This Week in Washington: President Biden delivers State of the Union Address, House votes to end CDC COVID-19 Foreign Air Traveler Vaccine Mandate

Upcoming Hearings

Congress

House

Senate

Administration

Proposed Rules

Final Rules

Reports


Upcoming Hearings

Feb. 16

Senate Committee on Health, Education, Labor and Pensions Hearing: “Examining Health Care Workforce Shortages: Where Do We Go From Here?”
10:00 a.m., Dirksen Senate Building 430

Congress

House

House Votes to Terminate CDC COVID-19 Vaccine Mandate for Foreign Travelers

On Feb. 8, the U.S. House of Representatives passed H.R. 185, which would end the Centers for Disease Control and Prevention (CDC) COVID-19 vaccine mandate for foreign air travelers. Democratic Reps. Craig (MN), David (NC), Higgins (NY), Horsford (NV), Titus (NV), Lee (NV), and Pappas (NH) joined House Republicans in voting against the vaccine mandate. The bill is not expected to move forward in the Senate.

Senate

Senate Judiciary Committee Advances Bipartisan Bills to Lower Prescription Drug Costs

On Feb. 9, the Senate Judiciary Committee reported out of committee five bills that are designed to lower prescription drug prices. The bills are:

  • 113, Prescription Pricing for the People Act of 2023, as amended, to require the Federal Trade Commission to study the role of intermediaries in the pharmaceutical supply chain and provide Congress with appropriate policy recommendations. The bill was introduced by Sens. Grassley and Cantwell and is cosponsored by Sens. Blumenthal, Lankford, Blackburn, Tuberville, Tillis, Capito, Braun, Boozman, Welch, Coons, Hirono and Feinstein.
  • 142, Preserving Access to Affordable Generics and Biosimilars Act, as amended, to prohibit brand-name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market, and to prohibit biological product manufacturers from compensating biosimilar and interchangeable companies to delay the entry of biosimilar biological products and interchangeable biological products. The bill was introduced by Sens. Klobuchar and Grassley and is cosponsored by Sens. Durbin, Cramer, Blumenthal, Kelly, Van Hollen, Booker, Ossoff and Ernst.
  • 148, Stop STALLING Act, as amended, to enable the Federal Trade Commission to deter filing of sham citizen petitions to cover an attempt to interfere with approval of a competing generic drug or biosimilar, to foster competition and to facilitate the efficient review of petitions filed in good faith to raise legitimate public health concerns. The bill was introduced by Sens. Klobuchar and Grassley and is cosponsored by Sens. Durbin, Braun, Blumenthal, Cruz, Booker and Ossoff.
  • 150, Affordable Prescriptions for Patients Act of 2023 to amend the Federal Trade Commission Act to prohibit product hopping. The bill was introduced by Sens. Cornyn and Blumenthal and is cosponsored by Sens. Grassley, Durbin, Cruz and Klobuchar.

For more information, click here.

Administration

White House Releases 2023 Health Initiatives Fact Sheet

On Feb. 7, the White House released a face sheet that outlines President Biden’s healthcare priorities for 2023. Top priorities include increasing funding to cancer research and treatment services, expanding access to peer support and mental health services, strengthening healthcare services for veterans and their families and broadening recovery and treatment services for individuals with substance-abuse disorders.

For more information, click here.

HHS Releases COVID-19 PHE Transition Guide

On Feb. 10, the Department of Health and Human Services (HHS) released a guide explaining what will and will not be affected by the termination of the COVID-19 public health emergency (PHE) on May 11, 2023. The guide expands on access to COVID-19 treatments, vaccines, telehealth, testing and more.

For more information, click here.

HHS OIG Releases Inflation Drug Rebate Technical Brief

On Feb. 9, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) released a technical brief outlining how the inflation-indexed rebates for Medicare Part B drugs will be calculated. The Inflation Reduction Act (IRA) requires pharmaceutical companies to pay rebates to the Medicare Trust Fund if their respective Part B prescription drug prices rise faster than the rate of inflation. The technical brief expands on administrative challenges the OIG expects the Centers for Medicare and Medicaid Services (CMS) to encounter when implementing rebates.

For more information, click here.

CDC Adds COVID-19 Vaccine to Recommended Immunization Schedules

On Feb. 9, the Centers for Disease Control and Prevention (CDC) added the COVID-19 vaccine to the recommended immunization schedule for children, adolescents and adults. The recommendation immunization schedule does not mandate the COVID-19 vaccine. The CDC is recommending healthy children and adults receive two doses of the Moderna, Pfizer or Novavax vaccine, followed by one dose of a bivalent booster. Immunocompromised children and adults are urged to receive three doses of a primary series vaccine and a subsequent bivalent vaccine.

For more information, click here.

CDC Announces Extension of COVID-19 and Mpox Wastewater Surveillance

On Feb. 8, the Centers for Disease Control and Prevention (CDC) announced that it would extend its national wastewater surveillance partnership with Biobot Analytics. Biobot Analytics has been providing the CDC with COVID-19 and Mpox wastewater data and analysis. The CDC is gathering the data to better track the prevalence and spread of both viruses, and to inform public health agencies about local resurgences.

For more information, click here.

CDC Study Highlights Effectiveness of COVID-19 Protective Measures

On Feb. 6, the Centers for Disease Control and Prevention (CDC) released a study highlighting the effectiveness of COVID-19 protective measures among essential and frontline workers who had previously been infected by COVID-19. Workers who received two or three doses of a COVID-19 mRNA vaccine were more than 40 percent less likely to be reinfected by COVID-19 than those who were unvaccinated. Additionally, workers who reported having worn a mask more than 50 percent of the time in public had a lower risk for reinfection than those who went unmasked.

For more information, click here.

CMS Releases Medicare Prescription Drug Inflation Rebate Program Guidance

On Feb. 9, the Centers for Medicare and Medicaid Services (CMS) released an initial guidance on the Medicare Prescription Drug Rebate Program, which went into effect on Oct. 1, 2022. The program was created under the Inflation Reduction Act and will require pharmaceutical companies to pay rebates to the Medicare Trust Fund when their prescription drug prices rise faster than the rate of inflation. The program is intended to help keep prescription drugs more affordable. CMS is requesting public comment on the program. Comments will be accepted until March 11, 2023.

For more information, click here.

FDA Releases Guidance on Neonatal Medical Products Safety Studies

On Feb. 10, the Food and Drug Administration (FDA) released guidance related to long-term safety studies for neonatal medical products. The guidance, titled “Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development,” seeks to help manufacturers of neonatal products understand how to develop long-term safety study plans and identify specific factors and characteristics that should be assessed.

For more information, click here.

FDA Revises Ibuprofen Oral Suspension Product Guidance

On Feb. 9, the Food and Drug Administration (FDA) revised the immediately-in-effect guidance it released on the compounding of ibuprofen oral suspension products, titled “Compounding Certain Ibuprofen Oral Suspension Products Under Section 503B of the Federal Food, Drug and Cosmetic Act.” The revised guidance addresses outsourcing facilities supplying ibuprofen oral suspension products to pharmacies, hospitals and health systems.

For more information, click here.

FDA Announces Withdrawal of Propofol Drug Product Guidance

On Feb. 9, the Food and Drug Administration (FDA) announced that it was withdrawing a guidance it issued in April 2020 regarding the repackaging and combining of propofol drug products. The guidance, titled “Temporary Policy on Repackaging or Combining Propofol Drug Products During the COVID-19 Public Health Emergency,” was issued by the FDA in response to the propofol drug shortage that was occurring during the April 2020 COVID-19 surge. The guidance granted pharmacies and outsourcing facilities temporary permission to repackage propofol drug products to be shipped to hospitals that reported having difficulty sourcing these products. The FDA has determined that the propofol drug products shortage no longer exists and is therefore withdrawing the guidance.

For more information, click here.

FDA Releases Draft Guidance on Infant Formula Protein Quality Testing

On Feb. 9, the Food and Drug Administration (FDA) released an industry draft guidance intended to help infant formula manufacturers understand how to test the protein quality of their products. The Federal Food, Drug, and Cosmetic (FD&C) Act requires the FDA to ensure that infant formulas meet sufficient fat, carbohydrate, protein and vitamin levels.

For more information, click here.

FDA Urges Public to Report Home COVID-19 Test Results

On Feb. 6, the Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) released an announcement that urges individuals to report their at-home COVID-19 test results to MakeMyTestCount.com, an online reporting website managed by the National Institute of Biomedical Imaging and Bioengineering and Care Evolution Healthcare Technology. The website is intended to assist public health departments with tracking the spread of COVID-19 and modifying their respective local, community and state response.

FDA Releases Drug and Biologic Firms’ Postmarketing Performance Report

On Feb. 3, the Food and Drug Administration (FDA) released a report on the postmarketing performance of drug and biologic firms in fiscal year (FY) 2021. The FDA can require drug and biologic manufacturers that recently received approval for one of their products to conduct post-approval studies and clinical trials of applicable products. These studies are intended to assess the clinical efficacy, safety, pharmacology and toxicology of the products.

For more information, click here.

FDA Announces Digital Health Technology Workshop with Duke-Margolis Health

On Feb. 3, the Food and Drug Administration (FDA) announced that it will be hosting a joint public workshop with Duke-Margolis Health regarding digital health technologies. The workshop, titled “Understanding Priorities for the Development of Digital Health Technologies To Support Clinical Trials for Drug Development and Review,” will be held virtually from March 28-29. The FDA and Duke-Margolis Health will discuss how to develop and enhance accessibility, diversity and clinical outcome measures of digital health technologies (DHTs).

For more information, click here.

Proposed Rules

SAMSHA Issues Proposed Rule To Eliminate X-Waiver Requirement

On Feb. 10, the Substance Abuse and Mental Health Services Administration (SAMHSA) issued a notice of proposed rulemaking to solicit public comment on its proposal to remove certain provisions under the Controlled Substances Act (CSA). The removal of these provisions is a result of the Consolidated Appropriations Act (CAA) of 2023. The CAA amended the CSA by eliminating the requirement that practitioners obtain a waiver to prescribe certain Schedule III-V drugs to treat opioid use disorder (OUD).

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

HHS Proposes Rule to Expand Access to ACA Birth Control Coverage

On Jan. 30, the Department of Health and Human Services (HHS) released a proposed rule that seeks to strengthen and expand health insurance birth control coverage for women. The proposed rule would prevent private health plans and insurers from excluding coverage of contraceptive services based on moral exemptions. It would also establish an independent birth control pathway for women covered under an objecting entity, which would allow them to access contraceptive services from a willing provider without any cost. Private health plans and insurers would still be allowed to deny birth control coverage based on religious exemptions and objecting private employers and universities would still have the right to choose whether to allow plan participants access to optional contraceptive services.

Public comments will be accepted until April 3, 2023. For more information, click here.

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.

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.

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 Issues Final Rule Regarding Medicare Advantage Risk Adjustment Data Validation Program

On Jan. 30, the Centers for Medicare and Medicaid Services (CMS) released a final rule that alters the audit methodology for the Medicare Advantage Risk Adjustment Data Validation (RADV) program and implements new requirements on Medicare Advantage Organizations (MAOs). The final rule establishes that CMS will begin extrapolating RADV audit findings with payment year (PY) 2018 and will not extrapolate audit findings for PYs 2011 through 2017. It also codifies CMS’ intention of not applying a fee-for-service adjustment factor to RADV program audits. The final rule will also require Medicare Advantage Organizations (MAOs) to remit improper payments identified by CMS during RADV audits.

The rule is set to go into effect on April 3, 2023. For more information, click here.

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

GAO Report Analyzes Rural Veterans’ Access to Intensive Mental Healthcare Services

On Feb. 9, the U.S. Government Accountability Office (GAO) released a report analyzing whether veterans in rural areas have adequate access to intensive mental healthcare services. GAO was required to look at rural veterans’ ease of access to mental healthcare services due to a provision in the Sgt. Ketchum Rural Veterans’ Mental Health Act of 2021. GAO found that veterans living in rural areas used mental healthcare programs at lower rates than those living in urban areas. GAO is making a few recommendations on how the Veterans Health Administration (VHA) can improve and strengthen outpatient intensive mental health programs in rural areas. The VHA has agreed to the recommendations and has identified steps to implement them.

For more information, click here.

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