This Week in Washington: House Republicans release debt ceiling plan, Speaker McCarthy moves forward with proposal that includes Medicaid work requirements

Upcoming Hearings

Congress

House

• Debt Ceiling Text Released
• Pharmacy Benefits Manager Accountability Act Introduced
• Doctors of Community Act Introduced

Senate

• INSULIN Act of 2023 Introduced
• Drug-Price Transparency for Consumers Act Reintroduced
• Senate Finance Committee Releases Legislative Framework to Address PBMs

Administration

• CMS Releases Medicare-Certified Hospice and Home Health Ownership Data
• CMS OMH Releases Disparities in Healthcare in Medicare Advantage Report
• CMS Approves Expansion of Illinois School-Based Health Service Medicaid Funding
• FDA Amends COVID-19 Bivalent Vaccine EUAs
• FDA Exempts Two Categories of Biological Products from Reporting Requirements
• FDA Requests Public Comment on Data and Technology Strategic Plan
• FDA Releases OTC Monograph Order Request Draft Guidance
• FDA Announces Public Meeting on Buprenorphine
• FDA Announces Advisory Committee Meeting to Discuss DMD Therapeutic
• FDA Announces Advisory Committee Meeting to Discuss Alzheimer’s Drug
• HHS Announces Access Program for COVID-19 Vaccines and Treatments
• HHS OCR Announces Expiration of COVID-19 PHE Enforcement Discretion
• SAMHSA Requests Public Comment on 2023-2026 Draft Strategic Plan

Proposed Rules

• HHS OCR Proposed Rule Modifies HIPAA and HITECH Privacy Rule
• HHS ONC Proposed Rule Updates Electronic Health Information Infrastructure
• CMS Proposed Rule Updates Hospital Inpatient and Long-Term Care Hospital PPS Rates
• CMS Proposed Rule Updates Inpatient Psychiatric Facility (IPF) PPS Rates
• CMS Proposed Rule Updates Skilled Nursing Facility PPS Rates
• CMS Proposed Rule Updates Inpatient Rehabilitation Facility PPS Rates
• CMS Releases Hospice Index, Payment Rate and Aggregate Cap Proposed Rule
• FDA Proposes New Tobacco Product Manufacturing Practices Requirements
• CMS Proposed Rule Revises Medicare DSH Section 1115 Waiver Calculation
• CMS Proposes Rule to Clarify Changes to DSH Payment Calculations

Final Rules

• CMS Releases Notice of Benefit and Payment Parameters for 2024 Final Rule
• CMS Finalizes Changes to Medicare Advantage, Part D, Cost Plan and PACE Regulations
• CMS Finalizes 2024 Medicare Advantage and Part C and D Payment Policies
• FDA Issues Final Rule Regarding Mammography Quality Standards
• FDA Delays Tobacco Product Required Warning Final Rule Effective Date
• CMS Issues Correction on Clinical Laboratory Improvement Amendments (CLIA) Final Rule

Reports

• GAO Releases Report Regarding the Exchange of Electronic Health Information
• HHS OIG Report Reveals Inaccuracies in CMS Nursing Home Deficiency Reporting

CBO Cost Estimates

• CBO Releases Reports Regarding Budget Baseline and Primer Development
• CBO Releases Cost Estimate for S. 206, END FENTANYL Act

Upcoming Hearings

April 26

House Appropriations Committee Oversight Hearing: “Provider Relief Fund and Healthcare Workforce Shortages”
10:00 a.m., Rayburn House Office Building 2358C
Announced witnesses are:

• Carole Johnson, Administrator of the Department of Health and Human Services Health Resources and Services Administration

House Energy and Commerce Committee Health Subcommittee Legislative Hearing: “Lowering Unaffordable Costs: Legislative Solutions To Increase Transparency and Competition in Health Care”
10:00 a.m., Rayburn House Office Building 2123
Witnesses to be announced.

House Ways and Means Committee Oversight Subcommittee Hearing: “Hearing on Tax-Exempt Hospitals and the Community Benefit Standard”
2:00 p.m., Longworth House Office Building 1100
Witnesses to be announced.

April 28

House Energy and Commerce Committee Oversight and Investigations Subcommittee Hearing: “Antimicrobial Resistance: Taking on the Next Emerging Public Health Threat”
9:00 a.m., Rayburn House Office Building 2123
Witnesses to be announced.

House

Debt Ceiling Text Released

On April 19, Speaker Kevin McCarthy (R-CA) unveiled the bill text of his proposal for raising the debt ceiling, cutting federal spending and negating some of President Biden’s priorities and initiatives.

The Speaker plans to bring the bill to the House floor for a vote this week even though it is unclear that even with the Republican caucus there are enough votes to pass the proposal. Republicans have 222 votes, and 218 are needed to pass.

The proposal is estimated to save over $4.5 trillion and includes a proposal to require Medicaid work requirements.

Conservative members want deeper cuts and stricter language on work requirements for food stamps, while moderates are concerned about spending cuts that are dead on arrival in the Senate. Some are concerned about cuts to energy tax credits and would oppose stricter language about food stamps.

For more information, click here.

Pharmacy Benefits Manager Accountability Act Introduced

On April 20, Reps. Kuster (D-NH), Carter (R-GA), Eshoo (D-CA) and Guthrie (R-KY) introduced the “Pharmacy Benefits Manager Accountability Act.” The bill would raise reporting requirements for pharmacy benefits managers (PBMs) in an effort to increase transparency in the drug supply chain. The bill will specifically:

• Require PBMs to submit an annual report to employers, health insurers and prescription drug sponsors starting Jan. 1, 2025, detailing which prescription drugs were dispensed by the PBM during the reporting period and outlining each drug’s wholesale acquisition and out-of-pocket costs. The report would also require PBMs to reveal how much they received in drug rebates, fees and alternative discounts, and how much health plan sponsors spent on prescription drugs during the reporting period;
• Require health insurers offering group health insurance coverage or entities providing pharmacy benefits management services to report the practices of pharmacy networks to the Comptroller General of the United States; and
• Strengthen the enforcement powers of the Secretary of the Department of Health and Human Services, the Secretary of the Department of Labor and the Secretary of the Department of the Treasury to ensure that violators are held accountable.

For more information, click here.

Doctors of Community Act Introduced

On April 11, Reps. Pallone (D-NJ), Vasquez (D-NM) and Ruiz (D-CA) introduced the Doctors of Community (DOC) Act. The bill would authorize the Teaching Health Center Graduate Medical Education (THCGME) program to support and fund primary care medical and dental residents. It would increase funding from $277 million in fiscal year (FY) 2024 to $582 million in FY 2033 and would increase the number of residency slots available each year. The THCGME program is a Health Resources and Services Administration (HRSA) program that seeks to support the training of medical professionals preparing to work in rural and underserved communities.

For more information, click here.

Senate

INSULIN Act of 2023 Introduced

On April 21, Sens. Shaheen (D-NH) and Collins (R-ME) introduced the Improving Needed Safeguards for Users of Lifesaving Insulin Now (INSULIN) Act of 2023. The bill will foster competition among the insulin product market, broaden patient access and extend patient protections. The bill specifically:

• Limits out-of-pocket costs for patients with diabetes by requiring group and individual market health insurers to waive any deductible and limit cost-sharing to no more than $35 or 25 percent of the list price of at least one insulin of each type and dosage form;
• Prohibits pharmacy benefit managers (PBMs) from placing utilization management tools on products with capped out-of-pocket costs;
• Requires PBMs to pass along to plan sponsors 100 percent of insulin rebates and discounts received from manufacturers;
• Creates a new expedited Food and Drug Administration (FDA) approval pathway for biologic drugs;
• Strengthens oversight over the FDA’s citizen petition process;
• Allows Medicare Part D plans to place biosimilar drugs on formulary immediately upon their introduction to the market; and
• Requires the Secretary of the Department of Health and Human Services (HHS), Administrator of the Centers for Medicare and Medicaid Services (CMS) and the Commissioner of the FDA to submit a report to Congress identifying variables delaying or restricting competition among the biosimilar insulin market.

For more information, click here.

Drug-Price Transparency for Consumers Act Reintroduced

On April 20, Sens. Durbin (D-IL) and Grassley (R-IA) reintroduced the Drug-Price Transparency for Consumers (DTC) Act. The bill seeks to strengthen prescription drug transparency by requiring prescription drug and biological product advertisements to disclose the list price of the drug or product being marketed.

Senate Finance Committee Releases Legislative Framework to Address PBMs

On April 20, Senate Finance Committee Chairman Ron Wyden (D-OR) and Ranking Member Mike Crapo (R-ID) released a legislative framework that the committee will use to develop policy solutions to modernize federal prescription drug programs and address the role of pharmacy benefits managers (PBMs). The bipartisan framework outlines the four challenges committee members have identified within the prescription drug supply chain and explains what steps the committee will take to address and resolve them.

For more information, click here.

Administration

CMS Releases Medicare-Certified Hospice and Home Health Ownership Data

On April 20, the Centers for Medicare and Medicaid Services (CMS) released ownership data for all Medicare-certified hospice and home health agencies. This is the first time CMS has made extensive ownership data publicly available. The ownership data includes the name, type, location, national provider identifier (NPI) and CMS Certification Number (CCN) of more than 6,000 hospice and 11,000 home health agencies. CMS has also released information on the hospice and home health agency mergers, acquisitions, consolidations and ownership changes that have occurred since 2016. The data is available on the CMS website.

For more information, click here.

CMS OMH Releases Disparities in Healthcare in Medicare Advantage Report

On April 19, the Centers for Medicare and Medicaid Services (CMS) Office of Minority Health (OMH) released a report that outlines the quality of care Medicare Advantage (MA) enrollees received in 2022. The report examines racial, ethnic and sex differences in MA healthcare and clinical care experiences and highlights existing health disparities. The report intends to assist healthcare professionals and organizations with the development of health equity and quality improvement efforts for racially and ethnically diverse populations.

For more information, click here.

CMS Approves Expansion of Illinois School-Based Health Service Medicaid Funding

On April 18, the Centers for Medicare and Medicaid Services (CMS) approved a state plan amendment (SPA) that will expand Medicaid funding for Illinois school-based health services. The SPA will allow schools in Illinois to receive Medicaid funds to support covered services for all children instead of just those that are part of an Individualized Education Program (IEP). Illinois becomes the 12th state to expand Medicaid payment for school-based healthcare services. The other states include AZ, CA, CO, CT, GA, KY, LA, MA, MI, NV and NC.

For more information, click here.

FDA Amends COVID-19 Bivalent Vaccine EUAs

On April 18, the Food and Drug Administration (FDA) amended the emergency use authorizations (EUAs) for the Moderna and Pfizer-BioNTech COVID-19 bivalent mRNA vaccines by authorizing current bivalent vaccines to be used for all doses administered to individuals 6 months of age or older. The monovalent Moderna and Pfizer-BioNTech COVID-19 vaccines are no longer authorized for use within the United States. The FDA hopes that this amendment will simplify the COVID-19 vaccination schedule for individuals.

For more information, click here.

FDA Exempts Two Categories of Biological Products from Reporting Requirements

On April 13, the Food and Drug Administration (FDA) announced that it was exempting two categories of biological products from all Federal Food, Drug, and Cosmetic (FD&C) Act reporting requirements. The two categories include blood and blood components for transfusions, and cell and gene therapy products where one lot treats a single patient. The FDA acknowledged that reporting requirements for these products was not necessary to protect public health.

For more information, click here.

FDA Requests Public Comment on Data and Technology Strategic Plan

On April 13, the Food and Drug Administration (FDA) Office of Digital Transformation (ODT) announced that it was seeking public comment on its development of an FDA Data and Technology Strategic Plan. The ODT oversees information technology, data and cybersecurity needs at the FDA and is developing the strategic plan to modernize and integrate the FDA’s technology and data capabilities. The ODT intends on releasing the finalized plan by Sept. 30. Public comments will be accepted until May 15, 2023.

For more information, click here.

FDA Releases OTC Monograph Order Request Draft Guidance

On April 12, the Food and Drug Administration (FDA) released a draft guidance on over-the-counter (OTC) monograph order requests (OMORs). The guidance is intended to inform requestors on what information they should provide when submitting an OMOR to the FDA, and how that information should be formatted. The guidance also identifies relevant guidance documents that requestors should use when preparing their OMORs.

For more information, click here.

FDA Announces Public Meeting on Buprenorphine

On April 11, the Food and Drug Administration (FDA) announced that it will hold a two-day public meeting in partnership with the Substance Abuse and Mental Health Services Administration (SAMHSA) and the Reagan-Udall Foundation. The meeting will focus on buprenorphine initiation strategies and best practices for opioid use disorder (OUD) care. The meeting will be held virtually on May 10 and 11.

For more information, click here.

FDA Announces Advisory Committee Meeting to Discuss DMD Therapeutic

On April 10, the Food and Drug Administration (FDA) announced that the FDA Cellular, Tissue, and Gene Therapies Advisory Committee will meet and discuss the biologics license application for delandistrogene moxeparvovec, a therapeutic developed by Sarepta Therapeutics, Inc., that is intended to treat ambulatory patients with Duchenne Muscular Dystrophy (DMD). The meeting will be held virtually on May 12, and public comments will be accepted until May 11.

For more information, click here.

FDA Announces Advisory Committee Meeting to Discuss Alzheimer’s Drug

On April 10, the Food and Drug Administration (FDA) announced that the FDA Peripheral and Central Nervous System Drugs Advisory Committee will review and discuss the confirmatory study results of Leqembi, an Alzheimer’s drug developed by Eisai, Inc. The FDA granted Leqembi accelerated approval in January. The meeting will be held virtually on June 9, and public comments will be accepted until June 8.

For more information, click here.

HHS Announces Access Program for COVID-19 Vaccines and Treatments

On April 18, the Department of Health and Human Services (HHS) announced that it will establish the HHS Bridge Access Program for COVID-19 Vaccines and Treatments Program, to ensure that uninsured individuals have continued access to COVID-19 vaccines and treatments. The program will create a $1.1 billion public-private partnership to ensure that uninsured individuals can continue receiving COVID-19 care at local pharmacies and health centers. The program will also support existing partnerships established by the Centers for Disease Control and Prevention (CDC), the Health Resources and Services Administration (HRSA) and local health departments (LHDs).

For more information, click here.

HHS OCR Announces Expiration of COVID-19 PHE Enforcement Discretion

On April 11, the Department of Health and Human Services (HHS) Office for Civil Rights (OCR) announced that OCR’s enforcement discretion of the Health Insurance Portability and Accountability Act of 1996 (HIPPA) and the Health Information Technology for Economic and Clinical Health (HITECH) Act will expire on May 11, simultaneous with the expiration of the COVID-19 public health emergency (PHE). The OCR exercised HIPPA enforcement discretion to support the healthcare sector throughout the pandemic. The OCR also announced that it will give healthcare providers a 90-calendar-day transition period to come into compliance with HIPPA Rules that relate to telehealth following the expiration of the PHE. The transition period will begin on May 12 and end on Aug. 9.

For more information, click here.

SAMHSA Requests Public Comment on 2023-2026 Draft Strategic Plan

On April 11, the Substance Abuse and Mental Health Services Administration (SAMHSA) released a draft of its 2023-2026 Strategic Plan. The plan outlines SAMHSA’s goals, objectives and priorities for the next four years. Goals include preventing overdoses; strengthening access to suicide prevention and crisis care; promoting resilience and emotional health for children, youth and families; integrating behavioral and physical healthcare; and expanding the behavioral health workforce. SAMHSA is requesting public comment on the plan. Public comments will be accepted until April 27.

For more information, click here.

Proposed Rules

HHS OCR Proposed Rule Modifies HIPAA and HITECH Privacy Rule

On April 12, the Department of Health and Human Services (HHS) Office for Civil Rights (OCR) released a proposed rule that would modify the Standards for Privacy of Individually Identifiable Health Information “privacy rule” under the Health Insurance Portability and Accountability Act of 1996 (HIPPA) and the Health Information Technology for Economic and Clinical Health (HITECH) Act of 2009. The proposed rule would limit the use and disclosure of an individual’s protected health information (PHI) if it relates to an individual accessing lawful reproductive healthcare services. It would specifically prohibit the disclosure of such information for criminal, civil or administrative investigations or proceedings against individuals or regulated entities.

Public comments will be accepted until June 19, 2023. For more information, click here.

HHS ONC Proposed Rule Updates Electronic Health Information Infrastructure

On April 11, the Department of Health and Human Services (HHS) Office of the National Coordinator for Health Information Technology (ONC) released a proposed rule that would make several changes to the nationwide health information technology infrastructure. The proposed rule would:

• Implement the Electronic Health Record Reporting Program and make it a requirement for health information technology (Health IT) developers who are seeking certification;
• Modify and expand exceptions in information blocking regulations;
• Make revisions to the ONC Health IT Certification Program criteria;
• Adopt the United States Core Data for Interoperability (USCDI) Version 3 as standard for the ONC Health IT Certification Program; and
• Update implementation specifications and standards.

Public comments will be accepted until June 20, 2023. For more information, click here.

CMS Proposed Rule Updates Hospital Inpatient and Long-Term Care Hospital PPS Rates

On April 10, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule that would update the hospital inpatient prospective payment system (PPS) and long-term care hospital PPS for fiscal year (FY) 2024. The proposed rule would:

• Increase inpatient PPS payment rates by a net 2.8 percent;
• Increase the cost outlier threshold by 4.8 percent;
• Increase the federal capital by 4.5 percent;
• Exclude “dual reclass” hospitals from the rural wage index policy;
• Consider rural reclassified hospitals as geographically rural when calculating the wage index;
• Support graduate medical training in rural areas by allowing graduate medical education payments to go toward rural emergency hospitals;
• Restore program integrity restrictions on “high Medicaid facilities”;
• Add 15 and remove 16 Medicare Severity Diagnosis Related Groups (MS-DRGs);
• Allow web-based surveys to be used for Hospital Consumer Assessment of Healthcare Providers and Systems; and
• Seek public comment and information on supporting safety-net providers.

Public comments will be accepted until June 9, 2023. For more information, click here.

CMS Proposed Rule Updates Inpatient Psychiatric Facility (IPF) PPS Rates

On April 4, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule that would update the Inpatient Psychiatric Facility (IPF) Prospective Payment System’s (PPS) Medicare payment policies and rates, as well as the IPF Quality Reporting Program (QRP), for fiscal year (FY) 2024. The proposed rule would:

• Result in a 1.9 percent (approximately $55 million) payment increase for IPFs in FY 2024, based on a 3.0 percent increase in the IPF PPS payment rate;
• Adopt a 2021-based IPF market basket;
• Update and increase the labor-related share (LRS) to 78.5 percent;
• Make it easier for hospitals to open new IPF units, by allowing them to open new units at any time during the cost reporting period, so long as they notify their CMS Regional Office and Medicare Administrative Contractor within 30 days; and
• Make changes to the IPF QRP measures.

Public comments will be accepted until June 5, 2023. For more information, click here.

CMS Proposed Rule Updates Skilled Nursing Facility PPS Rates

On April 4, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule that would update the Skilled Nursing Facility (SNF) Prospective Payment System’s (PPS) Medicare payment policies and rates, as well as the SNF Quality Reporting Program (QRP) and SNF Value-Based Purchasing (VBP) Program, for fiscal year (FY) 2024. The proposed rule would:

• Result in a 3.7 percent (approximately $1.2 billion) Medicare Part A payment increase for SNFs in FY 2024, based on a 2.7 percent market basket update; a 3.6 percent increase in the market basket forecast error adjustment; a 0.2 percent decrease in the productivity adjustment; and a 2.3 percent decrease in the FY 2024 SNF PPS rates; and
• Make multiple changes to the SNF QRP measures.

Public comments will be accepted until June 5, 2023. For more information, click here.

CMS Proposed Rule Updates Inpatient Rehabilitation Facility PPS Rates

On April 3, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule that would update the Inpatient Rehabilitation Facility (IRF) Prospective Payment System’s (PPS) Medicare payment policies and rates, as well as the IRF Quality Reporting Program (QRP), for fiscal year (FY) 2024. The proposed rule would:

• Result in a 3.0 percent payment increase for IRFs, based on the proposed market basket update of 3.2 percent minus the 0.2 percentage point productivity adjustment;
• Increase IRF outlier payments by 0.7 percent;
• Make it easier for hospitals to open IRF units by allowing them to immediately start billing under the IRS PPS at any time during the cost reporting period, so long as they notify the CMS Regional Office and Medicare Administrative Contractor in writing within 30 days; and
• Make changes to the IRF QRP measures.

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

CMS Releases Hospice Index, Payment Rate and Aggregate Cap Proposed Rule

On March 31, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule that would make changes to hospice wage index rates, payment rates and aggregate cap amounts for fiscal year (FY) 2024. The proposed rule intends to inform patients and caregivers on hospice utilization trends, hospice center ownership information and Medicare hospice and non-hospice spending amounts. The proposed rule will:

• Codify the Hospice Quality Reporting Program (HQRP) data completion threshold policy;
• Provide an update on future Quality Measures (QM) development and health equity efforts;
• Provide an update on the Consumer Assessment of Healthcare Providers and Systems, Hospice Survey Mode Experiment; and
• Require physicians who order or certify hospice services for Medicare beneficiaries to be enrolled in Medicare or validly opted-out.

Public comments will be accepted until May 30, 2023. For more information, click here.

FDA Proposes New Tobacco Product Manufacturing Practices Requirements

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

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

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

CMS Proposed Rule Revises Medicare DSH Section 1115 Waiver Calculation

On Feb. 28, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule that would change how it defines Medicaid-eligible patients who can be included in Medicare disproportionate share hospital (DSH) payment calculations. CMS is proposing to do this by limiting the types of Medicaid Section 1115 waiver days that can be used by hospitals when calculating their disproportionate patient percentage (DPP) Medicaid fraction. CMS is proposing to allow hospitals to only count Section 1115 waiver days for patients who received a health insurance plan directly from a Section 1115 demonstration, that covers inpatient hospital services or who received, with the help of Section 1115 demonstration premium assistance, a health insurance plan that covers 100 percent of the patient’s premium costs.

Public comments will be accepted until May 1, 2023. For more information, click here.

CMS Proposes Rule to Clarify Changes to DSH Payment Calculations

On Feb. 24, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule that would clarify changes made to the Medicaid disproportionate share hospital (DSH) payment limit calculation by the Consolidated Appropriations Act of 2021. The proposed rule is intended to give states and hospitals a better understanding of how the limit is calculated. It also outlines technical and administrative changes CMS made recently to the DSH program.

Public comments will be accepted until April 25, 2023. For more information, click here.

Final Rules

CMS Releases Notice of Benefit and Payment Parameters for 2024 Final Rule

On April 19, the Centers for Medicare and Medicaid Services (CMS) released a final rule that will finalize standards for issuers that offer qualified health plans (QHPs) through federally-facilitated exchanges (FFEs) and state-based exchanges on the federal platform (SBE-FPs), and changes made to the payment parameters and provisions of the Department of Health and Human Services (HHS)-operated risk adjustment and risk adjustment data validation programs. The final rule will:

• Make it easier for individuals losing Medicaid or Children’s Health Insurance Program (CHIP) coverage to obtain health coverage by granting them a special enrollment period (SEP) 60 days before or 90 days after losing coverage;
• Grant healthcare plan assisters permission to provide enrollment assistance to individuals;
• Add Substance Use Disorder Treatment Centers and Mental Health Facilities to the essential community provider (ECP) list;
• Extend the requirement to contract with at least 35 percent of available ECPs in a service area to Federally Qualified Health Centers and Family Planning Providers;
• Refine health plan designs for standardized plan options; and
• Limit the number of non-standardized plan options offered by issuers of qualified health plans (QHPs) to four in each service area.

The rule will go into effect on June 18, 2023. For more information, click here.

CMS Finalizes Changes to Medicare Advantage, Part D, Cost Plan and PACE Regulations

On April 5, the Centers for Medicare and Medicaid Services (CMS) released a final rule that will finalize revisions made to the Medicare Advantage (MA), Prescription Drug Benefit and Cost Plan program regulations, as well as the Programs of All-Inclusive Care for the Elderly (PACE) regulations, for calendar year (CY) 2024. The final rule will:

• Require that MA plans comply with national coverage determinations (NCDs), local coverage determinations (LCDs), and general coverage and benefit conditions included in Traditional Medicare regulations;
• Require that coordinated care plan prior authorization policies may only be used to confirm the presence of diagnoses or other medical criteria and/or ensure that an item or service is medically necessary;
• Require coordinated care plans to provide a minimum 90-day transition period to enrollees who are undergoing treatment and switch to a new MA plan;
• Require all MA plans to establish a Utilization Management Committee and review policies to ensure consistency with Traditional Medicare guidelines;
• Require that approval of a prior authorization request be valid for as long as medically reasonable and necessary;
• Prohibit MA plan television ads from using words, imagery or names that may mislead or confuse beneficiaries;
• Expand access to behavioral healthcare by adding clinical psychologists and licensed clinical social workers to the list of evaluated specialties;
• Promote equitable care by adding a health equity index to the Star Ratings program and require MA and Part D plans to provide care to underserved populations; and
• Implement certain provisions of the Inflation Reduction Act (IRA), the Consolidated Appropriations Act (CAA) of 2021 and the Bipartisan Budget Act (BBA) of 2018.

The rule will go into effect on June 5, 2023. For more information, click here.

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

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

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

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

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

FDA Issues Final Rule Regarding Mammography Quality Standards

On March 9, the Food and Drug Administration (FDA) issued a final rule that updates the regulations implemented by the Mammography Quality Standards Act of 1992. The FDA has decided to update the regulations due to advancements made in mammography technology and information. The final rule will:

• Improve the delivery of mammography services;
• Strengthen communication of healthcare information;
• Require mammography facilities to provide patients with additional health information;
• Ensure the availability of qualified mammography personnel;
• Bolster medical outcome audits;
• Modernize technological aspects of mammography services; and
• Implement enforcement tools to deal with noncompliant facilities.

The rule will go into effect on Sept. 10, 2024. For more information, click here.

FDA Delays Tobacco Product Required Warning Final Rule Effective Date

On Nov. 25, the Food and Drug Administration (FDA), in compliance with an order issued by the U.S. District Court for the Eastern District of Texas, delayed the effective date of a final rule published on March 18, 2020, titled “Tobacco Products; Required Warnings for Cigarette Packages and Advertisements.” The rule, which was originally supposed to go into effect on June 18, 2021, establishes new cigarette health warnings for cigarette packages and advertisements.

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

CMS Issues Correction on Clinical Laboratory Improvement Amendments (CLIA) Final Rule

On Nov. 17, the Centers for Medicare and Medicaid Services (CMS) corrected a technical error that was found in a final rule published in the Federal Register on July 11, 2022. The final rule updates proficiency testing (PT) regulations under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), to address analytes and newer technologies.

The rule goes into effect July 11, 2024. For more information, click here.

Reports

GAO Releases Report Regarding the Exchange of Electronic Health Information

On April 21, the Government Accountability Office (GAO) released a report on the use of electronic health information exchange among hospitals and physicians. GAO interviewed state health officials, hospitals and physicians regarding the methods they use to exchange health information, to identify whether they frequently used electronic health information exchanges. The GAO discovered that the use of various electronic exchange methods has increased among medium and large-sized hospitals and physician offices but that use among small and rural hospitals remains low. The GAO conducted this study because it was asked to analyze what impact the implementation of the Health Information Technology for Economic and Clinical Health (HITECH) Act had on the use of electronic health information exchange.

For more information, click here.

HHS OIG Report Reveals Inaccuracies in CMS Nursing Home Deficiency Reporting

On April 13, the Department of Health and Human Services (HHS) Office of the Inspector General (OIG) released a report that revealed that the Centers for Medicare and Medicaid Services (CMS) had inaccurately reported nursing home deficiencies that had been highlighted in state survey agency inspection reports. State survey agencies are responsible for evaluating Medicare- and Medicaid-certified nursing homes to ensure that they are in compliance with federal fire safety, health and emergency preparedness requirements. CMS reviews these inspection results and is supposed to publicly report any inspection deficiencies to its Care Compare website. The HHS OIG looked at 100 nursing home inspection reports and determined that CMS had not accurately reported the results for 67 of the nursing homes on the Care Compare website.

For more information, click here.

CBO Cost Estimates

CBO Releases Reports Regarding Budget Baseline and Primer Development

On April 19, the Congressional Budget Office (CBO) released three reports that describe how it develops the budget baseline and other primers. They are as follows:

• How Research Is Used to Assess Policy Proposals at CBO.
  • For more information click here.

• CBO Describes Its Cost-Estimating Process.
  • For more information, click here.

• CBO Explains How It Develops the Budget Baseline.
  • For more information, click here.

CBO Releases Cost Estimate for S. 206, END FENTANYL Act

On April 10, the Congressional Budget Office (CBO) released a cost estimate for S. 206, END FENTANYL Act. The bill would require the U.S. Customs and Border Protection (CBP) to review its policies and manuals regarding inspections at ports of entry at least once every three years. The bill would also require CBP to report to Congress any policy changes that are made after such a review. The CBO predicted that the implementation of S. 206 would cost less than $500,000 over the 2023-2028 period and that spending would be subject to the availability of appropriated funds.

For more information, click here.