Washington Healthcare Update - November 2021 #1

McGuireWoods Consulting
Contact

This week in Washington: The budget reconciliation saga continues.

Congress

Upcoming Hearings/Markups

House

  • Build Back Better Activity

Senate

  • Senators Request Update on CMS Efforts to Streamline Prior Authorization Processes

Administration

  • Dr. Rahul Gupta Confirmed as White House Office of National Drug Control Policy Office Director
  • HHS Releases New Overdose Prevention Strategy
  • NIH Announces New Partnership to Address Gene Therapy Development
  • CDC to Allow Fourth COVID-19 Booster Dose for Certain Immunocompromised People
  • FDA Authorizes Pfizer’s COVID-19 Vaccine for Children Aged 5-11

Proposed Rules

  • HHS Issues Proposed Rule to Withdraw the SUNSET Rule
  • FDA Issues Draft Industry Guidance on Real-World Data Standards
  • FDA Issues Proposed Rule on Over-the-Counter Hearing Aids
  • HHS Issues Proposed Rule to Repeal Two Trump-Era HHS Final Rules
  • FDA Issues Guidance on Continuous Manufacturing of Drug Substances and Products
  • FDA Issues Guidance Updating Unique Device Identification Policy

Final Rules

  • HHS Issues Final Rule to Rescind Trump-Era “Gag Rule” on Title X Grantees
  • FDA Issues Final Rules for Premarket Review of New Tobacco Products
  • FDA Issues Final Rule on De Novo Pathway for Medical Devices
  • HHS Issues Final Rule to Rescind 2020 Rule on Insulin and Epinephrine

Reports

  • GAO Report on Concerns for Oversight and Accountability in VA Healthcare
  • GAO Report on Federal COVID-19 Response

Upcoming Hearings/Markups

November 2

House Veterans’ Affairs Committee, Subcommittee on Technology Modernization Hearing: “Next Steps: Examining Plans for the Continuation of the Department of Veterans Affairs Electronic Health Record Modernization Program”
10:00 a.m.
For more information, click here.

November 4

Senate Health, Education, Labor and Pensions Committee Hearing: “Next Steps: The Road Ahead for the COVID-19 Response.”
10:00 a.m.
For more information, click here.

House Judiciary Committee Hearing: “The Texas Abortion Ban and its Devastating Impact on Communities and Families”
10:00 a.m.
For more information, click here.

Congress

House

Build Back Better Activity

On Oct. 27, House Speaker Nancy Pelosi (D-CA) wrote a “Dear Colleague” letter stating that the House was close to agreement on the priorities and budget of the Build Back Better Act.

The letter can be found here.

On Oct. 28, President Biden announced the updated Build Back Better framework. The framework includes $1.85 trillion in spending, a considerable decrease from the earlier $3.5 trillion proposed.

Healthcare measures in the framework include $150 billion for home- and community-based services, a decrease from the $400 billion originally support by President Biden. The bill includes an expansion of Affordable Care Act (ACA) tax credits through 2025. In addition, the bill would expand tax credits for people in Medicaid non-expansion states through 2025.

Healthcare provisions notably missing from the new framework include a $500 billion federal paid family and medical leave benefit. In addition, the proposed expansion of Medicare to cover vision, dental and hearing services has been limited to just hearing. The expanded child tax credit would be extended until 2023 and not made permanent. The outline also leaves out a proposal to lower prescription drugs by allowing Medicare to negotiate directly with pharmaceutical companies.

The Build Back Better framework can be found here.

The House Rules Committee met on Oct. 29 to determine the rules by which the Build Back Better Act would be debated on the House floor.

The bill text can be found here.

Senate

Senators Request Update on CMS Efforts to Streamline Prior Authorization Processes

On Oct. 28, a group of 29 senators led by Sens. Sherrod Brown (D-OH) and John Thune (R-SD) wrote to the Centers for Medicare and Medicaid Services (CMS) Administrator Chiquita Brooks-LaSure requesting an update on CMS efforts to streamline prior authorization protocols across programs, including Medicare Advantage (MA) plans. The letter cites the Improving Seniors’ Timely Access to Care Act as a balanced approach to prior authorization in the MA program that could be adopted by CMS.

The letter can be found here.

Administration

Dr. Rahul Gupta Confirmed as White House Office of National Drug Control Policy Office Director

On Oct. 28, the Senate voted to confirm Dr. Rahul Gupta as the Director of the White House Office of National Drug Control Policy (ONDCP). Dr. Gupta most recently served as Chief Medical Officer and Senior Vice President at the March of Dimes.

HHS Releases New Overdose Prevention Strategy

On Oct. 27, Health and Human Services (HHS) Secretary Xavier Becerra announced the new HHS Overdose Prevention Strategy. The new strategy is designed to increase access to care and services for individuals using substances and their families. The new strategy includes a multiple substances and different treatment approaches.

The Overdose Prevention Strategy can be found here.

NIH Announces New Partnership to Address Gene Therapy Development

On Oct. 27, the National Institutes of Health (NIH) announced that it would be forming the Bespoke Gene Therapy Consortium (BGTC) to streamline the gene therapy development process and address the needs of people with rare diseases. The new consortium involves a partnership between NIH, the Food and Drug Administration (FDA), 10 pharmaceutical companies and five nonprofit organizations.

CDC to Allow Fourth COVID-19 Booster Dose for Certain Immunocompromised People

On Oct. 25, the Centers for Disease Control and Prevention (CDC) updated its COVID-19 booster recommendation to say that certain immunocompromised individuals can receive a fourth dose of an approved COVID-19 vaccine. The fourth dose can be any of the three FDA-authorized or -approved vaccines and should be administered to severely immunocompromised people six months after they receive their third dose.

FDA Authorizes Pfizer’s COVID-19 Vaccine for Children Aged 5-11

On Oct. 29, the Food and Drug Administration (FDA) authorized Pfizer’s COVID-19 vaccine for children aged 5-11. This decision will make the lower-dose vaccine available to 28 million children.

The authorization was expected after the FDA’s Vaccines and Related Biological Products Advisory Committee voted on Oct. 26 to recommend authorizing the vaccine for children aged 5-11.

Proposed Rules

HHS Issues Proposed Rule to Withdraw the SUNSET Rule

On Oct. 29, the Department of Health and Human Services (HHS) issued a proposed rule that would withdraw the January 2021 final rule titled “Securing Updated and Necessary Statutory Evaluations Timely (SUNSET).” The SUNSET final rule required HHS regulations with a significant economic impact to be review every 10 years, with regulations automatically expiring if they were not reviewed. This would have impacted more than 17,000 HHS regulations and required a review process considerably faster than HHS ever conducted.

The rule would have gone into effect in March 2021, but HHS issued a delay following a lawsuit.

Comments will be accepted until Dec. 28, 2021.

The proposed rule can be found here.

FDA Issues Draft Industry Guidance on Real-World Data Standards

On Oct. 22, the Food and Drug Administration (FDA) announced industry draft guidance titled “Data Standards for Drug and Biological Product Submissions Containing Real-World Data.” The guidance includes recommendations to help sponsors comply with the Federal Food, Drug and Cosmetic Act when submitting study data from real-world data sources.

Public comments will be accepted until Dec. 21, 2021.

The draft guidance can be found here.

FDA Issues Proposed Rule on Over-the-Counter Hearing Aids

On Oct. 20, the Food and Drug Administration (FDA) issued a proposed rule titled “Medical Devices: Ear, Nose, and Throat Devices; Establishing Over-the-Counter Hearing Aids.” The proposed rule would establish a new category of over-the-counter (OTC) hearing aids that could be sold to consumers directly without a medical exam or audiologic hearing. The proposed rule comes after President Biden’s July Executive Order aimed at promoting competition in the economy directed the FDA to increase access to OTC hearing aids.

Public comments will be accepted until Jan. 18, 2022.

The proposed rule can be found here.

HHS Issues Proposed Rule to Repeal Two Trump-Era HHS Final Rules

On Oct. 20, the Department of Health and Human Services (HHS) issued a proposed rule to repeal two final rules: the Dec. 7, 2020, rule titled “Department of Health and Human Services Good Guidance Practices” and the Jan. 14, 2021, rule titled “Department of Health and Human Services Transparency and Fairness in Civil Administrative Enforcement Actions.” HHS stated that the 2020 Good Guidance rule conflicts with the Food and Drug Administration’s (FDA) good guidance regulations and complicates the Centers for Medicare and Medicaid Services’ (CMS) issuing of Medicaid and Children’s Health Insurance Program (CHIP) guidance.

Public comments will be accepted until Nov. 19, 2021.

The proposed rule can be found here.

FDA Issues Guidance on Continuous Manufacturing of Drug Substances and Products

On Oct. 12, the Food and Drug Administration issued a draft guidance document titled “Q13 Continuous Manufacturing of Drug Substances and Drug Products,” which was prepared with the support of the International Council for Harmonisation (ICH). The draft guidance provides clarification on the development and operation of continuous manufacturing and builds on prior guidelines Q7-Q10.

Comments are accepted until Dec. 13, 2021.

The guidance can be found here.

FDA Issues Guidance Updating Unique Device Identification Policy

On Oct. 14, the Food and Drug Administration (FDA) issued a draft guidance titled “Select Updates for Unique Device Identification: Policy Regarding Global Unique Device Identification Database Requirements for Certain Devices.” The guidance revises the 2020 Unique Device Identification Guidance. The updated guidance explains there are certain class I devices for which the FDA will not enforce the Global Unique Device Identification Database (GUDID) submission requirements, and also states how a class I device labeler can determine if the device is in the scope of compliance policy.

Comments will be accepted until Dec. 13, 2021.

The guidance can be found here.

Final Rules

HHS Issues Final Rule to Rescind Trump-Era “Gag Rule” on Title X Grantees

On Oct. 7, the Department of Health and Human Services (HHS) issued a final rule that would rescind a 2019 Trump-era rule that prevented Title X grantees from referring patients for abortion, often referred to as the “gag rule.” The Biden administration had announced its intention to roll back the rule in an April 14 rulemaking, stating that it had decreased the number of Title X grantees by 25 percent and could have led to 181,477 unintended pregnancies.

The rule will go into effect on Nov. 7, 2021.

The final rule can be found here.

FDA Issues Final Rules for Premarket Review of New Tobacco Products

On Oct. 4, the Food and Drug Administration (FDA) issued two final rules related to the premarket review of new tobacco products. The rules provide information for the content and review of Premarket Tobacco Product Applications (PMTAs) and Substantial Equivalence (SE) Reports, two pathways commonly used to receive FDA marketing authorization. Both rules will be effective Nov. 4, 2021.

The final rule titled “Premarket Tobacco Product Applications and Recordkeeping Requirements” can be found here.

The final rule titled “Content and Format of Substantial Equivalence Reports; Food and Drug Administration Actions on Substantial Equivalence Reports” can be found here.

The FDA press release on the rules can be found here.

FDA Issues Final Rule on De Novo Pathway for Medical Devices

On Oct. 4, the Food and Drug Administration (FDA) published a final rule titled “Medical Device De Novo Classification Process,” which establishes requirements for the medical device De Novo classification process. The final rule also provides information on how medical device markers can pursue marketing authorization via the De Novo pathway for low- and moderate-risk devices with no existing predicate comparison device. Although the De Novo pathway has existed since 1997, this rule will be the first to explain the FDA procedures for reviewing De Novo applications and specify what needs to be included in an application.

The rule goes into effect Jan. 3, 2022.

The final rule can be found here.

HHS Issues Final Rule to Rescind 2020 Rule on Insulin and Epinephrine

On Oct. 1, the Department of Health and Human Services (HHS) issued a final rule to rescind a December 2020 final rule titled “Implementation of Executive Order on Access to Affordable Life-Saving Medications.” The Trump-era rule required health centers to pass on 340B discounts for insulin and injectable epinephrine to patients. Health centers had opposed the rule. In its rule to rescind the Trump administration rule, HHS stated that the 2020 rule had excessive administrative costs and burdens for health centers that would have resulted in reduced resources for critical services for patients who use insulin and epinephrine. The rule states that HHS is exploring nonregulatory options to implement the executive order.

The rule is effective Nov. 1, 2021.

The final rule can be found here.

Reports

GAO Report on Concerns for Oversight and Accountability in VA Healthcare

On Oct. 27, the Government Accountability Office (GAO) published a report titled “Veterans Health Care: Addressing High Risk Concerns for Oversight and Accountability Are Key to Ensuring Quality of Care and Patient Safety.” The report stated that the GAO has identified concerns within the Department of Veterans Affairs (VA) oversight of its healthcare system. The GAO states that providers removed from VA employment were potentially providing care in a community care network. In addition, the VA lacks information on the number of veteran suicides taking place on VA campuses. The VA also needs to provide documentation of the process to assess performance of its regional healthcare networks. The report observes that while the VA has taken some steps to address oversight and accountability based on prior GAO recommendations, more needs to be done.

The full report can be found here.

GAO Report on Federal COVID-19 Response

On Oct. 27, the Government Accountability Office (GAO) released a report titled “COVID-19: Additional Actions Needed to Improve Accountability and Program Effectiveness of Federal Response.” This is the eighth comprehensive report on the federal response to the COVID-19 pandemic. The GAO made 16 new recommendations, which include measures related to fiscal relief funds for providers, recovery funds for states and localities, worker safety and health and assessing fraud risk.

The full report with more detailed information about the recommendations can be found here.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

© McGuireWoods Consulting | Attorney Advertising

Written by:

McGuireWoods Consulting
Contact
more
less

McGuireWoods Consulting on:

Reporters on Deadline

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
Custom Email Digest
- hide
- hide

This website uses cookies to improve user experience, track anonymous site usage, store authorization tokens and permit sharing on social media networks. By continuing to browse this website you accept the use of cookies. Click here to read more about how we use cookies.