Washington Healthcare Update

January 17, 2023

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This Week in Washington: House assigns members to committees and finalizes committee chairmanships

Congress

House

Administration

Proposed Rules

Final Rules

Reports

Congress

House

House Passes Abortion Bill

On Jan. 11, the House of Representatives approved a bill on a vote of 220-210 that would require infants born alive after an attempted abortion receive the same protection under the law and degree of care as any newborn. Medical providers could face up to five years in prison for failing to resuscitate babies born alive during abortions. Rep. Henry Cuellar (D-TX) joined Republicans while Rep. Vicente González (D-TX) voted present. The bill is not expected to pass the Senate.

Senate not in session

Administration

HHS Secretary Renews COVID-19 Public Health Emergency

On Jan. 11, Department of Health and Human Services (HHS) Secretary Xavier Becerra extended the ongoing COVID-19 Public Health Emergency (PHE) declaration to April. The COVID-19 PHE declaration will remain in effect for the next 90 days, after which it must be renewed to continue. The next key date will be mid-February because the administration has pledged to provide 60-day notice if it is not going to renew the PHE.

HHS Awards Millions to Youth Mental Health Programs

On Jan. 9, the Department of Health and Human Services (HHS) awarded $245 million of funding granted by the Bipartisan Safer Communities Act to youth and workforce mental health programs. Some of the funds will go toward primary school mental health programs such as the Project Advancing Wellness and Resiliency in Education (AWARE) program, and toward broader-reaching mental health services such as the National Child Traumatic Stress Initiative (NCTSI). Funds were also awarded to mental health training programs for primary care clinicians.

For more information, click here.

CMS Announces Implementation Steps for the Inflation Reduction Act’s Medicare Drug Price Negotiation Program

On Jan. 11, the Centers for Medicare and Medicaid Services (CMS) announced when it would begin implementing new Medicare drug price negotiation measures introduced by the Inflation Reduction Act (IRA). CMS will begin negotiations this year and is expecting the first negotiated price agreements to go into effect in 2026. On Sept. 1, 2023, CMS will publish the first list of Medicare Part D drugs that were selected for negotiation. CMS will continue selecting Part D drugs and release the next list in 2027.

For more information, click here.

CMS Begins Awarding Medicare-funded Residency Slots

On Jan. 9, the Centers for Medicare and Medicaid Services (CMS) awarded the first 200 of 1,000 Medicare-funded physician residency slots it has pledged toward hospitals serving underserved communities. CMS will continue phasing in 200 slots per year over the next five years, as established by policies in the Fiscal Year (FY) 2022 Inpatient Prospective Payment System (IPPS) final rule. CMS aims to expand health equity and access to care by awarding the slots to hospitals in communities that lack access to critical services such as primary care and mental health specialists.

CMS Announces Release Date for Short-Term Plan Rule

On Jan. 4, the Centers for Medicare and Medicaid Services (CMS) announced that it would release a proposed rule regarding the sale of short-term limited duration (STLD) health plans in April. CMS had originally planned on releasing the short-term rule in August 2022.

FDA Sends Letters of Acknowledgment to Infant Formula Manufacturers

On Jan. 9, the Food and Drug Administration (FDA) sent letters of acknowledgment to 11 infant formula manufacturers who expressed an interest in keeping their product on the U.S. market, after they received FDA enforcement discretion letters in September 2022. The FDA enforcement discretion letter had asked manufacturers to submit a list of the product(s) that the manufacturer promised would comply with all FDA regulatory requirements. Infant formula manufacturers had previously been notified of the FDA’s enforcement discretion over the testing, importation, sale and distribution of infant formula products in the U.S.

For more information, click here.

FDA Announces Joint eSTAR Pilot Program with Health Canada

On Jan. 10, the Food and Drug Administration (FDA) announced that it would begin testing an electronic Submission Template and Resource (eSTAR) Pilot Program in partnership with Health Canada. eSTAR is an electronic form that is intended to assist applicants who wish to submit a 510(k) comprehensive medical device submission to the FDA Center for Devices and Radiological Health (CDRH). The FDA and Health Canada will allow nine participants to take part in the pilot program and will jointly determine the feasibility of using a single eSTAR program once the pilot is complete.

For more information, click here.

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 Health Care 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 Benefit and Payment Parameters for 2024

On Dec. 21, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule that outlines proposed payments and provisions for risk adjustment and risk adjustment data validation programs, operated by the Department of Health and Human Services (HHS). The proposed rule also outlines proposed 2024 user fee rates for issuers offering qualified health plans (QHPs) through federally-facilitated exchanges (FFEs), and state-based exchanges on the federal platform (SBE-FPs).

The proposed rule would also introduce requirements related to:

  • Updating standardized plan options
  • Reducing plan choice overload
  • Re-enrollment hierarchy
  • Plan and plan variation marketing name requirements for QHPs
  • Essential community provider (ECP) and network adequacy
  • Failure to file and reconcile
  • Special enrollment periods (SEPs)
  • Annual household income verification
  • Deadline for QHP issuers to report enrollment and payment inaccuracies
  • State Exchange improper payment measurement program
  • Requirements for agents, brokers and web-brokers assisting FFE and SBE-FP consumers

Public comments will be accepted until Jan. 30, 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.

HRSA Proposed Rule Changes Concerning 340B Disputes

On Nov. 29, the Health Resources and Services Administration (HRSA) released a proposed rule that outlines changes to how the administrative dispute resolution (ADR) process should be handled, for diversions, duplicate discounts and overcharges under the 340B program. HRSA aims to make the process less formal and more expeditious. The proposed changes include:

  • Establishing a more accessible and timely ADR process, while structuring the process to be less formal and rigid.
  • Eliminating the $25,000 minimum dispute threshold for drug makers and 340B providers to use the process.
  • Restructuring the ADR panel to be composed of subject-matter experts from HRSA’s Office of Pharmacy Affairs.
  • Requiring that covered entities and drug companies attempt to resolve disputes in good faith on their own before the ADR process is initiated.
  • Allowing for a reconsideration process when either covered entities or drug companies are dissatisfied with the ADR panel’s decision.

Public comments will be accepted until Jan. 30, 2023. For more information, click here.

Final Rules

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

Kaiser Family Foundation Analysis Estimates Millions of Americans are Eligible for Free or Nearly Free Affordable Care Act Health Coverage

On Jan. 10, the Kaiser Family Foundation (KFF) released the results of an analysis it conducted to determine whether uninsured individuals could qualify for free or nearly free Affordable Care Act (ACA) health plans. KFF concluded that roughly 5 million uninsured Americans could get free or nearly free ACA plans if they enroll by the end of open enrollment period on Jan. 15. Nearly free plans would require individuals to pay for the nonessential portions of their premiums, which typically amounts to a few dollars per month. Very low deductible and $0 premium ACA plans, also referred to as silver plans, are available to all Marketplace subsidy-eligible enrollees who do not earn more than 150 percent of the federal poverty guideline. As of 2021, 28 million Americans remained uninsured.

For more information, click here.