Washington Healthcare Update

May 28, 2024

This Week in Washington: Senate Finance Committee releases draft proposal outline concerning GME program; Senate HELP Committee marks up seven healthcare bills; NIH issues first-of-its-kind policy proposal to promote equal access to drugs, devices, vaccines and biologics that stem from NIH-owned inventions.

Congress

House

Senate

Administration

Proposed Rules

Final Rules

Reports

Note

House

House Ways and Means and Budget Committee Chairmen Request Budgetary Analysis on Permanent AHA Enhanced Tax Credits

On May 17, House Ways and Means Committee Chairman Jason Smith (R-MO) and House Budget Committee Chairman Jodey Arrington (R-TX) sent a letter to Congressional Budget Office Director Phillip L. Swagel and Joint Committee on Taxation Chief of Staff Thomas A. Barthold requesting an analysis on the budgetary effects of making permanent the Affordable Care Act (ACA) premium tax credits.

The chairmen are requesting an analysis on the:

  • Budgetary effects on outlays, revenues and the deficit for each fiscal year in the 10-year budget window, as well as the cumulative five and 10-year estimates;
  • Change in Americans’ sources of health coverage, including the number of individuals who would no longer have employer-sponsored insurance over the 10-year window;
  • Percentage of the new ACA premium tax credit spending, if the policy was made permanent, that would go to households with incomes above 400 percent of the federal poverty level for coverage years beginning Jan. 1, 2025 and ending Jan. 1, 2035; and
  • Average value of the premium tax credits for new marketplace enrollees under the policy and the average tax benefit of the employer-sponsored insurance tax exclusion for a person projected to no longer enroll in employment-based coverage under the policy.

For more information, click here.

House Energy and Commerce Committee Subcommittee on Health Holds Hearing on FDA Regulation of Drugs, Biologics and Devices

On May 22, the House Energy and Commerce Committee Subcommittee on Health held a hearing to examine the Food and Drug Administration’s (FDA) regulation of drug, biologics and medical devices. Members discussed rare-disease drug regulation, the FDA laboratory-developed test final rule, accelerated approval pathway and prescription drug user fee amendments. Witnesses were:

  • Patricia Cavazzoni, M.D., Director of the FDA Center for Drug Evaluation and Research
  • Peter Marks, M.D., Ph.D., Director of the FDA Center for Biologics Evaluation and Research
  • Jeff Shuren, M.D., J.D., Director of the FDA Center for Devices and Radiological Health

For more information, click here.

House Ways and Means Committee Subcommittee on Health Holds Hearing on Independent Medicine Challenges

On May 23, the House Ways and Means Committee held a hearing to examine the challenges independent physicians and practices face when providing care. Members discussed the impacts of prior authorization, workforce shortages, Medicare physician fee schedule reimbursements and the role of private equity in healthcare. Witnesses were:

  • Jennifer Gholson, MD, Family Practitioner, Summit
  • Timothy Richardson, MD, Independent Physician, Wichita Urology
  • Chris Kean, COO, The San Antonio Orthopaedic Group
  • Seemal Desai, MD, Founder, Innovative Dermatology
  • Ashish Jha, MD, Dean of the Brown School of Public Health

For more information, click here.

Senate

Senate Finance Committee Releases Draft Proposal Outline Concerning GME Program

On May 24, Senate Finance Committee Chairman Ron Wyden (D-OR), Senate Health, Education, Labor and Pensions Committee Ranking Member Bill Cassidy (R-LA) and Sens. Cornyn (R-TX), Menendez (D-NJ), Bennet (D-CO), Tillis (R-NC), Cortez-Masto (D-NV) and Blackburn (R-TN) released a draft proposal outline concerning the graduate medical education (GME) program.

The outline includes proposals that aim to improve the GME program and:

  • Expand and improve the distribution of Medicare-supported GME residency training positions to rural areas and specialties in shortage;
  • Support rural hospitals with the infrastructure needed to facilitate residency training programs; and
  • Improve data collection to ensure federal GME funds are being used to train in specialties and areas facing physician shortages.

For more information, click here.

Senate Finance Committee Chairman Sends Letter Concerning Fraudulent Enrollments

On May 21, Senate Finance Committee Chairman Ron Wyden (D-OR) sent a letter to Centers for Medicare and Medicaid Services (CMS) Administrator Chiquita Brooks-LaSure concerning fraudulent Marketplace plan enrollments.

The chairman is urging CMS to:

  • Enforce civil monetary penalties on brokers who submit fraudulent enrollments;
  • Strengthen its oversight of direct enrollment entity policies and business practices; and
  • Proactively inform consumers who may have been impacted.

For more information, click here.

Senate HELP Committee Marks Up Seven Healthcare Bills

On May 23, the Senate Health, Education, Labor and Pensions Committee marked up and reported out of committee seven healthcare bills that will reauthorize programs concerning Alzheimer’s disease, caregiver respite care, poison control centers and emergency medical services for children. The bills were:

S. 3679, Dr. Lorna Breen Health Care Provider Protection Reauthorization Act: Reauthorizes the Dr. Lorna Breen Health Care Provider Act through fiscal year 2029 to promote the use of mental health and substance use disorder services by healthcare providers.

S. 3765, Emergency Medical Services for Children Reauthorization Act of 2024: Reauthorizes the Emergency Medical Services for Children program through fiscal year 2029.

S. 4351, Poison Control Centers Reauthorization Act: Reauthorizes certain poison control programs through fiscal year 2029.

S. 3775, BOLD Infrastructure for Alzheimer’s Reauthorization Act of 2024: Reauthorizes the Building Our Largest Dementia Infrastructure for Alzheimer’s Act through fiscal year 2029.

S. 4325, Lifespan Respite Care Act: Reauthorizes the Lifespan Respite Care program through fiscal year 2029.

S. 3757, Congenital Heart Futures Reauthorization Act of 2024: Reauthorizes the Centers for Disease Control and Prevention’s Congenital Heart Disease, Research, Surveillance and Awareness Program through fiscal year 2029.

S. 4045, East Palestine Health Impact Monitoring Act of 2024: Requires the Secretary of Health and Human Services to award a grant, contract or cooperative agreement to an eligible entity to study the public health impacts resulting from the February 2023 train derailment in East Palestine, OH.

In addition, the committee reported out of committee the nomination of Stephen H. Ravas to become Inspector General of the Corporation for National and Community Service.

For more information, click here.

Senate Finance Committee Holds Hearing on OUD Prevention and Treatment

On May 23, the Senate Finance Committee held a hearing to examine opioid use disorder (OUD) prevention and treatment strategies. Members discussed the importance of school-based OUD services and ensuring that incarcerated individuals maintain Medicaid coverage and access to OUD treatments.

Witnesses were:

  • Tony Vezina, Executive Director, 4th Dimension Recovery Center (4D)
  • Jeanmarie Perrone, MD, Director, Center for Addition Medicine and Policy, University of Pennsylvania
  • Caleb J. Banta-Green, Ph.D., MPH, MSW, Research Professor, University of Washington School of Medicine
  • Abigail J. Herron, DO, Vice President and Chief Behavioral Health Officer, The Institute for Family Health

For more information, click here.

Senate Judiciary Committee Holds Hearing on Prescription Drug Market Competition

On May 21, the Senate Judiciary Committee held a hearing on prescription drug market competition, accessibility and affordability. Members discussed the need to address improper drug patents and called on Senate Majority Leader Chuck Schumer (D-NY) to schedule floor votes on bills reported out of the committee concerning patent reforms and generic and biosimilar access.

Witnesses were:

  • William Feldman, MD, DPhil, MPH, Associate Physician, Division of Pulmonary and Critical Care Medicine, Brigham and Women’s Hospital
  • David Mitchell, President and Founder, Patients for Affordable Drugs
  • Adam Mossoff, Professor of Law, George Mason Antonin Scalia Law School
  • Arti Rai, Elvin R. Duke Law Elvin R. Latty Distinguished Professor of Law
  • Jocelyn Ulrich, Vice President of Policy and Research, PhRMA

For more information, click here.

Sen. Paul Introduces CRA Resolution that Would Overturn LDT Final Rule

On May 17, Sen. Paul (R-KY) introduced a Congressional Review Act resolution that would overturn the Food and Drug Administration’s laboratory-developed test rule. A companion resolution was introduced in the House by Rep. Finstad (R-MN).

For more information, click here.

Administration

ARPA-H Launches Healthcare Facility Cybersecurity Program

On May 20, the Advanced Research Projects Agency for Health announced the launch of the Universal Patching and Remediation for Autonomous Defense Program. The program aims to strengthen hospital cybersecurity systems and address healthcare data security vulnerabilities.

For more information, click here.

CMS Launches Web Portal to Report EMTALA Complaints

On May 21, the Centers for Medicare and Medicaid Services announced that it will launch a web portal to make it easier for individuals to report denials of care and potential violations of the Emergency Medical Treatment and Labor Act.

For more information, click here.

FDA Launches OUD Educational Campaign

On May 23, the Food and Drug Administration launched the Prescribe with Confidence opioid-use disorder (OUD) educational campaign. The campaign aims to raise awareness about OUD and provide clinicians the resources needed to recognize and treat OUD.

For more information, click here.

NIH Releases Draft Policy Proposal to Promote Equal Access to Products Stemming from NIH-Owned Inventions

On May 22, the National Institutes of Health (NIH) released a draft policy proposal that would require organizations partnering with NIH through its licensing agreements to provide plans for patient access to those products. This move comes as drug price control advocates are pushing to expand the Department of Health and Human Services’ best price provision related to NIH-owned inventions.

For more information, click here.

Proposed Rules

<strong>CMS Proposed Rule Would Establish Increasing Organ Transplant Access Model

On May 8, the Centers for Medicare and Medicaid Services released a proposed rule that would establish the Increasing Organ Transplant Access (IOTA) Medicare payment model. The IOTA Model would be a mandatory, six-year model and would begin on Jan. 1, 2025.

The model aims to:

  • Increase access to kidney transplants for end-stage renal disease patients;
  • Improve quality of care for people seeking kidney transplants;
  • Reduce disparities among individuals undergoing the kidney transplant process; and
  • Facilitate the efficiency and capability of transplant hospitals selected to participate.

Public comments will be accepted until July 16, 2024. For more information, click here.

CMS Proposed Rule Updates Payment Rates for Inpatient and LTC Hospitals for FY2025

On April 10, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule that would update the Medicare fee-for-service payment rates and policies for inpatient and long-term care hospitals (LTCHs) for fiscal year (FY) 2025.

The proposed rule would:

  • Increase LTCH standard rate payments by 1.2 percent;
  • Raise the fixed-loss amount for high-cost outlier payments to $90,921, reducing overall standard rate payments by 1.3 percent;
  • Rebase the LTCH market basket using a 2022 base year;
  • Adopt and modify patient assessment items related to health-related social needs within the LTCH Quality Reporting Program;
  • Require LTCHs to collect and report specific data related to living situation, food and utilities beginning in FY2028; and
  • Extend the window in which patient assessments must be done from three to four days after admission.

CMS is also requesting comments on two requests for information related to the development of a LTCH QRP (Quality Reporting Program) Star Rating System and future QRP measures.

Public comments will be accepted until June 10, 2024. For more information, click here.

FDA Proposed Rule Establishes Criteria for Drug Products with Demonstrable Compounding Difficulties

On March 20, the Food and Drug Administration released a proposed rule that would establish criteria for the lists of drug products or categories of drug products that present demonstrable difficulties for compounding under the Federal Food, Drug and Cosmetic Act.

The proposed rule would:

  • Create separate lists for 503A and 503B products that present demonstrable difficulties for compounding;
  • Establish six criteria used to determine which list/lists products are placed on; and
  • Add oral solid modified-release drug products that employ coated systems, liposome drug products and drug products produced using hot melt extrusion as categories to the 503A and 503B product lists.

Public comments will be accepted until June 18, 2024. For more information, click here.

Final Rules

CMS Final Rule Expands Access to Healthcare for DACA Recipients

On May 3, the Centers for Medicare and Medicaid Services released a final rule to expand access to healthcare for Deferred Action for Childhood Arrivals (DACA) recipients. The rule will allow DACA recipients to:

  • Enroll in a Qualified Health Plan through the Affordable Care Act Health Insurance Marketplace; and
  • Obtain coverage through a Basic Health Program.

DACA recipients and other newly eligible individuals will be able to select a health plan through the Marketplace during a 60-day special enrollment period following the implementation of the rule.

The rule will go into effect on Nov. 1, 2024. For more information, click here.

HHS OCR Final Rule Strengthens Protections Against Disability Discrimination

On May 1, the Department of Health and Human Services (HHS) Office for Civil Rights released a final rule that prohibits discrimination on the basis of disability and strengthens protections for disabled individuals under Section 504 of the Rehabilitation Act. The rule will:

  • Ensure that medical treatment decisions are not based on negative biases and stereotypes about disabled individuals or judgements that a disabled individual is a burden on others;
  • Prohibit the use of measures, assessments or tools that discount the value of a life extension on the basis of disability;
  • Define what accessibility means for websites and mobile applications and ensure that services delivered through these platforms are accessible to and usable by disabled individuals;
  • Adopt U.S. Access Board standards for accessible medical diagnostic equipment;
  • Outline requirements to ensure nondiscrimination in the services provided by HHS-funded child welfare agencies; and
  • Clarify obligations to provide services in integrated services.

In addition, the rule aligns existing requirements with the Americans with Disabilities Act.

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

HHS OCR Final Rule Prevents Discrimination in Grant Programs

On April 30, the Department of Health and Human Services (HHS) Office for Civil Rights and the Assistant Secretary for Financial Resources released a final rule that affirms nondiscrimination in HHS-funded programs and services. The rule will:

  • Clarify and reaffirm the prohibition of discrimination on the basis of sex, including sexual orientation and gender identity, in HHS programs; and
  • Confirm protections in programs, services and grants that provide aid to refugees, early childhood education services, substance use disorder treatments, community mental health services, maternal and child health services and community services.

The rule will go into effect on June 3, 2024. For more information, click here.

IHS Final Rule Removes Outdated Regulations

On April 30, the Indian Health Service (IHS) released a final rule that aligns IHS regulations with current text of the Hyde Amendment and 25 U.S. Code 1676.

The rule will go into effect on May 30, 2024. For more information, click here.

DOL EBSA Final Rule Rescinds 2018 Association Health Plan Rule

On April 30, the Department of Labor (DOL) Employee Benefits Security Administration released a final rule that rescinds a DOL final rule released in 2018, which modified the definition of “employer” under federal law and expanded the availability of Association Health Plans.

The U.S. District Court for the District of Columbia ruled that provisions in the rule were an unreasonable interpretation of the Employee Retirement Income Security Act in 2019.

The rule will go into effect on July 1, 2024. For more information, click here.

FDA Releases Final Rule Concerning Laboratory Developed Tests

On April 29, the Food and Drug Administration (FDA) released a final rule that will classify laboratory-developed tests (LDTs) and in vitro diagnostic (IVD) products as medical devices subject to rules under the Federal Food, Drug and Cosmetic Act. The rule will phase out the FDA’s general enforcement discretion approach for most LDTs over four years and require compliance with:

  • Medical device regulation, correction and removal reporting and compliant file quality system requirements after one year;
  • Registration, listing, labeling and investigational use requirements after two years;
  • Quality system requirements in 21 CFR Part 820 after three years;
  • Premarket review requirements for high-risk IVDs offered as LDTs (unless a premarket submission has been received by the beginning of this stage) after three and a half years; and
  • Premarket review requirements for moderate- and low-risk IVDs after four years.

LDTs developed by a healthcare system laboratory that target unmet needs of patients, those approved by New York State’s Clinical Laboratory Evaluation Program and tests first marketed prior to May 6, are exempted from the rule.

The rule will go into effect on July 5, 2024. For more information, click here.

FTC Final Rule Revises Health Breach Notification Rule

On April 26, the Federal Trade Commission (FTC) released a final rule that revises the Health Breach Notification Rule that requires vendors of personal health records (PHR) and related entities not covered by the Health Insurance Portability and Accountability Act, to notify individuals and the FTC of unsecured PHR data breaches. The rule will:

  • Modify the definition of PHR identifiable health information and add new definitions for covered healthcare provider and healthcare services or supplies;
  • Clarify that a “breach of security” includes an unauthorized acquisition of identifiable health information that occurs as a result of a data security breach or unauthorized disclosure;
  • Revise the definition of a PHR-related entity to make clear that the rule applies to entities that offer products and services through online services, including mobile applications;
  • Clarify multiple sources of PHR identifiable health information;
  • Expand the use of electronic notification and consumer notice content; and
  • Require covered entities to report breaches involving 500 or more individuals to the FTC at the same time notices are sent to affected individuals and no later than 60 calendar days after discovery of the breach.

The final rule has not yet been submitted to the Federal Register but will go into effect 60 days after submission.

For more information, click here.

CMS Releases Final Rule Concerning Nondiscrimination in Health Programs

On April 26, the Centers for Medicare and Medicaid Services released a final rule that revises Section 1557 of the Affordable Care Act to advance health equity and reduce disparities. The rule will:

  • Apply nondiscrimination standards to all Department of Health and Human Services (HHS)-administered health programs and activities;
  • Reinstate Section 1557’s application to health insurance issuers that receive federal financial assistance;
  • Affirm that sex discrimination protections apply to discrimination on the basis of sexual orientation, gender identity, pregnancy and sex characteristics and stereotypes;
  • Require state and federally-facilitated exchanges, recipients of federal financial assistance and HHS programs to inform individuals that language assistance services and auxiliary aids are available; and
  • Require covered entities to train staff on Section 1557 policies.

The rule also clarifies nondiscrimination requirements for telehealth services and patient care decision support tools.

The rule will go into effect on July 5, 2024. Some provisions of the rule will be phased in to allow covered entities to come into compliance.

For more information, click here.

CMS Releases Final Rule Concerning Medicaid and CHIP Access to Care

On April 22, the Centers for Medicare and Medicaid Services (CMS) released a final rule that will improve access to care, strengthen quality and health outcomes and address health equity issues for Medicaid and Children’s Health Insurance Program (CHIP) managed care enrollees.

The rule will:

  • Establish maximum wait times for obstetric, primary care and outpatient mental health and substance use disorder services;
  • Require states to implement a remedy plan for managed care organizations that fail to meet required standards;
  • Prohibit the use of separate payment terms;
  • Remove the requirement that providers must be in-network with managed care plans to receive state-directed payments; and
  • Require managed care plans to report any identified or recovered overpayments to states within 30 calendar days.

In addition, the rule will implement revisions concerning In Lieu of Service and Setting, External Quality Review and the Medicaid and CHIP Quality Rating System.

The rule will go into effect on July 9, 2024. For more information, click here.

CMS Final Rule Implements SNF Minimum Staffing Levels

On April 22, the Centers for Medicare and Medicaid Services (CMS) released a final rule that will establish minimum staffing levels for long-term care (LTC) and skilled-nursing facilities (SNFs) and strengthen transparency of worker compensation. The rule will require facilities to:

  • Have a registered nurse (RN) on-site 24 hours a day, seven days a week;
  • Provide a minimum of 3.48 hours of nursing care per resident day, including a minimum of 0.55 hours of care from a RN and 2.45 hours of care from a nurse aide per resident day;
  • Use evidence-based methods when planning care for their residents and the facility assessment when assessing the needs of each resident in the facility;
  • Develop staffing plans to maximize recruitment and retention of staff in accordance with Executive Order 14095; and
  • Implement new Medicaid Institutional Payment Transparency Reporting provisions.

The rule will be implemented in phases across a three-year period. Nursing homes may apply for a temporary exemption to the rule but must meet certain hardship criteria. Notably, there are two bills in Congress that, if enacted, would prevent the rule from going forward.

The rule will go into effect on June 21, 2024. For more information, click here.

CMS Releases Final Rule Concerning Access to Medicaid Services

On April 22, the Centers for Medicare and Medicaid Services (CMS) released a final rule to improve access to care, service quality and outcomes under Medicaid fee-for-service (FFS), managed care and home and community-based services (HCBS). The rule will require states to:

  • Rename and expand the scope of Medical Care Advisory Committees and require states to establish a Beneficiary Advisory Committee;
  • Meet nationwide incident management system standards for monitoring HCBS programs;
  • Ensure that a minimum of 80 percent of Medicaid payments for homemaker, home health aide and personal care services be spent on compensation for direct-care workers furnishing these services within six years;
  • Publicly publish all FFS Medicaid fee schedule payment rates; and
  • Establish and manage a grievance process for beneficiaries receiving HCBS in FFS plans.

The final rule will go into effect on July 9, 2024. For more information, click here.

HHS OCR Releases Rule Concerning HIPAA Reproductive Care Privacy

On April 22, the Department of Health and Human Services Office for Civil Rights (OCR) released a final rule concerning Health Insurance Portability and Accountability Act (HIPAA) reproductive healthcare privacy provisions. The rule will:

  • Prohibit the use or disclosure of reproductive healthcare protected health information (PHI) when it is requested to investigate or impose liability on patients and providers who seek, obtain or provide lawful reproductive healthcare services;
  • Require providers, health plans, clearinghouses and business associates to obtain a signed attestation that acknowledges PHI related to reproductive healthcare is not to be used for prohibited purposes; and
  • Require providers, health plans and clearinghouses to modify their Notice of Privacy Practices to support reproductive healthcare privacy.

The final rule will go into effect on June 25, 2024. For more information, click here.

HRSA Final Rule Revises 340B Administrative Dispute Resolution Process

On April 18, the Health Resources and Services Administration (HRSA) released a final rule that modifies requirements and procedures for the 340B Program administrative dispute resolution (ADR) process. The rule aims to make the process more accessible, administratively feasible and timely. It will:

  • Eliminate the $25,000 minimum dispute threshold for drug manufacturers and 340B providers;
  • No longer require the ADR process to be governed by the Federal Rules of Evidence and Civil Procedure;
  • Require members of the ADR panel to be 340B subject matter experts under the HRSA Office of Pharmacy Affairs;
  • Require parties to engage in good-faith efforts to resolve disputes before initiating the ADR process;
  • Prioritize the ADR process for disputes related to overcharging, discount diversion or duplicate discounts; and
  • Establish an ADR dispute appeal and reconsideration process.

The rule will go into effect on June 18, 2024. For more information, click here.

CMS Releases CY2025 Medicare Advantage and Part D Final Rule

On April 4, the Centers for Medicare and Medicaid Services (CMS) released a final rule that will amend regulations for the Medicare Advantage (MA), Part D, Cost Plan and Programs of All-Inclusive Care for the Elderly programs. The rule will:

  • Codify nine core chronic diseases and HIV/AIDS to the Part D Medication Therapy Management Program eligibility criteria;
  • Add the “Outpatient Behavioral Health” facility-specialty type to network adequacy standards;
  • Cap compensation for MA plan agents and brokers;
  • Require MA organizations to establish bibliographies for each of the Special Supplemental Benefits for the Chronically Ill that they include in their bid;
  • Streamline enrollment for dual-eligible beneficiaries and limit out-of-network patient cost-sharing for certain plans serving dual-eligible populations;
  • Require Quality Improvement Organizations to review the appeals process for enrollees if their MA plan terminates coverage for certain post-acute care services; and
  • Lower the D-SNP (dual eligible special needs plans) look-alike threshold from 80 to 70 percent.

In addition, the rule will standardize the MA Risk Adjustment Data Validation appeals process and provide Part D sponsors flexibility to substitute lower cost biosimilar biological products for reference products.

The final rule will go into effect on June 3, 2024, but the applicability of the provisions depend on plan coverage dates.

For more information, click here.

CMS Releases Notice of Benefit and Payment Parameters for 2025 Final Rule

On April 2, the Centers for Medicare and Medicaid Services (CMS) released the Notice of Benefit and Payment Parameters for 2025 final rule, which finalizes standards for issuers, Marketplaces and requirements for agents, brokers, direct-enrollment entities and assisters. The rule will:

  • Implement new network adequacy standards on State and State-based Marketplaces;
  • Allow states to add routine non-pediatric dental benefits as an Essential Health Benefit (EHB);
  • Revise prescription drug benefits;
  • Simplify plan choice and selection by revising the Marketplace re-enrollment hierarchy and the EHB-Benchmark Plan update process;
  • Align special enrollment period coverage dates with regular coverage effective dates;
  • Enhance standards and guaranteed consumer protections;
  • Establish new Marketplace call center standards; and
  • Implement a Federally-Facilitated Marketplace user fee rate of 1.5 percent and a State-based Marketplace user fee rate of 1.2 percent of total monthly premiums.

In addition to CMS, the Department of Treasury is proposing the rule.

The final rule will go into effect on June 4, 2024. For more information, click here.

CMS Releases Final Rule Concerning STLDI Plans

On March 28, the Centers for Medicare and Medicaid Services (CMS) released a final rule that restricts the length of short-term, limited-duration insurance (STLDI) plans. The rule will:

  • Limit the initial coverage period of a STLDI plan to no more than three months;
  • Cap the maximum coverage period to four months;
  • Prohibit plan “stacking” by considering multiple plan purchases from the same issuer as a renewal or extension;
  • Require plan and fixed indemnity policy applications, enrollment, reenrollment and consumer-facing marketing materials to be more transparent; and
  • Revise requirements for hospital indemnity or other fixed indemnity insurance to be considered an excepted benefit in the group and individual health insurance markets.

In addition to CMS, the Internal Revenue Service and the Employee Benefits Security Administration are proposing the rule.

The final rule will go into effect on June 17, 2024. For more information, click here.

CMS Final Rule Amends Medicaid Eligibility and Enrollment Process

On March 27, the Centers for Medicare and Medicaid Services (CMS) released a final rule that will streamline the process of eligibility determinations, enrollment and renewal processes for Medicaid, the Children’s Health Insurance Program (CHIP) and the Basic Health Program. The rule will:

  • Prohibit CHIP premium lock-out periods and annual and lifetime limits on CHIP benefits;
  • Remove the State option to require a waiting period prior to CHIP enrollment;
  • Modernize eligibility determination information and documentation recordkeeping requirements for states;
  • Eliminate the State option to require in-person interviews as part of the application and renewal processes for non-MAGI (modified adjusted gross income) beneficiaries;
  • Implement provisions aimed at simplifying the coverage enrollment and renewal process for individuals 65 and older or living with a disability; and
  • Require states to use specific types of available information to update an individual’s address.

In addition, the rule will grant individuals 15 days to return information requested for an initial application and 30 days when needed to retain enrollment.

The final rule will go into effect on June 3, 2024. For more information, click here.

FDA Issues Final Rule Regarding Mammography Quality Standards

On March 9, 2023, 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

HHS OIG Releases Report Concerning Medicaid Managed Care

On May 20, the Department of Health and Human Services Office of Inspector General (OIG) released a report concerning Medicaid managed care. The OIG was interested in determining whether drug claim paid amounts equaled the amount Medicaid reimbursed pharmacies in the Transformed Medicaid Statistical Information System (T-MSIS).

After examining state survey and T-MSIS pharmacy claim data, the OIG found that:

  • State requirements varied for how plans should report the paid amount for drug claims;
  • T-MSIS paid amounts did not equal pharmacy-reported reimbursement; and
  • Many states did not conduct activities to validate drug claim paid amounts.

For more information, click here.

CBO Releases Report on Testimony Concerning Budgetary Impacts of Hospital and Physician Consolidation

On May 23, the Congressional Budget Office (CBO) released a report of the testimony given by CBO Director of Health Analysis Chapin White before the House Budget Committee during its hearing on healthcare consolidation.

For more information, click here.

FDA CDER Releases FY2023 GDUFA Science and Research Report

On May 23, the Food and Drug Administration Center for Drug Evaluation and Research released the fiscal year 2023 Generic Drug User Fee Amendments Science and Research Report. The report summarizes active research projects and priority areas including:

  • Drug impurities;
  • Complex active pharmaceutical ingredients;
  • Dosage forms and formulations;
  • Routes of Delivery;
  • Drug-Device Combination Products;
  • Quantitative Methods and Models; and
  • Data Analytics and Artificial Intelligence.

For more information, click here.

GAO Releases Report Concerning Long-Term Care Ombudsman Program

On May 23, the Government Accountability Office (GAO) released a report concerning the Long-Term Care Ombudsman Program and the challenges state ombudsman program and Administration for Community Living officials face in providing services.

After interviewing officials, the GAO found that:

  • Ombudsman work has become increasingly complex and necessitates different types of resources;
  • The rise in assisted living facilities has increased the workload for ombudsmen; and
  • A shortage of resources has hindered the ability of officials to hire necessary staff and maintain funding and staffing levels.

The GAO conducted this study because it was asked to review the Long-Term Care Ombudsman Program.

For more information, click here.

Note

The next Washington Healthcare Update will be published on June 10.

Authors

Stephanie Kennan
Senior Vice President
Federal Public Affairs
Washington, DC
Gina Sherick
Policy Consultant
Federal Public Affairs
Washington, DC