Washington Healthcare Update

September 18, 2023

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This Week in Washington: House stalls on defense spending bill, but begins negotiations among Republicans on appropriations; Senate was expected to move forward on three appropriations bills, but has now stalled; House to vote on large healthcare package on transparency

Upcoming Hearings

Congress

House

Senate

Administration

Proposed Rules

Final Rules

Reports

CBO Cost Estimates

Upcoming Hearings

September 19

House

House Energy and Commerce Committee Health Subcommittee Hearing: “Examining Policies to Improve Seniors’ Access to Innovative Drugs, Medical Devices, and Technology”
10:00 a.m., Rayburn House Office Building 2322
Witnesses to be announced.

House Committee on Ways and Means Full Committee Hearing: “Hearing on Reduced Care for Patients: Fallout From Flawed Implementation of Surprise Medical Billing Protections”
10:00 a.m., Longworth House Office Building 1100
Witnesses to be announced.

House Committee on Oversight and Accountability Full Committee Hearing: “The Role of Pharmacy Benefit Managers in Prescription Drug Markets Part II: Not What the Doctor Ordered”
10:00 a.m., Rayburn House Office Building 2154
Witnesses to be announced.

House Committee on Veterans’ Affairs Subcommittee on Health Hearing: “VA’s Federal Supremacy Initiative: Putting Veterans First?”
10:15 a.m., Cannon House Office Building 360
Witnesses to be announced.

Senate

Senate Finance Committee Subcommittee on Health Care Hearing: “Aging in Place: The Vital Role of Home Health in Access to Care”
10:00 a.m., Dirksen Senate Office Building 215
Announced witnesses are:

  • Carrie Edwards, RN, BSN, MHA, LSSGB, Director of Home Care Services at Mary Lanning Healthcare
  • Judith Stein, JD, Executive Director/Attorney at the Center for Medicare Advocacy
  • Tracy M. Mroz, PhD, OTR/L, FAOTA, Associate Professor at the University of Washington
  • William A. Dombi, JD, President of the National Association of Home Care and Hospice
  • David C. Grabowski, PhD, Professor at Harvard Medical School

September 20

House

House Energy and Commerce Committee Oversight and Investigations Subcommittee Hearing: “At What Cost: Oversight of How the IRA’s Price Setting Scheme Means Fewer Cures for Patients”
2:00 p.m., Rayburn House Office Building 2123
Witnesses to be announced.

Senate

Senate Committee on Veterans’ Affairs Full Committee Hearing: “Invisible Wounds of War: Improving Mental Health and Suicide Prevention Measures for our Nation’s Veterans”
3:30 p.m., Russell Senate Office Building 418
Witnesses to be announced.

House

House Delays Vote on Defense Spending Bill

On Sept. 13, House Republicans delayed a procedural vote on the defense appropriations bill after House Freedom Caucus members stated they would not vote for the bill due to a lack of spending cuts outlined in other appropriations bills. In the meantime, the Main Street Republican Caucus and the House Freedom Caucus negotiated to develop a plan to have a Continuing Resolution through Oct. 31, with an eight percent across-the-board reduction in spending except for the Department of Defense and the Department of Veterans Affairs. It is unclear that there are enough votes in the House to pass such a measure.

House to Vote on Lower Costs, More Transparency Act

The House is expected to vote on the Lower Costs, More Transparency Act, a large healthcare package seeking to increase healthcare pricing transparency. The legislation contains provisions that would implement site-neutral payments for off-campus hospital outpatient departments, ban pharmacy benefit manager (PBM) spread pricing, extend funding for health programs and require hospitals and other providers to publish the prices they charge for services.

The package includes:

H.R. 3561, PATIENT Act of 2023
This legislation would expand hospital price transparency requirements, extend funding for the Community Health Center Fund and other programs, and implement site-neutral payments for drugs administered by physicians in off-campus hospital outpatient departments.

H.R. 4839, Hospital and ASC Price Transparency Act of 2023
This legislation would require hospitals to publicly disclose the standard charges for all items and services for at least 300 shoppable services.

H.R. 3248, Diagnostic Lab Testing Transparency Act
This legislation would strengthen price transparency of clinical diagnostic laboratory tests under the Medicare program and require providers to disclose the discounted cash price and insurer- negotiated minimum and maximum rates of tests.

H.R. 4882, Clinical Laboratory Price Transparency Act of 2023
This legislation would require providers to publicly disclose the cash and insurer-negotiated rates for clinical diagnostic laboratory tests offered by a lab included on the list of shoppable services by the Centers for Medicare and Medicaid Services (CMS).

H.R. 4828, Imaging Services Price Transparency Act of 2023
This legislation would require providers to disclose the cash price and insurer-negotiated rates for certain imaging services.

H.R. 4905, Health Insurance Price Transparency Act of 2023
This legislation would require health insurers to share cost-sharing and pricing information with patients.

H.R. 4507, Transparency in Coverage Act of 2023
This legislation would require insurers to share pricing information for healthcare services and require PBMs to share cost information with plan sponsors.

H.R. 2697, Pharmacy Benefit Manager Accountability Act
This legislation would require PBMs to disclose information regarding the rebates, fees and alternative discounts they receive from prescription drugs. It would also require PBMs to disclose drug wholesale acquisition costs and enrollee total out-of-pocket spending.

H.R. 4822, Health Care Price Transparency Act
This legislation would require PBMs to share net price data, aggregate rebate information, out-of-pocket spending and acquisition costs for all drug classes upon request by an employer.

H.R. 3282, Promoting Transparency and Health Competition in Medicare Act
This legislation would require public reporting of data from healthcare entities who share common ownership interests within the Medicare program, specifically insurers who own pharmacies, PBMs and healthcare providers.

H.R. 4883, Medicare Common Ownership Transparency Act of 2023
This legislation would require Medicare Advantage (MA) organizations to disclose common ownership of pharmacies, PBMs and providers to the Department of Health and Human Services (HHS).

H.R. 3284, Providers and Payers COMPETE Act
This legislation would require the HHS Secretary to submit an annual report to Congress detailing the impact Medicare regulations have on healthcare payer and provider consolidation.

H.R. 3839, Increasing Transparency in Generic Drug Applications Act
This legislation would improve the Food and Drug Administration’s (FDA) review process of generic drugs and allow the FDA to inform drug sponsors about differences between their application and the reference product.

H.R. 1613, Drug Price Transparency in Medicaid Act
This legislation would prohibit PBMs from using spread pricing within the Medicaid program.

H.R. 3237, to amend title XVIII of the Social Security Act to require each off-campus outpatient department of a provider to include a unique identifier on claims for items and services, and to require providers with a department to submit to the Centers for Medicare and Medicaid services an attestation with respect to each such department.
This legislation would require off-campus outpatient departments to use a unique health identifier when billing for services.

H.R. 3417, FAIR Act
This legislation would require off-campus outpatient departments to bill for services provided using a unique health identifier.

H.R. 4509, Transparency in Billing Act
This legislation would require group health plans to only pay claims submitted by hospitals that have implemented accurate billing practices, policies and procedures.

H.R. 2559, Strengthening Community Care Act of 2023
This legislation would extend funding for the Community Health Center Fund, the National Health Service Corps and the Teaching Health Center Graduate Medical Education Program.

H.R. 2550, Special Diabetes Program Reauthorization Act of 2023
This legislation would reauthorize funding for the Special Diabetes Program through calendar year (CY) 2025.

H.R. 2547, Special Diabetes Program for Indians Reauthorization Act of 2023
This legislation would reauthorize funding for the Special Diabetes Program for Indians through CY2025.

H.R. 2665, Supporting Safety Net Hospitals Act
This legislation would delay cuts to the Medicaid Disproportionate Share Hospital (DSH) payment for fiscal years (FYs) 2024-2025.

H.R. 4527, Health Data Access, Transparency, and Affordability (DATA) Act
This legislation would improve transparency of the health insurance market and ensure that plan fiduciaries can access cost and quality of care information of their plan.

H.R. 4508, Hidden Fee Disclosure Act
This legislation would clarify and strengthen employer-sponsored health plan disclosure requirements.

For more information, click here.

House Committee Chairmen Send Letter to HHS Reiterating Request for COVID-19 Origin Information

On Sept. 14, House Energy and Commerce Committee Chairman Cathy McMorris Rodgers (R-WA), Subcommittee on Oversight and Investigations Chairman Morgan Griffith (R-VA) and Subcommittee on Health Chairman Brett Guthrie (R-KY) sent a letter to the Secretary of the Department of Health and Human Services (HHS) Xavier Becerra, requesting that officials comply with the committee’s requests for COVID-19 origins information.

The chairmen are urging HHS to send requested COVID-19 origin documents and communications by Sept. 21 and stated that they will consider the use of subpoenas if they do not receive them in time. House Committee on Oversight and Accountability Chairman James Comer (R-KY) and Select Subcommittee on the Coronavirus Pandemic Chairman Brad Wenstrup (R-OH) also signed the letter.

For more information, click here.

Rep. Stewart Resigns from Congress

On Sept. 15, Rep. Stewart (R-UT) resigned from Congress. He represented Utah’s 2nd congressional district and was a member of the House Appropriations Committee and the House Permanent Select Committee on Intelligence. There will be a two-month gap before a special election is held to elect his successor on Nov. 21. His resignation comes at a critical time in Congress, with the GOP holding a slim nine vote majority in the House of Representatives.

Senate

Senate Vote on “Mini Omnibus” of Three Appropriations Bills May Be Delayed

On Sept. 12, the Senate voted 85-12 to begin debate on the Agriculture-FDA, Military Construction-VA, and Transportation-HUD appropriations bills. The Senate was expected to vote on the mini omnibus this week, however, one senator is objecting because he wants a freestanding Military Construction bill. This is providing time for the House Republicans to continue their negotiations.

Majority Leader Leads Senate Forum on AI

On Sept. 13, Senate Majority Leader Chuck Schumer (D-NY) led the Senate AI Insight Forum. The forum was attended by tech industry leaders and more than 60 senators and staff, and aimed to spur discussion on artificial intelligence (AI) and on the manner in which Congress should draft legislation to regulate the development and use of AI technologies. It was the first of a series of AI-focused forums that the Majority Leader had called for in his AI framework released in June.

For more information, click here.

Senate HELP Committee Chairman Unveils Bipartisan Primary Care and Health Workforce Act

On Sept. 14, Senate Health, Education, Labor and Pensions (HELP) Committee Chairman Bernie Sanders (I-VT) released a draft of the Bipartisan Primary Care and Health Workforce Act and announced that he and Sen. Marshall (R-KS) had reached an agreement on the bill. The legislation would address primary care challenges and health workforce shortages and would reauthorize community health and medical education programs. It would:

  • Reauthorize $5.8 billion per year in funding for the Community Health Center Fund through fiscal year (FY) 2026;
  • Reauthorize $1.5 billion in funding for the Teaching Health Center Graduate Medical Education Program through FY 2028;
  • Reauthorize $950 million per year in funding for the National Health Service Corps through FY 2026;
  • Provide $1.2 billion in grants to community colleges and universities to increase nursing program enrollment;
  • Provide $300 million to primary care doctor residency programs and invest in dental training and workforce programs; and
  • Implement provisions aimed at prohibiting anticompetitive practices by hospitals and insurance companies, including banning certain facility fees.

The Senate HELP Committee will mark up the legislation on Sept. 21. Ranking Member Bill Cassidy (R-LA) announced that he opposes the bill, arguing that it lacks full Hyde amendment protections related to abortion and fails to specify how funding increases will be paid.

For more information on the bill, click here.

Sen. Romney Announces Plan to Retire

On Sept. 13, Sen. Romney (R-UT) announced that he will not run for reelection and will retire after his current term ends on Jan. 3, 2025.

Administration

White House Announces New Cancer Moonshot Funding and Programs

On Sept. 13, the White House announced additional funding and programs for the Cancer Moonshot Initiative. The initiative aims to cut the cancer death rate by half over the next 25 years. New funding and programs include:

  • $240 million for the Advanced Research Projects Agency for Health (ARPA-H), which will be awarded to cancer researchers and innovators pursuing new cancer prevention, detection and treatment tools;
  • The Biomedical Data Fabric Toolbox for Cancer, a data sharing and integration partnership between ARPA-H, the National Institutes of Health (NIH), National Cancer Institute (NCI) and other agencies;
  • ARPANET-H, a new nationwide health innovation network focused on bringing cancer trials to underserved communities;
  • A new $15 million program within the Centers for Disease Control and Prevention (CDC) aimed at increasing awareness of smoking cessation services and strengthening the enforcement of policies banning menthol tobacco products;
  • A new partnership between the National Aeronautics and Space Administration (NASA) Division for Biological and Physical Sciences and the International Space Station (ISS) National Laboratory aimed at advancing cancer research and technology in space; and
  • The addition of 30 new sites to the Department of Veterans Affairs (VA) National TeleOncology program, which provides veterans in rural areas with highly specialized virtual cancer care.

In addition, the White House announced a series of new partnerships with private sector stakeholders and non-governmental organizations.

For more information, click here.

CMS Unveils 34 Part B Drugs Selected for Medicare Drug Inflation Rebate Program

On Sept. 13, the Centers for Medicare and Medicaid Services (CMS) unveiled a list of 34 Medicare Part B prescription drugs that qualify for the Medicare Prescription Drug Inflation Rebate Program and that may have lower coinsurance rates between Oct. 1 and Dec. 31, 2023. The coinsurance adjustments may help beneficiaries save up to $618 per average dose of medication.

For more information, click here.

DEA Considers Extending Telemedicine Flexibility for Controlled Substances

On Sept. 12, Drug Enforcement Administration (DEA) Administrator Anne Milgram announced that the DEA will open an additional comment period for its telemedicine prescribing rules proposal. The proposal, originally adopted during the COVID-19 public health emergency, allows practitioners to prescribe certain controlled substance medications to patients via telehealth without an initial in-person medical evaluation.

FDA Advisory Committee Concludes Phenylephrine is Ineffective

On Sept. 11 and 12, the Food and Drug Administration (FDA) held a Nonprescription Drugs Advisory Committee meeting to discuss the effectiveness of oral phenylephrine after recent data revealed the drug was ineffective at relieving congestion. The committee concluded that the drug is ineffective but noted that there are no safety concerns regarding the recommended dose of oral phenylephrine.

For more information, click here.

FDA Issues Warning Letters Regarding Unapproved Eye Products

On Sept. 12, the Food and Drug Administration (FDA) sent warning letters to eight companies regarding the manufacture and marketing of unapproved ophthalmic drug products. The drugs are being illegally marketed to treat conditions such as glaucoma, cataracts and conjunctivitis and contain traces of silver. The FDA is concerned that the drugs may pose an increased risk of harm to users.

The companies include Boiron Inc, CVS Health, DR Vitamin Solutions, Natural Ophthalmics Inc., OcluMed LLC, Similasan AG/Similasan USA, TRP Company Inc. and Walgreens Boots Alliance, Inc.

For more information, click here.

FDA Announces FY 2024 OTC Monograph Order Request Fee Rates

On Sept. 11, the Food and Drug Administration (FDA) announced the over-the-counter (OTC) monograph order request (OMOR) fee rates for the OTC monograph drug user fee program (OMUFA) for fiscal year (FY) 2024. Tier 1 fees are $537,471 and tier 2 fees are $107,494. The fees will go into effect on Oct. 1 and will remain in effect through Sept. 30, 2024.

For more information, click here.

FDA Approves Updated COVID-19 Vaccines

On Sept. 11, the Food and Drug Administration authorized and approved updated Moderna and Pfizer-BioNTech COVID-19 vaccines for emergency use. The updated vaccines are formulated to target the Omicron variant XBB 1.5.

The FDA also updated guidance clarifying when children may receive a booster shot. Children five years old and older may receive a single booster dose after two months of receiving their previous shot. Children between the ages of six months and four years may receive two doses of the booster shot dependent on when they received their previous shot.

For more information, click here.

FDA Publishes Postmarket Device Safety-Related Communications Report to Congress

On Sept. 7, the Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) published a Postmarket Device Safety-Related Communications Report to Congress. The report intends to inform healthcare providers, patients and consumers about the benefits and risks of marketed medical devices.

For more information, click here.

FDA Approves Esophageal Retractor Device

On Sept. 6, the Food and Drug Administration (FDA) granted marketing authorization to the S4 Medical Corp. Esophageal Retractor. The esophageal retractor is a catheter-based device that is designed to reduce the risk of esophageal injury during ablation procedures to treat atrial fibrillation.

FDA Awards Grants for Pediatric Medical Device Development

On Sept. 6, the Food and Drug Administration (FDA) awarded five grants through its Pediatric Device Consortia (PDC) Grants Program totaling $6.75 million. The grants are intended to support the research, production and distribution of pediatric medical devices and will be allocated annually to each consortium over the next five years.

Grantees include the Alliance for Pediatric Device Innovation, Midwest Pediatric Device Consortium, Southwest National Pediatric Device Consortium, The Consortium for Technology and Innovation in Pediatrics: CTIP 3.0 and the UCSF-Stanford Pediatric Device Consortium.

For more information, click here.

FTC Warns Pharmaceutical Companies About Improper Patent Listings

On Sept. 14, the Federal Trade Commission (FTC) issued a warning to pharmaceutical companies, stating that improper Orange Book patent listings would be investigated and that companies found violating the law could face criminal action. The warning comes after the FTC announced it would meet to determine whether intentionally submitting improper patent listings was a form of anticompetitive behavior.

For more information, click here.

HRSA Awards $8 Million to Strengthen Primary Care Language and Disability Training

On Sept. 15, the Health Resources and Services Administration (HRSA) awarded $8 million to primary care programs to train students and medical residents on how to provide appropriate care to individuals with limited English proficiency or intellectual and developmental disabilities. The training seeks to improve healthcare access for historically underrepresented communities.

For more information, click here.

NIH Establishes New Health and Disease Research Consortium

On Sept. 12, the National Institutes of Health (NIH) established the Multi-Omics for Health and Disease Consortium. The consortium will develop strategies for clinical studies involving patients from ancestrally diverse populations and will support genomics, epigenomic and metabolomic data research. Approximately $50.3 million will be awarded to the consortium over the next five years.

For more information, click here.

Proposed Rules

CMS Proposed Rule Establishes Minimum Staffing and Payment Reporting Standards

On Sept. 1, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule that would establish minimum nursing staffing standards for long-term care (LTC) facilities and implement provisions aimed at increasing transparency of Medicaid institutional payments. The proposed rule would:

  • Require nursing facilities participating in Medicare and Medicaid to provide at a minimum, 0.55 hours of care from a registered nurse (RN) per resident per day and 2.45 hours of care from a nurse aide per resident per day;
  • Require nursing facilities to maintain at least one nurse on-site at all times;
  • Implement new nursing facility assessment requirements; and
  • Require states to publicly report on the percentage of Medicaid payments for home and community-based services that are spent on compensation for direct care workers.

Public comments will be accepted until Nov. 6, 2023. For more information, click here.

CMS Proposed Rule Strengthens Coverage of Mental Health Insurance Benefits

On July 25, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule that would implement amendments relating to the Paul Wellstone and Pete Domenici Mental Health Parity and Addiction Equity Act of 2008 (MHPAEA). The proposed rule would:

  • Clarify that the MHPAEA ensures an individual’s right to access mental health and substance use disorder benefits in parity with medical/surgical benefits;
  • Provide examples that make clear that plans and issuers may not use restrictive prior authorization and other medical management techniques or standards related to network composition for mental health and substance use disorder benefits;
  • Clarify that certain factors may not be used to determine out-of-network reimbursement rates for mental health and substance use disorder providers;
  • Require plans and issuers to gather and analyze outcomes data and take action to resolve material differences in access to mental health and substance use disorder benefits and medical/surgical benefits;
  • Codify a requirement that directs plans and issuers to conduct meaningful comparative analyses to measure the impact of nonquantitative treatment limitation (NQTL); and
  • Implement a sunset provision adopted in the Consolidated Appropriations Act of 2023, that allows self-funded, non-federal government plan elections to opt out of compliance with MHPAEA.

In addition to CMS, the Internal Revenue Service and the Employee Benefits Security Administration are proposing the rule. The agencies are also seeking comments and information on proposed new data requirements for limitations related to the composition of a health plan’s or issuer’s network.

Public comments will be accepted until Oct. 2, 2023. For more information, click here.

FDA Proposes Rule to Broaden Prescription Drug Labeling Regulations

On May 30, the Food and Drug Administration (FDA) released a proposed rule that would amend human prescription drug product labeling regulations for medication guides. The proposed rule would require prescription drug and biological product applicants to include a new one-page medication guide known as the Patient Medication Information (PMI) along with products that are used, dispensed or administered in an outpatient setting. Blood and blood components transfused in an outpatient setting would also require a PMI. The PMI would include essential information such as the product’s name, important safety information, common side effects and directions for use.

Public comments will be accepted until Nov. 27, 2023. For more information, click here.

OCR Proposed Rule Strengthens Protections Against Disability Discrimination

On Sept. 7, the Department of Health and Human Services (HHS) Office for Civil Rights (OCR) released a proposed rule that seeks to strengthen access to healthcare and human services for individuals with disabilities. It also aims to prohibit discrimination on the basis of a disability among healthcare and human services programs. The proposed rule would:

  • Clarify the application of Section 504 and ensure its consistency with the Americans with Disabilities Act, the Rehabilitation Act and case law;
  • Clarify obligations for mobile, web and kiosk accessibility;
  • Establish standards for accessible medical equipment;
  • Prohibit the use of value assessment methods that negatively assess individuals with disabilities and limit their access to aids, benefits and services; and
  • Clarify obligations to provide services to disabled persons in integrated and appropriate settings.

Public comments will be accepted until Nov. 13, 2023. For more information, click here.

Final Rules

CMS Final Rule Mandates Medicaid and CHIP Program Core Set Measures Reporting

On Aug. 31, the Centers for Medicare and Medicaid Services (CMS) released a final rule that would establish mandatory state reporting requirements for the following quality measures:

  • Core set of Children’s Health Care Quality measures under Medicaid and the Children’s Health Insurance Program (CHIP);
  • Behavioral health measures on the Core Set of Adult Health Care Quality Measures for Medicaid; and
  • Core Sets of Health Home Quality Measures for Medicaid.

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

CMS Final Rule Updates Inpatient and Long-Term Care Hospital PPS Rates in FY 2024

On Aug. 1, the Centers for Medicare and Medicaid Services (CMS) released a final rule that would update the Medicare hospital inpatient prospective payment system (PPS) and long-term care hospital (LTCH) PPS rates in fiscal year (FY) 2024. The final rule would also update the Hospital Value-Based Purchasing (VBP) Program and the Inpatient Quality Reporting Program (QRP). It would:

  • Increase Medicare inpatient PPS rates by 3.1 percent. This is based on a 3.3 percent market basket increase and a decrease in productivity of 0.2 percent;
  • Finalize changes to graduate medical education (GME) payments for Rural Emergency Hospitals;
  • Extend the low wage index hospital policy that considers rural reclassified hospitals as geographically rural when calculating the wage index;
  • End the New COVID-19 Treatments Add-on Payment (NCTAP) policy;
  • Revise physician self-referral data and information and reinstate program integrity restrictions on certain physician-owned hospitals;
  • Add one new measure to the Hospital VBP;
  • Add three new measures to the Inpatient QRP; and
  • Finalize a CMS proposal relating to the calculation of Medicaid 1115 demonstration days used in the Medicare disproportionate share hospital (DSH) adjustment.

The final rule will go into effect on Oct. 1, 2023. For more information, click here.

CMS Final Rule Updates PPS Rates for Skilled Nursing Facilities in FY 2024

On July 31, the Centers for Medicare and Medicaid Services (CMS) released a final rule that would update the prospective payment system (PPS) for skilled nursing facilities (SNFs) in fiscal year (FY) 2024. The final rule would also update the SNF Quality Reporting Program (QRP) and the SNF Value-Based Purchasing (VBP) Program. It would:

  • Increase SNF PPS payments by a net 4.0 percent;
  • Codify changes to the Patient Driven Payment Model (PDPM) International Classification of Diseases, 10th revision, Clinical Modification codes;
  • Finalize a requirement that would exclude marriage and family therapy and mental health counseling services from SNF Consolidated Billing;
  • Add two new measures to the SNF QRP;
  • Add four new measures to the SNF VBP Program; and
  • Streamline CMS administrative procedures to strengthen its enforcement of nursing home quality compliance.

The rule will go into effect on Oct. 1, 2023. Two amendments in the rule will go into effect on Jan. 1, 2024.

For more information, click here.

CMS Final Rule Updates Hospice Wage Index and Payment Rate in FY 2024

On July 28, the Centers for Medicare and Medicaid Services (CMS) released a final rule that would update the hospice wage index, payment rates and aggregate cap amount in fiscal year (FY) 2024. The final rule would also implement updates to the Hospice Quality Reporting Program (HQRP). It would:

  • Codify hospice data submission thresholds for the HQRP;
  • Implement updates to the CMS Hospice Special Focus Program (SFP);
  • Update health equity and future quality reporting measures;
  • Update the Hospice Outcomes and Patient Evaluation tool; and
  • Require hospice certifying physicians to be Medicare-enrolled or to validly opt out.

The rule will go into effect on Oct. 1, 2023. For more information, click here.

CMS Final Rule Updates PPS Rates for Inpatient Psychiatric Facilities in FY 2024

On July 27, the Centers for Medicare and Medicaid Services (CMS) released a final rule that would update the prospective payment system (PPS) rates for inpatient psychiatric facilities (IPFs) in fiscal year (FY) 2024. The final rule would also implement updates to the IPF Quality Reporting Program (QRP). It would:

  • Update the IPF PPS payment rate by 3.3 percent;
  • Adopt a 2021-based IPF market basket;
  • Adopt four new QRP measures;
  • Allow IPFs to open new units and be paid under the IPF PPS at any time during the cost reporting period;
  • Remove two QRP measures beginning in FY 2025; and
  • Adopt a data validation pilot program beginning in FY 2025.

The rule will go into effect on Oct. 1, 2023. For more information, click here.

CMS Final Rule Updates PPS Rates for Inpatient Rehabilitation Facilities in FY 2024

On July 27, the Centers for Medicare and Medicaid Services (CMS) released a final rule that would update the prospective payment system (PPS) rates for inpatient rehabilitation facilities (IRFs) in fiscal year (FY) 2024. The final rule would also implement updates to the IRF Quality Reporting Program (QRP). It would:

  • Increase IRF PPS payment rates by an estimated 4 percent, approximately $355 million more relative to FY 2023. This is based off a market basket update of 3.6 percent, minus a 0.2 percentage point for productivity and a 0.6 percentage point increase in the outlier threshold;
  • Allow hospitals to open a new IRF and receive payment under the IRF PPS at any time during the cost reporting period;
  • Adopt a 2021-based IRF market basket and implement updated market basket cost weights, price proxies and labor-related share;
  • Adopt two new QRP measures, modify one measure and remove three measures; and
  • Finalize proposals that require the public reporting of four QRP measures.

The rule will go into effect on Oct. 1, 2023. For more information, click here.

DEA Releases Temporary Rule Extending COVID-19 Telemedicine Flexibilities

On May 10, the Drug Enforcement Administration (DEA) and the Substance Abuse and Mental Health Services Administration (SAMHSA) released a temporary rule that extends telemedicine flexibilities adopted during the COVID-19 public health emergency (PHE). The temporary rule follows two Notices of Proposed Rulemaking (NPRM) regarding the virtual prescribing of controlled substances that the DEA released in March 2023, which received more than 38,000 public comments. The temporary rule specifically:

  • Extends through Nov. 11, 2023, the COVID-19 PHE controlled substance prescribing flexibilities that allow practitioners to prescribe controlled substances via telemedicine without having to evaluate patients in person.
  • Implements a one-year grace period through Nov. 11, 2024, for practitioners and patients who have or who develop a telemedicine relationship on or before Nov. 11, 2023. A “telemedicine relationship” is considered to exist if a practitioner has already issued a prescription for a controlled substance to a patient.

The temporary rule will stay in effect through Nov. 11, 2024. For more information, click here.

CMS Finalizes 2024 Medicare Advantage and Part C and D Payment Policies

On March 31, the Centers for Medicare and Medicaid Services (CMS) released a final rule that will finalize the calendar year (CY) 2024 payment policies for the Medicare Advantage (MA) and Medicare Part C and D programs. The final rule implements several changes that were made with regard to the Medicare programs listed above, which are outlined in a Rate Announcement released by CMS. The final rule will:

  • Finalize technical changes and updates made to the MA risk adjustment model, which include transitioning the model to reflect International Classification of Diseases 10 (ICD-10) condition categories and updating the model with recent Medicare data years. CMS intends on phasing in the updated model over the next three years.
  • Finalize changes to the Medicare Part C and D Star Ratings. CMS will provide a list of the eligible disasters for the extreme and uncontrollable circumstances adjustment and of non-substantive updates made to several measure specifications.

CMS’ rate announcement update reflects a 3.32 percent increase in MA payments, equivalent to approximately $13.8 billion. Additionally, the update reflects a 2.28 percent increase in the MA payment effective growth rate, a 1.24 percent decline in star ratings and a 4.4 percent increase in the MA risk score trend.

The rule will go into effect on Jan. 1, 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.

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 will go into effect on Nov. 6, 2023. For more information, click here.

Reports

GAO Releases Report Regarding How HHS Agencies Can Protect Against Political Interference

On Sept. 14, the Government Accountability Office (GAO) released a report regarding safeguards that can help Department of Health and Human Services (HHS) agencies, including the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA) and the National Institutes of Health (NIH), protect themselves against political interference. The GAO convened a roundtable of 11 subject-matter experts to hear their perspectives and reviewed federal guidance related to scientific integrity.

The GAO discovered that the agencies have taken or are in the process of implementing more safeguards to protect against political interference. This includes clarifying how allegations of political interference can be reported and training staff on how to monitor for inappropriate political influence. The GAO conducted this study because it had previously issued political influence safeguard recommendations in April 2022.

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CBO Cost Estimates

CBO Releases Cost Estimate for H.R. 5378, the Lower Costs, More Transparency Act

On Sept. 14, the Congressional Budget Office (CBO) released a cost estimate for H.R. 5378, the Lower Costs, More Transparency Act. The bill would increase healthcare pricing transparency by requiring healthcare providers to publicly list their service charges. It would also ban pharmacy benefit manager (PBM) spread pricing, implement site-neutral payment policies for off-campus hospital outpatient departments and reauthorize several medical education programs.

The CBO estimates that sections 101-110 and section 401 of the bill will have no effect on direct spending or revenues. It also estimates that section 402, which interacts with section 106, will have no cost. The CBO has not completed an analysis of any effects on spending subject to appropriation.

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