This Week in Washington: Senate Finance Committee releases discussion draft concerning generic drug shortages; FDA releases laboratory-developed tests final rule; Administration extends ACA subsidies for Deferred Action for Childhood Arrivals (DACA) recipients.

House

House Energy and Commerce Committee Subcommittee on Health Holds Hearing on Medicaid Proposals

On April 30, the House Energy and Commerce Committee Subcommittee on Health held a hearing to discuss proposals aimed at improving Medicaid program access and integrity. One of the proposals would prohibit the Centers for Medicare and Medicaid Services’ (CMS) minimum nursing home staffing rule from being implemented.

The proposals are:

H.R. 124, Byron Nash Renal Medullary Carcinoma Awareness Act of 2023: Supports education on the risk of renal medullary carcinoma for individuals with sickle cell disease eligible to receive care under Medicaid.

H.R. 468, Building America’s Health Care Workforce Act: Extends nursing home waivers to retain temporary nurse aides for more than 120 days and allows competency requirement evaluations to be conducted at nursing homes that employ temporary nurse aides.

H.R. 670, Think Differently Database Act: Establishes a publicly available clearinghouse within the Department of Health and Human Services (HHS) to improve accessibility of health service information and resources for individuals with intellectual disabilities.

H.R. 3227, Ensuring Seniors’ Access to Quality Care Act: Modifies requirements that prohibit nursing homes subject to civil monetary penalties from running nurse aide training and competency evaluations, so long as the facility has addressed deficiencies and has not been found to have deficiencies related to patient harm or quality of care for more than two years.

H.R. 7513, Protecting America’s Seniors Access to Care Act: Prohibits the Secretary of HHS from finalizing regulations that would require long-term care facilities to adhere to minimum staffing standards.

H.R. 7573, Stop Unfair Medicaid Recoveries Act: Repeals the requirement that States establish a Medicaid Estate Recovery Program and limits the ability of States to place liens on a Medicaid beneficiary’s property.

H.R. 8084, To amend title XIX of the Social Security Act to require States to verify certain eligibility criteria for individuals enrolled for medical assistance quarterly, and for other purposes: Requires States to perform quarterly verifications of the Social Security Administration’s Death Master File and disenroll deceased individuals enrolled for medical assistance under the State plan.

H.R. 8089, To amend title XIX of the Social Security Act to require certain additional provider screening under the Medicaid program: Requires certain additional provider screening under the Medicaid program.

H.R. 8094, To amend title XIX of the Social Security Act to modify certain asset recovery rules: Modifies asset recovery under a State plan and allows States to choose to not pursue adjustments or recoveries of medical assistance through property liens, if after the death of an individual, the individual’s home would be transferred to another individual who is eligible for Medicaid or has an income that is 138 percent of the Federal Poverty Level or below.

H.R. 8106, To amend title XIX of the Social Security Act to remove the requirement that an individual need an institutional level of care in order to qualify for home and community-based services under a Medicaid waiver: Amends waivers to allow States to provide home and community-based services (HCBS) to beneficiaries who do not meet an institutional level of care and requires States to report on the state of waiting lists for HCBS care.

H.R. 8107, To amend title XIX of the Social Security Act to remove certain age restrictions on Medicaid eligibility for working adults with disabilities: Amends the Medicaid buy-in program to repeal the eligibility pathway age limit of 65 to allow current beneficiaries to continue to be able to retain coverage through the program.

H.R. 8108, To amend title XIX of the Social Security Act to require medical assistance under the Medicaid program for certain home and community-based services for military families: Requires States that currently provide Medicaid coverage for HCBS to dependents of military families to maintain the coverage for care in the event that the family moves out of state for active duty.

H.R. 8109, To amend the Deficit Reduction Act of 2005 to make permanent the Money Follows the Person rebalancing demonstration: Permanently extends the Money Follows the Person rebalancing demonstration to support the transition from living in an inpatient facility to HCBS, for long-term services and supports-eligible individuals.

H.R. 8110, To amend title XIX of the Social Security Act to make permanent the State option to extend protection against spousal impoverishment for recipients of home and community-based services under Medicaid: Permanently extends spousal impoverishment protections for beneficiaries receiving HCBS.

H.R. 8111, To amend title XIX of the Social Security Act to ensure the reliability of address information provided under the Medicaid program: Streamlines processes for States and managed care organizations to update address information for currently enrolled beneficiaries to ensure that beneficiaries reside in the State.

H.R. 8112, To amend title XIX of the Social Security Act to require certain additional provider screening under the Medicaid program: Requires states to check the CMS Data Exchange database to identify providers who have been removed from participating in the Medicaid program.

H.R. 8113, To amend title XIX of the Social Security Act to require reporting on certain directed payments under the Medicaid program: Requires States to report on provider-level data from amounts paid by the State through state-directed payments.

H.R. 8114, To prohibit the Secretary of Health and Human Services from finalizing a rule proposed by the Centers for Medicare and Medicaid Services to place certain limitations on Medicaid payments for home and community-based services: Prohibits the Secretary of HHS from finalizing regulations that would require pass-through payment requirements for HCBS.

H.R. 8115, To amend title XIX of the Social Security Act to allow for the deferral or disallowance of portions of payments for certain managed care violations under Medicaid: Establishes enforcement mechanisms for the Secretary of HHS to make partial deferrals of payments to Medicaid managed care organizations to ensure compliance with federal laws.

For more information, click here.

House Ways and Means Committee To Mark Up Two-Year Telehealth Extension

On May 8, the House Ways and Means Committee will mark up a two-year extension of Medicare telehealth flexibilities that are set to expire at the end of the year. The House and Senate have been discussing whether flexibilities should be extended or made permanent.

House Veterans Affairs Committee Mark Up Includes Six Healthcare Bills

On May 1, the House Veterans Affairs Committee marked up and reported out of committee 21 bills, including six healthcare bills regarding preventative health evaluations, medical facilities and quality management and administrative investigations. One of the bills concerns the inclusion of psychiatric drugs in the Department of Veterans Affairs (VA) drug formulary.

The bills are:

H.R. 4424, Vietnam Veterans Liver Fluke Cancer Study Act: Directs the VA Secretary to study and report on the prevalence of cholangiocarcinoma in veterans who served in the Vietnam theater of operations during the Vietnam era.

H.R. 6324, Fiscal Year 2024 Veterans Affairs Major Medical Facility Authorization Act: Authorizes major VA medical facility projects for fiscal year 2024.

H.R. 6373, Veterans STAND Act: Directs the VA Secretary to offer annual preventative health evaluations to veterans with a spinal cord injury or disorder and increases access to assistive technologies.

H.R. 7347, To amend title 38, United States Code, to direct the Secretary of Veterans Affairs to report on whether the Secretary will include certain psychedelic drugs in the formulary of the Department of Veterans Affairs: Directs the VA Secretary to report on whether the Secretary will include certain psychedelic drugs in the formulary of the VA.

H.R. 3225, BUILD for Veterans Act of 2023: Improves the management and performance of the capital asset programs of the VA.

H.R. 5794, Veterans Affairs Peer Review Neutrality Act of 2023: Eliminates conflicts of interest in conduct of quality management and administrative investigations by the Veterans Health Administration.

In addition, the committee marked up 15 bills concerning veteran benefits, work study opportunities, employment barriers, claims and appeals processes and fraud prevention efforts.

For more information, click here.

Senate

Senate Finance Committee Releases Discussion Draft Concerning Generic Drug Shortages

On May 3, the Senate Finance Committee released a discussion draft to address and mitigate generic drug shortages. The draft would establish a voluntary Medicare Drug Shortage Prevention and Mitigation Program that would require participants to meet minimum standards and requirements to receive Medicare incentive payments. They include:

  • Minimum three-year contracts with generic drug manufacturers;
  • Purchase volume and stable pricing commitments;
  • Contingency contracts with alternate manufacturers;
  • Prohibition of exclusive provider contracting requirements; and
  • Transparency standards to address quality control issues.

In addition, the draft would modify the Medicaid Drug Rebate Program to allow for reductions or waivers to the inflation rebate for certain generic drugs in the event of a shortage.

The committee is requesting comments on the proposal. Comments are due by June 6.

For more information, click here.

Twenty-Two Senators Send Letter Concerning VA Access to Non-Opioid Pain Alternatives

On April 16, Sen. Jeanne Shaheen (D-NH) and 21 other senators sent a letter to Department of Veterans Affairs (VA) Secretary Denis McDonough concerning access to non-opioid pain alternatives throughout the VA healthcare system.

The senators are urging the VA to stop utilizing opioid treatments for acute pain and are requesting information on the:

  • Number of non-opioid pain alternatives currently on the VA National Formulary;
  • Steps the VA has taken to transition away from opioids to treat acute pain;
  • Frequency at which VA facilities and community care sites dispense and use non-opioid pain alternatives; and
  • Actions Congress could take to help facilitate VA efforts.

For more information, click here.

Senate HELP Committee Holds Hearing on Minority Healthcare Professional Shortages and Maternal Mortality

On May 2, the Senate Health, Education, Labor and Pensions Committee held a hearing to discuss the shortage of minority healthcare professionals and maternal mortality. During the hearing, Ranking Member Bill Cassidy (R-LA) urged the Senate Finance Committee to expand and allocate graduate medical education residency slots in underserved communities. Witnesses were:

  • The Honorable Laphonza Butler, United States Senator, California
  • The Honorable Michael C. Burgess, MD, United States Congressman, Twenty-Sixth Congressional District of Texas
  • Yolanda Lawson, MD, President of the National Medical Association
  • Samuel Cook, MD, Resident at the Morehouse School of Medicine
  • Michael Galvez, MD, Valley Children’s Hospital, Co-Creator of National Latino Physician Day
  • Jaines Andrades, DNP, AGACNP-BC, Nurse Practitioner at Baystate Health
  • Brian Stone, MD, FACS, President of Jasper Urology Associates

For more information, click here.

Senate Armed Services Committee Subcommittee on Personnel Holds Hearing on DOD Prescription Drug Shortage Capabilities

On April 30, the Senate Armed Services Committee Subcommittee on Personnel held a hearing to examine Department of Defense (DOD) biomedical research and development capabilities and discuss how the department addresses prescription drug shortages. Members also discussed the possibility of granting DOD authority to manufacture prescription drugs to combat shortages. Witnesses were:

  • The Honorable Lester Martínez-López, Assistant Secretary of Defense for Health Affairs, Department of Defense
  • David J. Smith, Deputy Assistant Secretary of Defense for Health Readiness Policy and Oversight, Department of Defense
  • Mark Dertzbaugh, Principal Assistant for Research and Technology, United States Army Medical Research and Development Command
  • Matthew R. Beebe, Director of Acquisition (J7), Defense Logistics Agency
  • Melissa Barber, Postdoctoral Fellow, Yale Law School, Yale School of Medicine and Affiliate, Yale Collaboration for Regulatory Rigor, Integrity and Transparency
  • Bryce H. P. Mendez, Specialist in Defense Health Care Policy, Congressional Research Service
  • Colonel Victor A. Suarez, USA (Ret.), Founder and Principal Growth Partner, Blu Zone Bioscience and Supply Chain Solutions, LLC.

For more information, click here.

MACPAC Chair and Appointed Members Announced

On May 2, Government Accountability Office Comptroller General Gene L. Dodaro announced the appointment of a new chairman and two members, in addition to the reappointment of four members, to the Medicaid and Children’s Health Insurance Program Payment and Access Commission (MACPAC). They are:

  • Verlon Jones, MPA, Executive Vice President and Chief Safety Officer at Acentra Health and MACPAC Chair
  • Robert Duncan, MBA, Executive Vice President and Chief Operating Officer at Connecticut Children’s Hospital-Hartford, MACPAC Vice Chair
  • Doug Brown, RPh, MBA, Senior Vice President of Value and Access at COEUS Consulting
  • Michael Nardone, MPA, Former Director of the Disabled and Elderly Health Program Group at the Centers for Medicare and Medicaid Services Center for Medicaid and CHIP Services
  • Heidi Allen, PhD, MSW, Associate Professor at Columbia University School of Social Work
  • John McCarthy, MPA, Founding Partner at Speire Healthcare Strategies

For more information, click here.

Read more on healthcare policy in McGuireWoods Consulting’s Washington Healthcare Update.