This Week in Washington: Fighting over how to proceed on the debt limit; Congress still finalizing committee assignments

Upcoming Hearings

Congress

House

• Reps. Lee, DeGette, Pressley and Schakowsky Introduce the Ensuring Equal Access to Abortion Coverage in Health Insurance Act
• Reps. Carter and Blunt Rochester Introduce Bipartisan Essential Medicines Strategic Stockpile Act

Senate

• Sens. Barrasso, Tester, Daines and Hickenlooper Issue Letter to CMS Regarding Nursing Home Staffing Mandates

Administration

• FDA Announces Pediatric Medical Device Development Funding Opportunity
• FDA Proposes New Individual Risk Assessment for Blood Donors
• FDA Revokes EUA for COVID-19 Drug Evusheld
• FDA Declares Existing Regulatory Food and Supplements Framework Inadequate for CBD Products
• FDA Advisors Unanimously Vote on Simplifying COVID-19 Vaccination Process
• FDA Releases Industry Guidance for Cannabis and Cannabis-Derived Compound Drug Clinical Research
• FDA Issues Marketing Denial Orders for Two Menthol E-Cigarette Products
• FDA Issues Draft Guidance Regarding Lead Levels in Children’s and Babies’ Processed Foods
• FDA Issues Immediately-In-Effect Guidance on Ibuprofen Oral Suspension Products
• CMS Releases 2022 Accomplishments List
• CMS Releases Notice Explaining Price Metric Changes for Covered Outpatient Drugs
• HHS Awards $139 Million to Indian Special Diabetes Program

Proposed Rules

• HHS Proposes Rule to Clarify Beneficiary Religious Protections
• HHS Office for Civil Rights Releases Proposed Rule Seeking to Clarify Healthcare Provider Conscience Protection Rights
• SAMHSA Seeking Public Comments Regarding Opioid Use Disorder Treatment Medication Requirement Reforms
• SAMHSA Introduces Proposed Rule to Better Align SUD Patient Privacy with HIPAA
• CMS Releases Proposed Changes to Contract Year 2024 Medicare Program Plans
• CMS Proposes MA Plan Marketing, Part D Low-income Access, Prior Authorization and Behavioral Health Reforms
• CMS Proposes Healthcare Plan Exchange Rule for 2024
• CMS Requests Information on Essential Health Benefits Proposed Rule
• HHS Proposes Adopting Healthcare Attachments Standards
• FDA Proposed Rule Would Replace Investigational New Drug Annual Report
• FDA Proposes Exempting Certain Conventional Food, Dietary Supplements and Cosmetics From Investigational New Drug Requirements

Final Rules

• CMS Final Rule Adds Items to DMEPOS Order List and Updates Healthcare Common Procedure Coding System (HCPCS)
• FDA Delays Tobacco Product Required Warning Final Rule Effective Date
• CMS Issues Correction on Clinical Laboratory Improvement Amendments (CLIA) Final Rule

Reports

• KFF Releases Report on Long COVID
• HHS Report Shows Estimated Impact of Inflation Reduction Act Medicare Part B and D Insulin Price Cap Provision

Upcoming Hearings

Feb. 1

House Committee on Energy and Commerce Health Subcommittee Hearing: “Lives Worth Living: Addressing the Fentanyl Crisis, Protecting Critical Lifelines, and Combatting Discrimination Against Those With Disabilities”
10:00 a.m., Rayburn House Office Building 2123

House Committee on Oversight and Accountability Hearing: “Federal Pandemic Spending: A Prescription for Waste, Fraud, and Abuse”
10:00 a.m., Rayburn House Office Building 2154

Announced Witnesses Are:

• Michael Horowitz, Chairman of the Pandemic Response Accountability Committee
• Gene Dodaro, Comptroller General for the Government Accountability Office
• David M. Smith, Assistant Director for the Secret Service’s Office of Investigations

Congress

House

Reps. Lee, DeGette, Pressley and Schakowsky Introduce the Ensuring Equal Access to Abortion Coverage in Health Insurance Act

On Jan. 26, Reps. Lee (D-CA), DeGette (D-CO), Pressley (D-MA) and Schakowsky (D-IL) introduced the Ensuring Equal Access to Abortion Coverage in Health Insurance (EACH) Act. The bill reverses the restrictions placed by the Hyde Amendment on Medicaid and federal health insurance coverage of abortion.

Reps. Carter and Blunt Rochester Introduce Bipartisan Essential Medicines Strategic Stockpile Act

On Jan. 23, Reps. Buddy Carter (R-GA) and Lisa Blunt Rochester (D-DE) introduced the Essential Medicines Strategic Stockpile Act. The bill seeks to strengthen U.S. generic drug stockpiles to prevent drug shortages during public health emergencies and decrease U.S. dependence on foreign pharmaceutical markets. The bill would require the Department of Health and Human Services (HHS) to select 50 drugs to include in the stockpile, keep an updated list of the drugs and make the list publicly available.

Senate

Sens. Barrasso, Tester, Daines and Hickenlooper Issue Letter to CMS Regarding Nursing Home Staffing Mandates

On Jan. 20, Sens. Barrasso (R-WY), Tester (D-MT), Daines (R-MT) and Hickenlooper (D-CO) sent a letter to the Centers for Medicare and Medicaid Services (CMS), expressing their concerns over CMS’ intent to issue new nursing home staffing mandates. The senators are concerned that new nursing home staffing mandates would adversely impact nursing homes in rural areas. The senators are urging CMS to consider proposals to address the staffing and operational challenges experienced by nursing homes in rural, underserved areas.

For more information, click here.

Administration

FDA Announces Pediatric Medical Device Development Funding Opportunity

On Jan. 27, the Food and Drug Administration (FDA) announced that it is opening a new funding opportunity for developers of pediatric medical devices. The grant program will provide device manufacturers access to an advising platform, through which they can learn about pediatric device regulatory, business, prototyping, engineering and laboratory testing processes. Applications for the grant program will be accepted until March 29, 2023.

FDA Proposes New Individual Risk Assessment for Blood Donors

On Jan. 27, the Food and Drug Administration (FDA) announced that it is proposing a change to blood donor eligibility for men who report having sex with a male partner or partners (MSM). The proposed guidelines would also apply to women who report having sex with MSM men. Under current FDA blood donation guidelines, gay and bisexual men are prohibited from donating blood if they report having sexual contact with other men within the previous three months. The new individual risk assessment would eliminate the time-deferred restriction and would evaluate prospective donors based on how many sexual partners they had within the previous three months, and whether they had engaged in anal sex with their partner or partners.

For more information, click here.

FDA Revokes EUA for COVID-19 Drug Evusheld

On Jan. 26, the Food and Drug Administration (FDA) revoked the emergency use authorization (EUA) for the COVID-19 drug Evusheld. The FDA revoked the EUA after it received data showing that the drug was ineffective against currently circulating COVID-19 variants.

FDA Declares Existing Regulatory Food and Supplements Framework Inadequate for CBD Products

On Jan. 26, the Food and Drug Administration (FDA) announced that it would begin working on creating a new regulatory framework to review cannabidiol (CBD) products. The agency is concerned about the safety of CBD products after studies revealed possible interactions between CBD and medications, and potential harm to the liver and male reproductive system in long-term users. The FDA denied petitions it had received to classify CBD products as dietary supplements.

For more information, click here.

FDA Advisors Unanimously Vote on Simplifying COVID-19 Vaccination Process

On Jan. 26, the Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) met to discuss the composition and immunization schedule of future COVID-19 vaccines. The committee voted unanimously on combining all primary and booster COVID-19 vaccine strains into a single, one-dose shot. The agency also considered, but did not vote on, a proposal to do away with the current COVID-19 booster-dose schedule recommendation. The proposal calls on the FDA to make a single COVID-19 booster-dose available during the fall, rather than offering booster-doses year-round.

For more information, click here.

FDA Releases Industry Guidance for Cannabis and Cannabis-Derived Compound Drug Clinical Research

On Jan. 24, the Food and Drug Administration (FDA) released an industry guidance for the clinical research of drugs containing cannabis and cannabis-derived compounds. The guidance outlines the legal definitions and regulatory controls of cannabis and lays out recommendations for cannabis products that qualify as a drug under the Federal Food, Drug, and Cosmetic Act.

For more information, click here.

FDA Issues Marketing Denial Orders for Two Menthol E-Cigarette Products

On Jan. 24, the Food and Drug Administration (FDA) issued two marketing denial orders (MDOs) for menthol e-cigarette products produced by the R.J. Reynolds Vapor Company. The FDA ruled that the tobacco product applications submitted for the Vuse Vibe Tank Menthol 3.0% and the Vuse Ciro Cartridge Menthol 1.5% vape pods failed to present enough evidence that they helped long-term smokers more than they prevented youth uptake and abuse. The FDA will allow R.J. Reynolds to submit new product applications for both products.

For more information, click here.

FDA Issues Draft Guidance Regarding Lead Levels in Children’s and Babies’ Processed Foods

On Jan. 24, the Food and Drug Administration (FDA) released a draft guidance outlining action levels for the amount of lead that is found in processed foods for young children and babies under two years of age. The FDA is concerned about the amount of lead that is found in these foods, due to the negative impact lead exposure has on children’s health and development. The agency is urging infant and baby food manufacturers to increase testing for lead and other heavy metals in their products.

For more information, click here.

FDA Issues Immediately-In-Effect Guidance on Ibuprofen Oral Suspension Products

On Jan. 20, the Food and Drug Administration (FDA) Center for Drug Evaluation and Research issued an immediately-in-effect guidance on the compounding of certain ibuprofen oral suspension products. The guidance was issued in response to the high consumer demand for pediatric fever-reducing medications, driven by the current surge of COVID-19, respiratory syncytial virus (RSV) and influenza. The FDA is also concerned about reports of hospitals and health systems having difficulty obtaining oral suspension products for their patients.

For more information, click here.

CMS Releases 2022 Accomplishments List

On Jan. 26, the Centers for Medicare and Medicaid Services (CMS) released a list of the agency’s 2022 accomplishments. The list details what actions CMS undertook to meet its six strategic pillars of advancing health equity, expanding access to affordable and quality care, engaging with partners and communities, driving healthcare innovation, protecting healthcare program sustainability and fostering positivity and inclusivity in CMS operations.

For more information, click here.

CMS Releases Notice Explaining Price Metric Changes for Covered Outpatient Drugs

On Jan. 23, the Centers for Medicare and Medicaid Services (CMS) released a notice, informing drug manufacturers of changes that were made to pricing metrics of drug manufacturer covered outpatient drugs (COD). CMS was required to change COD pricing metrics following the enactment of various legislation, including the Inflation Reduction Act (IRA) and the Infrastructure Investment and Jobs Act of 2021. The notice seeks to help drug manufacturers understand how the changes in pricing metrics impact manufacturers’ average manufacturer price (AMP) and Medicaid’s “best price” policies.

For more information, click here.

HHS Awards $139 Million to Indian Special Diabetes Program

On Jan. 25, the Department of Health and Human Services (HHS) awarded $139 million to the Special Diabetes Program for Indians (SDPI). The program aims to support diabetes prevention and treatment services in American Indian and Alaska Native communities across 35 states.

Proposed Rules

HHS Proposes Rule to Clarify Beneficiary Religious Protections

On Jan. 13, nine federal agencies, including the Department of Health and Human Services (HHS), released a proposed rule that seeks to clarify and restore religious liberty protections for individuals who receive federally funded social services. The proposed rule would require federal grantees who administer social service programs to notify individuals that they may not be discriminated against based on their religion. The rule would also advise federal agencies on how they can assist individuals with finding providers that are more reflective of their beliefs.

In addition to HHS, the Departments of Agriculture, Education, Homeland Security, Housing and Urban Development, Justice, Labor and Veterans Affairs and the U.S. Agency for International Development are proposing the rule.

Public comments will be accepted until March 14, 2023. For more information, click here.

HHS Office for Civil Rights Releases Proposed Rule Seeking to Clarify Healthcare Provider Conscience Protection Rights

On Jan. 5, the Department of Health and Human Services (HHS) Office for Civil Rights (OCR) released a proposed rule that seeks to partially rescind a 2019 final rule titled “Protecting Statutory Conscience Rights in Health Care; Delegations of Authority.” The proposed rule would keep a framework in place created by a 2011 final rule titled “Regulation for the Enforcement of Federal Health Care Provider Conscience Protection Laws.” Certain provisions of the 2019 final rule related to federal conscience protections would be retained, but those that are redundant and confusing would be eliminated.

Public comments will be accepted until March 6, 2023. For more information, click here.

SAMHSA Seeking Public Comments Regarding Opioid Use Disorder Treatment Medication Requirement Reforms

On Dec. 16, the Substance Abuse and Mental Health Services Administration (SAMHSA) issued a notice of proposed rulemaking, requesting public comments on its proposal to modify regulations for opioid use disorder treatment medications. The proposed rule seeks to make treatment in Opioid Treatment Programs (OTP) more accessible to patients, and easier to deliver to providers. The proposed rule also seeks to increase the uptake of evidence-based treatments for substance use disorders and is in line with the Department of Health and Human Services’ (HHS) Overdose Prevention Strategy.

Public comments will be accepted until Feb. 14, 2023. For more information, click here.

SAMHSA Introduces Proposed Rule to Better Align SUD Patient Privacy with HIPAA

On Nov. 28, the Substance Abuse and Mental Health Services Administration (SAMHSA) released a proposed rule that would align certain policies in the Confidentiality of Substance Use Disorder Patient Records with the Health Insurance Portability and Accountability Act (HIPAA), per Congress’ instruction in the CARES Act.

The proposed rule would allow providers to disclose Part 2 records after patients give consent once, and that consent would apply to all future uses. They would also be able to redisclose those records as permitted by the HIPAA privacy rule. Additionally, the rule would give patients the ability to obtain a list of disclosure situations and the right to request restrictions on certain disclosures. It would also give the Department of Health and Human Services (HHS) new enforcement powers, like civil money penalties for those that violate Part 2 protections.

Public comments will be accepted until Jan. 31, 2023. For more information, click here.

CMS Releases Proposed Changes to Contract Year 2024 Medicare Program Plans

On Dec. 27, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule that would revise regulations for Medicare Advantage, Prescription Drug Benefit, Cost Plan and Programs of All-Inclusive Care for the Elderly (PACE) plans. The proposed rule would implement changes related to:

• Star Ratings
• Medication therapy management
• Marketing and communications
• Health equity
• Provider directories
• Coverage criteria
• Prior authorization
• Passive enrollment
• Network adequacy
• Identification of overpayments
• Formulary changes

Public comments will be accepted until Feb. 13, 2023. For more information, click here.

CMS Proposes MA Plan Marketing, Part D Low-income Access, Prior Authorization and Behavioral Health Reforms

On Dec. 14, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule that seeks to overhaul marketing practices for Medicare Advantage (MA) plans. The proposed rule comes after CMS told MA plan issuers that it was concerned with the manner in which MA plans were marketed, particularly on television and by third-party marketing organization ads.

Some of the proposed rule changes include:

• Prohibiting television advertisements that don’t specify a plan name.
• Prohibiting advertisements that use words and imagery that may mislead or confuse MA plan beneficiaries.
• Prohibiting the use of Medicare language or logos in advertisements.
• Prohibiting MA plan marketers from using the words “best” and “most” to describe their plans, unless they have documentation to support such statements.
• Banning sales presentations that immediately follow an educational event.
• Banning agent distribution and collection of Scope of Appointment and Business Reply Cards at educational events.
• Banning agents from conducting sales or enrollment meetings with beneficiaries within 48 hours after obtaining their consent.

Additionally, the proposed rule seeks to expand access to low-income Part D subsidies and biosimilars. CMS would like to grant Part D low-income subsidies to individuals who currently qualify for partial low-income subsidies. The agency wants to ensure that individuals who qualify for full low-income subsidies do not have to face deductibles, premiums or fixed copay requirements for certain drugs. CMS is also proposing that Part D plan sponsors be able to substitute brand drugs with lower-cost options.

The proposed rule also contains language regarding the prior authorization process and behavioral health reforms. CMS is incorporating several recommendations from a report on prior authorization request denials, issued by the Office of the Inspector General (OIG). The proposed rule also includes provisions that seek to grant MA enrollees access to behavioral health service providers. The proposed rule would require MA organizations to include behavioral health services in care coordination programs.

Public comments will be accepted until Feb. 13, 2023. For more information, click here.

CMS Proposes Healthcare Plan Exchange Rule for 2024

On Dec. 12, the Centers for Medicare and Medicaid Services (CMS) released the 2024 proposed rule for plans in the exchange. The proposed rule includes key changes to network adequacy standards and will slightly lower user fees for 2024. In addition, the rule:

• Proposes to limit to two the nonstandardized plan options for each product network type and metal tier level, with an exception for catastrophic plans. This requirement only applies to HealthCare.gov, which residents in 38 states use to buy ACA plans. It does not apply to state-run marketplaces.
• Seeks to add to the standardized plan option requirements including a proposal to no longer include a standard option for the nonexpanded bronze plan tier.

Public comments will be accepted until March 13, 2023. For more information, click here.

CMS Requests Information on Essential Health Benefits Proposed Rule

On Dec. 2, the Centers for Medicare and Medicaid Services (CMS) issued a request for information on a proposed rule that relates to the essential health benefits (EHBs) included in the Patient Protection and Affordable Care Act (ACA). CMS is requesting comments to gain a better understanding of the coverage of EHBs in health plans, and to evaluate whether EHBs should be modified or updated to account for changes in medical evidence and scientific advancements.

Public comments will be accepted until Jan. 31, 2023. For more information, click here.

HHS Proposes Adopting Healthcare Attachments Standards

On Dec. 15, the Office of the Secretary of the Department of Health and Human Services (HHS) released a proposed rule that would implement standards for “health care attachments” transactions, to support healthcare claims and prior authorization transactions. The proposed rules would also implement a standard for electronic signatures and modify the standard for referral certification and authorization transactions.

Public comments will be accepted until March 21, 2023. For more information, click here.

FDA Proposed Rule Would Replace Investigational New Drug Annual Report

On Dec. 9, the Food and Drug Administration (FDA) released a proposed rule that would change the investigational new drug (IND) annual reporting requirement. The proposed rule would replace the IND annual report with a new report titled the Food and Drug Administration Development Safety Update Report (FDA DSUR). The FDA intends to make the new report consistent with the format and content of the development safety update report that is supported by the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH).

Public comments will be accepted until March 9, 2023. For more information, click here.

FDA Proposes Exempting Certain Conventional Food, Dietary Supplements and Cosmetics From Investigational New Drug Requirements

On Dec. 9, the Food and Drug Administration (FDA) released a proposed rule that seeks to exempt certain clinical investigations of lawfully marketed conventional foods, dietary supplements and cosmetics from the investigational new drug application (IND) requirement, when the clinical investigations are conducted for the purposes of studying the products’ potential use as a drug. Although these products would be exempt from IND requirements, they would still be subject to other investigations to ensure the rights and safety of individuals. The FDA believes the proposed rule will reduce regulatory burden on the agency.

Public comments will be accepted until March 9, 2023. For more information, click here.

Final Rules

CMS Final Rule Adds Items to DMEPOS Order List and Updates Healthcare Common Procedure Coding System (HCPCS)

On Jan. 17, the Centers for Medicare and Medicaid Services (CMS) released a final rule that will update the Healthcare Common Procedure Coding System (HCPCS) codes for required Face-to-Face Encounter and Written Order Prior to Delivery (F2F/WOPD) requirements applicable to Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) orders. The update follows CMS’ decision to add new non-statutorily required DMEPOS items to the F2F/WOPD list. CMS believes the addition of these items will protect Medicare enrollees and further reduce Medicare fraud, waste and abuse.

The rule is set to go into effect on April 17, 2023. For more information, click here.

FDA Delays Tobacco Product Required Warning Final Rule Effective Date

On Nov. 25, the Food and Drug Administration (FDA), in compliance with an order issued by the U.S. District Court for the Eastern District of Texas, delayed the effective date of a final rule published on March 18, 2020, titled “Tobacco Products; Required Warnings for Cigarette Packages and Advertisements.” The rule, which was originally supposed to go into effect on June 18, 2021, establishes new cigarette health warnings for cigarette packages and advertisements.

The rule is now set to go into effect on Nov. 6, 2023. For more information, click here.

CMS Issues Correction on Clinical Laboratory Improvement Amendments (CLIA) Final Rule

On Nov. 17, the Centers for Medicare and Medicaid Services (CMS) corrected a technical error that was found in a final rule published in the Federal Register on July 11, 2022. The final rule updates proficiency testing (PT) regulations under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), to address analytes and newer technologies.

The rule goes into effect July 11, 2024. For more information, click here.

Reports

KFF Releases Report on Long COVID

On Jan. 26, the Kaiser Family Foundation (KFF) released a report analyzing Long COVID. KFF found that between June 2022 and January 2023, the percentage of individuals reporting Long COVID symptoms dropped from 19 percent to 11 percent. The report also found that more than 50 percent of people who had reported experiencing Long COVID symptoms in the past no longer experience any symptoms. KFF chose to conduct the study due to the ongoing efforts to understand the effects and impacts of Long COVID.

For more information, click here.

HHS Report Shows Estimated Impact of Inflation Reduction Act Medicare Part B and D Insulin Price Cap Provision

On Jan. 24, the Department of Health and Human Services (HHS) Assistant Secretary for Planning and Evaluation (ASPE) Office of Health Policy released a report showing the estimated impact that the insulin price cap provision of the Inflation Reduction Act (IRA) would have had on Medicare Part B and D beneficiary costs, had it been in effect in 2020. As of Jan. 1, 2023, the IRA caps the out-of-pocket insulin price for Medicare Part D beneficiaries to $35 per month. A similar price cap will take effect on July 1, 2023, for Medicare Part B beneficiaries. HHS estimates that the IRA insulin price cap would have saved roughly 1.5 million Americans an average of $500 in 2020. This amounts to roughly $734 million in savings for Part D beneficiaries and $27 million for Part B beneficiaries. HHS believes the insulin provision will have the biggest impact for beneficiaries living in Texas, California and Florida.

For more information, click here.