This Week in Washington: Senate Finance Committee reports out Better Mental Health Care, Lower-Cost Drugs and Extenders Act; Senate confirms NIH Director; House Speaker Proposes Laddered Continuing Resolution.

Upcoming Hearings

Congress

House

• House Speaker Proposes Laddered Continuing Resolution
• House Ways and Means Committee Chairman Sends Letter Regarding No Surprises Act Implementation
• House Energy and Commerce Committee Chairmen Threaten to Subpoena SAMHSA Over Use of COVID-19 Supplemental Funds
• House Energy and Commerce Committee Chairmen Threaten to Subpoena FDA Over Risky Virus and Biological Agent Research
• House Members Send Letter Concerning Use of AI in Prior Authorization

Senate

• Senate Finance Committee Reports Out Better Mental Health Care, Lower-Cost Drugs and Extenders Act
• Senate Finance Committee Chairman and Ranking Member Send Letter Concerning Federal Agency Use of AI
• Senate Confirms NIH Director

Administration

• CMS Releases Guidance Regarding Optional State Medicaid and CHIP Application SOGI Questions
• CMS Releases Guidance on Medicaid and CHIP Managed Care Programs
• CMS Releases Fact Sheet on MA, Prescription Drug Benefit Program and PACE Proposed Rule
• CMS Releases Fact Sheet on 2024 Medicare PFS Final Rule
• CMS Publishes Blog Post Regarding Behavioral Health Services
• FDA Approves First Vaccine for Chikungunya Virus
• FDA Approves First Treatment for Congenital Thrombotic Thrombocytopenic Purpura
• FDA Approves First OTC COVID-19 Antigen Home Test
• FDA Approves Weight Management Medication
• FDA Issues Warning Regarding Saline and Sterile Water Medical Products
• FDA Authorizes Marketing of Pediatric Automated Glycemic Controller

Proposed Rules

• 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 Laboratory Developed Tests
• FDA Proposes Rule to Broaden Prescription Drug Labeling Regulations

Final Rules

• 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 Streamlines Medicare Savings Program Enrollment Process
• 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 on Condition of Indian Health Service Facilities
• GAO Releases Report on CDC Funding for Public Health Infrastructure

CBO Cost Estimates

• CBO Releases Cost Estimate on Better Mental Health Care, Lower-Cost Drugs, and Extenders Act and Modernizing and Ensuring PBM Accountability Act Provisions

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Upcoming Hearings

Senate

Nov. 14

Senate Finance Committee Subcommittee on Health Care Hearing: “Ensuring Medicare Beneficiary Access: A Path to Telehealth Permanency”
2:30, Dirksen Senate Office Building 215
Announced witnesses are:

• Nicki Perisho, BSN, R.N., Principal Investigator and Program Director of the Northwest Regional Telehealth Resource Center
• Eric Wallace, M.D., FASN, Professor of Medicine and Medical Director at UAB EMedicine, Co-Director of Home Dialysis and Director of the Division of Nephrology Rare Kidney Disease Clinic at the UAB Department of Medicine
• Chad Ellimoottil, M.D., M.S., Associate Professor and Medical Director of Virtual Care at the University of Michigan
• Ateev Mehrota, M.D., MPH, Professor of Health Care Policy at the Harvard Medical School Department of Health Care Policy

Nov. 15

Senate Committee on Veterans’ Affairs Full Committee Hearing: “VA’s Fourth Mission: Supporting Our Nation’s Emergency Preparedness and Response”
3:30 p.m., Russell Senate Office Building 418
Witnesses to be announced.

House

Nov. 14

House Committee on Veterans’ Affairs Subcommittee on Health Oversight Hearing: “Emerging Therapies: Breakthroughs in the Battle Against Suicide?”
2:00 p.m., Cannon House Office Building 360
Announced witnesses are:

• Carolyn Clancy, M.D., Assistant Under Secretary for Health at the U.S. Department of Veterans Affairs Office of Discovery, Education and Affiliate Networks
• Ilse Wiechers, M.D., Deputy Executive Director of the U.S. Department of Veterans Affairs Office of Mental Health and Suicide Prevention
• Rachel Yehuda, Ph.D., Patient Care Center Director at the U.S. Department of Veterans Affairs Bronx Veterans Affairs Medical Center
• Jonathan M. Lubecky, U.S. Army SGT (Ret.), Veteran Clinical Trial Participant
• Frederick Barrett, Ph.D., Associate Professor of Psychiatry and Behavior Sciences at the Johns Hopkins Center for Psychedelic and Consciousness Research
• Mike Mullette, Chief Operating Officer of the Multidisciplinary Association for Psychedelic Studies – Public Benefit Corporation (MAPS PBC)
• Rajeev Ramchand, Ph.D, Co-Director of the RAND Epstein Family Veterans Policy Research Institute
• Brett Waters, Co-Founder and Executive Director of the Reason for Hope and Veteran Mental Health Leadership Coalition
• Juliana Mercer, USMC (Ret.), Director of Veteran Advocacy and Public Policy at Healing Breakthrough

Nov. 15

House Committee on Veterans’ Affairs Subcommittee on Technology Modernization Oversight Hearing: “Electronic Health Record Modernization Deep Dive: System Uptime”
12:00 p.m., Cannon House Office Building 360
Witnesses to be announced.

Congress

House

House Speaker Proposes Laddered Continuing Resolution

With the expiration of the current continuing resolution (CR) set for Friday, Speaker Johnson has floated a “laddered” CR. The first part of the CR would extend at current levels funding for Agriculture, Military Construction-VA, Energy-Water and Transportation-HUD appropriations until Jan. 19. The second part of the CR would fund at current levels all other appropriations until Feb. 2. The proposal does not provide funding for Ukraine or Israel.

The House Rules Committee is expected to consider the legislation this afternoon. If the proposal makes it through the Rules Committee, a floor vote is expected on Tuesday.

House Ways and Means Committee Chairman Sends Letter Regarding No Surprises Act Implementation

On Nov. 9, House Ways and Means Committee Chairman Jason Smith (R-MO) led Republican committee members in sending letters to Department of Health and Human Services Secretary Xavier Becerra, Department of Treasury Secretary Janet Yellen and Department of Labor Acting Secretary Julie Su concerning the implementation of the No Surprises Act.

The Chairman and members are concerned that the agencies have not initiated rulemaking related to Advanced Explanation of Benefits for health plans and have not yet enforced independent dispute resolution patient protections. On Sept. 19, the committee held a hearing to discuss challenges surrounding the bill’s implementation and on Oct. 18, the committee held a roundtable with federal officials to evaluate the status of the bill’s implementation among federal agencies.

For more information, click here.

House Energy and Commerce Committee Chairmen Threaten to Subpoena SAMHSA Over Use of COVID-19 Supplemental Funds

On Nov. 1, 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 Substance Abuse and Mental Health Services Administration (SAMHSA) Assistant Secretary and Administrator Miriam Delphin-Rittmon, warning that the committee could subpoena SAMHSA if it fails to provide information regarding the use of COVID-19 supplemental funds.

The chairmen are requesting that SAMHSA provide state payment management system and federal financial reports for programs that received supplemental funds including those related to certified community behavioral health clinics, suicide prevention programs, 9-8-8 crisis care services and the Substance Use Prevention, Treatment and Recovery Services Block Grant.

For more information, click here.

House Energy and Commerce Chairmen Threaten to Subpoena FDA Over Risky Virus and Biological Agent Research

On Nov. 9, 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 Food and Drug Administration (FDA) Commissioner Robert Califf, warning that the committee could subpoena the FDA if it does not provide documents regarding research on risky viruses and biological agents conducted at FDA facilities.

The committee has been investigating the origins of the COVID-19 pandemic and federal laboratory biosafety protocols since earlier this year and sent letters to the FDA in March and June requesting information on gain-of-function studies.

For more information, click here.

House Members Send Letter Concerning Use of AI in Prior Authorization

On Nov. 3, Rep. Chu (D-CA) led 31 Democratic representatives in sending a letter to Centers for Medicare and Medicaid Services (CMS) Administrator Chiquita Brooks-LaSure regarding the use of artificial intelligence (AI) tools by Medicare Advantage (MA) plan issuers when making prior authorization coverage decisions.

The members are concerned that the use of AI tools during the prior authorization process is resulting in more frequent and repeated denials of care and they are calling on CMS to strengthen its oversight and monitoring of MA plans’ use of such tools. They are also urging CMS to implement stricter prior authorization reporting requirements.

For more information, click here.

Senate

Senate Finance Committee Reports Out Better Mental Health Care, Lower-Cost Drugs and Extenders Act

On Nov. 8, the Senate Finance Committee marked up and reported out of committee the Better Mental Health Care, Lower-Cost Drugs and Extenders Act. 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 set to expire.

The legislation would also implement new disclosure requirements for Medicare Advantage (MA) plans. MA plans would be required to publicly display provider directory information on a website starting in 2026, which would need to be updated every 90 days. They would also be required to submit annual reports of the accuracy of these directories to the Department of Health and Human Services.

To read the Chairman’s Mark of the bill, click here.

For more information, click here.

Senate Finance Committee Chairman and Ranking Member Send Letter Concerning Federal Agency Use of AI

On Nov. 8, Senate Finance Committee Chairman Ron Wyden (D-OR) and Ranking Member Mike Crapo (R-ID) sent a letter to Department of Homeland Security (DHS) Secretary Alejandro Mayorkas and Customs and Border Protection (CBP) Acting Commissioner Troy Miller regarding the agencies’ use of artificial intelligence (AI) technology.

The Chairman and Ranking Member are concerned that the use of AI is resulting in unsafe and biased outcomes and are requesting that the agencies provide information on whether any safety guardrails have been implemented. On Oct. 5, the Chairman and Ranking Member sent a letter to Department of Health and Human Services (HHS) Secretary Xavier Becerra requesting information on HHS’ implementation of AI tools.

To read the letter to DHS and CBP, click here.

To read the letter to HHS, click here.

Senate Confirms NIH Director

On Nov. 7, the Senate confirmed Dr. Monica Bertagnolli to be the next director of the National Institutes of Health on a 62-36 vote. Fourteen Republican senators joined Democrats in voting to confirm Dr. Bertagnolli.

Administration

CMS Releases Guidance Regarding Optional State Medicaid and CHIP Application SOGI Questions

On Nov. 9, the Centers for Medicare and Medicaid Services released an informational bulletin outlining the steps that states should take if they wish to incorporate optional sexual orientation and gender identity (SOGI) questions on Medicaid and Children’s Health Insurance Program applications.

For more information, click here.

CMS Releases Guidance on Medicaid and CHIP Managed Care Programs

On Nov. 7, the Centers for Medicare and Medicaid Services released an informational bulletin intended to inform Medicaid and Children’s Health Insurance Program stakeholders of updates made to the managed care program reporting requirements, web-based reporting portal, rate certifications and contract review and approval process.

For more information, click here.

CMS Releases Fact Sheet on MA, Prescription Drug Benefit Program and PACE Proposed Rule

On Nov. 6, the Centers for Medicare and Medicaid Services released a fact sheet on a proposed rule it released that would amend regulations pertaining to the Medicare Advantage (MA), Prescription Drug Benefit, Medicare Cost Plan and Programs of All-Inclusive Care for the Elderly programs.

The proposed rule seeks to improve access to behavioral health service providers, strengthen MA supplemental benefits and restrict MA plan marketing payment practices.

For more information, click here.

CMS Releases Fact Sheet on 2024 Medicare PFS Final Rule

On Nov. 2, the Centers for Medicare and Medicaid Services published a fact sheet on a final rule it released concerning the calendar year (CY) 2024 Medicare Physician-Fee-Schedule (PFS), which will cut physician payments by 3.4 percent.

The Senate Finance Committee has been working towards addressing cuts to the Medicare PFS. On Nov. 8, the committee reported out legislation that would increase PFS payments for certain behavioral health integration service providers beginning in CY 2026 and increase PFS payments by 1.25 percent in CY 2024.

For more information, click here.

CMS Publishes Blog Post Regarding Behavioral Health Services

On Nov. 6, the Centers for Medicare and Medicaid Services published a blog post outlining how final rules it released regarding the Medicare physician-fee schedule and outpatient prospective payment system seek to improve access to behavioral health services and support the behavioral health workforce.

For more information, click here.

FDA Approves First Vaccine for Chikungunya Virus

On Nov. 9, the Food and Drug Administration approved Ixchiq, the first vaccine formulated to target the chikungunya virus, a mosquito-borne virus that can cause severe disease and chronic joint pain. Ixchiq is approved for individuals 18 years and older who are at high risk of exposure to the virus.

For more information, click here.

FDA Approves First Treatment for Congenital Thrombotic Thrombocytopenic Purpura

On Nov. 9, the Food and Drug Administration approved Adzynma, the first treatment for adult and pediatric patients with congenital thrombotic thrombocytopenic purpura (cTTP). cTTP is a rare blood disorder that causes blood clots in small blood vessels. Adzynma is a recombinant protein product intended to be used for cTTP prophylactic and on-demand enzyme replacement therapy.

For more information, click here.

FDA Approves First OTC COVID-19 Antigen Home Test

On Nov. 9, the Food and Drug Administration approved ACON Laboratories’ Flowflex COVID-19 Antigen Home Test. Flowflex received authorization for emergency use in 2021 and is now the first over-the-counter COVID-19 antigen test to be cleared for marketing.

For more information, click here.

FDA Approves Weight Management Medication

On Nov. 8, the Food and Drug Administration approved Zepbound (tirzepatide), an injectable medication used for chronic weight management in obese or overweight adults who have one weight-related condition. Zepbound is intended to be used in combination with a reduced calorie diet and increased physical activity.

For more information, click here.

FDA Issues Warning Regarding Saline and Sterile Water Medical Products

On Nov. 6, the Food and Drug Administration issued a warning to consumers, healthcare providers and facilities, urging them not to use saline and sterile water medical products manufactured by Nurse Assist, LLC, due to contamination risk. Nurse Assist, LLC, has issued a recall for its 0.9% Sodium Chloride Irrigation USP and Sterile Water for Irrigation USP products.

For more information, click here.

FDA Authorizes Marketing of Pediatric Automated Glycemic Controller

On Nov. 3, the Food and Drug Administration authorized the marketing of the Control-IQ Technology automated glycemic controller. The controller is intended to be used in combination with integrated continuous glucose monitors and controlled-enabled insulin pumps for type 1 diabetics ages 2 and older.

Proposed Rules

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 Laboratory Developed Tests

On Sept. 29, the Food and Drug Administration (FDA) released a proposed rule that would amend regulations and classify in vitro diagnostic products (IVDs) as medical devices under the Federal Food, Drug and Cosmetic (FD&C) Act. The proposed rule also clarifies that the FDA will phase out the general enforcement discretion approach for laboratory developed tests (LDTs) and states that LDTs will fall under the same enforcement approach as other IVDs.

Public comments will be accepted until Dec. 1, 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.

Final Rules

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 Streamlines Medicare Savings Program Enrollment Process

On Sept. 19, the Centers for Medicare and Medicaid Services (CMS) released a final rule that would streamline enrollment into the Medicare Savings Program (MSP) and align it with other public program requirements and processes. It would:

• Automatically enroll the majority of Supplemental Security Income (SSI) recipients into the Qualified Medicare Beneficiary eligibility group;
• Require states to use Medicare Part D low-income subsidy (LIS) program data when making QMP eligibility determinations;
• Eliminate duplicative paperwork; and
• Reduce the cost of prescription drugs.

The final rule will go into effect on Nov. 17, 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 on Condition of Indian Health Service Facilities

On Nov. 8, the Government Accountability Office (GAO) released a report on the state of Indian Health Service (IHS) facilities. The GAO reviewed IHS facilities and equipment and asked IHS officials about the challenges they face.

The GAO discovered that 61 percent of IHS facilities are in fair or poor condition and lack adequate space for modern healthcare delivery needs. The GAO also discovered that funding constraints and workforce staffing shortages are making it difficult for IHS officials to improve facilities. The GAO conducted this study because it was asked to review IHS’ facilities and equipment and how they impact the provision of healthcare.

For more information, click here.

GAO Releases Report on CDC Funding for Public Health Infrastructure

On Nov. 7, the Government Accountability Office (GAO) released a report highlighting the need for continued federal support of public health infrastructure in states, localities and territories. The GAO was interested in understanding the challenges jurisdictions face in maintaining public health infrastructure.

After analyzing Centers for Disease Control and Prevention data on public health infrastructure funds and interviewing stakeholder groups, the GAO discovered that jurisdictions are concerned about how they will be able to support public health infrastructure without temporary COVID-19 public health emergency funds. The GAO conducted this study because it was directed to report on the federal response to the COVID-19 pandemic by a provision in the Coronavirus Aid, Relief, and Economic Security Act.

For more information, click here.

CBO Cost Estimates

CBO Releases Cost Estimate on Better Mental Health Care, Lower-Cost Drugs, and Extenders Act and Modernizing and Ensuring PBM Accountability Act Provisions

On Nov. 6, the Congressional Budget Office (CBO) released a cost estimate of the Better Mental Health Care, Lower-Cost Drugs, and Extenders Act and certain provisions included in the Modernizing and Ensuring PBM Accountability Act.

The CBO predicts that the bills will collectively decrease budget authority by $866 million and will increase estimated outlays by $3.1 billion between fiscal years (FYs) 2024 and 2028 but will have no effect on direct spending by FY 2033.

For more information, click here.