Washington Healthcare Update

April 22, 2024

This Week in Washington: House Energy and Commerce Committee chairmen and ranking members request information on Change Healthcare cyberattack impacts; FDA establishes CDER Center for Clinical Trial Innovation; House Energy and Commerce Committee Oversight and Investigations Subcommittee holds hearing concerning improper payments.

Congress

House

Senate

Administration

Proposed Rules

Final Rules

Reports

House

House Energy and Commerce Committee Chairmen and Ranking Members Request Information on Impacts of Change Healthcare Cyberattack

On April 15, House Energy and Commerce Committee Chairman Cathy McMorris Rodgers (R-WA) and two subcommittee chairmen, Brett Guthrie (R-KY) and Morgan Griffith (R-VA), in addition to Ranking Member Frank Pallone (D-NJ) and two subcommittee ranking members Anna Eshoo (D-CA) and Kathy Castor (D-FL) sent a letter to UnitedHealth Group Chief Executive Officer Sir Andrew Witty concerning the Change Healthcare cyberattack.

The chairmen and ranking members are requesting information on the actions UnitedHealth took to address and resolve the attack and on the outreach it conducted to inform the healthcare community of potential disruptions.

For more information, click here.

House Veterans Affairs Committee Subcommittee on Health Marks Up 11 Healthcare Bills

On April 16, the House Veterans Affairs Committee Subcommittee on Health marked up and reported out of committee 11 healthcare bills, including bills related to emergency transportation, maternal health and hyperbaric oxygen therapy. One of the bills concerns the inclusion of psychiatric drugs in the Department of Veterans Affairs drug formulary.

The bills are:

H.R. 3584, Veterans CARE Act: Directs the Secretary of Veterans Affairs (VA Secretary) to conduct and support research on the efficacy and safety of medicinal cannabis.

H.R. 3644, ACT for Veterans Act: Extends the authorization period for emergency treatment in non-Department of Veterans Affairs medical facilities under the Veterans Community Care Program.

H.R. 3649, Veterans National Traumatic Brain Injury Treatment Act: Directs the VA Secretary to establish a pilot program to furnish hyperbaric oxygen therapy to a veteran who has a traumatic brain injury or post-traumatic stress disorder.

H.R. 4424, Vietnam Veterans Liver Fluke Cancer Study Act: Directs the VA Secretary to study and report on the prevalence of cholangiocarcinoma in veterans who served in the Vietnam theater of operations during the Vietnam era.

H.R. 5530, VA Emergency Transportation Access Act: Prohibits the VA Secretary from making changes to the Department of Veterans Affairs rate of payment or reimbursement provided for transportation of veterans and other eligible individuals on special modes of transportation.

H.R. 6324, Fiscal Year 2024 Veterans Affairs Major Medical Facility Authorization Act: Authorizes major medical facility projects for the Department of Veterans Affairs for fiscal year 2024.

H.R. 6373, Veterans STAND Act: Directs the VA Secretary to offer annual preventative health evaluations to veterans with a spinal cord injury or disorder and increase access to assistive technologies.

H.R. 7347, To amend title 38, United States Code, to direct the Secretary of Veterans Affairs to report on whether the Secretary will include certain psychedelic drugs in the formulary of the Department of Veterans Affairs: Directs the VA Secretary to report on whether the Secretary will include certain psychedelic drugs in the formulary of the Department of Veterans Affairs.

H.R. 3225, BUILD for Veterans Act of 2023: Improves the management and performance of the capital asset programs of the Department of Veterans Affairs.

H.R. 5794, Veterans Affairs Peer Review Neutrality Act of 2023: Eliminates conflicts of interest in conduct of quality management and administrative investigations by the Veterans Health Administration.

H.R. 3303, Maternal Health for Veterans Act: Supports programs of the Department of Veterans Affairs relating to the coordination of maternity healthcare.

For more information, click here.

House Energy and Commerce Committee Subcommittee on Health Holds Hearing on Health Sector Cybersecurity

On April 16, the House Energy and Commerce Committee Subcommittee on Health held a hearing to discuss healthcare cybersecurity practices and vulnerabilities. Subcommittee members also discussed the possibility of amending HIPAA to give healthcare entities more clearinghouse options following a cyberattack. The Change Healthcare cyberattack prompted the subcommittee to look into this. Witnesses were:

  • Greg Garcia, Executive Director for Cybersecurity at the Healthcare Sector Coordinating Council
  • Robert Sheldon, Senior Director of Public Policy and Strategy at CrowdStrike
  • John Riggi, National Advisor for Cybersecurity and Risk at the American Hospital Association
  • Scott MacLean, Board Chair for the College of Healthcare Information Management Executives (CHIME)
  • Adam Bruggeman, MD, Orthopedic Surgeon at Texas Spine Center

For more information, click here.

House Energy and Commerce Committee Oversight and Investigations Subcommittee Holds Hearing Concerning Improper Payments

On April 16, the House Energy and Commerce Committee Oversight and Investigations Subcommittee held a hearing to discuss improper Medicare and Medicaid payments. The hearing focused on the fiscal implications of improper payments and ways to strengthen their oversight. Witnesses were:

  • The Honorable Gene Dodaro, Comptroller General of the Government Accountability Office
  • The Honorable Christi Grimm, Inspector General of the Department of Health and Human Services
  • Timothy Hill, MPA, Medicaid and CHIP Payment and Access Commission Member
  • Michael Chernew, Ph.D, Medicare Payment Advisory Commission Chair

For more information, click here.

House Appropriations Committee Agriculture, Rural Development and FDA Subcommittee Holds Hearing on President’s FY2025 FDA Budget Request

On April 18, the House Appropriations Committee Agriculture, Rural Development and Food and Drug Administration (FDA) Subcommittee held a hearing to discuss the president’s fiscal year 2025 budget request for the FDA. The FDA Commissioner testified.

For more information, click here.

Senate

Senate HELP Committee Ranking Member Sends Letter Concerning FDA Classification of CDS Software

On April 17, Senate Health, Education, Labor and Pensions Committee Ranking Member Bill Cassidy (R-LA) sent a letter to Food and Drug Administration (FDA) Commissioner Robert Califf concerning the September 2022 final guidance, which seeks to regulate clinical decision support (CDS) software as a medical device.

The ranking member believes that the FDA’s categorization of CDS as a medical device disregards congressional intent and may jeopardize access to advanced tools used to improve patient care. Congress excluded CDS software from being categorized as a medical device in the 21st Century Cures Act.

For more information, click here.

Senate Finance Committee Majority Staff Release Report on State Attorneys General Misusing Authority to Obtain Transgender Care Records

On April 16, the Senate Finance Committee majority staff released a report concerning transgender healthcare record requests by state attorneys general in Tennessee, Indiana, Missouri and Texas. The majority staff reviewed information on such requests and how medical providers responded to them.

The majority staff discovered that some state attorneys general are misusing their Medicaid investigative and consumer protection authorities to obtain sensitive health records of teens and adults seeking gender-affirming care. The staff also found that some providers complied with the request for health records while others refused, citing patient privacy concerns.

For more information, click here.

Administration

White House Releases U.S. Global Health Security Strategy

On April 16, the White House released the U.S. Global Health Security Strategy. The strategy outlines the steps the U.S. will take to meet global health security objectives established in the 2022 National Biodefense Strategy and Implementation Plan and the Global Health Security and International Pandemic Prevention, Preparedness and Response Act of 2022.

For more information, click here.

CMS Asks Patients to Report Unauthorized Plan Switching

In response to reports of patients experiencing unauthorized switching from ACA plans to other plans, the Centers for Medicare and Medicaid Services (CMS) is asking for patients to report to CMS if they have this experience. CMS will be able to get the consumer back into the plan they chose, and restore any subsidies for which the consumer was eligible.

Meanwhile, a lawsuit was filed in the U.S. District Court for the Southern District of Florida alleging two call centers paid tens of thousands of dollars to buy names of people who responded to misleading ads touting free government subsidies and other rewards. The sales agents then used the information to either enroll them in ACA plans or switch their existing policies without their consent.

As a result, the lawsuit alleges, consumers lost their access to their doctors or medications and faced financial costs or had to repay tax credits that were paid toward the unauthorized coverage. Some consumers were switched multiple times or had duplicative coverage.

The platforms in this case were not open to the public but only to the call center agencies granted permission by the platforms.

The suit claims the targeted individuals had low enough incomes to qualify for larger subsidies. The sales push began after March 2022, when a special enrollment period for low-income people became available. The suit asserts that those involved did not meet the privacy and security rules required for participation in the ACA marketplace. The lawsuit also alleges violations of the federal Racketeer Influenced and Corrupt Organizations Act, known as RICO.

FDA Approves Lumisight

On April 17, the Food and Drug Administration approved Lumisight (pegulicianine), a fluorescent imaging drug intended for adults with breast cancer. The drug is used to assist the intraoperative detection of cancerous tissue within the resection cavity following removal of the primary specimen during lumpectomy surgery.

For more information, click here.

FDA Establishes CDER Center for Clinical Trial Innovation

On April 15, the Food and Drug Administration Center for Drug Evaluation and Research (CDER) announced the launch of the CDER Center for Clinical Trial Innovation. The new center will focus on promoting clinical trial innovation activities that improve the quality and efficiency of drug development and regulatory decision making.

For more information, click here.

FDA Announces Funding Opportunity for Medical Policy Activity Meeting Organizers

On April 4, the Food and Drug Administration Center for Drug Evaluation and Research announced a Notice of Funding Opportunity for institutions and organizations that convene meetings for multiple stakeholders who research and address issues concerning medical products, policy and surveillance methods and systems. Applications are due June 17.

For more information, click here.

FTC Stops Telehealth Company from Disclosing Health Data in Advertisements

On April 12, the Federal Trade Commission took the first enforcement action through the Opioid Addiction Recovery Fraud Prevention Act to stop a telehealth company from disclosing health data to advertising platforms. The company is Monument, which virtually treats patients with alcohol addiction.

There is a proposed ban on data sharing with third parties and a $2.5 million civil penalty. Monument allegedly shared as many as 84,000 users’ personal health data to third parties – including Meta and Google without patient consent after promising to keep such information confidential. An outside assessor hired by the company found that Monument also failed to comply with HIPAA.

SAMHSA OTP Telehealth Rule Implementation Faces Obstacles

On Jan. 31, the Substance Abuse and Mental Health Services Administration issued a final rule that allows some opioid treatment program (OTP) providers to prescribe medication for opioid use disorder (OUD) like buprenorphine via telehealth without an initial in-person exam and dispense take-home doses of methadone to stable patients.

It remains unclear whether the rule will benefit OTP patients equally due to uncertainty surrounding how states will implement the rule and how Medicare Advantage and Medicaid managed care organizations will pay for the services. States also have the discretion to offer more restrictive OUD treatment services than the federal government.

Proposed Rules

CMS Proposed Rule Updates Payment Rates for Inpatient and LTC Hospitals for FY2025

On April 10, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule that would update the Medicare fee-for-service payment rates and policies for inpatient and long-term care hospitals (LTCHs) for fiscal year (FY) 2025.

The proposed rule would:

  • Increase LTCH standard rate payments by 1.2 percent;
  • Raise the fixed-loss amount for high-cost outlier payments to $90,921, reducing overall standard rate payments by 1.3 percent;
  • Rebase the LTCH market basket using a 2022 base year;
  • Adopt and modify patient assessment items related to health-related social needs within the LTCH Quality Reporting Program;
  • Require LTCHs to collect and report specific data related to living situation, food and utilities beginning in FY2028; and
  • Extend the window in which patient assessments must be done from three to four days after admission.

CMS is also requesting comments on two requests for information related to the development of a LTCH QRP (Quality Reporting Program) Star Rating System and future QRP measures.

The American Hospital Association raised concerns about the proposed rule and stated in a press release that the payment update is inadequate and will exacerbate resource challenges for hospitals.

Public comments will be accepted until June 10, 2024. For more information, click here.

CMS Proposed Rule Updates Inpatient Rehabilitation Facility PPS Rates for FY2025

On March 29, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule that would update the prospective payment system (PPS) rates for inpatient rehabilitation facilities (IRFs) for fiscal year (FY) 2025 and modify the IRF Quality Reporting Program (QRP).

The proposed rule would:

  • Update the IRF PPS payment rates by 2.8 percent or $255 million;
  • Update the IRF PPS wage index using Office of Management and Budget statistical area delineations of revised census data;
  • Phase out the rural adjustment for IRFs that transition from rural to urban status under the new Core-Based Statistical Areas; and
  • Adopt four new items into the IRF Patient Assessment Instrument, modify the Transportation item and remove the “Admission Class” assessment item, beginning on Oct. 1, 2026.

In addition, CMS is requesting comments on two requests for information concerning the development of an IRF QRP Star Rating System and future QRP measures.

Public comments will be accepted until May 28, 2024. For more information, click here.

CMS Proposed Rule Would Update Hospice Payment Rate and Cap Amount for FY2025

On March 28, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule that would update the Medicare hospice payment and aggregate cap amounts for fiscal year (FY) 2025 and modify the Hospice Quality Reporting Program (HQRP).

The proposed rule would:

  • Update the hospice payment rate by 2.6 percent, an estimated increase of $705 million;
  • Implement a hospice cap amount of $34,364.85;
  • Add two new process measures to the HQRP;
  • Implement the Hospice Outcomes and Patient Evaluation (HOPE) patient-level data collection tool beginning in FY2025 to replace the Hospice Item Set structure; and
  • Modify the Hospice Consumer Assessment of Healthcare Providers and Systems Survey.

In addition, CMS is seeking comments on a request for information concerning the implementation of a separate payment mechanism to account for high-intensity palliative care services.

Public comments will be accepted until May 28, 2024. For more information, click here.

CMS Proposed Rule Would Update Inpatient Psychiatric Facility PPS Rates for FY2025

On March 28, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule that would update the prospective payment system (PPS) rates for inpatient psychiatric facilities (IPFs) for fiscal year (FY) 2025 and modify the IPF Quality Reporting Program (QRP).

The proposed rule would:

  • Update IPF PPS payment rates by 2.7 percent;
  • Revise IPF PPS patient-level adjustment factors;
  • Require IPFs to submit patient-level quality data every quarter;
  • Increase the cost of electroconvulsive therapy to $660.30 per treatment; and
  • Adopt one new measure under the IPF QRP.

In addition, CMS is requesting comments on two requests for information concerning the development of an IPF PPS Patient Assessment Instrument and potential revisions to the IPF PPS Facility-Level Adjustment Factors.

Public comments will be accepted until May 28, 2024. For more information, click here.

CMS Proposed Rule Would Update Skilled Nursing Facility PPS Rates for FY2025

On March 28, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule that would update the prospective payment system (PPS) rates for skilled nursing facilities (SNFs) for fiscal year (FY) 2025 and modify the SNF Quality Reporting Program (QRP) and Value-Based Purchasing (VBP) Program.

The proposed rule would:

  • Update SNF PPS rates by 4.1 percent, or $1.3 billion;
  • Revise ICD-10 code mappings to improve payment and coding accuracy;
  • Expand CMS’ ability to impose financial penalties on nursing homes for health and safety deficiencies;
  • Add four new social determinants of health (SDOH) assessments and modify one SDOH assessment item for the SNF QRP beginning in FY2027; and
  • Adopt a measure selection, retention and removal policy and update the Total Nurse Staffing measure and case-mix methodology in the SNF VBP program.

In addition, CMS is requesting comments on two requests for information concerning future updates to the Non-Therapy Ancillary component of the Patient-Driven Payment Model and SNF QRP quality measures.

Public comments will be accepted until May 28, 2024. For more information, click here.

FDA Proposed Rule Would Ban Electrical Stimulation Devices

On March 26, the Food and Drug Administration (FDA) released a proposed rule that would ban electrical stimulation devices (ESDs) intended for self-injurious behavior (SIB) or aggressive behavior (AB). The FDA believes the devices present an unreasonable and substantial risk of illness or injury that cannot be corrected or eliminated by labeling.

The proposed rule would:

  • Designate ESDs for SIB or AB as banned devices; and
  • Apply the ban to devices already in use, commercially distributed and those set to be sold or commercially distributed in the future.

Public comments will be accepted until May 28, 2024. For more information, click here.

FDA Proposed Rule Establishes Criteria for Drug Products with Demonstrable Compounding Difficulties

On March 20, the Food and Drug Administration released a proposed rule that would establish criteria for the lists of drug products or categories of drug products that present demonstrable difficulties for compounding under the Federal Food, Drug and Cosmetic Act.

The proposed rule would:

  • Create separate lists for 503A and 503B products that present demonstrable difficulties for compounding;
  • Establish six criteria used to determine which list/lists products are placed on; and
  • Add oral solid modified-release drug products that employ coated systems, liposome drug products and drug products produced using hot melt extrusion as categories to the 503A and 503B product lists.

Public comments will be accepted until June 18, 2024. For more information, click here.

Final Rules

HRSA Final Rule Revises 340B Administrative Dispute Resolution Process

On April 18, the Health Resources and Services Administration (HRSA) released a final rule that modifies requirements and procedures for the 340B Program administrative dispute resolution (ADR) process. The rule aims to make the process more accessible, administratively feasible and timely. It will:

  • Eliminate the $25,000 minimum dispute threshold for drug manufacturers and 340B providers;
  • No longer require the ADR process to be governed by the Federal Rules of Evidence and Civil Procedure;
  • Require members of the ADR panel to be 340B subject matter experts under the HRSA Office of Pharmacy Affairs;
  • Require parties to engage in good-faith efforts to resolve disputes before initiating the ADR process;
  • Prioritize the ADR process for disputes related to overcharging, discount diversion or duplicate discounts; and
  • Establish an ADR dispute appeal and reconsideration process.

The American Hospital Association and 340B Health have expressed their support for the rule.

The rule will go into effect on June 18, 2024. For more information, click here.

CMS Releases CY2025 Medicare Advantage and Part D Final Rule

On April 4, the Centers for Medicare and Medicaid Services (CMS) released a final rule that will amend regulations for the Medicare Advantage (MA), Part D, Cost Plan and Programs of All-Inclusive Care for the Elderly programs. The rule will:

  • Codify 9 core chronic diseases and HIV/AIDS to the Part D Medication Therapy Management Program eligibility criteria;
  • Add the “Outpatient Behavioral Health” facility-specialty type to network adequacy standards;
  • Cap compensation for MA plan agents and brokers;
  • Require MA organizations to establish bibliographies for each of the Special Supplemental Benefits for the Chronically Ill that they include in their bid;
  • Streamline enrollment for dual-eligible beneficiaries and limit out-of-network patient cost-sharing for certain plans serving dual-eligible populations;
  • Require Quality Improvement Organizations to review the appeals process for enrollees if their MA plan terminates coverage for certain post-acute care services; and
  • Lower the D-SNP look-alike threshold from 80 to 70 percent.

In addition, the rule will standardize the MA Risk Adjustment Data Validation appeals process and provide Part D sponsors flexibility to substitute lower cost biosimilar biological products for reference products.

The final rule will go into effect on June 3, 2024, but the applicability of the provisions depend on plan coverage dates.

For more information, click here.

CMS Releases Notice of Benefit and Payment Parameters for 2025 Final Rule

On April 2, the Centers for Medicare and Medicaid Services (CMS) released the Notice of Benefit and Payment Parameters for 2025 final rule, which finalizes standards for issuers, Marketplaces and requirements for agents, brokers, direct-enrollment entities and assisters. The rule will:

  • Implement new network adequacy standards on State and State-based Marketplaces;
  • Allow states to add routine non-pediatric dental benefits as an Essential Health Benefit (EHB);
  • Revise prescription drug benefits;
  • Simplify plan choice and selection by revising the Marketplace re-enrollment hierarchy and the EHB-Benchmark Plan update process;
  • Align special enrollment period coverage dates with regular coverage effective dates;
  • Enhance standards and guaranteed consumer protections;
  • Establish new marketplace call center standards; and
  • Implement a Federally-Facilitated Marketplace user fee rate of 1.5 percent and a State-based Marketplace user fee rate of 1.2 percent of total monthly premiums.

In addition to CMS, the Department of Treasury is proposing the rule.

The final rule will go into effect on June 4, 2024. For more information, click here.

CMS Releases Final Rule Concerning STLDI Plans

On March 28, the Centers for Medicare and Medicaid Services (CMS) released a final rule that restricts the length of short-term, limited-duration insurance (STLDI) plans. The rule will:

  • Limit the initial coverage period of an STLDI plan to no more than three months;
  • Cap the maximum coverage period to four months;
  • Prohibit plan “stacking” by considering multiple plan purchases from the same issuer as a renewal or extension;
  • Require plan and fixed indemnity policy applications, enrollment, reenrollment and consumer-facing marketing materials to be more transparent; and
  • Revise requirements for hospital indemnity or other fixed indemnity insurance to be considered an excepted benefit in the group and individual health insurance markets.

In addition to CMS, the Internal Revenue Service and the Employee Benefits Security Administration are proposing the rule.

The final rule will go into effect on June 17, 2024. For more information, click here.

CMS Final Rule Amends Medicaid Eligibility and Enrollment Process

On March 27, the Centers for Medicare and Medicaid Services (CMS) released a final rule that will streamline the process of eligibility determinations, enrollment and renewal processes for Medicaid, the Children’s Health Insurance Program (CHIP) and the Basic Health Program. The rule will:

  • Prohibit CHIP premium lock-out periods and annual and lifetime limits on CHIP benefits;
  • Remove the State option to require a waiting period prior to CHIP enrollment;
  • Modernize eligibility determination information and documentation recordkeeping requirements for states;
  • Eliminate the State option to require in-person interviews as part of the application and renewal processes for non-MAGI (modified adjusted gross income) beneficiaries;
  • Implement provisions aimed at simplifying the coverage enrollment and renewal process for individuals 65 and older or living with a disability; and
  • Require states to use specific types of available information to update an individual’s address.

In addition, the rule will grant individuals 15 days to return information requested for an initial application and 30 days when needed to retain enrollment.

The final rule will go into effect on June 3, 2024. For more information, click here.

CMS Final Rule to Cut Medicaid Disproportionate Share Hospital Payments

On Feb. 24, the Centers for Medicare and Medicaid Services (CMS) released a final rule that will implement changes made to Social Security Act provisions governing Medicaid Disproportionate Share Hospital (DSH) payments by the Consolidated Appropriations Act of 2021 (CAA 2021).

CAA 2021 made several changes concerning Medicaid DSH payments. It notably modified the calculation of the Medicaid portion of the hospital-specific DSH limit to only include costs and payments for services furnished to beneficiaries for whom Medicaid is the primary payer for such services.

This final rule will:

  • Cut DSH payments by $8 billion annually from fiscal years 2024 to 2027;
  • Implement CAA 2021 changes to Medicaid DSH payments and clarify the timing and availability of data, methodology and technical requirements;
  • Revise regulatory payment and financing definitions in addition to other regulatory language that could be subject to misinterpretation;
  • Refine administrative procedures used by states to comply with federal regulations; and
  • Remove regulatory requirements that have been difficult to administer.

The final rule will go into effect on April 23, 2024. For more information, click here.

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.

FDA Issues Final Rule Regarding Mammography Quality Standards

On March 9, 2023, 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

Brookings Institution Releases Report Concerning No Surprises Act Arbitration Process

On March 27, the Brookings Institution released a report concerning the outcomes of disputes decided during the first half of 2023 under the No Surprises Act independent dispute resolution (IDR) arbitration process. CMS released data of the disputes on February 15.

Brookings analyzed data for three categories of services including imaging, emergency care and neonatal/pediatric critical care and discovered that 74 percent of disputes were generated by private-equity backed staffing firms Envision Healthcare, TeamHealth, SCP Health and Radiology Partners. Brookings also determined that IDR decisions greatly exceed Medicare rates and prior in-network commercial market prices.

For more information, click here.

CBO Releases Report Regarding Accountable Care Organization Performance

On April 16, the Congressional Budget Office (CBO) released a report concerning the past performance of Medicare Accountable Care Organizations (ACOs). The CBO was interested in understanding what factors have contributed to or limited the ability of ACOs to achieve net budgetary savings for the Medicare program.

After interviewing academic and government experts and analyzing peer-review journals and studies, the CBO discovered that:

  • ACOs led by independent physician groups, those with a larger proportion of primary care providers and those whose initial baseline spending was higher than the regional average, are associated with greater savings; and
  • Some factors limit the savings from Medicare ACOs, including a lack of resources, weak incentives to reduce spending and the ability of providers to selectively enter and exit the program on the basis of the financial benefits or losses they anticipate.

For more information, click here.

GAO Releases Report Concerning Medicaid Program Access and Use of COVID-19 Vaccination Data

On April 18, the Government Accountability Office (GAO) released a report concerning Medicaid programs’ access to and use of COVID-19 immunization information to improve vaccination rates among beneficiaries.

After reviewing federal laws and interviewing officials, the GAO discovered that some states encountered state immunization and Medicaid system interoperability challenges. The GAO also found that Medicaid programs relied on incentives and targeted outreach to increase vaccination rates among beneficiaries. The GAO conducted this study because it was asked to examine Medicaid programs’ access and use of immunization systems to improve COVID-19 vaccination rates.

For more information, click here.

GAO Releases Report Concerning Federal Response to Mpox Public Health Emergency

On April 18, the Government Accountability Office (GAO) released a report concerning the federal government’s response to the Mpox public health emergency and the challenges that arose during the Department of Health and Human Services’ (HHS) initial response.

After reviewing HHS documentation and interviewing federal officials, the GAO discovered that jurisdictions encountered challenges when communicating with HHS to stay informed of the availability of vaccines, tests and treatments. The GAO also determined that HHS does not have a coordinated, department-wide, after-action program to identify and resolve recurring emergency response challenges. The GAO conducted this study because it was asked to review the federal response to the Mpox public health emergency.

For more information, click here.

GAO Releases Report Concerning Medicare and Medicaid Improper Payments

On April 16, the Government Accountability Office (GAO) released a report concerning improper Medicare and Medicaid payments. The report describes GAO recommendations that the Centers for Medicare and Medicaid Services have implemented to improve Medicare fraud prevention and Medicaid managed care oversight. It also outlines recommendations that remain unimplemented.

In addition, the report contains the testimony given by Comptroller General Gene L. Dodaro during the House Energy and Commerce Committee Oversight and Investigations Subcommittee hearing concerning improper Medicare and Medicaid payments.

For more information, click here.

GAO Releases Report Concerning State PBM Regulation

On April 15, the Government Accountability Office (GAO) released a report describing actions state regulators in Arkansas, California, Louisiana, Maine and New York have taken to regulate pharmacy benefit managers (PBMs).

After reviewing state laws and interviewing regulators, state health plan associations and other stakeholders, the GAO found that the selected states have enacted laws establishing:

  • Fiduciary and other “duty of care” requirements;
  • Drug pricing and pharmacy reimbursement requirements;
  • Transparency, licensure and reporting requirements; and
  • Pharmacy network and access requirements.

The GAO conducted this study because it was asked to review states’ regulation of PBMs serving private health plans.

For more information, click here.

KFF Releases Report Concerning Medicaid Unwinding Survey

On April 12, the Kaiser Family Foundation (KFF) released a report on a survey it conducted concerning the Medicaid unwinding and renewal process. KFF interviewed 1,227 adults who had Medicaid coverage prior to April 1, 2024.

The survey found that:

  • 83 percent of people enrolled in Medicaid prior to the unwinding retained coverage or reenrolled into the program, 8 percent are enrolled in other coverage and 8 percent remained uninsured;
  • 20 percent of enrollees who lost coverage in 2023 remain uninsured; and
  • 4 percent of pre-unwinding enrollees reported having employer coverage, 2 percent have Medicare and 2 percent purchased a marketplace plan.

For more information, click here.

Authors

Stephanie Kennan
Senior Vice President
Federal Public Affairs
Washington, DC
Gina Sherick
Policy Consultant
Federal Public Affairs
Washington, DC