This Week in Washington: House Energy and Commerce subcommittees look at role of AI and CDC respiratory disease preparedness; FDA releases final rule on prescription drug advertisements.

Congress

House

• House Energy and Commerce Committee Oversight and Investigations Subcommittee Holds Hearing on CDC Respiratory Disease Preparedness
• House Energy and Commerce Committee Subcommittee on Health Holds Hearing on Role of AI in Healthcare
• House Energy and Commerce Committee Chairmen Send Letter Regarding Rise of Respiratory and Pneumonia Cases in China

Senate

• Senators Send Letter Concerning Attempts by Insurers to Evade Medical Loss Ratio Requirement
• Senate Majority Whip Sends Letter Regarding New Medicare Coverage for Dental Care Services
• Senate HELP Committee Chairman Announces Hearing on Prescription Drug Costs
• Senate Finance Committee Chairman Announces Hearing on Prescription Drug Shortages

Administration

• White House to Broaden HHS Authority to Strengthen Medical Supply Chain
• HHS Announces Extension of Two Federal IDR Process Flexibilities
• HHS Issues Notice Regarding Cybersecurity Vulnerability
• HHS OIG Releases Fall 2023 Semiannual Report to Congress
• HHS OIG Releases Report on Improper MCO Capitation Payments
• HHS OIG Issues Alert Concerning Remote Patient Monitoring Fraud Scheme
• ASPR Announces Partnership to Distribute Free COVID-19 Tests in Schools
• CMS Releases State Health Official Letter Outlining Mandatory Medicaid and CHIP Reporting Requirements
• CMS Extends MCP Model Application Deadline
• FDA Announces Next Principal Deputy Commissioner
• FDA Announces Joint Public Meeting on Improving Quality of Clinical Studies
• FDA Approves First Desmoid Tumor Therapy
• FDA Issues Guidance Regarding COVID-19 Drug and Biological Product Development
• FDA Issues Final Guidance Regarding Section 506J Device Manufacturing Disruptions

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

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 Specifies When and How CMS Imposes Civil Money Penalties
• 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

Reports

• GAO Releases Report Regarding CMS Plan to Include Phosphate Binders in ESRD Bundled Payments

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Congress

House

House Energy and Commerce Committee Oversight and Investigations Subcommittee Holds Hearing on CDC Respiratory Disease Preparedness

On Nov. 30, the House Energy and Commerce Committee Oversight and Investigations Subcommittee held a hearing to discuss Centers for Disease Control and Prevention (CDC) readiness and preparedness plans for future public health crises and the spread of influenza, COVID-19 and respiratory syncytial virus.

The subcommittee also evaluated efforts the CDC has taken to resolve decision-making, health department coordination and data collection and analysis challenges it experienced during the COVID-19 pandemic. Witnesses included:

• The Honorable Mandy Cohen, M.D., Director of the Centers for Disease Control and Prevention

For more information, click here.

House Energy and Commerce Committee Subcommittee on Health Holds Hearing on Role of AI in Healthcare

On Nov. 29, the House Energy and Commerce Committee Subcommittee on Health held a hearing to discuss how artificial intelligence (AI) is being implemented in medical devices, and how it could reduce administrative burden for physicians. The subcommittee also discussed the risks and benefits of using AI technology and the implications it could have on patient and consumer data privacy, cybersecurity and drug development. Witnesses included:

• Michael Schlosser, M.D., MBA, Senior Vice President of Care Transformation and Innovation at HCA Healthcare
• Benjamin Nguyen, Senior Product Manager at Transcarent
• Peter Shen, Head of Digital Health in North America for Siemens Healthineers
• Christopher Longhurst, M.D., Chief Medical Officer, Chief Digital Officer and Association Dean at UC San Diego Health
• David Newman-Toker, M.D., Ph.D., Professor of Neurology and Director of the Johns Hopkins University School of Medicine Department of Neurology Division of Neuro-Visual and Vestibular Disorders

For more information, click here.

House Energy and Commerce Committee Chairmen Send Letter Regarding Rise of Respiratory and Pneumonia Cases in China

On Nov. 29, 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 in response to the rise of respiratory disease and pneumonia cases in China. The chairmen are requesting that the CDC provide information on any communications it has had with Chinese health officials and federal agencies concerning the recent virus outbreak.

For more information, click here.

Senate

Senators Send Letter Concerning Attempts by Insurers to Evade Medical Loss Ratio Requirement

On Nov. 22, Sens. Warren (D-MA) and Braun (R-IN) sent a letter to Department of Health and Human Services (HHS) Inspector General Christi Grimm, requesting that the HHS Office of Inspector General investigate whether health insurance companies, including Cigna, CVS, Aetna and United Health Group, are attempting to evade the Medical Loss Ratio (MLR) statutory requirement by increasing the cost of generic drug prices at specialty pharmacies that they own. The MLR requires insurance companies to spend a minimum of 80 or 85 percent of consumers’ premium dollars on medical claims and quality improvements.

The senators are concerned over the findings of a report that revealed that insurers are charging significantly more for generic drugs dispensed by specialty pharmacies they own compared to generic drugs dispensed by independent pharmacies.

For more information on the letter, click here.

Senate Majority Whip Sends Letter Regarding New Medicare Coverage for Dental Care Services

On Nov. 28, Senate Majority Whip Dick Durbin (D-IL) sent a letter to Centers for Medicare and Medicaid Services (CMS) Administrator Chiquita Brooks-LaSure, urging CMS to notify states about changes made to Medicare coverage and billing practices for oral healthcare services in the 2024 Medicare Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment System final rule.

In addition, the majority whip is requesting that the CMS Medicaid Director send a letter to states to encourage them to expand coverage and billing practices for dental care services for Medicaid enrollees.

For more information, click here.

Senate HELP Committee Chairman Announces Hearing on Prescription Drug Costs

On Nov. 21, Senate Health, Education, Labor and Pensions (HELP) Committee Chairman Bernie Sanders (I-VT) announced that the HELP committee will hold a hearing on Jan. 25 to discuss the cost of prescription drugs. The hearing will focus on the impacts high prescription drug prices are having on public health.

For more information, click here.

Senate Finance Committee Chairman Announces Hearing on Prescription Drug Shortages

On Nov. 21, Senate Finance Committee Chairman Ron Wyden (D-OR) announced that the Finance committee will hold a hearing on prescription drug shortages on Dec. 5. The committee will examine supply chain challenges and impacts and will discuss potential policy solutions. Announced witnesses are:

• 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.

Administration

White House to Broaden HHS Authority to Strengthen Medical Supply Chain

On Nov. 27, the White House announced that the president will issue a presidential determination to broaden the Department of Health and Human Services’ (HHS) authorities under Title III of the Defense Production Act, so it can increase investments in manufacturing of essential medicines, medical countermeasures and inputs deemed essential to national defense.

In addition, HHS will be required to designate a new Supply Chain Resilience and Shortage Coordinator to enhance critical medical product and food supply chain resilience.

For more information, click here.

HHS Announces Extension of Two Federal IDR Process Flexibilities

On Nov. 22, the Department of Health and Human Services, in addition to the Departments of Labor and Treasury, announced that two flexibilities concerning the federal independent dispute resolution (IDR) process will be extended.

Through Jan. 16, disputing parties may request additional time beyond the current five-day deadline to respond to an IDR entity’s request for information and IDR entities may provide parties an additional 10 business days to submit an offer beyond the original offer deadline.

HHS Issues Notice Regarding Cybersecurity Vulnerability

On Dec. 1, the Department of Health and Human Services Health Sector Cybersecurity Coordination Center issued a notice regarding an ongoing cybersecurity vulnerability impacting NetScaler ADC and NetScaler Gateway software.

For more information, click here.

HHS OIG Releases Fall 2023 Semiannual Report to Congress

On Dec. 1, the Department of Health and Human Services Office of Inspector General (HHS OIG) released its Fall 2023 Semiannual Report to Congress. The report highlights audits and investigations the HHS OIG has conducted in 2023, and reports it has issued concerning improper Medicare payments, nursing home reporting inaccuracies and Food and Drug Administration enforcement actions against tobacco retailers.

For more information, click here.

HHS OIG Releases Report on Improper MCO Capitation Payments

On Nov. 29, the Department of Health and Human Services Office of Inspector General (HHS OIG) released a report regarding capitation payments that were improperly made to managed care organizations (MCOs) on behalf of deceased Medicaid enrollees. The HHS OIG discovered that approximately $318 million in improper payments were made by states to MCOs between July 2009 and Dec. 2019.

For more information, click here.

HHS OIG Issues Alert Concerning Remote Patient Monitoring Fraud Scheme

On Nov. 22, the Department of Health and Human Services Office of Inspector General (HHS OIG) issued a consumer alert concerning a remote patient monitoring fraud scheme. The HHS OIG has discovered scammers who are signing up Medicare enrollees for remote patient monitoring and billing them monthly for services that are unnecessary or never provided.

For more information, click here.

ASPR Announces Partnership to Distribute Free COVID-19 Tests in Schools

On Nov. 29, the Administration for Strategic Preparedness and Response announced that it had formed a partnership with the Department of Education to distribute free COVID-19 tests to schools across the country. The tests will be made freely available to traditional and charter learning education agencies nationwide.

For more information, click here.

CMS Releases State Health Official Letter Outlining Mandatory Medicaid and CHIP Reporting Requirements

On Dec. 1, the Centers for Medicare and Medicaid Services released a state health official letter that outlines mandatory reporting requirements for the Medicaid and Children’s Health Insurance Program (CHIP) that were included in the Mandatory Medicaid and CHIP Core Set Reporting final rule, which was released on Aug. 31.

The letter includes guidance on data reporting and compliance requirements, stratification categories, attribution rules, a State Plan Amendment and the populations that must be included in reporting.

For more information, click here.

CMS Extends MCP Model Application Deadline

On Nov. 29, the Centers for Medicare and Medicaid Services announced that the application deadline for the Making Care Primary model will be extended to Dec. 14. Applications were originally due Nov. 30.

For more information, click here.

FDA Announces Next Principal Deputy Commissioner

On Nov. 29, Food and Drug Administration (FDA) Commissioner Robert Califf announced that FDA Chief Scientist Dr. Namandjé Bumpus will become the agency’s next principal deputy commissioner following the retirement of Janet Woodcock early next year.

FDA Announces Joint Public Meeting on Improving Quality of Clinical Studies

On Nov. 28, the Food and Drug Administration announced that it will host a joint public meeting with Duke-Margolis that will focus on how the quality of clinical studies could be improved. The meeting will be held on Jan. 31 and will highlight the barriers and best practices of quality by design and risk-based monitoring clinical study approaches.

For more information, click here.

FDA Approves First Desmoid Tumor Therapy

On Nov. 27, the Food and Drug Administration approved Ogsiveo (nirogacestat), a tablet used to treat patients with desmoid tumors. Ogsiveo was approved after a double-blind, placebo-controlled trial demonstrated the drug provided clinically meaningful and statistically significant improvement in progression-free survival compared to a placebo.

For more information, click here.

FDA Issues Guidance Regarding COVID-19 Drug and Biological Product Development

On Nov. 22, the Food and Drug Administration (FDA) issued guidance regarding the development of COVID-19 drug and biological products. The guidance outlines FDA recommendations on how stakeholders should consider phase 2 and 3 drug trial design and population, efficacy endpoints and safety and statistical considerations.

For more information, click here.

FDA Issues Final Guidance Regarding Section 506J Device Manufacturing Disruptions

On Nov. 17, the Food and Drug Administration (FDA) issued final guidance that clarifies how device manufacturers should report a permanent discontinuance or interruption in the production of a Section 506J device that could lead to a supply shortage. In addition, the FDA issued draft guidance that outlines proposed changes to the language of Sections III and IV of the final guidance.

For more information on the final guidance, click here.

For more information on the draft guidance, 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.

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 Specifies When and How CMS Imposes Civil Money Penalties

On Oct. 11, the Centers for Medicare and Medicaid Services (CMS) released a final rule that specifies how and when it will calculate and impose civil money penalties (CMPs) when group and non-group health plan responsible reporting entities (RREs) fail to meet their Medicare Secondary Payer (MSP) reporting requirements. It also outlines CMP amounts and clarifies under which circumstances penalties will and will not be imposed.

The final rule will go into effect on Dec. 11, 2023. 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.

Reports

GAO Releases Report Regarding CMS Plan to Include Phosphate Binders in ESRD Bundled Payments

On Nov. 30, the Government Accountability Office (GAO) released a report regarding a plan by the Centers for Medicare and Medicaid Services (CMS) to include phosphate binders within the bundled payments CMS makes to dialysis organizations beginning in 2025. Phosphate binders are oral drugs used to treat mineral and bone disorders in end-stage renal disease patients.

After interviewing dialysis organization representatives, the GAO found that organizations are concerned that they lack the operational capacity to dispense oral drugs and that the modified bundled payment may not be enough to cover the costs of acquiring, shipping and dispensing phosphate binders. Dialysis organizations will be responsible for dispensing phosphate binders.

For more information, click here.