This Week in Washington: Senate Finance Committee reports out Modernizing and Ensuring PBM Accountability Act; House Ways and Means Committee reports out healthcare bills; Senate Appropriations Committee reports out FY 2024 Labor-HHS funding bill; Congress leaves for August recess

Upcoming Hearings

Congress

House

• House Ways and Means Committee Marks Up Two Healthcare Bills
• House Energy and Commerce Committee Chairman Issues Drug Shortage Discussion Draft

Senate

• Senate Finance Committee Marks Up Modernizing and Ensuring PBM Accountability Act
• Senate Appropriations Committee Marks Up FY 2024 Labor-HHS Funding Bill
• Senate HELP Committee Chairman Cancels Two Days of Mark Ups

Administration

• CMS Releases Medicaid and CHIP Coverage Renewal Data
• CMS Releases Medicaid and CHIP Mental Health and SUD Action Plan Overview and Guide
• CMS Updates Overall Hospital Quality Star Ratings
• CMS Issues Civil Monetary Penalties Over Hospital Price Transparency Non-Compliance
• FDA Approves Second OTC Naloxone Nasal Spray
• FDA Releases Draft Guidance on Opioid Use Disorder Device Innovation
• FDA Approves Warfarin Therapy Reversal Drug
• FDA Approves Pediatric Pulmonary Artery Stenosis Stent
• FDA Approves Anthrax Post-Exposure Vaccine
• HRSA Awards $11 Million Toward Healthcare Workforce Residency Programs

Proposed Rules

• CMS Proposed Rule Strengthens Coverage of Mental Health Insurance Benefits
• CMS Proposed Rule Contains RFI on Episode-based Payment Model
• CMS Proposed Rule Updates CY 2024 Medicare PFS Payments
• CMS Proposed Rule Revises FY 2024 Medicare Hospital OPPS and ASC Payment Systems
• CMS Proposed Rule Updates Medicare Home Health PPS Rates for CY 2024
• CMS Proposed Rule Outlines Remedy to 340B Program Payment Adjustments
• CMS Proposed Rule Modifies Definition of Short-term Health Plans
• CMS Proposed Rule Updates and Revises ESRD PPS for CY 2024
• FDA Proposes Rule to Broaden Prescription Drug Labeling Regulations
• FDA Proposes New Tobacco Product Manufacturing Practices Requirements
• OCR Proposed Rule Reaffirms Federal Discrimination Protections in HHS Grants

Final Rules

• CMS Final Rule Updates Hospice Wage Index and Payment Rate in FY 2024
• CMS Final Rule Updates PPS Rates for Inpatient Psychiatric Facilities in FY 2024
• CMS Final Rule Updates PPS Rates for Inpatient Rehabilitation Facilities in FY 2024
• OIG Final Rule Outlines Civil Money Penalty Regulations
• CMS Final Rule Clarifies Medicare DSH Payment Adjustment Part C Days
• CMS Final Rule Eliminates COVID-19 Healthcare Worker Vaccination Requirement
• DEA Releases Temporary Rule Extending COVID-19 Telemedicine Flexibilities
• CMS Finalizes 2024 Medicare Advantage and Part C and D Payment Policies
• FDA Issues Final Rule Regarding Mammography Quality Standards
• FDA Delays Tobacco Product Required Warning Final Rule Effective Date

Reports

• GAO Releases Report Concerning FDA Implementation of Exclusivity Provisions in the CARES Act

CBO Cost Estimates

• CBO Responds to Request for Cost Estimate on Primary Care and Health Workforce Expansion Act
• CBO Releases Preliminary Cost Estimate of the Modernizing and Ensuring PBM Accountability Act

Other

• McGuireWoods Consulting Telehealth Flexibility Guidance Now Available

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Upcoming Hearings

House

The House has recessed for its August district work period.

Senate

The Senate has recessed for its August state work period.

Congress

House

House Ways and Means Committee Marks Up Two Healthcare Bills

On July 26, the House Ways and Means Committee reported out two healthcare bills on a party line vote. The bills are:

H.R. 4822, the Health Care Price Transparency Act of 2023
This legislation would implement additional site-neutral payment cuts and regulatory measures on off-campus hospital outpatient departments. It would also impose Medicare sequester cuts on hospitals, codify hospital price transparency regulations, require healthcare plans to limit beneficiary cost-sharing for a month’s supply of a drug covered under Medicare Part D, and establish an electronic prior authorization system for Medicare Advantage plans.

H.R. 3284, the Providers and Payers COMPETE Act
This legislation would require the Secretary of Health and Human Services (HHS) to submit an annual report to Congress outlining the effects of Medicare payment rules on provider and payer consolidation. The report would also detail the effects of payer and provider consolidation with respect to Centers for Medicare and Medicaid (CMS) Innovation Center models.

During the markup, the committee rejected four amendments. Among them was an amendment offered by Rep. Pascrell (D-NJ) that would have required the disclosure of hospitals and nursing homes owned by private equity entities.

For more information, click here.

House Energy and Commerce Committee Chairman Issues Drug Shortage Discussion Draft

On July 28, House Energy and Commerce Committee Chairman Cathy McMorris Rodgers (R-WA) released a discussion draft concerning drug shortages. The discussion draft outlines proposals that the committee developed from stakeholder feedback from a request for information (RFI) the Chair and Senate Finance Committee Ranking Member Mike Crapo (R-ID) issued on drug shortages in June.

Among the policy proposals are provisions that would:

• Exempt certain specified drugs from increases in rebates under the Medicaid program;
• Implement a cap on total rebates for certain generic drugs;
• Exempt generic, sterile injection drugs from the 340B Drug Discount Program;
• Direct the Government Accountability Office (GAO) to study the number of generic drugs that are subject to 340B penny pricing;
• Direct the Health Resources and Services Administration (HRSA) to issue guidance on preventing drug diversions during shortages;
• Reduce inflation rebate amounts for certain shortage drugs subject to rebate waivers under the Medicare program;
• Direct the Department of Health and Human Services (HHS) to study Medicare coding policies for generic sterile injectables and other Part B drugs facing shortages;
• Strengthen reporting requirements for Group Purchasing Organizations; and
• Require the Food and Drug Administration (FDA) to issue noncompliance letters relating to drug volume reporting.

The committee is seeking public comment on the draft discussion and will accept comments until Aug. 25, 2023.

For more information, click here.

Senate

Senate Finance Committee Marks Up Modernizing and Ensuring PBM Accountability Act

On July 26, on a 26 to 1 vote, the Senate Finance Committee reported out of committee the Modernizing and Ensuring PBM Accountability (MEPA) Act. The legislation would update federal prescription drug programs and implement provisions aimed at reforming pharmacy benefit manager (PBM) practices. It would:

• Prohibit PBMs and their affiliates from deriving income or renumeration for Medicare Part D covered drugs based on a manufacturer’s price for the drug;
• Require PBMs to define and apply drug and drug pricing terms in contracts with Part D plan sponsors in a transparent and consistent manner;
• Strengthen PBM reporting requirements and expand the amount of information that PBMs provide to Part D plan sponsors and the Secretary of Health and Human Services (HHS);
• Allow Part D plan sponsors to audit their PBM for compliance with contract requirements;
• Require the HHS Secretary to implement standard Part D measures to assess network pharmacy performance;
• Ban PBM spread pricing in the Medicaid program; and
• Require retail community pharmacies to participate in the National Average Drug Acquisition Cost (NADAC) survey.

For more information, click here.

Senate Appropriations Committee Marks Up FY 2024 Labor-HHS Funding Bill

On July 27, the Senate Appropriations Committee reported out of committee the fiscal year (FY) 2024 Labor, Health and Human Services (HHS) and Education appropriations bill. The legislation would authorize $224.4 billion in total discretionary funding, of which $117 billion would go to the Department of Health and Human Services (HHS). In addition, it included $2 billion in supplemental funding. The bill would:

• Authorize $47.8 billion in funding for the National Institutes of Health (NIH);
• Authorize $5 billion in funding for opioid and substance use disorder treatment and prevention programs;
• Authorize $1.5 billion in funding for the NIH Advanced Research Projects Agency for Health (ARPA-H);
• Authorize $3.67 billion in funding for the Administration for Strategic Preparedness and Response (ASPR);
• Retain funding for the Teen Pregnancy Prevention Program;
• Increase funding for the Ending the HIV Epidemic Initiative;
• Increase funding for childcare and mental health programs; and
• Award $2 billion in additional emergency funding to HHS.

For more information, click here.

Senate HELP Committee Chairman Cancels Two Days of Mark Ups

On July 26 and 27, the Senate Health, Education, Labor and Pensions (HELP) Committee was scheduled to mark up legislation relating to primary care, health workforce development, and job and apprenticeship programs. However, both markups were canceled by committee Chairman Bernie Sanders (I-VT). Ranking Member Bill Cassidy (R-LA) raised concerns about the postponements.

The bills that were scheduled to be marked up include:

Primary Care and Health Workforce Expansion Act
This legislation would authorize $86.5 billion in funding for various health workforce development programs, including the National Health Service Corps and the Primary Care Training and Enhancement Program. It would also implement new prior authorization requirements, prohibit hospitals from charging facility fees when patients receive care from off-site physicians and place a cap on hospital and physician fees.

National Apprenticeship Act of 2023
This legislation would support the creation and expansion of registered, youth and pre-apprenticeship programs. It would also grant the Department of Labor Office of Apprenticeship (OA) additional statutory authority to support state apprenticeship programs and agencies.

Youth Apprenticeship Advancement Act
This legislation would support the expansion of youth apprenticeship opportunities available to high school students and would authorize an investment of $500 million in youth apprenticeship programs over the next five years.

JOBS Act of 2023
This legislation would expand Pell Grant eligibility to students who are enrolled in short-term job training programs that result in their obtaining industry-recognized credentials and certificates.

Gateway to Careers Act of 2023
This legislation would create a grant program aimed at strengthening job training. The grant program would support workforce partnerships established among community colleges, industry stakeholders and other community organizations.

For more information on the primary care legislation markup, click here.

For more information on the job and apprenticeship program legislation markup, click here.

Administration

CMS Releases Medicaid and CHIP Coverage Renewal Data

On July 28, the Centers for Medicare and Medicaid Services (CMS) released data on ongoing Medicaid and Children’s Health Insurance Program (CHIP) coverage renewals. The data revealed that 715,000 people lost their Medicaid coverage in April and 500,000 renewals remain pending. Approximately 80 percent of disenrollments have occurred due to procedural reasons, and nearly half of renewals were conducted on an ex parte basis.

For more information, click here.

CMS Releases Medicaid and CHIP Mental Health and SUD Action Plan Overview and Guide

On July 25, the Centers for Medicare and Medicaid Services (CMS) released the Medicaid and Children’s Health Insurance Program (CHIP) Mental Health (MH) and Substance Use Disorder (SUD) Action Plan overview and guide. The overview and guide outline the strategies CMS is using to improve treatment and support of enrollees with these conditions. CMS is primarily focused on increasing access to prevention and treatment services, expanding home- and community-based services and coverage of non-traditional services and settings, and improving the quality of care for MH and SUD conditions.

For more information on the action plan overview, click here.

For more information on the action plan guide, click here.

CMS Updates Overall Hospital Quality Star Ratings

On July 26, the Centers for Medicare and Medicaid Services (CMS) updated the overall hospital quality star ratings on the CMS Care Compare website. The Care Compare website allows patients and caregivers to compare hospitals and access information on more than 100 quality measures. For the first time, CMS has included Veterans Health Administration (VA) hospitals in its annual quality star ratings update.

For more information, click here.

CMS Issues Civil Monetary Penalties Over Hospital Price Transparency Non-Compliance

On July 25, the Centers for Medicare and Medicaid Services (CMS) announced that it had imposed civil monetary penalties on three hospitals that were not complying with the Hospital Price Transparency Final Rule that went into effect on Jan. 1, 2021. The final rule requires all hospitals to disclose the standard charges for items and services they provide.

For more information, click here.

FDA Approves Second OTC Naloxone Nasal Spray

On July 28, the Food and Drug Administration (FDA) approved RiVive, an over-the-counter (OTC) naloxone hydrochloride nasal spray intended to reverse a known or suspected opioid overdose. This is the second OTC naloxone nasal spray to be granted FDA approval. The FDA decided to grant RiVive approval after data showed that it was as effective as an approved prescription naloxone product.

For more information, click here.

FDA Releases Draft Guidance on Opioid Use Disorder Device Innovation

On July 27, the Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) released draft guidance outlining how clinical studies for devices seeking to treat opioid use disorder (OUD) should be designed to support marketing submissions. The draft guidance recommends that stakeholders control for bias, monitor drug use, conduct follow-up studies and evaluate participant retention and data analysis plans. The FDA is seeking comments on the draft guidance and will accept them until Oct. 26.

For more information, click here.

FDA Approves Warfarin Therapy Reversal Drug

On July 21, the Food and Drug Administration (FDA) approved Balfaxar (prothrombin complex concentrate, human-lans), a drug intended to rapidly restore the blood coagulation factor in adult patients undergoing vitamin K antagonist and warfarin therapy before an urgent surgical or invasive procedure.

Patients undergoing warfarin therapy are at significant risk of experiencing heavy bleeding during invasive procedures. Balfaxar seeks to reduce this risk by replenishing the levels of blood clotting factors in patients. The FDA decided to grant the drug approval after a randomized, double-blind, multicenter study showed that the drug had a similar efficacy rate as its comparator drug Kcentra.

For more information, click here.

FDA Approves Pediatric Pulmonary Artery Stenosis Stent

On July 21, the Food and Drug Administration (FDA) approved the Cordis Palmaz Mullins XD Pulmonary Stent. The stent is intended to treat pediatric patients who are receiving treatment for pulmonary artery stenosis (PAS), a heart condition in which the pulmonary artery narrows and prevents normal blood flow.

For more information, click here.

FDA Approves Anthrax Post-Exposure Vaccine

On July 20, the Food and Drug Administration (FDA) approved Cyfendus (anthrax vaccine adsorbed, adjuvanted), a vaccine intended to be administered to patients 18 to 65 years old following suspected or confirmed exposure to Bacillus anthracis. The FDA is recommending that the vaccine be administered in conjunction with other recommended antibacterial drugs.

For more information, click here.

HRSA Awards $11 Million Toward Healthcare Workforce Residency Programs

On July 26, the Health Resources and Services Administration (HRSA) announced that it had awarded $11 million toward programs focused on implementing medical residency programs in rural communities. The funding is intended to help address the shortage of medical health professionals and lack of access to care in rural areas.

For more information, click here.

Proposed Rules

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 comment 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.

CMS Proposed Rule Contains RFI on Episode-based Payment Model

On July 14, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule that seeks comment through a request for information (RFI) on the design of a future CMS Center for Medicare and Medicaid Innovation episode-based payment model. The Center is considering designing and implementing a new episode-based payment model that would focus on healthcare equity, quality and costs. The Center is seeking information from individuals who have experience with bundled payments and noted that responses to the RFI may be used to inform potential future rulemaking and policy development.

Public comments will be accepted until Aug. 17, 2023. For more information, click here.

CMS Proposed Rule Updates CY 2024 Medicare PFS Payments

On July 13, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule that updates the Medicare physician fee schedule (PFS) payment rates for calendar year (CY) 2024. The proposed rule would:

• Decrease the conversion factor by 3.34 percent to $32.75;
• Delay implementation of a policy that defines the substantive portion of a split or shared visit based on the amount of time spent by a billing practitioner;
• Create a new benefit category for marriage and family therapists and mental health counselors under Medicare Part B;
• Establish new payment codes for mobile psychotherapy for crisis services;
• Implement five new optional Merit-based Incentive Payment System Value Reporting Pathways; and
• Extend several telehealth waivers.

Public comments will be accepted until Sept. 11, 2023. For more information, click here.

CMS Proposed Rule Revises FY 2024 Medicare Hospital OPPS and ASC Payment Systems

On July 13, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule concerning the Medicare hospital Outpatient Prospective Payment System (OPPS) and the Medicare Ambulatory Surgical Center (ASC) payment system for fiscal year (FY) 2024. The proposed rule would:

• Increase OPPS payment rates for hospitals that meet applicable quality reporting requirements by 2.8 percent. This is based off of a projected hospital market basket percentage increase of 3.0 percent minus a 0.2 percent productivity adjustment;
• Update the productivity-adjusted hospital market basket update factor to ASC rates by 2.8 percent and extend its application through calendar years (CYs) 2024 and 2025;
• Establish the Intensive Outpatient Program (IOP) under Medicare and implement various IOP service provisions;
• Update partial hospitalization program (PHP) Medicare payment rates;
• Strengthen hospital price transparency;
• Adopt and codify several standard quality program reporting policies; and
• Expand access to behavioral healthcare and promote safe and effective patient-centered care.

Public comments will be accepted until Sept. 11, 2023. For more information, click here.

CMS Proposed Rule Updates Medicare Home Health PPS Rates for CY 2024

On July 10, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule that updates the Medicare Home Health Prospective Payment System (PPS) rates for calendar year (CY) 2024. The proposed rule would:

• Apply a permanent PPS adjustment of negative 5.653 percent;
• Cut reimbursement rates for home health providers by 2.2 percent;
• Add and remove quality measures from the Home Health quality reporting program;
• Codify requirements for negative wound therapy;
• Establish regulations and implement the items and services payment for lymphedema compression treatment and home intravenous globulin services;
• Address concerns about unnecessary utilization, costs and care quality; and
• Add an informal dispute resolution (IDR) and special focus program (SFP) for hospice programs.

Public comments will be accepted until Aug. 29, 2023. For more information, click here.

CMS Proposed Rule Outlines Remedy to 340B Program Payment Adjustments

On July 7, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule that outlines how 340B hospitals will be reimbursed for funds they did not receive due to an adjustment made to the Medicare payment rates for drugs acquired under the 340B program between calendar years (CY) 2018 and 2022. The adjustment was ruled unlawful by the U.S. Supreme Court last year when the Court unanimously agreed that the Department of Health and Human Services (HHS) had exceeded its statutory authority by adjusting the Outpatient Prospective Payment System (OPPS) payment rates for 340B hospitals without first conducting a statutorily mandated survey of hospitals’ acquisition costs.

Under the proposed rule:

• CMS would pay back the outstanding reimbursement funds to applicable 340B hospitals in a one-time lump-sum payment. CMS projects this amount to total approximately $10.5 billion.
• CMS would recoup funds from hospitals that received increased rates for non-drug services between CYs 2018 and 2022. CMS plans to do this by adjusting the OPPS conversion factor by minus 0.5 percent beginning in CY 2025. This adjustment would remain in effect for an estimated 16 years or until all overpaid funds are recouped.

Public comments will be accepted until Sept. 11, 2023. For more information, click here.

CMS Proposed Rule Modifies Definition of Short-term Health Plans

On July 7, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule that would amend the definition of short-term, limited duration-insurance (STLDI) plans and modify conditions for hospital indemnity insurance to be considered an excepted benefit in group and individual health insurance markets. The proposed rule would:

• Restrict the length of STLDI plans to three months and implement a maximum coverage period of four months;
• Prohibit issuers from offering STLDI plans to consumers who have previously purchased plans from the same or a different issuer;
• Prohibit fixed indemnity excepted benefits coverage from paying benefits on a per-service basis in the individual market;
• Implement additional payment standards for fixed indemnity excepted benefits coverage in individual and group markets;
• Require that fixed indemnity excepted benefits be offered as independent, non-coordinated coverage; and
• Propose amendments to revise current notice language to clarify the differences between STLDI and fixed indemnity excepted benefits coverage and comprehensive coverage.

In addition to CMS, the Internal Revenue Service and the Employee Benefits Security Administration are proposing the rule. The agencies are also seeking comment and information on specified disease-excepted benefits coverage and level-funded plans.

Public comments will be accepted until Sept. 11, 2023. For more information, click here.

CMS Proposed Rule Updates and Revises ESRD PPS for CY 2024

On June 30, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule that updates and revises the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) for calendar year (CY) 2024. The proposed rule would:

• Increase payment rates for freestanding ESRD facilities by 1.6 percent and hospital-based facilities by 2.6 percent;
• Increase the ESRD PPS base rate to $269.99;
• Implement a transitional pediatric ESRD dialysis add-on payment adjustment for CYs 2024 to 2026;
• Implement a new three-year add-on payment for new renal dialysis drugs and biological products at the end of the Transitional Add-on Payment Adjustment two-year period;
• Waive low-volume payment amount attestation requirements for ESRD facilities that were impacted by disasters and emergencies;
• Create a new adjustment that increases payment to low-volume, geographically isolated and rural ESRD facilities; and
• Codify new quality reporting measures and remove older measures.

Public comments will be accepted until Aug. 25, 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.

FDA Proposes New Tobacco Product Manufacturing Practices Requirements

On March 8, the Food and Drug Administration (FDA) released a proposed rule that would improve the manufacture, design, packing and storage of tobacco products. The proposed rule seeks to ensure that tobacco products comply with the Federal Food, Drug, and Cosmetic (FD&C) Act. The FDA has noted that it will help minimize and prevent tobacco product contamination, as well as inconsistencies in e-cigarette liquid concentrations and labeling. The proposed rule will also:

• Establish tobacco product design and development controls;
• Ensure that tobacco products meet established specifications;
• Crack down on tobacco products that do not meet specifications;
• Require manufacturers to take action in cases of product contamination;
• Require investigations of products that do not meet specifications; and
• Establish the ability to trace all components, ingredients, additives and materials used by tobacco product manufacturers.

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

OCR Proposed Rule Reaffirms Federal Discrimination Protections in HHS Grants

On July 11, the Department of Health and Human Services (HHS) Office for Civil Rights (OCR) and the Office of the Assistant Secretary for Financial Resources (ASFR) released a proposed rule that reaffirms federal protections against discrimination in HHS-funded programs and services. The proposed rule would:

• Clarify that discrimination on the basis of sexual orientation and gender identity is prohibited by federal statutes administered by HHS;
• Confirm non-discrimination protections in HHS programs as well as services and grants relating to refugee and homelessness assistance, substance abuse treatment and prevention, community mental health, and maternal and child health; and
• Clarify that individuals with religious objections may seek an exemption from or modification of program requirement when appropriate.

Public comments will be accepted until Sept. 11, 2023. For more information, click here.

Final Rules

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.

OIG Final Rule Outlines Civil Money Penalty Regulations

On July 3, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) released a final rule that amends the HHS OIG civil money penalty (CMP) regulations. The final rule outlines penalties that can be imposed against developers of health information technology and health information networks and exchanges if they violate information blocking regulations. The CMPs were authorized under the 21st Century Cures Act. The final rule also modifies 42 CFR parts 1003 and 1005 and adds Cures Act statutory provision language to them.

The rule will go into effect on Aug. 2, 2023. Some provisions will go into effect on Sept. 1, 2023.

For more information, click here.

CMS Final Rule Clarifies Medicare DSH Payment Adjustment Part C Days

On June 7, the Centers for Medicare and Medicaid Services (CMS) released a final rule that establishes a policy that governs how the hospital inpatient days of Medicare Part C beneficiaries should be considered when calculating a hospital’s disproportionate share (DSH) payment adjustment. The policy is intended to provide clarity on how Part C days will be treated for DSH calculations that are not governed by the FY 2014 inpatient prospective payment system (IPPS)/long-term care hospital (LTCH) prospective payment system (PPS) final rule.

The rule will go into effect on Aug. 8, 2023. For more information, click here.

CMS Final Rule Eliminates COVID-19 Healthcare Worker Vaccination Requirement

On May 31, the Centers for Medicare and Medicaid Services (CMS) released a final rule that eliminates the COVID-19 vaccination requirement for healthcare workers. The vaccination requirement, which required all staff working in long-term care (LTC) facilities to receive an initial COVID-19 vaccine, was originally proposed in a Nov. 2021 interim final rule. The rule faced a series of legal challenges and officially went into effect in Jan. 2022, following a ruling by the U.S. Supreme Court.

Although the vaccination requirement is eliminated, the final rule will still require LTC facilities to provide education about COVID-19 vaccines and to offer them to residents, clients and staff. CMS announced that it will rely on proposed quality reporting measures to encourage providers to stay up to date on vaccines.

The rule will go into effect on Aug. 4, 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.

GAO Releases Report Concerning FDA Implementation of Exclusivity Provisions in the CARES Act

On July 28, the Government Accountability Office (GAO) reported on the FDA’s implementation of the exclusivity provisions in the CARES Act. This report is an update to a July 2020 report concerning the Food and Drug Administration’s (FDA) new tools to regulate over-the-counter drugs like sunscreen and cold medicine. In this most recent report, the GAO found that the FDA is still preparing to review and approve over-the-counter drugs under a faster newer process, but no companies have requested approval for over-the-counter drug innovations. The FDA has reported that they do not expect to receive any request before October at the earliest.

For more information, click here.

CBO Cost Estimates

CBO Responds to Request for Cost Estimate on Primary Care and Health Workforce Expansion Act

On July 27, the Congressional Budget Office (CBO) released a copy of a letter CBO Director Phillip Swagel sent to Senate Health, Education, Labor and Pensions (HELP) Committee Ranking Member Bill Cassidy (R-LA) in response to his request for a cost estimate of the Primary Care and Health Workforce Expansion Act. Director Swagel noted that the provisions in the legislation are complex and that the CBO will likely require many weeks to analyze their impact on direct spending and revenue.

For more information, click here.

CBO Releases Preliminary Cost Estimate of the Modernizing and Ensuring PBM Accountability Act

On July 24, the Congressional Budget Office (CBO) released a preliminary cost estimate of the Modernizing and Ensuring PBM Accountability Act. The cost estimate outlines the impact various provisions of the legislation will have on estimated budget authority and outlays. The CBO predicts that between fiscal years (FYs) 2023 and 2028, estimated budget authority will increase by $974 million and estimated outlays will decrease by $666 million.

For more information, click here.

Other

McGuireWoods Consulting Telehealth Flexibility Guidance Now Available

McGuireWoods Consulting has compiled a list of all the telehealth flexibilities that were issued during the COVID-19 public health emergency. The list outlines flexibilities relating to physicians, hospitals, home health agencies and other providers, and displays their current status.

For more information, click here.