Washington Healthcare Update

This Week in Washington: Senate Finance Committee chairman sends letters concerning MA marketing practices; Senate Committee on Aging holds hearing on assisted living facilities; CMS requests information on MA prior authorization, beneficiary access and benefits data; Administration touts marketplace enrollment.

House

Senate

Administration

Proposed Rules

Final Rules

Reports

GAO Releases Report Regarding Hospital Financing

Congress

House

House Members Send Letter Concerning Tianeptine

On Jan. 18, Rep. Jackson (D-NC) led Reps. McCormick (R-GA), Rose (R-TN), Boebert (R-CO) and Nickel (D-NC) in sending a letter to Food and Drug Administration (FDA) Commissioner Robert Califf, requesting information on the actions the FDA has taken to address the use of tianeptine.

Tianeptine is an opioid-like antidepressant that has not been approved for medical use and has been shown to be extremely addictive. The FDA recently warned consumers of purchasing and using tianeptine products after it received reports of adverse effects linked to their use, including seizures and hospitalizations.

For more information, click here.

Forty-Six Representatives Send Letter Concerning Surveillance Colonoscopies

On Jan. 10, Rep. Dingell (D-MI) led 45 representatives in sending a letter to Department of Health and Human Services (HHS) Secretary Xavier Becerra, urging HHS to expand access to preventative care by requiring insurers to cover surveillance colonoscopies without cost-sharing.

The members are requesting that HHS clarify in its federal frequently asked question guidance for insurers regulated by the Affordable Care Act, that follow-up surveillance colonoscopies should be treated as a preventive service. Insurers currently treat an additional colonoscopy screening as a diagnostic service.

For more information, click here.

Rep. Underwood Renews Push to Make ACA Tax Credits Permanent

On Jan. 24, Rep. Underwood (D-IL) renewed her push to make the enhanced tax credits of the American Care Act (ACA) permanent and announced that she is looking at legislative vehicles through which this could be accomplished. ACA tax credits were originally set to expire in 2023 but were extended through 2025 by the Inflation Reduction Act.

House Committee on Education and the Workforce Seeks to Strengthen ERISA

On Jan. 22, House Committee on Education and the Workforce Chairman Virginia Foxx (R-NC) led the committee in sending a letter to employer health benefit stakeholders, requesting they provide feedback on how to strengthen and clarify Employee Retirement Income Security Act preemption.

The committee, which has jurisdiction over employer-sponsored health coverage, is seeking information concerning transparency, portability, data sharing, quality measures, fiduciary obligations, high-cost specialty drugs and Health Insurance Portability and Accountability Act protections.

For more information, click here.

Senate

Senate Finance Committee Chairman and Ranking Member Release White Paper on Mitigating Generic Drug Shortages

On Jan. 25, Senate Finance Committee Chairman Ron Wyden (D-OR) and Ranking Member Mike Crapo (R-ID) released a white paper outlining legislative proposals they may incorporate into legislation to reform the Medicare and Medicaid programs to prevent generic drug shortages. The Finance Committee is considering reforming Medicare payment for generic sterile injectables and implementing incentives for hospitals and pharmacies to engage in shortage prevention and mitigation activities.

The committee is also considering reforming the Medicare Drug Rebate Program and implementing new Part D pilot programs to encourage pharmacies to purchase generic medicines.

For more information, click here.

Senate Finance Committee Chairman Sends Letters Concerning MA Marketing Practices

On Jan. 23, Senate Finance Committee Chairman Ron Wyden (D-OR) sent letters to Medicare Advantage (MA) third-party marketing organizations (TPMOs) eHealth, GoHealth, Agent Pipeline, SelectQuote and TRANZACT, seeking information on how they use insurance agents, lead generators and other data to target, market to and direct seniors towards certain MA plans.

The chairman is concerned that TPMOs are using misleading information to sell Medicare plans and are selling seniors’ personal data to lead generators. Last year, the chairman urged the Centers for Medicare and Medicaid Services to implement stronger marketing rules and the committee held a hearing to evaluate the MA enrollment period and marketing rule developments.

For more information, click here.

Senators Send Letter Concerning FTC Investigation of PBM Business Practices

On Jan. 22, Sens. Grassley (R-IA) and Cantwell (D-WA) led 12 senators in sending a letter to Federal Trade Commission (FTC) Chair Lina Khan, requesting that the FTC complete its investigation of pharmacy benefit manager (PBM) business practices and publicly release a progress report on the status of its investigation.

The FTC launched an inquiry into PBM business practices in June 2023 and has been investigating the impact that vertically integrated PBMs have on the access and affordability of prescription drugs.

For more information, click here.

Senate Committee on Aging Holds Hearing on Assisted Living Facilities

On Jan. 25, the Senate Committee on Aging held a hearing on assisted living facilities and discussed how assisted living care could be expanded and strengthened. Witnesses included:

Patricia “Patty” Vessenmeyer, Advocate
Jennifer Craft Morgan, Director and Professor at the Georgia State University Gerontology Institute
Julie Simpkins, Co-President of Gardant Management Solutions
Richard Mollot, Executive Director of the Long Term Care Community Coalition

For more information, click here.

Telemental Health Care Access Act Reintroduced

On Jan. 24, Senate Health, Education, Labor and Pensions Committee Ranking Member Bill Cassidy (R-LA) and Sens. Smith (D-MN), Thune (R-SD) and Cardin (D-MD) reintroduced the Telemental Health Care Access Act. The legislation would remove the statutory requirement that Medicare beneficiaries be seen in person within six months of being treated for mental health services through telehealth.

For more information, click here.

Medicare Transaction Fraud Prevention Act Introduced

On Jan. 24, Senate Health, Education, Labor and Pensions Committee Ranking Member Bill Cassidy (R-LA) and Sen. Braun (R-IN) introduced the Medicare Transaction Fraud Prevention Act. The legislation would direct the Centers for Medicare and Medicaid Services to establish a two-year pilot period to oversee Medicare-covered purchasing of durable medical equipment and other diagnostic testing related products.

A companion bill was introduced in the House by Rep. Schweikert (R-AZ).

For more information, click here.

MedPAC and MACPAC Release 2024 Data Book on Dually Eligible Beneficiaries

On Jan. 22, the Medicare Payment Advisory Commission and the Medicaid and Children’s Health Insurance Program Payment and Access Commission jointly released the 2024 data book for beneficiaries dually eligible for Medicare and Medicaid.

The data book is separated into six sections that focus on the following:

Overview of dual-eligible beneficiaries;
Characteristics of dual-eligible beneficiaries;
Eligibility pathways, managed care enrollment and continuity of enrollment;
Utilization of and spending on Medicare and Medicaid services for dual-eligible beneficiaries;
Medicare and Medicaid spending for dual-eligible beneficiaries by LTSS use; and
Trends in dual-eligible population composition, spending and service use.

For more information, click here.

Administration

HHS Touts Marketplace Enrollment

On Jan. 24, the Department of Health and Human Services announced that 21.3 million people enrolled in an Affordable Care Act Health Insurance Marketplace plan during the 2024 Open Enrollment Period. This is nearly five million more enrollees than last year.

For more information, click here.

HHS OCR Issues Guidance Concerning Non-Discrimination Obligations

On Jan. 25, the Department of Health and Human Services Office of Civil Rights issued guidance intended to remind hospitals and long-term care facilities of their obligation to adhere to patient visitation non-discrimination regulations.

For more information, click here.

ASPR Releases Voluntary Healthcare Cybersecurity Performance Goals

On Jan. 24, the Administration for Strategic Preparedness and Response released voluntary healthcare cybersecurity performance goals and a new gateway website for Health Care and Public Health (HPH) sector organizations. The goals and website are intended to help HPH organizations prioritize and implement high-impact cybersecurity practices.

For more information, click here.

CMS Issues RFI on Medicare Advantage Program Data

On Jan. 25, the Centers for Medicare and Medicaid Services issued a request for information and announced that it is seeking public feedback concerning the Medicare Advantage (MA) program, specifically MA access to care, prior authorization, provider directories, supplemental benefits, marketing, care quality and outcomes and more.

Public comments will be accepted until May 29.

For more information, click here.

CMS Announces $50 Million in Grants to Strengthen School-Based Health Services

On Jan. 24, the Centers for Medicare and Medicaid Services announced the availability of $50 million in grants intended to help states implement and expand the use of school-based health services for children enrolled in Medicaid and the Children’s Health Insurance Program. Grant applications are due by March 25.

For more information, click here.

CMS Releases 2024 Federal Poverty Level Standards

On Jan. 24, the Centers for Medicare and Medicaid Services Center for Medicaid and Children’s Health Insurance Program Services released an informational bulletin concerning 2024 federal poverty level standards. The 2024 poverty guideline for a family or a household of four living in the District of Columbia or within the 48 contiguous states is $31,200.

For more information, click here.

CMS Releases 2024-2025 Medicaid Managed Care Rate Development Guide

On Jan. 22, the Centers for Medicare and Medicaid Services released the 2024-2025 Medicaid Managed Care Rate Development Guide. The guide outlines federal standards for rate development and describes the information required from states and their actuaries for actuarial rate certifications.

For more information, click here.

CMS to Release EMTALA Informational Resources

On Jan. 22, the Centers for Medicare and Medicaid Services announced that it will release new informational resources to educate the public about their rights to emergency medical care and to inform hospitals about their obligations under the Emergency Medical Treatment and Labor Act.

For more information, click here.

FDA Announces Opportunity to Participate in Prototype Assessment Protocol Evaluation Program

On Jan. 25, the Food and Drug Administration announced that it will begin accepting requests to participate in the Center for Drug Evaluation and Research voluntary Quality Management Maturity Prototype Assessment Protocol Evaluation Program. Applications are due by March 25.

For more information, click here.

FDA Releases Guidance Concerning Tentatively Approved ANDA Amendments

On Jan. 24, the Food and Drug Administration released guidance concerning the preparation and submission of amendments to tentatively approved new drug applications (ANDAs). The guidance outlines recommendations on the timing and content of ANDA amendments.

For more information, click here.

FDA Releases Guidance on Revision of ANDA Labeling Following RLD Labeling Revision

On Jan. 24, the Food and Drug Administration released guidance aimed at informing applicants and holders of an abbreviated new drug application on how to update their labeling following revisions to the labeling of a reference listed drug.

For more information, click here.

FDA Warns Consumers Not to Purchase or Use Neptune’s Fix Products

On Jan. 23, the Food and Drug Administration warned consumers not to purchase or use any Neptune’s Fix Elixir, Extra Strength and Tablets products after it received reports of adverse events related to their use, including seizures and loss of consciousness. Neptune’s Fix products contain tianeptine, an unapproved opioid-like antidepressant.

For more information, click here.

FDA Announces Recall of Kilitch Healthcare India Limited Eye Drops

On Jan. 19, the Food and Drug Administration announced that Kilitich Healthcare India Limited has issued a voluntary recall of its Carboxymethylcellulose Sodium 0.5% and 1.0% eye drop products.

For more information, click here.

FDA Adds Boxed Warning to Prolia

On Jan. 19, the Food and Drug Administration (FDA) added a boxed warning to Prolia (denosumab), a medicine used to treat osteoporosis. The FDA added the warning after it discovered that Prolia can lead to severe hypocalcemia in patients with advanced chronic kidney disease, particularly those on dialysis.

For more information, click here.

Proposed Rules

DOJ Civil Rights Division Proposes Rule Regarding Medical Diagnostic Equipment Access for the Disabled

On Jan. 9, the Department of Justice Civil Rights Division released a proposed rule that seeks to improve access to medical diagnostic equipment (MDE) for people with disabilities. The proposed rule would update regulations under Title II of the Americans with Disabilities Act (ADA) and would implement new technical standards that state and local governments would have to adhere to, to meet obligations under Title II of the ADA.

The proposed rule would:

Adopt the U.S. Access Board’s MDE standards as the technical standards for accessible MDE;
Require state and local government entities to ensure that programs, services and activities using MDE are accessible to individuals with disabilities;
Require entities to address access barriers resulting from a lack of existing accessible MDE;
Implement new requirements for newly acquired MDE; and
Ensure that staff are able to successfully operate accessible MDE and assist with transfers and positioning of individuals with disabilities.

Public comments will be accepted until Feb. 12, 2024. For more information, click here.

FDA Proposes Rule Regarding Classification of Wound Dressings and Washes

On Nov. 30, the Food and Drug Administration (FDA) released a proposed rule that would classify certain types of wound dressings and liquid wound washes containing antimicrobials and other chemicals, as solid wound dressings. The FDA currently regulates gel, cream, ointment and liquid wound dressings and washes as unclassified devices requiring premarket notification.

Under the proposed rule, the FDA would classify wound dressings and liquid wound washes with a high level of antimicrobial resistance concern as Class III medical devices. In addition, wound dressings and washes with a medium or low level of antimicrobial resistance would be classified as Class II medical devices.

Public comments will be accepted until Feb. 28, 2024. For more information, click here.

IHS Proposed Rule Removes Outdated Regulations

On Jan. 8, the Indian Health Service (IHS) released a proposed rule that aims to remove outdated regulations in the Code of Federal Regulations that do not align with current statutory text of the Hyde Amendment. The proposed rule intends to eliminate confusion regarding the legal effect of outdated regulations and seeks to align IHS guidelines with congressional guidelines governing the Department of Health and Human Services.

Public comments will be accepted until March 8, 2024. For more information, click here.

Final Rules

CMS Final Rule Improves Prior Authorization Process and Access to Health Information

On Jan. 17, the Centers for Medicare and Medicaid Services released a final rule that seeks to expand access to health information and improve the prior authorization process. The final rule will:

Require Medicare Advantage organizations, Medicaid and Children’s Health Insurance Program fee-for-service programs and managed care plan entities to send prior authorization decisions within 72 hours for expedited requests and seven calendar days for standard requests for medical items and services;
Require impacted payers to include a specific reason for denying a prior authorization request, publicly report prior authorization metrics and implement a Health Level 7 Fast Healthcare Interoperability Resources Prior Authorization application programming interface (API);
Require impacted payers to include information about prior authorizations in their current Patient Access API and implement a Provider Access API to retrieve patient claims, encounter, clinical and prior authorization data;
Add a new Electronic Prior Authorization measure for eligible clinicians under the Merit-based Incentive Payment System Promoting Interoperability performance category; and
Require hospitals and critical access hospitals in the Medicare Promoting Interoperability Program to report their use of payers’ Prior Authorization APIs to submit an electronic prior authorization request.

The final rule will go into effect on April 8, 2024. For more information, click here.

FCC Final Rule Updates Rural Health Care Program

On Jan. 10, the Federal Communications Commission (FCC) released a final rule that updates the Rural Health Care (RHC) Program and strengthens access to telehealth services in rural areas. The rule seeks to support rural healthcare providers with the costs of broadband and other eligible services and implements four updates to the RHC program, which include:

Permitting conditional approval of eligibility for healthcare providers to allow them to begin competitive bidding and request funding;
Granting program participants more flexibility by pushing back the deadline for providers to change their Service Provider Identification Number to align with the invoice deadline;
Eliminating the “standard urban distance” component of the urban rate rules; and
Allowing healthcare providers to request changes to the dates of their evergreen contracts following a funding commitment.

In addition, the FCC also released a proposed rule that seeks to remove barriers to building advanced broadband networks and expedite utility pole improvements and copper network retirements.

The final rule will go into effect on Feb. 12, 2024. For more information, click here.

OCR Final Rule Strengthens Conscience Protections

On Jan. 9, the Department of Health and Human Services Office for Civil Rights (OCR) released a final rule that seeks to strengthen the process for enforcing federal conscience laws and provide new protections against conscience and religious discrimination. The final rule will:

Partially rescind a May 2019 conscience final rule that was deemed unlawful by three federal district courts. The rule strengthened the rights of healthcare workers to refuse to provide services such as abortions and gender-affirming care based on moral and religious beliefs;
Restore OCR’s role in overseeing the enforcement process for federal healthcare conscience protection statutes;
Strengthen protections against discrimination on the basis of conscience;
Encourage entities to post a notice of rights to inform providers and patients of their rights under federal healthcare conscience protection statutes; and
Implement a severability provision to preserve portions of the rule if part of the rule is deemed unlawful.

In addition, the final rule states that OCR investigations will be prompt and clarifies that certain conscience statutes apply to more than just providers.

The final rule will go into effect on March 11, 2024. For more information, click here.

CMS Final Rule Updates CLIA Fees and Clarifies Fee Regulations

On Dec. 28, the Centers for Medicare and Medicaid Services (CMS) released a final rule that updates Clinical Laboratory Improvement Amendments of 1988 (CLIA) fees and clarifies CLIA fee regulations. The final rule will:

Implement a sustainable funding process for the CLIA program through a biennial two-part increase of CLIA fees;
Finalize the incorporation of limited/specific laboratory fees, including fees for follow-up surveys, substantiated compliant surveys and revised certificates;
Finalize the distribution of administrative overhead costs of test complexity determination for waived tests and test systems with a nominal increase in Certificate of Waiver (CoW) fees;
Clarify the methodology used to calculate program compliance fees;
Amend histocompatibility and personnel regulations under CLIA to address obsolete regulations and update the regulations to incorporate technological changes; and
Amend provisions governing alternative sanctions, including civil money penalties, a directed plan of correction, a direct portion of a plan of correction and on-site state monitoring, to allow for their imposition on CoW laboratories.

In addition to CMS, the Centers for Disease Control and Prevention is also proposing the rule.

The rule will go into effect on Jan. 27, 2024. However, some sections will go into effect on Dec. 28, 2024.

For more information, click here.

ONC Final Rule Establishes Transparency Requirements for Artificial Intelligence and Predictive Algorithms

On Dec. 13, the Department of Health and Human Services Office of the National Coordinator for Health Information Technology (ONC) released a final rule that updates the ONC Health IT Certification Program and establishes new standards, implementation specifications and certification criteria. The final rule will:

Establish transparency requirements for artificial intelligence and other predictive algorithms that are part of certified health IT;
Adopt the United States Core Data for Interoperability Version 3 as the new baseline standards within the ONC Health IT Certification Program as of Jan. 1, 2026;
Revise certain information-blocking definitions and exceptions to support information sharing; and
Require developers of certified health IT to report certain metrics as part of their participation in the Certification Program, to better understand how certified health IT is used to support care delivery.

The final rule will go into effect on Feb. 8, 2024. For more information, click here.

FDA Final Rule Implements Direct-To-Consumer Prescription Drug Ad Standards

On Nov. 21, the Food and Drug Administration (FDA) released a final rule that implements new standards for direct-to-consumer (DTC) television and radio prescription drug advertisements. The final rule will require advertisers to:

Present information using language that is clear and readily understandable by consumers;
Place textual information against a contrasting background for a sufficient duration, using a font style and size that is easily legible;
Announce prescription drug information in the same volume, articulation and pacing used in the rest of the ad;
Certify that no distracting representations including statements, text, images or sounds are used during the ad’s major statement; and
Simultaneously present visual and audible information for ads in television format.

The final rule complements a final guidance the FDA issued in June that outlined how advertisers should present quantitative efficacy and risk information in DTC promotional labeling and ads.

The final rule will go into effect on May 20, 2024. The compliance date of the rule is Nov. 20, 2024.

For more information, click here.

FDA Issues Final Rule Regarding Mammography Quality Standards

On March 9, the Food and Drug Administration (FDA) issued a final rule that updates the regulations implemented by the Mammography Quality Standards Act of 1992. The FDA has decided to update the regulations due to advancements made in mammography technology and information. The final rule will:

Improve the delivery of mammography services;
Strengthen communication of healthcare information;
Require mammography facilities to provide patients with additional health information;
Ensure the availability of qualified mammography personnel;
Bolster medical outcome audits;
Modernize technological aspects of mammography services; and
Implement enforcement tools to deal with noncompliant facilities.

The rule will go into effect on Sept. 10, 2024. For more information, click here.

Reports

GAO Releases Report Regarding Hospital Financing

On Jan. 25, the Government Accountability Office (GAO) released a report concerning hospital financing and the potential impacts of expanding the Federal Housing Administration (FHA) Hospital Mortgage Insurance Program to ineligible hospitals including psychiatric and long-term care hospitals.

After analyzing FHA documents and data, interviewing representatives and examining Centers for Medicare and Medicaid Services hospital financial data, the GAO determined that expanding the Hospital Mortgage Insurance Program could increase program participation and risks. The GAO recommends limiting the volume of new loans and requiring frequent reporting on new program activity. The GAO conducted this study because it was asked to evaluate the potential effects of expanding Hospital Mortgage Insurance Program eligibility.

For more information, click here.