COVID-19 Public Health Emergency (PHE). What are the major MA flexibilities and requirements related to the pandemic, and have they ended along with the PHE?
Numerous states—including Illinois, Hawaii, Tennessee, Montana, New Hampshire and Indiana—have been busy finalizing rulemaking and legislation impacting interstate compacts, professional practice standards and COVID-19 licensure flexibilities. What have these states been up to over the last month?
The Biden administration previously announced its intent to end the COVID-19 National Emergency (NE) and the COVID-19 Public Health Emergency (PHE) on May 11, 2023 (read our series introduction for more information). On April 10, 2023, President Biden signed a resolution moving up the end of the NE to April 10, 2023 (the PHE ended on May 11). The US Departments of Labor (DOL), Health and Human Services, and the Treasury (the Departments) issued a set of FAQs (available here) on March 29, 2023 (FAQs), which anticipated that the NE would end on May 11, 2023 (see our prior article explaining the FAQs). Plan sponsors should continue to treat May 11 as the end of the NE consistent with the FAQs until the Departments say otherwise.
During the COVID-19 pandemic, the Departments provided relief from certain benefit plan deadlines, including:
- The minimum 60-day election period for the Consolidated Omnibus Budget Reconciliation Act (COBRA) continuation coverage.
- The date for making COBRA premium payments (45 days for the initial, then minimum 30-day grace periods).
- The date for individuals to notify the plan of certain qualifying events (divorce, dependent child aging out of plan coverage) or determination of disability as it relates to COBRA coverage.
- The date for providing a COBRA election notice (typically within 14 days after the plan receives notice of a qualifying event).
- The 30-day period (or 60-day period, if applicable) to request Health Insurance Portability and Accountability Act (HIPAA) special enrollment.
- The date within which individuals may file a benefit claim or an appeal of an adverse benefit determination under a plan’s claims procedures.
- The date within which claimants may file a request for an external review after receipt of an adverse benefit determination or final internal adverse benefit determination.
This article discusses how the affected tolled deadlines will be phased out and what actions employers may need to take.
EBSA Disaster Relief Notice 2020-01, later extended by EBSA Disaster Relief Notice 2021-01, provided that the deadline by which action needs to be taken for the events described above was tolled until the earlier of: (i) one year from the date the deadline would have first started running for that individual or (ii) sixty (60) days from the end of the NE (the Outbreak Period). This guidance created a tolling deadline specific to each affected individual. Where the individual has not reached the one-year anniversary of the date of the initial deadline, timeframes will begin to run again sixty (60) days after the end of the NE (i.e., July 10, 2023).
The FAQs released by the Departments at the end of March provided much-needed clarification and various helpful examples for employers of how the outbreak period should be taken into consideration when calculating the tolled deadlines. For example, if an employee experiences a qualifying event under COBRA and loses coverage on April 1, 2023, the deadline for the individual to make a COBRA election is tolled until the earlier [...]
The end of the COVID-19 public health emergency also means the end of coverage of self-administered, over-the-counter COVID tests. In this MedTech Dive opinion article, McDermott+Consulting’s Amy Kelbick and Eric Zimmerman argue that insurers, including Medicare, should continue to cover COVID tests at no cost and without requiring a prescription even after the public health emergency ends.
The Biden administration has announced that the federal government will wind down its remaining COVID-19 vaccination mandates (including those for federal workers, contractors and international air travelers) effective May 11, 2023. This action coincides with the conclusion of the COVID-19 public health emergency (PHE). Additionally, the US Department of Health and Human Services (HHS) will initiate steps to terminate the vaccination prerequisites for healthcare facilities that are certified by the Centers for Medicare & Medicaid Services (CMS).
The US Departments of Labor, Health and Human Services, and the Treasury (the Departments) have released a series of Frequently Asked Questions (FAQs) in response to Braidwood Mgmt. Inc. v. Becerra, a recent case that invalidated a portion of the Affordable Care Act (ACA) preventive services mandate. The FAQs aim to address inquiries from stakeholders, while also emphasizing the Departments’ opposition to the Braidwood ruling. The Departments urge plans and issuers to continue providing coverage for preventive services at no additional cost to patients.
There has been a flurry of activity in Congress focused on healthcare issues over the last two weeks. Committees in both the US House and Senate held hearings on legislation focused on increasing transparency and competition in the healthcare system that could have significant impacts for certain healthcare providers, healthcare plans and pharmacy benefit managers.
Preparing for the End of the COVID-19 Emergency: Tri-Agencies Issue FAQs to Assist Plans and Issuers
The Biden administration has announced its intention to end the COVID-19 National Emergency (NE) and the COVID-19 Public Health Emergency (PHE) on May 11, 2023 (read our series introduction for more information).
On March 29, 2023, the US Departments of Labor, Health and Human Services, and Treasury (the Departments) issued a set of Frequently Asked Questions (available here), which answered questions from stakeholders relating to the various laws, regulations and other guidance enacted or adopted in connection with the NE and PHE. The FAQs include eight questions related to the anticipated end of the “Outbreak Period” on July 10, 2023, which is 60 days after the end of the NE and PHE on May 11 (rules regarding the Outbreak Period are set forth in our earlier articles here and here). Below are the highlights:
- Following the end of the PHE, plans and issuers can impose cost-sharing, prior authorization or other medical management requirements for COVID-19 diagnostic tests, although the Departments encourage plans not to do so.
- Plans and issuers are encouraged to notify plan participants of changes regarding COVID-19 diagnosis, testing and treatment. Special rules apply under which Summaries of Benefits and Coverage (SBCs) need not be amended mid-year.
- While plans and issuers will no longer be required to post prices for diagnostic tests furnished after May 11, they are nevertheless encouraged to do so.
- Plans must continue to cover vaccines that qualify as preventive services, without cost-sharing, when provided in-network.
- The FAQs provide examples relating to the application and termination of extended time periods for elections under the Consolidated Omnibus Budget Reconciliation Act (COBRA) and the Health Insurance Portability and Accountability Act (HIPAA).
- In what is a welcome surprise, the FAQs confirm that individuals covered by a High-Deductible Health Plan (HDHP) will remain Health Savings Account (HSA)-eligible until further notice even if the HDHP in which they are enrolled provides medical care services and items purchased related to testing for and treatment of COVID-19 prior to the satisfaction of the HDHP’s applicable minimum deductible.
To keep employers apprised of the rules and to assist with providing notice to plan participants of the changes that will accompany the end of the NE and PHE, the Department of Labor has issued two blog posts, which are available here and here.
Action Items: We urge plan sponsors to pay particular attention to notifying employees of the upcoming changes that will accompany the end of the PHE and NE and to ensure that participants covered under an HDHP understand that they may continue to contribute to their HSAs. Employers should consider communicating these changes to their employees.
For any questions regarding the end of the PHE and/or NE, please contact your regular McDermott lawyer or one of the authors.