Washington Healthcare Update - October 2021 #3

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This week in Washington: Debt ceiling measure signed by President Biden; default averted for at least a month. Discussions about budget reconciliation continue.

Congress

Upcoming Hearings/Markups

House

  • House Passes Debt Ceiling Extension
  • Speaker Pelosi Says Congress Will Fund Reconciliation Measures for Shorter Time Frame
  • Energy and Commerce Committee Health Subcommittee to Discuss Public Health Legislation
  • 95 House Members Ask CMS to Finalize Durable Medical Equipment Proposed Rule
  • Rep. Golden Raises Concern About “Critical Errors” in Reconciliation Medicare Proposal

Senate

  • Senate Finance Committee Hearing to Discuss Medicare Drug Price Negotiations
  • Sens. Warren and Grassley Request the Release of Over-the-Counter Hearing Aid Proposed Rule

Administration

  • HHS Announces Medicare Open Enrollment Period
  • HHS Announces COVID-19 Equity Task Force Meeting
  • HHS Announces $100 Million in Funding to Recruit and Retain Primary Care Providers in Underserved Areas
  • FDA Vaccines and Related Biological Products Advisory Committee Meeting
  • FDA to Withdraw Policies that Allowed Distilleries, Breweries and Other Manufacturers to Make Hand Sanitizer
  • FDA Permits E-Cigarette Marketing
  • FDA to Hold Meeting on Enhanced Drug Distribution Security
  • FDA to Meet to Discuss Merck’s COVID-19 Pill EUA
  • CMS Approves Request to Cover LGBTQ+ Care in Colorado
  • CMS Seeks Comment on its Public Information Collection

Other Activity

  • Oncologists Look to Congress to Change Mandatory Radiation Oncology Model
  • LTC Pharmacies Ask HHS to Remove Them from Provider Relief Cap

Proposed Rules

  • FDA Issues Guidance on Continuous Manufacturing of Drug Substances and Products
  • FDA Issues Final Guidance on Sodium Level Targets
  • 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

Courts

  • 5th Circuit Allows Texas' Abortion Law to Remain in Effect

Reports

  • House Ways and Means Committee Democratic Staff Report on Race in Clinical Algorithms
  • GAO Report on Indian Health Service COVID-19 Flexibilities

Congress

Upcoming Hearings/Markups

October 20

House Ways and Means Committee, Subcommittee on Health: “Enhancing Public Health: Legislation to Protect Children and Families
10:30 a.m.
For more information, click here.

Senate Finance Committee Hearing: “Health Insurance Coverage in America: Current and Future Role of Federal Programs
10:00 a.m.
For more information, click here.

October 21

House Appropriations Committee, Subcommittee on Military Construction, Veterans Affairs and Related Agencies: “Update on VA’s Electronic Health Record Modernization Implementation
10:00 a.m.
For more information, click here.

Congress

House

House Passes Debt Ceiling Extension

On Oct. 12, the House voted to pass legislation to raise the U.S. debt ceiling through Dec. 3. The bill passed the Senate the previous week. The measure was signed by President Biden on Oct. 14. With this action, a default is avoided for at least a month.

Speaker Pelosi Says Congress Will Fund Reconciliation Measures for Shorter Time Frame

On Oct. 12, House Speaker Nancy Pelosi (D-CA) stated that Congress will likely vote on a smaller reconciliation package that funds policy priorities for a shorter period of time than was previously planned. The time frame will be decreased in order to reduce the overall cost of the bill while maintaining the original programs.

Energy and Commerce Committee Health Subcommittee to Discuss Public Health Legislation

On Oct. 20, the Energy and Commerce Committee’s Subcommittee on Health will meet to discuss public health legislation. The bills under consideration can be found below.

  • H. R. 623, the “Gabriella Miller Kids First Research Act 2.0”
  • H. R. 1193, the “Cardiovascular Advances in Research and Opportunities Legacy Act”
  • H. R. 1956, the “Increasing Access to Quality Cardiac Rehabilitation Care Act of 2021”
  • H. R. 2161, the “Children and Media Research Advancement Act” or the “CAMRA Act”
  • H. R. 3749, the “Katherine’s Law for Lung Cancer Early Detection and Survival Act of 2021”
  • H. R. 4555, the “Oral Health Literacy and Awareness Act of 2021”
  • H. R. 4612, the “Protecting Access to Lifesaving Screenings Act of 2021” or the “PALS Act”
  • H. R. 5487, the “Stillbirth Health Improvement and Education for Autumn Act of 2021” or the “SHINE for Autumn Act of 2021”
  • H. R. 5551, the “Improving the Health of Children Act”
  • H. R. 5552, the “Lead Poisoning Prevention Act”
  • H. R. 5558, the “Prostate Cancer Prevention Act”
  • H. R. 5561, the “Early Hearing Detection and Intervention Act”

95 House Members Ask CMS to Finalize Durable Medical Equipment Proposed Rule

In an Oct. 12 letter, 95 House members asked the Centers for Medicare and Medicaid Services (CMS) to finalize the Durable Medical Equipment (DME), Prosthetics, Orthotics and Supplies Proposed Rule. The proposed rule was issued on Oct. 27, 2020 and included a provision to extend the Medicare “50/50” blended rate for DME in rural areas. The letter requested that CMS consider policies to ensure that Medicare beneficiaries have access to DME.

Rep. Golden Raises Concern About “Critical Errors” in Reconciliation Medicare Proposal

On Oct. 14, Rep. Jared Golden (D-ME) wrote a letter to Rep. Richard Neal (D-MA), Chair of the House Ways and Means Committee, and Rep. Frank Pallone (D-NJ), Chair of the House Energy and Commerce Committee, stating that the current budget reconciliation proposal to add dental, vision and hearing benefits to Medicare is insufficient. In the letter, Rep. Golden said that the flaws in the reconciliation proposal, especially in the dental benefit, should be fixed, even if this results in removing the proposal from the reconciliation package.

Rep. Golden stated that while he supports budget reconciliation measures such as adding dental, vision and hearing benefits to Medicare and letting Medicare negotiate lower drug prices, it is important that these measures are done in a responsible manner that strengthens Medicare in the long term. The letter comes as Democrats are facing pressure to reduce the cost of the reconciliation package.

The full letter can be found here.

Senate

Senate Finance Committee Hearing to Discuss Medicare Drug Price Negotiations

On Oct. 20, the Senate Finance Committee will hold a hearing titled “Health Insurance Coverage in America: Current and Future Role of Federal Programs.” The hearing will include discussions on allowing Medicare to negotiate drug prices. The witness list includes Linda Blumberg, Fellow at the Urban Institute; Sara Collins, Vice President for Health Care Coverage and Access at The Commonwealth Fund; Douglas Holtz-Eakin, President of the American Action Forum; and Frederick Isasi, Executive Director of Families USA.

For more information on the hearing, click here.

Sens. Warren and Grassley Request the Release of Over-the-Counter Hearing Aid Proposed Rule

On Oct. 12, Sens. Elizabeth Warren (D-MA) and Chuck Grassley (R-IA) wrote to Acting Food and Drug Administrator (FDA) Janet Woodcock calling on the agency to issue the over-the-counter hearing aid proposed rule before Nov. 6, 2021. The letter notes that in July, President Biden directed the Department of Health and Human Services (HHS) to publish a proposed rule on over-the-counter hearing aids within 120 days of the Executive Order on Promoting Competition in the American Economy.

The letter can be found here.

Administration

HHS Announces Medicare Open Enrollment Period

On Oct. 15, the Department of Health and Human Services (HHS) announced the beginning of the Medicare Open Enrollment Period. During the open enrollment period, Medicare beneficiaries can make changes to their health or prescription drug plans. Medicare Open Enrollment occurs annually from Oct. 15 to Dec. 7, and coverage changes take effect on Jan. 1.

HHS Announces COVID-19 Equity Task Force Meeting

On Oct. 14, the Department of Health and Human Services (HHS) announced that the COVID-19 Equity Task Force will meet on Oct. 28. The meeting will include a presentation and vote on the Task Force Final Report, which includes the recommended Implementation and Accountability Plans. The meetings will be open to the public.

Additional information about the meeting can be found here.

HHS Announces $100 Million in Funding to Recruit and Retain Primary Care Providers in Underserved Areas

On Oct. 14, the Department of Health and Human Services (HHS) announced $100 million in American Rescue Plan funding for programs that recruit and retain primary care clinicians living and working in underserved areas. The funding will be administered through the Health Resources and Services Administration’s (HRSA) State Loan Repayment Program (SLRP), and represents a five-fold increase. The application process will begin on April 8, 2022, and the program will start on Sept. 1, 2022.

For more information, click here.

FDA Vaccines and Related Biological Products Advisory Committee Meeting

On Oct. 14 and 15, the Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee met to discuss COVID-19 booster authorizations, among other things.

On Oct. 14, the commission voted unanimously to authorize Moderna’s COVID-19 vaccine booster for individuals 65 and above, at high risk, or facing occupational hazards that increase their likelihood of catching COVID-19. On Oct. 15 the commission also voted unanimously to recommend Johnson & Johnson COVID-19 booster doses for all adults at least two months after the first dose.

FDA to Withdraw Policies that Allowed Distilleries, Breweries and Other Manufacturers to Make Hand Sanitizer

On Oct. 12, the Food and Drug Administration (FDA) announced that it will withdraw three policies that allowed certain businesses such as breweries and distilleries to produce hand sanitizer during the COVID-19 pandemic. Manufacturers currently producing hand sanitizer under the policies must either stop by Dec. 31 or make sure they comply with the applicable manufacturing requirements for over-the-counter topical antiseptics.

FDA Permits E-Cigarette Marketing

On Oct. 12, the Food and Drug Administration (FDA) announced it had authorized the marketing of three new tobacco products. This is the first time electronic nicotine delivery systems (ENDS) have received FDA authorization via the Premarket Tobacco Product Application (PMTA) pathway. Under the PMTA pathway, manufacturers must prove that marketing of a tobacco product is appropriate for the protection of public health.

The FDA press release can be found here.

FDA to Hold Meeting on Enhanced Drug Distribution Security

The Food and Drug Administration (FDA) will hold a public meeting on drug distribution security on Nov. 16, 2021, from 9 a.m. to 4 p.m. (ET). The meeting is an opportunity for stakeholders to comment on the implementation of the enhanced drug distribution security provisions of the Drug Supply Chain Security Act set to go into effect in 2023.

For additional information and event registration, click here.

FDA to Meet to Discuss Merck’s COVID-19 Pill EUA

On Oct. 14, the Food and Drug Administration announced that its Antimicrobial Drugs Advisory Committee will meet on Nov. 30 to discuss Merck and Ridgeback’s application for emergency use authorization (EUA) for the drug molnupiravir. The experimental drug would be used to treat mild to moderate COVID cases for people who are at high risk of severe complications. Merck applied for EUA on Oct. 11.

CMS Approves Request to Cover LGBTQ+ Care in Colorado

On Oct. 12, the Centers for Medicare and Medicaid Services (CMS) approved a request to provide gender-affirming care in individual and small group health insurance markets as part of Colorado’s new Essential Health Benefit (EHB) benchmark. Changes to the EHB benchmark plan include a wider range of covered services for transgender people.

The CMS press release can be found here.

CMS Seeks Comment on its Public Information Collection

On Oct. 14, the Centers for Medicare and Medicaid Services (CMS) announced an opportunity for public comment regarding its method for collecting information from the public. CMS stated that people are invited to send comments regarding CMS’s burden estimates, the accuracy and utility of information collection, and ways to enhance the quality of information collected.

Comments must be received by Dec. 13, 2021.

The CMS notice can be found here.

Other Activity

Oncologists Look to Congress to Change Mandatory Radiation Oncology Model

Oncologists are disappointed that the Biden administration will not change the mandatory radiation oncology model announced in the Trump administration. They are now asking Congress to make changes. The demonstration was introduced in 2020 and would provide bundled payments for a 90-day episode of care to certain radiotherapy providers for a list of cancers. Providers would be randomly selected to participate in the mandatory model.

The American Society for Radiation Oncology has stated that the demonstration will be detrimental to more than half of the participants.

LTC Pharmacies Ask HHS to Remove Them from Provider Relief Cap

Long-term care (LTC) pharmacies are asking the Department of Health and Human Services (HHS) to separate them from retail pharmacies when calculating Phase 4 provider relief distributions. The pharmacies stated that the 10 percent cap on annual patient care revenue is arbitrary and not fair given that LTC pharmacy revenues are 30-35 percent of total revenue. In addition, LTC pharmacies expressed concern they are being excluded from rural provider relief distribution since HHS does not count Medicare Part D and other bundled payments as indirect payments.

Currently, HHS only reimburses LTC pharmacies for lost patient care revenue and expenses. HHS does not reimburse for lost revenue caused by decreased drug sales.

Proposed Rules

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 Final Guidance on Sodium Level Targets

On Oct. 13, the Food and Drug Administration issued a final guidance titled “Voluntary Sodium Reduction Goals: Target Mean and Upper Bound Concentrations for Sodium in Commercially Processed, Packaged, and Prepared Foods.” In the guidance, the FDA recommends that U.S. food manufacturers, restaurants and food service operators make gradual cuts to the amount of sodium in food products with the objective of reducing the average individual sodium intake by 12 percent over the next 2.5 years. The FDA states that the recommendations in the guidance, which are nonbinding, would improve high blood pressure-related health problems.

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.

Final Rules

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

On Oct. 4, 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 30 days after publication.

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.

Courts

Find a comprehensive look at “The Courts and Healthcare Policy” here.

5th Circuit Allows Texas’ Abortion Law to Remain in Effect

On Oct. 14, a 5th Circuit judge stated that Texas’ law SB8, which bans nearly all abortions, can remain in effect while courts decide if the law violates the constitution. A U.S. district court had previously blocked enforcement of the law for several days.

Reports

House Ways and Means Committee Democratic Staff Report on Race in Clinical Algorithms

On Oct. 14, the House Ways and Means Committee Democratic staff released a report titled “Fact Versus Fiction: Clinical Decision Support Tools and the (Mis)Use of Race” that analyzed the use of race in clinical algorithms. The report also explores potential strategies to address inequalities in clinical decision support tools (CDSTs) that lead to disparities in patient outcomes.

The full report can be found here.

GAO Report on Indian Health Service COVID-19 Flexibilities

On Oct. 14, the Government Accountability Office (GAO) published a report titled “COVID-19 Contracting: Indian Health Service Used Flexibilities to Meet Increased Medical Supply Needs.” The report states that the Indian Health Service (IHS) faced unprecedented demand for medical supplies during the COVID-19 pandemic but was able to acquire the necessary products from a variety of vendors using emergency contracting flexibilities. However, the report notes that IHS’s contracting officials did not notice that some supplies were delivered late. IHS is currently in the process of obtaining new software to improve contractor oversight.

The full report 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.

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