Washington Healthcare Update

January 9, 2023

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This Week in Washington: 118th Congress begins, House finally chooses Speaker 

Congress

House

Senate

Administration

Proposed Rules

Final Rules

Reports

Congress

House

House Names Speaker

Although in the past, members of Congress are generally sworn in following the selection of a Speaker, the need for 15 ballots to choose a Speaker delayed this important step. On Jan. 9, it is expected that the House will finalize choosing members to be chairman of committees for which there is a race. The Ways and Means Committee is one such committee.

Rep. Frank Pallone Releases Names of Democratic Energy and Commerce Subcommittee Staff Leadership

On Jan. 3, House Energy and Commerce Committee Ranking Member Rep. Frank Pallone (D-NJ) announced the names of the Democratic committee staff that will lead the minority staff for the Energy and Commerce Committee’s subcommittees during the 118th Congress. They are as follows:

Jennifer Epperson – Communications and Technology Subcommittee
Lisa Hone – Consumer Protection and Commerce Subcommittee
Tuley Wright – Energy Subcommittee
Caitlin Haberman – Environment and Climate Change Subcommittee
Una Lee – Health Subcommittee
Will McAuliffe – Oversight and Investigations Subcommittee

Senate

Sen. Bernie Sanders Takes Over as Senate HELP Committee Chair

Vermont Sen. Bernie Sanders will chair the Senate Health, Education, Labor and Pensions (HELP) Committee for the 118th Congress. As chair, Sanders has vowed to challenge drug manufacturers, insurers and work for lower prescription drug costs.

Administration

FDA Approves Alzheimer’s Drug Lecanemab

On Jan. 6, the Food and Drug Administration (FDA) granted accelerated approval to lecanemab, an Alzheimer’s Disease drug that has the ability to remove amyloid beta from the brain of Alzheimer’s patients. The drug will be sold under the name Leqembi. The approval has prompted debate among doctors concerning the drug’s efficacy and safety. 

For more information, click here.

FDA Advisory Committee to Meet Next Month to Discuss Emergent Naloxone Nasal Spray

On Jan. 6, the Food and Drug Administration (FDA) announced that the FDA Nonprescription Drugs Advisory and the Anesthetic and Analgesic Drug Products Advisory Committees would meet publicly next month to discuss Emergent BioSolutions’ proposed nonprescription naloxone nasal spray. The meeting is scheduled for Feb. 15, 2023.

FDA Grants Healthcare Providers and Pharmacies Permission to Dispense Mifepristone Pill

On Jan. 3, the Food and Drug Administration (FDA) finalized changes to rules relating to the prescription of the abortion pill mifepristone. Licensed healthcare providers and certain pharmacies will now be allowed to dispense the drug. The decision follows proposed changes the FDA introduced in 2021, prior to the overturning of Roe v. Wade. According to the FDA, pharmacies that become certified under the mifepristone Risk Evaluation, and Mitigation Strategy (REMS) will be able to dispense the pill directly to patients who hold a prescription from a certified mifepristone prescriber. The agency also announced that the drug could be prescribed via telehealth.

For more information, click here.

CMS Expands Access to Specialty Care for Medicaid and CHIP Beneficiaries

On Jan. 5, the Centers for Medicare and Medicaid Services (CMS) announced that state Medicaid and CHIP programs will be allowed to directly pay specialty care providers who consult with a beneficiary’s primary care provider. CMS believes the new guidance will improve access to behavioral healthcare for millions of Americans. Patients will not have to be present for consultations to be reimbursable. The guidance gives Medicaid and CHIP agencies flexibility to coordinate payment methods when reimbursing consulting practitioners and eliminates the need for separate payment agreements.

For more information, click here.

CMS Releases Information Bulletin Outlining Medicaid Continuous Enrollment Condition Provisions

On Jan. 5, the Centers for Medicare and Medicaid Services (CMS) released an informational bulletin that explains the impact the 2023 Consolidated Appropriations Act (CAA) will have on Medicaid continuous enrollment provisions included in the Families First Coronavirus Response Act (FFCRA). FFCRA Medicaid continuous enrollment provisions were set to expire upon the termination of the COVID-19 public health emergency (PHE). As established by the CAA, the provisions will now end on March 31, 2023.

For more information, click here.

CMS Urges States to Offer Better Flexibility for Medicaid Enrollees’ Needs

On Jan. 4, the Centers for Medicare and Medicaid Services (CMS) issued new guidance to states on how they can expand healthcare access and better address unmet social needs, such as housing instability and food insecurity, for people with Medicaid coverage. CMS is encouraging states to make use of “in lieu of services and settings” in Medicaid managed care. States may now use in lieu of services and settings to provide medically appropriate and affordable meals to people with chronic health conditions exacerbated by poor diet choices and a lack of access to nutritious food sources.

For more information, click here.

DOJ Files Lawsuit Against AmerisourceBergen Corp. and Subsidiaries

On Dec. 29, the U.S. Department of Justice (DOJ) filed a civil complaint against pharmaceutical distributors AmerisourceBergen Drug Corporation and Integrated Commercialization Solutions, LLC, alleging that the companies repeatedly failed to report suspicious orders for prescription opioids and helped fuel the U.S. prescription opioid epidemic. The Controlled Substances Act (CSA) requires pharmaceutical distributors that sell controlled substances to monitor and report to the Drug Enforcement Agency (DEA) suspicious orders placed by pharmacies and customers. The DOJ alleges that AmerisourceBergen failed to report hundreds of thousands of suspicious opioid orders over the past decade. If AmerisourceBergen is found liable, it could face costly civil penalties for each reporting violation, possibly totaling billions of dollars.

For more information, click here.

Proposed Rules

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

GAO Releases Report on VHA Specialty Healthcare

On Jan. 4, the U.S. Government Accountability Office (GAO) released a report analyzing the state of specialty care in the Veterans Health Administration (VHA). The report looked at how many specialty care appointments met referral timeliness standards established by the VHA. According to these standards, specialty care appointments at VHA facilities must be scheduled within three business days from the date a VHA provider enters a referral. Community care appointments must be made within seven days. GAO conducted the study because it had previously identified challenges that the VHA faced in scheduling appointments. GAO concludes that the VHA has improved its specialty care scheduling process by adopting previous GAO recommendations, but that further work is needed to reduce errors and delays in scheduling appointments.

For more information, click here.

MACPAC Report Reveals Varying Base Medicaid Payment Rates for Nursing Facility Services

On Jan. 4, the Medicaid and CHIP Payment and Access Commission (MACPAC) released a report revealing variations found in average base Medicaid payment rates for U.S. nursing facility services. Across states and state facilities, Medicaid nursing facility payments appear to vary widely, anywhere from 62 to 182 percent of the national average. Medicaid payments are exceeding the costs of care for Medicaid-covered residents, despite being typically lower than other payers. MACPAC is recommending that facilities begin collecting additional payment and financing data, to better understand the relationship between payments and access to quality and affordable care.

For more information, click here.