This Week in Washington: House Energy and Commerce Committee markup includes 19 healthcare bills; Senate HELP Committee to mark up SUPPORT Act Reauthorization and three other bills; House to vote on Lower Costs, More Transparency Act and SUPPORT Act Reauthorization; Comments sought on march-in rights.

Congress

House

• House Energy and Commerce Committee Marks Up 19 Healthcare Bills
• House to Vote on Lower Costs, More Transparency Act and Support for Patients and Communities Reauthorization Act
• House Energy and Commerce Committee Chairman Announces Hearing on AI
• House Energy and Commerce Committee Chairmen Threaten to Subpoena CDC Over Lab Safety Practices
• Innovation in Pediatric Drugs Act of 2023 Introduced

Senate

• Senate HELP Committee to Mark Up SUPPORT Act Reauthorization and Three Other Bills
• Senate HELP Committee Ranking Member Sends Letter Concerning Patient Access to Gene Therapies
• Senate Finance Committee Reports Final Legislative Text of Better Mental Health Care, Lower-Cost Drugs and Extenders Act
• Senate Finance Committee Holds Hearing on Prescription Drug Shortages
• Senators Send Letters Concerning Private Equity Ownership of Hospitals

Administration

• Comments Sought on Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights
• White House Announces Initiatives Aimed at Curbing Private Equity Ownership and Anticompetitive Practices
• HHS Sends Joint Letter Concerning Access to Naloxone and Opioid Overdose Reversal Medications
• HHS Releases Concept Paper Outlining Healthcare Cybersecurity Strategy
• FDA Approves First Cell-Based Gene Therapy for Sickle Cell Disease Patients
• FDA Approves First Oral Monotherapy for Paroxysmal Nocturnal Hemoglobinuria
• FDA Issues Draft Guidance on Translation of GLP Study Reports
• FDA Commissioner Stresses Importance of Clinical Trial Transparency and Oversight
• NIH Expands Home Test to Treat Program

Proposed Rules

• CMS Proposed Rule Outlines Benefit and Payment Parameters for 2025
• CMS Proposes Rule to Strengthen Medicare Advantage, Part D and Behavioral Healthcare Access
• CMS Proposes Rule to Penalize Providers Who Block Electronic Health Information
• CMS Proposes Rule Regarding Federal IDR Process
• FDA Proposes Rule Regarding Classification of Wound Dressings and Washes

Final Rules

• FDA Final Rule Implements Direct-To-Consumer Prescription Drug Ad Standards
• CMS Final Rule Implements Nursing Home Ownership and Management Disclosure Requirements
• CMS Final Rule Outlines Remedy for 340B Payment Cuts Deemed Unlawful Between CYs 2018-2022
• CMS Final Rule Updates 2024 Medicare Physician Fee Schedule
• CMS Final Rule Updates 2024 Hospital OPPS and ASC Payment System
• CMS Final Rule Updates 2024 Home Health Prospective Payment System
• CMS Final Rule Updates 2024 ESRD Prospective Payment System
• CMS Final Rule Mandates Medicaid and CHIP Program Core Set Measures Reporting
• CMS Finalizes 2024 Medicare Advantage and Part C and D Payment Policies
• FDA Issues Final Rule Regarding Mammography Quality Standards

Courts

• U.S. Supreme Court Hears Purdue Pharma Case

Reports

• GAO Releases Report Regarding Federal Agency Cybersecurity Incident Response Preparedness

CBO Cost Estimates

• CBO Releases Cost Estimate of Lower Costs, More Transparency Act

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House

House Energy and Commerce Committee Marks Up 19 Healthcare Bills On Dec. 5 and 6, the House Energy and Commerce Committee marked up and reported out of committee 44 bills, including 19 healthcare bills. The bills were: H.R. 2365, National Plan to End Parkinson’s Act This legislation would direct the Department of Health and Human Services Secretary (HHS Secretary) to coordinate and improve federal prevention, treatment and cure strategies for Parkinson’s disease. It would also require HHS to form an advisory council to assess current national Parkinson’s disease recommendations and strategies. H.R. 5372, Expanding Seniors’ Access to Lower Cost Medicines Act of 2023 This legislation would allow changes in insurance plan formularies for biosimilar products to be made mid-year beginning in 2025. H.R. 2880, Protecting Patients Against PBM Abuses Act This legislation would ban PBM spread pricing and would delink PBM compensation from the cost of medications. It would also prohibit PBMs from compensating network pharmacies less than affiliated pharmacies and would increase data transparency of PBM rebates and administrative fees. H.R. 5393, To amend title XVIII of the Social Security Act to ensure fair assessment of pharmacy performance and quality under Medicare Part D, and for other purposes This legislation would require prescription drug plans (PDPs) to only use pharmacy performance measures that are established by the HHS Secretary. It would also establish a process to allow PDPs to submit information about pricing prescription drug claims to their network pharmacies. H.R. 5385, Medicare PBM Accountability Act This legislation would strengthen reporting requirements for PBMs and would require them to submit information on drug costs and pricing, generic and biosimilar formulary placement, PBM affiliates, conflicts of interest, drug dispensing and Part D drugs to the HHS Secretary. H.R. 5386, Cutting Copays Act This legislation would set copays for generic drugs to $0 for low-income patients in the Medicare Low-Income Subsidy program. H.R. 4881, To amend title XVIII of the Social Security Act to limit cost sharing for drugs under the Medicare program This legislation would limit patient cost-sharing for Medicare Part D drugs beginning in 2027 and would limit beneficiary out-of-pocket costs to no more than what an insurance company pays for highly rebated drugs once all discounts are accounted for. H.R. 5389, National Coverage Determination Transparency Act This legislation would require the HHS Secretary to determine whether a request for a National Coverage Determination (NCD) is complete within 30 days of receiving a request. It would also require the Secretary to make all NCD applications public on the Centers for Medicare and Medicaid Services (CMS) website and would allow the Secretary to work directly with entities that submit NCD applications. H.R. 133, Mandating Exclusive Review of Individual Treatments (MERIT) Act This legislation would clarify that NCDs for Medicare-covered drugs and biologics must be made with respect to each drug or biologic and not the class of the drug or biologic. H.R. 5396, Coverage Determination Clarity Act of 2023 This legislation would prohibit Local Coverage Determinations (LCDs) from being more restrictive than NCDs and would require the HHS Secretary to review LCDs annually to evaluate their consistency. H.R. 5371, Choices for Increased Mobility Act of 2023 This legislation would clarify that expenses for titanium or carbon fiber materials used in the construction of wheelchair bases are not covered under Medicare Part B. It would also clarify that Medicare Part B beneficiaries may pay out of pocket for wheelchair upgrades if they wish. H.R. 5388, Supporting Innovation for Seniors Act This legislation would expand a flexibility under the Medicare Advantage (MA) Value-Based Insurance Design Model that allows MA plans to expand access to innovative medical devices and technologies using their existing supplemental benefit funds. H.R. 5380, To amend title XVIII of the Social Security Act to increase data transparency for supplemental benefits under Medicare Advantage This legislation would require MA plans to report on the utilization of supplemental benefits by enrollees. H.R. 3842, Expanding Access to Diabetes Self-Management Training Act of 2023 This legislation would require the Center for Medicare and Medicaid Innovation to test a model covering virtual diabetes outpatient self-management training services and would remove patient cost-sharing and deductible requirements for Medicare Part B diabetes outpatient self-management training services. H.R. 5397, Joe Fiandra Access to Home Infusion Act of 2023 This legislation would codify a proposed CMS durable medical equipment (DME) policy that clarifies coverage of an external infusion pump under the Medicare DME benefit. H.R. 5555, DMEPOS Relief Act of 2023 This legislation would require the HHS Secretary to make payment adjustments to certain Medicare items and durable medical equipment included in the 2021 Durable Medicare Equipment, Prosthetics/Orthotics and Supplies competitive bidding program. H.R. 6545, Physician Fee Schedule Update and Improvements Act This legislation would increase the Medicare payment add-on adjustment made in the 2024 Physician Fee Schedule from 1.25 percent to 2.5 percent and extend incentive payments for participation in alternative payment models. It would also extend the floor for the work geographic index. H.R. 6364, Medicare Telehealth Privacy Act of 2023 This legislation would prohibit the HHS Secretary from publicly disclosing the addresses of physician and practitioner residences from which telehealth services are provided. H.R. 1352, Increasing Access to Biosimilars Act of 2023 This legislation would create a pilot program to evaluate the benefits of providing additional shared savings payments to Medicare biosimilar providers. In addition, the committee marked up bills related to energy and manufacturing infrastructure, consumer protections, internet broadband and technology innovation and safety. For more information, click here. House to Vote on Lower Costs, More Transparency Act and Support for Patients and Communities Reauthorization Act This week, the House plans to vote on the Lower Costs, More Transparency Act and the Support for Patients and Communities Reauthorization Act. The vote will be held under suspension of the rules. This prohibits amendments from being offered. The Lower Costs, More Transparency Act is a legislative package that includes provisions seeking to increase healthcare pricing transparency by implementing site-neutral payments for off-campus hospital outpatient departments, extending funding for health programs, banning pharmacy benefit manager spread pricing and requiring hospitals and other providers to publish the prices they charge for services. The Support for Patients and Communities Reauthorization Act will reauthorize community-based opioid use disorder prevention, treatment and recovery programs. The legislation was not considered earlier because Republicans sought to include a provision that would reclassify xylazine as a Schedule III drug under the Controlled Substances Act. House Energy and Commerce Committee Chairman Announces Hearing on AI On Dec. 6, House Energy and Commerce Committee Chairman Cathy McMorris Rodgers (R-WA) announced that the committee will hold a hearing to discuss the projected impacts of artificial intelligence on supply chains, energy, healthcare and emerging technologies. The hearing will be held on Dec. 13. Announced witnesses are:

• Director Helena Fu, Director of Critical and Emerging Technology of the Department of Energy Office of the Undersecretary for Science
• Micky Tripathi, National Coordinator for Health Information Tech at the U.S. Department of Health and Human Services
• Saif Khan, Senior Advisor to the Department of Commerce Secretary for Critical and Emerging Technologies

For more information, click here. House Energy and Commerce Committee Chairmen Threaten to Subpoena CDC Over Lab Safety Practices On Dec. 7, House Energy and Commerce Committee Chairman Cathy McMorris Rodgers (R-WA) and two subcommittee chairmen, Brett Guthrie (R-KY) and Morgan Griffith (R-VA), sent a letter to Centers for Disease Control and Prevention (CDC) Director Mandy Cohen, warning that the committee could subpoena the CDC if it does not provide documents regarding laboratory safety practices at CDC facilities. For more information, click here. Innovation in Pediatric Drugs Act of 2023 Introduced On Dec. 7, Reps. Eshoo (D-CA) and McCaul (R-TX) introduced the Innovation in Pediatric Drugs Act of 2023. The legislation would require rare disease drugs to be studied in children, grant the Food and Drug Administration additional authority to penalize companies that fail to complete required pediatric studies and increase funding for the National Institutes of Health Best Pharmaceuticals for Children Act Program. For more information, click here.

Senate

Senate HELP Committee to Mark Up SUPPORT Act Reauthorization and Three Other Bills On Dec. 12, the Senate Health, Education, Labor and Pensions Committee will mark up the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Reauthorization Act. The bipartisan legislation would reauthorize programs that provide community-based prevention, treatment and recovery services for individuals with substance use and behavioral health disorders. The markup is also scheduled to include the Screening for Communities to Receive Early and Equitable Needed Services for Cancer Act of 2023, which would reauthorize the National Breast and Cervical Cancer Early Detection Program, the Advancing Research in Education Act, which would reauthorize the Education Science Reform Act and the Modernizing Opioid Treatment Access Act, which would allow certain providers to prescribe methadone for opioid use disorder. For more information, click here. Senate HELP Committee Ranking Member Sends Letter Concerning Patient Access to Gene Therapies On Dec. 5, Senate Health, Education, Labor and Pensions Committee Ranking Member Bill Cassidy (R-LA) sent a letter to gene therapy stakeholders, requesting feedback on how access to gene therapies for patients with ultra-rare diseases could be improved. The ranking member is seeking responses to questions concerning gene therapy insurance coverage, pricing strategies, supply chain contract designs and physician prescribing methods. The ranking member is also seeking input on how the federal government could play a role in overseeing access to gene therapies in the commercial market. Responses are due by Jan. 22. For more information, click here. Senate Finance Committee Reports Final Legislative Text of Better Mental Health Care, Lower-Cost Drugs and Extenders Act On Dec. 7, the Senate Finance Committee reported the final legislative text of the Better Mental Health Care, Lower-Cost Drugs and Extenders Act, which was marked up and reported out of committee on Nov. 8. The legislation seeks to increase Medicare reimbursement rates for doctors and providers, expand mental health and substance use disorder services, lower prescription drug costs and extend Medicare and Medicaid programs that are set to expire. For more information, click here. Senate Finance Committee Holds Hearing on Prescription Drug Shortages On Dec. 5, the Senate Finance Committee held a hearing to examine the causes of prescription drug shortages and supply chain challenges. The committee also discussed the impacts of shortages on patients and providers and potential policy solutions. Announced witnesses were:

• Inmaculada Hernandez, PharmD., Ph.D., Professor at the University of California, San Diego Skaggs School of Pharmacy and Pharmaceutical Sciences Division of Clinical Pharmacy
• Marta E. Wosińska, Ph.D., Senior Fellow at the Brookings Institution Schaeffer Initiative on Health Policy
• Allan Coukell, Senior Vice President of Public Policy at Civica Rx
• Jason Westin, M.D., M.S., FACP, Director of the Clinical Research Program and Section Chief of Aggressive Lymphoma at the M.D. Anderson Cancer Center Department of Lymphoma and Myeloma

For more information, click here. Senators Send Letters Concerning Private Equity Ownership of Hospitals On Dec. 6, Sens. Whitehouse (D-RI) and Grassley (R-IA) sent letters to four private equity firm chief executive officers, requesting that they provide information concerning their ownership of hospitals. The senators are concerned that private equity ownership in healthcare is negatively impacting quality of care and resources among hospitals and resulting in facility staffing shortages, closures and debt. In addition, the senators sent a letter to the chief executive officer of the Ottumwa Regional Health Center, seeking information on whether the health center experienced operational and financial hardships after it was acquired by a private equity firm in 2010. For more information, click here.

Administration

Comments Sought on Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights In March, the Department of Commerce and the Department of Health and Human Services jointly announced that they would establish an Interagency Working Group, to review federal march-in authority under the Bayh-Doyle Act and develop a framework outlining the factors that federal agencies may consider when deciding whether to exercise march-in rights. The National Institute of Standards and Technology (NIST), the convening agency for the Interagency Working Group for Bayh-Doyle, announced on Dec. 7 that it is seeking comments on the Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights. Comments will be accepted until Feb. 6. In addition, NIST will host an informational webinar on Dec. 13, to discuss the draft framework and clarify what comments it is seeking. For more information, click here. White House Announces Initiatives Aimed at Curbing Private Equity Ownership and Anticompetitive Practices On Dec. 7, the White House announced that it would pursue new initiatives aimed at curbing anticompetitive practices and private equity ownership among physician practices, nursing homes, hospices and other healthcare providers. The initiatives are also intended to lower healthcare and prescription drug costs. As part of the initiative, the Department of Health and Human Services will share data with the Federal Trade Commission and the Department of Justice to help identify anticompetitive behavior. The departments will also issue a request for information to gather comments on how private equity ownership of healthcare providers is impacting patients. In addition, the Centers for Medicare and Medicaid Services will focus on strengthening its data capabilities and its oversight of deceptive Medicare Advantage marketing practices. For more information, click here. HHS Sends Joint Letter Concerning Access to Naloxone and Opioid Overdose Reversal Medications On Dec. 8, the Department of Health and Human Services, the White House Office of National Drug Control Policy and the Department of Housing and Urban Development jointly sent a letter to public health departments, urging them to partner with housing providers and community development organizations to expand access to naloxone and other opioid overdose reversal medications. For more information, click here. HHS Releases Concept Paper Outlining Healthcare Cybersecurity Strategy On Dec. 6, the Department of Health and Human Services (HHS) released a concept paper outlining a cybersecurity strategy the agency intends on implementing, to protect patients, hospitals and other healthcare providers from cyberattacks. The strategy is built around the following four objectives:

• Establish voluntary cybersecurity performance goals for the healthcare sector;
• Provide resources to incentivize and implement cybersecurity practices;
• Implement an HHS-wide strategy to support greater enforcement and accountability; and
• Expand cybersecurity support functions within the Administration for Strategic Preparedness and Response and enhance coordination with federal agencies.

In addition, HHS is seeking to increase civil monetary penalties for Health Insurance Portability and Accountability Act violations and establish an investment program to support the adoption of cybersecurity practices by hospitals. For more information, click here. FDA Approves First Cell-Based Gene Therapy for Sickle Cell Disease Patients On Dec. 8, the Food and Drug Administration approved Casgevy and Lyfgenia, two cell-based gene therapies intended to treat sickle cell disease in patients 12 years and older. Both therapies involve modifying a patient’s blood stem cells via genome editing technologies, including CRISPR/Cas9, and transplanting the modified stem cells back into the patient. For more information, click here. FDA Approves First Oral Monotherapy for Paroxysmal Nocturnal Hemoglobinuria On Dec. 6, the Food and Drug Administration approved Fabhalta (iptacopan), the first oral monotherapy treatment for adults with paroxysmal nocturnal hemoglobinuria (PNH), a chronic and rare blood disorder. Fabhalta was approved after clinical trial data showed that it increased hemoglobin levels in PNH patients. FDA Issues Draft Guidance on Translation of GLP Study Reports On Dec. 5, the Food and Drug Administration issued draft guidance on the translation of good laboratory practice study reports. The draft guidance intends to inform stakeholders on how they can accurately translate study reports from a non-English language into English. For more information, click here. FDA Commissioner Stresses Importance of Clinical Trial Transparency and Oversight On Dec. 4, the Food and Drug Administration released a commentary written by Commissioner Robert Califf concerning clinical trial transparency and oversight. The commissioner is urging stakeholders to comply with clinical trial reporting requirements and is encouraging them to submit results information to the ClinicalTrials.gov database. For more information, click here. NIH Expands Home Test to Treat Program On Dec. 6, the National Institutes of Health announced that the Home Test to Treat Program has been expanded to include free testing, telehealth and treatment for COVID-19 and for influenza type A and B. The program previously only covered COVID-19 health services. For more information, click here.

Proposed Rules

CMS Proposed Rule Outlines Benefit and Payment Parameters for 2025 On Nov. 15, the Centers for Medicare and Medicaid Services released a proposed rule that would implement proposed standards for qualified health plans (QHPs) that are offered through the health insurance marketplace for 2025. It would also establish new requirements for health plan agents, brokers, direct enrollment entities and assisters. The proposed rule would:

• Require state marketplaces and state-based marketplaces on the federal platform (SBM-FPs) to establish quantitative time and distance QHP network adequacy standards;
• Allow states to add routine adult dental services as an essential health benefit;
• Revise certain prescription drug benefits;
• Enhance consumer protections and standards;
• Establish marketplace call center standards;
• Require state marketplaces and Medicaid/CHIP agencies to pay to access and use Verify Current Income Hub service income data;
• Implement a federally facilitated marketplace user fee of 2.2 percent and a SBM-FP user fee of 1.8 percent; and
• Implement a risk adjustment fee of $0.20 per member per month for the 2025 benefit year.

In addition, the proposed rule would grant states more flexibility when adopting income and resource disregards when determining financial eligibility for Medicaid for non-Modified Adjusted Gross Income populations. Public comments will be accepted until Jan. 8, 2024. For more information, click here. CMS Proposes Rule to Strengthen Medicare Advantage, Part D and Behavioral Healthcare Access On Nov. 6, the Centers for Medicare and Medicaid Services released a proposed rule that would implement technical and policy changes to the Medicare Advantage (MA), Prescription Drug Benefit and Cost Plan programs in addition to the Programs of All-Inclusive Care for the Elderly (PACE) beginning in contract year (CY) 2025. The proposed rule would:

• Implement a $632 fixed payment for MA and Part D agents and brokers who assist individuals in enrolling in a MA or Part D plan;
• Establish a new MA facility-specialty type called “Outpatient Behavioral Health,” which will include marriage and family therapists, mental health counselors and other addiction and behavioral health providers;
• Encourage MA plans to increase engagement efforts and inform plan enrollees about supplemental benefits;
• Require MA plans to demonstrate that special supplemental benefits for the chronically ill (SSBCI) meet reasonable expectations of improving chronically ill enrollees’ health and well-being;
• Direct MA plans to analyze utilization management policies from a health equity perspective;
• Limit out-of-network cost sharing for dual eligible special needs plans; and
• Standardize the MA plan risk adjustment data validation (RADV) appeals process.

Public comments will be accepted until Jan. 5, 2024. For more information, click here. CMS Proposes Rule to Penalize Providers Who Block Electronic Health Information On Oct. 30, the Centers for Medicare and Medicaid Services released a proposed rule that would establish disincentives for healthcare providers who knowingly interfere with the access, exchange or use of electronic health information except when required by law or regulatory exception. The proposed rule would:

• Under the Medicare Promoting Interoperability Program, penalize hospitals that block information by reducing their annual market basket increase by 75 percent and reducing a critical access hospital’s payment to 100 percent of reasonable costs;
• Under the Merit-based Incentive Payment System Promoting Interoperability performance category, penalize clinicians or groups by awarding them a zero score for the category; and
• Under the Medicare Shared Savings Program, penalize accountable care organizations (ACO) and ACO participants, providers or suppliers by deeming them ineligible to participate in the program for at least one year.

Public comments will be accepted until Jan. 2, 2024. For more information, click here. CMS Proposes Rule Regarding Federal IDR Process On Oct. 27, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule that would amend requirements for the federal independent dispute resolution (IDR) process. The proposed rule would:

• Require group health plans and insurers to provide additional information at the time of an initial payment or notice of denial of payment for certain items and services covered by surprise billing protections;
• Implement changes to the IDR open negotiation process to incentivize stronger communication between disputing parties;
• Revise the process for initiating the federal IDR process; and
• Modify requirements related to IDR dispute eligibility review and the payment and collection of administrative and certified IDR entity fees.

In addition to CMS, the Employee Benefits Security Administration and Internal Revenue Service are proposing the rule. Public comments will be accepted until Jan. 2, 2024. For more information, click here. FDA Proposes Rule Regarding Classification of Wound Dressings and Washes On Nov. 30, the Food and Drug Administration (FDA) released a proposed rule that would classify certain types of wound dressings and liquid wound washes containing antimicrobials and other chemicals, as solid wound dressings. The FDA currently regulates gel, cream, ointment and liquid wound dressings and washes as unclassified devices requiring premarket notification. Under the proposed rule, the FDA would classify wound dressings and liquid wound washes with a high level of antimicrobial resistance concern as Class III medical devices. In addition, wound dressings and washes with a medium or low level of antimicrobial resistance would be classified as Class II medical devices. Public comments will be accepted until Feb. 28, 2024. For more information, click here.

Final Rules

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

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

The final rule complements a final guidance the FDA issued in June that outlined how advertisers should present quantitative efficacy and risk information in DTC promotional labeling and ads. The final rule will go into effect on May 20, 2024. The compliance date of the rule is Nov. 20, 2024. For more information, click here. CMS Final Rule Implements Nursing Home Ownership and Management Disclosure Requirements On Nov. 15, the Centers for Medicare and Medicaid Services released a final rule that implements stricter ownership and management disclosure and reporting requirements for nursing homes enrolled in Medicare or Medicaid. The final rule will require nursing homes to:

• Disclose additional information regarding their owners, operators and management, specifically the individuals and entities that provide administrative services or clinical consulting services to the nursing home;
• Disclose entities that exercise financial control over the facility;
• Report the names of individuals or entities that lease or sublease property to the facility, or who own a whole or part interest equal to or exceeding 5 percent of the total value of such real property; and
• Provide information on the organizational structures of disclosed parties.

In addition, the final rule defines a private equity and real estate investment trust and finalizes definitions to assist nursing homes in collecting the requested data. The final rule will go into effect on Jan. 16, 2024. For more information, click here. CMS Final Rule Outlines Remedy for 340B Payment Cuts Deemed Unlawful Between CYs 2018-2022 On Nov. 2, the Centers for Medicare and Medicaid Services (CMS) released a final rule that outlines how it will pay back hospitals that participate in the 340B Drug Pricing Program and were impacted by payment cuts between calendar years (CYs) 2018 and 2022, which were deemed unlawful. The final rule clarifies that:

• CMS will repay impacted 340B hospitals in a single lump-sum payment equal to the difference in what CMS paid hospitals for 340B drugs between CYs 2018-2022 and the amount they would have paid if the payment cuts had not been implemented; and
• CMS will establish a policy to recoup funds from hospitals that received higher rates for non-drug services. CMS intends to achieve this by annually adjusting the outpatient prospective payment system conversion factor by minus 0.5 percent beginning in CY 2026 until the full amount is offset. This is projected to take 16 years.

The final rule will go into effect on Jan. 7, 2024. For more information, click here. CMS Final Rule Updates 2024 Medicare Physician Fee Schedule On Nov. 2, the Centers for Medicare and Medicaid Services released a final rule that updates the Medicare Physician Fee Schedule (PFS) payment rates for calendar year 2024. The final rule will:

• Decrease the PFS conversion factor by 3.4 percent from $33.89 to $32.74;
• Decrease overall PFS payment rates by 1.25 percent;
• Finalize separate coding and payment for new caregiver and health equity services;
• Allow eligible marriage and family therapists and addiction counselors to enroll in Medicare starting Jan. 1, 2024;
• Allow payments to be made for certain dental services linked to specific cancer treatments; and
• Enhance the Medicare Diabetes Prevention Program (MDPP) Expanded Model and allow MDPP suppliers to continue using COVID-19 public health emergency flexibilities and offer services virtually through Dec. 31, 2027.

The final rule will go into effect on Jan. 1, 2024. For more information, click here. CMS Final Rule Updates 2024 Hospital OPPS and ASC Payment System On Nov. 2, the Centers for Medicare and Medicaid Services released a final rule that updates the hospital outpatient prospective payment system (OPPS) and the ambulatory surgical center (ASC) payment system for calendar year 2024. It also finalizes changes to the Hospital Outpatient Quality, ASC Quality and Rural Emergency Hospital Quality reporting programs. The final rule will:

• Increase hospital OPPS and ASC payment rates by 3.1 percent, based on an inpatient hospital market basket percentage increase of 3.3 percent and a 0.2 percent reduction in the final productivity adjustment;
• Modify and adopt new quality reporting measures;
• Establish payments for intensive outpatient program services under Medicare;
• Update payment rates for partial hospitalization program services;
• Modify community mental health center conditions of participation; and
• Establish the Rural Emergency Hospital (REH) provider type.

The final rule will go into effect on Jan. 1, 2024. For more information, click here. CMS Final Rule Updates 2024 Home Health Prospective Payment System On Nov. 1, the Centers for Medicare and Medicaid Services released a final rule that updates payment policies and rates for Medicare Home Health Agencies for calendar year 2024. It also finalizes changes to the Home Health Quality Reporting and Value-based Purchasing Programs. The final rule will:

• Increase home health payments by 0.8 percent, based on a projected 3.0 percent increase in home health payments, a 2.6 percent decrease in the permanent behavior assumption adjustment and a 0.4 percent increase in the fixed-dollar ratio for outlier payments adjustment;
• Implement a permanent prospective payment adjustment of minus 2.89 percent;
• Increase the home health market basket percentage by 3.0 percent;
• Establish an informal dispute resolution and special focus program for hospice programs; and
• Add new and updated quality reporting measures.

The final rule will go into effect on Jan. 1, 2024. For more information, click here. CMS Final Rule Updates 2024 ESRD Prospective Payment System On Oct. 27, the Centers for Medicare and Medicaid Services released a final rule that updates the payment policies and rates for the end-stage renal disease (ESRD) prospective payment system (PPS) for renal dialysis services covered under Medicare for calendar year (CY) 2024. It also updates the acute kidney injury dialysis payment rate and requirements for the ESRD Quality Incentive Program. The final rule will:

• Increase the ESRD PPS base rate by 2.1 percent to $271.02;
• Implement new ESRD PPS claims reporting requirements;
• Finalize a new transitional add-on pediatric ESRD dialysis payment adjustment for CYs 2024, 2025 and 2026;
• Discuss the responses CMS received to a request for information it issued related to a low-volume payment adjustment; and
• Implement a payment adjustment for new renal dialysis drugs and biological products after the Transitional Drug Add-on Payment Adjustment (TDAPA) period.

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

Courts

U.S. Supreme Court Hears Purdue Pharma Case On Dec. 5, the U.S. Supreme Court heard Harrington v. Purdue Pharma, which will decide whether to allow a multibillion-dollar bankruptcy plan for Purdue Pharma to move forward. At stake is a settlement in which the Sackler family would pay up to $6 billion over 18 years, with $4.5 billion in the first nine years. Overall, the opioid settlement would end with Purdue Pharma paying $1.2 billion and the assets of the company being transferred to a new entity that would be owned by creditors, making addiction treatment and opioid reversal medicines available for no profit. The federal government is seeking to block the plan because it releases the Sackler family from civil liability for opioid-related claims. The plan is supported by state and local governments and victims of the opioid crises because they see it as the way to ensure they receive compensation and funding for opioid recovery projects. The company filed for bankruptcy in 2019. In September 2021, the bankruptcy court confirmed a plan to convert Purdue Pharma to a nonprofit devoted to addressing the problems created by the opioid epidemic. The Sackler family agreed to contribute up to $6 billion to the plan. The provisions of the plan would shield them from future civil liability for opioid-related claims. A federal district court struck down the bankruptcy court’s ruling, but a federal appeals court reinstated it earlier this year. In August, the Department of Justice requested the Supreme Court put the plan on hold and for the Court to hear arguments.

Reports

GAO Releases Report Regarding Federal Agency Cybersecurity Incident Response Preparedness On Dec. 4, the Government Accountability Office (GAO) released a report concerning the progress federal agencies have made in preparing for and responding to cybersecurity threats. The GAO was interested in understanding the challenges agencies encountered when implementing improvements to their response capabilities. After interviewing officials and reviewing documentation from the Office of Management and Budget, the Cybersecurity and Infrastructure Security Agency and federal agencies, the GAO discovered that agencies have been unable to fully improve their response capabilities due to staff shortages, event logging technical challenges and cyber threat information-sharing limitations. For more information, click here.

CBO Cost Estimates

CBO Releases Cost Estimate of Lower Costs, More Transparency Act On Dec. 8, the Congressional Budget Office (CBO) released a cost estimate of H.R. 5378, the Lower Costs, More Transparency Act. The legislation would implement site-neutral payments for off-campus hospital outpatient departments, extend funding for health programs, ban pharmacy benefit manager spread pricing and require hospitals to publish the prices they charge for services. The CBO projects that the bill would reduce the federal deficit by $715 million over the 2024-2033 period. For more information, click here.