Washington Healthcare Update

September 11, 2023

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This Week in Washington: House to unveil sweeping health bill

Upcoming Hearings

Congress

House

Senate

Administration

Proposed Rules

Final Rules

Courts

Reports

Note

Upcoming Hearings

September 13

House

House Appropriations Committee Subcommittee on Military Construction, Veterans Affairs, and Related Agencies Oversight Hearing: “Department of Veterans Affairs Implementation of the Electronic Health Record Modernization Initiative”
9:30 a.m., Rayburn House Office Building 2362A
Announced witnesses are:

  • Dr. Neil Evans, Acting Program Director of the Veterans Health Administration Electronic Health Record Modernization Integration Office
  • Dr. Jonathan Nebeker, Executive Director of the Veterans Health Administration Clinical Informatics and Chief Medical Informatics Officer
  • Mr. Mike Sicilia, Executive Vice President of Oracle Global Industries

September 14

House

House Energy and Commerce Committee Health Subcommittee Hearing: “Legislative Proposals to Prevent and Respond to Generic Drug Shortages”
10:00 a.m., Rayburn House Office Building 2123
Witnesses to be announced.

House Oversight and Accountability Committee Select Subcommittee on the Coronavirus Pandemic Hearing: “Oh Doctor, Where Art Thou? Pandemic Erosion of the Doctor-Patient Relationship”
10:00 a.m., Rayburn House Office Building 2247
Witnesses to be announced.

House Committee on Veterans’ Affairs Full Committee Oversight Hearing: “VA Electronic Health Record Modernization: Get Well Soon?”
10:30 a.m., Cannon House Office Building 360
Witnesses to be announced.

House

Appropriations Process Remains Top Priority

With the fiscal year set to expire on Sept. 30, time is running out for Congress to pass appropriations bills to fund the government through the new fiscal year. The House is expected to move appropriations bills for the Department of Defense, Department of Homeland Security and Department of Agriculture-Food and Drug Administration. The Senate is expected to move appropriations bills for the Department of Agriculture, Military Construction, and Veterans’ Affairs, the Department of Transportation and the Department of Housing and Urban Development. It is not yet known whether a continuing resolution will be passed to avert a government shutdown.

House Republicans Release Healthcare Package Draft

On Sept. 6, Republicans on the House Energy and Commerce, Ways and Means, and Education and Workforce committees released a draft of the Lower Cost, More Transparency Act. The legislation is a major healthcare package composed of bills advanced by the committees relating to price transparency, pharmacy benefit managers (PBMs), Medicare site-neutral payments and healthcare program funding. The proposal could change after consideration by the full GOP caucus. The package includes:

H.R. 3561, PATIENT Act of 2023
This legislation would expand hospital price transparency requirements, extend funding for the Community Health Center Fund and other programs, and implement site-neutral payments for drugs administered by physicians in off-campus hospital outpatient departments.

H.R. 4839, Hospital and ASC Price Transparency Act of 2023
This legislation would require hospitals to publicly disclose the standard charges for all items and services for at least 300 shoppable services.

H.R. 3248, Diagnostic Lab Testing Transparency Act
This legislation would strengthen price transparency of clinical diagnostic laboratory tests under the Medicare program and require providers to disclose the discounted cash price and insurer- negotiated minimum and maximum rates of tests.

H.R. 4882, Clinical Laboratory Price Transparency Act of 2023
This legislation would require providers to publicly disclose the cash and insurer-negotiated rates for clinical diagnostic laboratory tests offered by a lab included on the list of shoppable services by the Centers for Medicare and Medicaid Services (CMS).

H.R. 4828, Imaging Services Price Transparency Act of 2023
This legislation would require providers to disclose the cash price and insurer-negotiated rates for certain imaging services.

H.R. 4905, Health Insurance Price Transparency Act of 2023
This legislation would require health insurers to share cost-sharing and pricing information with patients.

H.R. 4507, Transparency in Coverage Act of 2023
This legislation would require insurers to share pricing information for healthcare services and require PBMs to share cost information with plan sponsors.

H.R. 2697, Pharmacy Benefit Manager Accountability Act
This legislation would require PBMs to disclose information regarding the rebates, fees and alternative discounts they receive from prescription drugs. It would also require PBMs to disclose drug wholesale acquisition costs and enrollee total out-of-pocket spending.

H.R. 4822, Health Care Price Transparency Act
This legislation would require PBMs to share net price data, aggregate rebate information, out-of-pocket spending and acquisition costs for all drug classes upon request by an employer.

H.R. 3282, Promoting Transparency and Health Competition in Medicare Act
This legislation would require public reporting of data from healthcare entities who share common ownership interests within the Medicare program, specifically insurers who own pharmacies, PBMs and healthcare providers.

H.R. 4883, Medicare Common Ownership Transparency Act of 2023
This legislation would require Medicare Advantage (MA) organizations to disclose common ownership of pharmacies, PBMs and providers to the Department of Health and Human Services (HHS).

H.R. 3284, Providers and Payers COMPETE Act
This legislation would require the HHS Secretary to submit an annual report to Congress detailing the impact Medicare regulations have on healthcare payer and provider consolidation.

H.R. 3839, Increasing Transparency in Generic Drug Applications Act
This legislation would improve the Food and Drug Administration’s (FDA) review process of generic drugs and allow the FDA to inform drug sponsors about differences between their application and the reference product.

H.R. 1613, Drug Price Transparency in Medicaid Act
This legislation would prohibit PBMs from using spread pricing within the Medicaid program.

H.R. 3237, to amend title XVIII of the Social Security Act to require each off-campus outpatient department of a provider to include a unique identifier on claims for items and services, and to require providers with a department to submit to the Centers for Medicare and Medicaid services an attestation with respect to each such department.
This legislation would require off-campus outpatient departments to use a unique health identifier when billing for services.

H.R. 3417, FAIR Act
This legislation would require off-campus outpatient departments to bill for services provided using a unique health identifier.

H.R. 4509, Transparency in Billing Act
This legislation would require group health plans to only pay claims submitted by hospitals that have implemented accurate billing practices, policies and procedures.

H.R. 2559, Strengthening Community Care Act of 2023
This legislation would extend funding for the Community Health Center Fund, the National Health Service Corps and the Teaching Health Center Graduate Medical Education Program.

H.R. 2550, Special Diabetes Program Reauthorization Act of 2023
This legislation would reauthorize funding for the Special Diabetes Program through calendar year (CY) 2025.

H.R. 2547, Special Diabetes Program for Indians Reauthorization Act of 2023
This legislation would reauthorize funding for the Special Diabetes Program for Indians through CY2025.

H.R. 2665, Supporting Safety Net Hospitals Act
This legislation would delay cuts to the Medicaid Disproportionate Share Hospital (DSH) payment for fiscal years (FYs) 2024-2025.

H.R. 4527, Health Data Access, Transparency, and Affordability (DATA) Act
This legislation would improve transparency of the health insurance market and ensure that plan fiduciaries can access cost and quality of care information of their plan.

H.R. 4508, Hidden Fee Disclosure Act
This legislation would clarify and strengthen employer-sponsored health plan disclosure requirements.

For more information, click here.

House Ways and Means Committee Chair Requests Information on Rural Health Disparities

On Sept. 7, House Ways and Means Committee Chairman Jason Smith (R-MO) sent a letter to stakeholders requesting their input on how to address the challenges facing patients living in rural and underserved areas when accessing healthcare services.

The Chairman noted that the committee is particularly interested in payment disparities that exist between geographic areas, payments for identical care provided in different sites of service and the long-term financial health of healthcare providers and facilities. The committee is also interested in innovative care models that could improve patient outcomes and incentives aimed at revitalizing the healthcare workforce.

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

Senate

Senate HELP Committee Ranking Member Releases White Paper on AI

On Sept. 6, Senate Health, Education, Labor and Pensions (HELP) Committee Ranking Member Bill Cassidy (R-LA) released a white paper on artificial intelligence (AI) and its projected risks and benefits to society. The white paper focuses on AI’s potential role within the healthcare space and examines how AI could strengthen pharmaceutical research and development, disease detection and treatment, health data privacy and healthcare workload. The paper also examines AI’s potential impact on education and job security.

The Ranking Member is requesting that stakeholders submit feedback on the outlined topics by Sept. 22.

For more information, click here.

Administration

CMS Extends “Four Walls” Requirement Grace Period for States and Tribal Facilities

On Sept. 8, Center for Medicaid and Children’s Health Insurance Program (CHIP) Services (CMCS) Deputy Administrator and Director Daniel Tsai announced that the Centers for Medicare and Medicaid Services (CMS) will extend the grace period related to the “four walls” requirement for states, Indian Health Services (IHS) and tribal facilities until Feb. 11, 2025. The grace period will allow applicable facilities to continue claiming Medicaid reimbursement for services provided outside the ”four walls” of the facility.

For more information, click here.

CMS Innovation Center Announces Health Equity Model

On Sept. 5, the Centers for Medicare and Medicaid Services (CMS) Center for Medicare and Medicaid Innovation (CMMI) announced the States Advancing All-Payer Health Equity Approaches and Development (AHEAD) Model. The new voluntary, state total cost of care (TCOC) model aims to improve population health and advance health equity by reducing disparities in health outcomes. Participating states will be given resources and funding to improve the overall health of their population and to strengthen primary care within their communities. CMS will release a notice of funding opportunity (NOFO) in late fall 2023 and will begin accepting applications in spring 2024.

In addition, the CMMI announced that it will begin accepting applications for the Making Care Primary (MCP) model. The MCP model is a new primary care model aimed at improving primary care partnerships, community-based connections, and care management and coordination. The model will launch on July 1, 2024. Applications will be accepted until Nov. 30, 2023.

For more information on the AHEAD model, click here.

For more information on the MCP model, click here.

CMS Announces First 10 Drugs Selected for Medicare Drug Price Negotiation

On Aug. 29, the Centers for Medicare and Medicaid Services (CMS) released the names of the first 10 Medicare Part D drugs that will be negotiated under the Medicare Drug Price Negotiation Program. Manufacturers of the selected drugs will have until Oct. 1 to sign agreements to participate in the negotiation process. CMS will hold meetings and ask participating manufacturers to submit data on their selected drug through the end of this year. The negotiation period will end on Aug. 1, 2024, and CMS will publish the maximum fair drug prices that have been negotiated by September 2024. Prices will take effect beginning in 2026.

For more information, click here.

FDA Announces PET Drug Manufacturing Workshop

On Sept. 6, the Food and Drug Administration (FDA) announced that it will host a two-day workshop on Positron Emission Tomography (PET) drug manufacturing. The workshop will provide stakeholders with information and perspectives on PET drug development and manufacturing and regulatory application pathways. It will also provide insights into Part 212 inspections, inspectional findings and trends, and product quality assurance. The workshop will be hosted on Nov. 13-14.

For more information, click here.

FDA Announces Orphan Products Grants Program Funding Opportunity

On Sept. 6, the Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) announced a new funding opportunity within the Orphan Product Grants Program. The funding opportunity intends to support clinical trials that evaluate the efficacy and safety of medical products for patients with rare diseases or conditions. The deadline for applications is Oct. 24.

For more information, click here.

FTC to Discuss Improper Orange Book Patent Listings

On Sept. 14, the Federal Trade Commission (FTC) will meet to discuss whether improper patent listings in the Food and Drug Administration (FDA) Orange Book should be considered an unfair competitive tactic. The FTC is concerned that improper listings may be driving up the cost of prescription drugs and limiting their access. The move comes after Sen. Warren (D-MA) and Rep. Jayapal (D-WA) sent a letter to FDA Commissioner Robert Califf expressing their concern over improper Orange Book patent listings and the impact they may be having on generic drug competition.

For more information on the FTC meeting, click here.

For more information on the letter, click here.

Proposed Rules

CMS Proposed Rule Strengthens Protections Against Disability Discrimination

On Sept. 7, the Department of Health and Human Services (HHS) Office for Civil Rights (OCR) released a proposed rule that seeks to strengthen access to healthcare and human services for individuals with disabilities. It also aims to prohibit discrimination on the basis of a disability among healthcare and human services programs. The proposed rule would:

  • Clarify the application of Section 504 and ensure its consistency with the Americans with Disabilities Act, the Rehabilitation Act and case law;
  • Clarify obligations for mobile, web and kiosk accessibility;
  • Establish standards for accessible medical equipment;
  • Prohibit the use of value assessment methods that negatively assess individuals with disabilities and limit their access to aids, benefits and services; and
  • Clarify obligations to provide services to disabled persons in integrated and appropriate settings.

Public comments will be accepted until Nov. 13, 2023. For more information, click here.

CMS Proposed Rule Establishes Minimum Staffing and Payment Reporting Standards

On Sept. 1, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule that would establish minimum nursing staffing standards for long-term care (LTC) facilities and implement provisions aimed at increasing transparency of Medicaid institutional payments. The proposed rule would:

  • Require nursing facilities participating in Medicare and Medicaid to provide at a minimum, 0.55 hours of care from a registered nurse (RN) per resident per day and 2.45 hours of care from a nurse aid per resident per day;
  • Require nursing facilities to maintain at least one nurse on-site at all times;
  • Implement new nursing facility assessment requirements; and
  • Require states to publicly report on the percentage of Medicaid payments for home and community-based services that are spent on compensation for direct care workers.

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

CMS Proposed Rule Strengthens Coverage of Mental Health Insurance Benefits

On July 25, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule that would implement amendments relating to the Paul Wellstone and Pete Domenici Mental Health Parity and Addiction Equity Act of 2008 (MHPAEA). The proposed rule would:

  • Clarify that the MHPAEA ensures an individual’s right to access mental health and substance use disorder benefits in parity with medical/surgical benefits;
  • Provide examples that make clear that plans and issuers may not use restrictive prior authorization and other medical management techniques or standards related to network composition for mental health and substance use disorder benefits;
  • Clarify that certain factors may not be used to determine out-of-network reimbursement rates for mental health and substance use disorder providers;
  • Require plans and issuers to gather and analyze outcomes data and take action to resolve material differences in access to mental health and substance use disorder benefits and medical/surgical benefits;
  • Codify a requirement that directs plans and issuers to conduct meaningful comparative analyses to measure the impact of nonquantitative treatment limitation (NQTL); and
  • Implement a sunset provision adopted in the Consolidated Appropriations Act of 2023, that allows self-funded, non-federal government plan elections to opt out of compliance with MHPAEA.

In addition to CMS, the Internal Revenue Service and the Employee Benefits Security Administration are proposing the rule. The agencies are also seeking comments and information on proposed new data requirements for limitations related to the composition of a health plan’s or issuer’s network.

Public comments will be accepted until Oct. 2, 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 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 Final Rule Updates Inpatient and Long-Term Care Hospital PPS Rates in FY 2024

On Aug. 1, the Centers for Medicare and Medicaid Services (CMS) released a final rule that would update the Medicare hospital inpatient prospective payment system (PPS) and long-term care hospital (LTCH) PPS rates in fiscal year (FY) 2024. The final rule would also update the Hospital Value-Based Purchasing (VBP) Program and the Inpatient Quality Reporting Program (QRP). It would:

  • Increase Medicare inpatient PPS rates by 3.1 percent. This is based on a 3.3 percent market basket increase and a decrease in productivity of 0.2 percent;
  • Finalize changes to graduate medical education (GME) payments for Rural Emergency Hospitals;
  • Extend the low wage index hospital policy that considers rural reclassified hospitals as geographically rural when calculating the wage index;
  • End the New COVID-19 Treatments Add-on Payment (NCTAP) policy;
  • Revise physician self-referral data and information and reinstate program integrity restrictions on certain physician-owned hospitals;
  • Add one new measure to the Hospital VBP;
  • Add three new measures to the Inpatient QRP; and
  • Finalize a CMS proposal relating to the calculation of Medicaid 1115 demonstration days used in the Medicare disproportionate share hospital (DSH) adjustment.

The final rule will go into effect on Oct. 1, 2023. For more information, click here.

CMS Final Rule Updates PPS Rates for Skilled Nursing Facilities in FY 2024

On July 31, the Centers for Medicare and Medicaid Services (CMS) released a final rule that would update the prospective payment system (PPS) for skilled nursing facilities (SNFs) in fiscal year (FY) 2024. The final rule would also update the SNF Quality Reporting Program (QRP) and the SNF Value-Based Purchasing (VBP) Program. It would:

  • Increase SNF PPS payments by a net 4.0 percent;
  • Codify changes to the Patient Driven Payment Model (PDPM) International Classification of Diseases, 10th revision, Clinical Modification codes;
  • Finalize a requirement that would exclude marriage and family therapy and mental health counseling services from SNF Consolidated Billing;
  • Add two new measures to the SNF QRP;
  • Add four new measures to the SNF VBP Program; and
  • Streamline CMS administrative procedures to strengthen its enforcement of nursing home quality compliance.

The rule will go into effect on Oct. 1, 2023. Two amendments in the rule will go into effect on Jan. 1, 2024.

For more information, click here.

CMS Final Rule Updates Hospice Wage Index and Payment Rate in FY 2024

On July 28, the Centers for Medicare and Medicaid Services (CMS) released a final rule that would update the hospice wage index, payment rates and aggregate cap amount in fiscal year (FY) 2024. The final rule would also implement updates to the Hospice Quality Reporting Program (HQRP). It would:

  • Codify hospice data submission thresholds for the HQRP;
  • Implement updates to the CMS Hospice Special Focus Program (SFP);
  • Update health equity and future quality reporting measures;
  • Update the Hospice Outcomes and Patient Evaluation tool; and
  • Require hospice certifying physicians to be Medicare-enrolled or to validly opt-out.

The rule will go into effect on Oct. 1, 2023. For more information, click here.

CMS Final Rule Updates PPS Rates for Inpatient Psychiatric Facilities in FY 2024

On July 27, the Centers for Medicare and Medicaid Services (CMS) released a final rule that would update the prospective payment system (PPS) rates for inpatient psychiatric facilities (IPFs) in fiscal year (FY) 2024. The final rule would also implement updates to the IPF Quality Reporting Program (QRP). It would:

  • Update the IPF PPS payment rate by 3.3 percent;
  • Adopt a 2021-based IPF market basket;
  • Adopt four new QRP measures;
  • Allow IPFs to open new units and be paid under the IPF PPS at any time during the cost reporting period;
  • Remove two QRP measures beginning in FY 2025; and
  • Adopt a data validation pilot program beginning in FY 2025.

The rule will go into effect on Oct. 1, 2023. For more information, click here.

CMS Final Rule Updates PPS Rates for Inpatient Rehabilitation Facilities in FY 2024

On July 27, the Centers for Medicare and Medicaid Services (CMS) released a final rule that would update the prospective payment system (PPS) rates for inpatient rehabilitation facilities (IRFs) in fiscal year (FY) 2024. The final rule would also implement updates to the IRF Quality Reporting Program (QRP). It would:

  • Increase IRF PPS payment rates by an estimated 4 percent, approximately $355 million more relative to FY 2023. This is based off a market basket update of 3.6 percent, minus a 0.2 percentage point for productivity and a 0.6 percentage point increase in the outlier threshold;
  • Allow hospitals to open a new IRF and receive payment under the IRF PPS at any time during the cost reporting period;
  • Adopt a 2021-based IRF market basket and implement updated market basket cost weights, price proxies and labor-related share;
  • Adopt two new QRP measures, modify one measure and remove three measures; and
  • Finalize proposals that require the public reporting of four QRP measures.

The rule will go into effect on Oct. 1, 2023. For more information, click here.

DEA Releases Temporary Rule Extending COVID-19 Telemedicine Flexibilities

On May 10, the Drug Enforcement Administration (DEA) and the Substance Abuse and Mental Health Services Administration (SAMHSA) released a temporary rule that extends telemedicine flexibilities adopted during the COVID-19 public health emergency (PHE). The temporary rule follows two Notices of Proposed Rulemaking (NPRM) regarding the virtual prescribing of controlled substances that the DEA released in March 2023, which received more than 38,000 public comments. The temporary rule specifically:

  • Extends through Nov. 11, 2023, the COVID-19 PHE controlled substance prescribing flexibilities that allow practitioners to prescribe controlled substances via telemedicine without having to evaluate patients in person.
  • Implements a one-year grace period through Nov. 11, 2024, for practitioners and patients who have or who develop a telemedicine relationship on or before Nov. 11, 2023. A “telemedicine relationship” is considered to exist if a practitioner has already issued a prescription for a controlled substance to a patient.

The temporary rule will stay in effect through Nov. 11, 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.

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.

Courts

Novartis Files Lawsuit Against CMS

On Sept. 1, Novartis filed a lawsuit against the Centers for Medicare and Medicaid Services (CMS) after its heart drug Entresto was listed among the 10 drugs that will undergo price negotiation under the Medicare Drug Price Negotiation Program. AstraZeneca, Johnson and Johnson, and Merck are also suing CMS over the program.

For more information, click here.

Astellas Withdraws Lawsuit Against CMS

On Sept. 6, Astellas announced that it would drop the lawsuit it filed against the Centers for Medicare and Medicaid Services (CMS) over the Medicare drug price negotiation program. The suit was withdrawn after CMS released a list of the first 10 drugs that will face negotiation. Astellas had been expecting its prostate cancer drug Xtandi to be selected for negotiation and acknowledged that this had driven the company to sue CMS in July.

For more information, click here.

Reports

GAO Releases Report on Medical Device Advertising

On Sept. 8, the Government Accountability Office (GAO) released a report regarding the advertising of medical devices and the role that the Federal Trade Commission (FTC) and the Food and Drug Administration (FDA) play in overseeing direct-to-consumer advertising. To investigate this, the GAO reviewed FTC and FDA documentation, interviewed agency officials and analyzed agency data.

The GAO discovered that the FTC and FDA had taken over 300 enforcement actions related to medical device ads between 2018 and 2022. Additionally, the GAO discovered that both agencies had conducted outreach to consumers and businesses to educate them on the rules regarding direct-to-consumer advertising. The GAO conducted this report because it was asked to review federal oversight and the effects of medical device direct-to-consumer advertising.

For more information, click here.

GAO Releases Report on Medicare Part D Drug Rebates

On Sept. 5, the Government Accountability Office (GAO) released a report regarding the impacts Medicare Part D prescription drug rebates are having on formularies and beneficiaries. The GAO reviewed CMS rebate and expenditure data and interviewed CMS officials, plan sponsors and manufacturers.

The GAO discovered that plan sponsors received $48.6 billion in rebates from drug manufacturers in 2021. The GAO also discovered that rebates may influence formulary design, affect beneficiary access for certain prescription drugs and result in higher beneficiary payments relative to payments for competing drugs with lower gross costs. The GAO conducted this report because it was asked to examine rebates in the Part D program.

For more information, click here.

NOTE:

McGuireWoods Consulting Telehealth Flexibility Guidance Now Available

McGuireWoods Consulting has compiled a list of all the telehealth flexibilities that were issued during the COVID-19 public health emergency. The list outlines flexibilities relating to physicians, hospitals, home health agencies and other providers, and displays their current status.

For more information, click here.