Washington Healthcare Update

September 25, 2023

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This Week in Washington: House appropriations talks continue, Senate vote to advance mini omnibus fails; Lower Costs, More Transparency Act pulled from House consideration; House Budget Committee marks up budget resolution

Upcoming Hearings

Congress

House

Senate

Administration

Proposed Rules

Final Rules

Reports

CBO Cost Estimates

Upcoming Hearings

September 27

Senate

Senate Committee on the Budget Full Committee Hearing: “Medicare Forever: Protecting Seniors by Making the Wealthy Pay Their Fair Share”
10:00 a.m., Dirksen Senate Office Building 106
Announced witnesses are:

  • The Honorable Marilyn Moon, Visiting Scholar from the Center for Medicare Advocacy
  • Chye-Ching Huang, Executive Director of the New York University School of Law Tax Law Center
  • James C. Capretta, Senior Fellow and Milton Friedman Chair of the American Enterprise Institute

House

Appropriations Talks Continue As Shutdown Nears

Both the House and Senate return Tuesday to consider appropriations. In the Senate, they are prepping a Continuing Resolution (CR) to go to sometime in December. Both Republicans and Democrats are involved in crafting it. However, because Sen. Rand Paul (R-KY) objects to the inclusion of funding for Ukraine, the Senate cannot speed up consideration of the legislation. Thus, the Senate legislation is unlikely to be sent to the House until the end of the week or Saturday at the earliest.

In the House, Speaker McCarthy has been discussing a CR only through early or mid-November. He has been told by several Republicans that if he gets a bill done with Democrats, they will trigger consideration of his removal.

The House leaders have lined up 4 appropriations bills to be considered this week – Defense, Ag, State-Foreign Ops and Homeland Security. However, there is a complicated rule to allow this to happen. Leadership is now trying to determine if they have enough votes for the rule. If the rule fails, they cannot move forward. On Saturday, McCarthy floated to his caucus a 30 day CR or a 45 day CR. He may try to attach a CR to the border security bill and possibly include a debt commission, after the four appropriations bills are considered. By then the Senate may be wrapping up their CR.

Lower Costs, More Transparency Act Pulled from House Consideration

On Sept. 18, the House was expected to hold a floor vote on the Lower Costs, More Transparency Act but the bill was unexpectedly pulled from consideration. The bill is a large healthcare package that includes provisions to increase hospital and other provider price transparency, implement site-neutral payments for off-campus hospital outpatient departments, ban pharmacy benefit manager (PBM) spread pricing and extend funding for health programs.

House Energy and Commerce Committee Chairman Cathy McMorris Rodgers (R-WA) has announced that she remains committed to getting the bill passed by year’s end.

House Budget Committee Marks Up Budget Resolution for FYs 2024-2033

On Sept. 20, the House Budget Committee reported out of committee the Concurrent Resolution on the Budget for fiscal years (FYs) 2024-2033. The budget resolution outlines House Republican spending priorities over the next 10 years. It seeks to balance the budget and reduce the deficit by a projected $16.3 trillion by 2033, resulting in an estimated $130 billion budget surplus in FY 2033. It would:

  • Cap FY 2024 discretionary spending at $1.47 trillion and limit spending growth at 1 percent per year;
  • Cut total discretionary spending by $4.6 trillion by FY 2033;
  • Cut mandatory spending by $8.7 by FY 2033;
  • Lower interest payments on the national debt by $3 trillion;
  • Repeal Inflation Reduction Act and Green New Deal provisions; and
  • Create a bipartisan commission to recommend changes and oversee the solvency of Social Security and Medicare.

In addition, the resolution contains several policy statements, including one that urges Congress to enact legislation implementing Medicaid work requirements and decreasing the share of federal funds supporting state healthcare services. It is doubtful that the budget resolution will be considered by the full House.

For more information, click here.

House Energy and Commerce Committee Chairmen Send Letter to CDC and USDA Regarding Federal Select Agent Program

On Sept. 15, House Energy and Commerce Committee Chairman Cathy McMorris Rodgers (R-WA), Subcommittee on Oversight and Investigations Chairman Morgan Griffith (R-VA) and Subcommittee on Health Chairman Brett Guthrie (R-KY) sent a letter to Centers for Disease Control and Prevention Director Mandy Cohen and Department of Agriculture Secretary Tom Vilsack requesting information on the federal select agent program (FSAP).

The FSAP oversees the possession, use and transfer of potentially dangerous biological agents and toxins. The chairmen are interested in the program because the committee is investigating the safety and security of federal high-containment laboratories.

For more information, click here.

Vote Planned for SUPPORT Act Reauthorization and Maternal Health Legislation

The House plans to vote this week on legislation to reauthorize the SUPPORT Act, and vote on maternal health legislation that was reported out of the Senate Health Education Labor and Pensions (HELP) Committee on Sept. 21.

The Preventing Maternal Deaths Reauthorization Act of 2023 reauthorizes the Center for Disease Control and Prevention’s support for state-based mortality review committees through fiscal year 2028. The legislation also includes a new provision directing CDC, in consultation with the Health Resources and Services Administration, to disseminate best practices on maternal mortality prevention to hospitals, state-based professional societies and perinatal quality collaboratives.

The Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities (SUPPORT) Act would advance the requirement that state Medicaid plans provide medication-assisted treatment and continued support for Naloxone for first responders.

Senate

Senate Vote to Move Forward “Mini Omnibus” Fails

On Sept. 20, the Senate failed to move forward a package of three appropriations bills known as a “mini omnibus” that combines the Agriculture-FDA, Military Construction-VA and Transportation-HUD appropriations bills. Republican senators continue holding out on supporting the bill, notably Sen. Rand Paul (R-KY) who announced that he will not support any bill that includes military aid to Ukraine.

Senate HELP Committee Marks Up Bipartisan Primary Care and Health Workforce Act

On Sept. 21, the Senate Health, Education, Labor and Pensions (HELP) Committee marked up and moved out of committee the Bipartisan Primary Care and Health Workforce Act. The legislation, which was introduced by Chairman Bernie Sanders (I-VT) and Sen. Marshall (R-KS), aims to address primary care challenges and health workforce shortages and would reauthorize community health and medical education programs. It would:

  • Reauthorize $5.8 billion per year in funding for the Community Health Center Fund through fiscal year (FY) 2026;
  • Reauthorize $1.5 billion in funding for the Teaching Health Center Graduate Medical Education Program through FY 2028;
  • Reauthorize $950 million per year in funding for the National Health Service Corps through FY 2026;
  • Provide $1.2 billion in grants to community colleges and universities to increase nursing program enrollment;
  • Provide $300 million to primary care doctor residency programs and invest in dental training and workforce programs; and
  • Implement provisions aimed at prohibiting anticompetitive practices by hospitals and insurance companies, including banning certain facility fees.

Ranking Member Bill Cassidy (R-LA) opposed the legislation, announcing that it is rushed and fails to specify how funding increases will be paid for. During the mark up, he submitted 67 amendments but withdrew the majority of them, citing a lack of support.

The Ranking Member and a number of HELP committee senators are concerned about cost offsets included in the bill that would draw funds from the Prevention and Public Health Fund. The Chairman has announced that he was continuing to look for other funding sources, including drawing funds from bills related to pharmacy benefit managers (PBMs) and generic drug access. He is also in discussions with the Chair of the Senate Finance Committee, Sen. Ron Wyden (D-OR), concerning potential pay for mechanisms.

In addition, the committee reported out of committee bills related to maternity and pediatric healthcare programs.

For more information, click here.

Administration

White House Establishes Office of Gun Violence Prevention

On Sept. 21, the White House announced that it would establish the Office of Gun Violence Prevention. The office will work toward developing executive actions and legislation to reduce gun violence.

For more information, click here.

White House Announces Restart of Mail Order COVID-19 Test Program

On Sept. 20, the White House announced that it will restart the federal mail order COVID-19 test program. Households will be able to order a maximum of four COVID-19 tests through the mail starting Sept. 25. In addition, the Department of Health and Human Services (HHS) Administration for Strategic Preparedness and Response (ASPR) announced that it had awarded $600 million to 12 domestic COVID-19 test manufacturers to increase the availability of rapid test kits.

For more information, click here.

HHS Awards $45 Million to Expand Access of Long COVID Care Services

On Sept. 20, the Department of Health and Human Services (HHS) Agency for Healthcare Research and Quality (AHRQ) announced that it had awarded $45 million in grants to expand access to healthcare services for individuals with Long COVID. The funding will help strengthen access to care, person-centered care coordination, multi-disciplinary behavioral healthcare networks and social support services.

For more information, click here.

CDC Awards $262 Million to Support Outbreak Analytics and Disease Modeling Network

On Sept. 19, the Centers for Disease Control and Prevention (CDC) announced that it had awarded $262 million in grants to support the establishment of the Outbreak Analytics and Disease Modeling Network (OADMN). The OADMN will support state and local stakeholders in developing and implementing tools to detect, respond to and mitigate public health emergencies.

CMS Announces Reinstatement of 500,000 Medicaid and CHIP Enrollees

On Sept. 21, the Centers for Medicare and Medicaid Services (CMS) announced that nearly 500,000 children and individuals had regained their Medicaid and Children’s Health Insurance Program (CHIP) coverage following a technical glitch known as “ex parte” in state enrollment systems that had automatically disenrolled enrollees who were still eligible for coverage. CMS had notified states of the technical glitch in a call to action issued on Aug. 30.

For more information, click here.

FDA Releases Guidance Regarding Use of Alternative Tools to Assess Drug Facilities

On Sept. 21, the Food and Drug Administration (FDA) released guidance regarding the use of alternative tools to assess drug manufacturing facilities identified in drug applications using new drug applications (NDA), abbreviated new drug applications (ANDA) or biologics license applications (BLA). The guidance seeks to encourage facilities to incorporate best practices.

For more information, click here.

FDA Releases Draft Guidance on PDUFA Product Meeting Management Practices

On Sept. 21, the Food and Drug Administration (FDA) released a draft guidance outlining good meeting practices and procedures for Prescription Drug User Fee Act (PDUFA) meetings held between the FDA and sponsors and applicants of drug and biological products. The draft guidance aims to promote consistent and well-managed meetings.

For more information, click here.

FDA Releases Guidance on Assessing Clinical Trial Confirmatory Evidence

On Sept. 19, the Food and Drug Administration (FDA) released guidance regarding the assessment of clinical trial factors used to confirm substantial evidence of a drug’s effectiveness. The guidance outlines factors that should be used to assess whether a single adequate and well-controlled clinical investigation demonstrates evidence of effectiveness. It also provides examples of data sources that could be considered confirmatory evidence.

For more information, click here.

FDA Releases Information Technology Strategy for FY 2024 to 2027

On Sept. 18, the Food and Drug Administration (FDA) released its information technology (IT) strategy for fiscal years (FYs) 2024 to 2027. The strategy revolves around six IT goals and objectives that include:

  • Creating a shared OneFDA Ecosystem;
  • Strengthening IT Infrastructure;
  • Modernizing Enterprise Services and Capabilities;
  • Sharing Data for Mission Outcomes;
  • Adopting AI and Mission-Driven Innovations; and
  • Cultivating Talent and Leadership.

For more information, click here.

FDA Releases Draft Guidance Regarding Labeling for Biosimilar Products

On Sept. 18, the Food and Drug Administration (FDA) released a draft guidance regarding labeling for biosimilar and interchangeable biosimilar products. The draft guidance intends to assist applicants with developing draft labeling for proposed biosimilar and interchangeable biosimilar products being submitted in an application under Section 351(k) of the Public Health Service Act.

For more information, click here.

FDA Releases Draft Guidance Regarding Prescription Drug Use-Related Software

On Sept. 18, the Food and Drug Administration (FDA) released a draft guidance regarding prescription drug use-related software. The draft guidance intends to clarify how the FDA will apply drug labeling authorities to end-user output of prescription drug use-related software and when and how sponsors should submit end-user output to the FDA.

For more information, click here.

Proposed Rules

CMS Proposed Rule Increases No Surprises Act IDR Administrative Fee

On Sept. 21, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule that would increase the administrative fee for disputes initiated within the No Surprises Act independent dispute resolution (IDR) process. The proposed rule would:

  • Increase the IDR administrative fee from $50 to $150 per party per dispute;
  • Increase the fee range for certified IDR entities by 20 percent for single determinations; and
  • Increase the fee range for certified IDR entities by 25 percent for batched determinations.

In addition, the Internal Revenue Service (IRS) and the Employee Benefits Security Administration are proposing the rule.

Public comments will be accepted until Oct. 26, 2023. For more information, click here.

CMS Extends Comment Period for Proposed Rule Strengthening Coverage of Mental Health Insurance Benefits

On Sept. 21, the Centers for Medicare and Medicaid Services (CMS) announced that it would extend the comment period for 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. 17, 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 aide 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.

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.

OCR 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.

Final Rules

CMS Final Rule Streamlines Medicare Savings Program Enrollment Process

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

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

The final rule will go into effect on Nov. 17, 2023. For more information, click here.

CMS Final Rule Mandates Medicaid and CHIP Program Core Set Measures Reporting

On Aug. 31, the Centers for Medicare and Medicaid Services (CMS) released a final rule that would establish mandatory state reporting requirements for the following quality measures:

  • Core set of Children’s Health Care Quality measures under Medicaid and the Children’s Health Insurance Program (CHIP);
  • Behavioral health measures on the Core Set of Adult Health Care Quality Measures for Medicaid; and
  • Core Sets of Health Home Quality Measures for Medicaid.

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

CMS 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.

Reports

GAO Releases Report Regarding Medicaid Integrity and Audit Coordination

On Sept. 21, the Government Accountability Office (GAO) released a report regarding the integrity of the Medicaid program and the state of coordination between the Centers for Medicare and Medicaid Services (CMS) and state Medicaid auditors. The GAO analyzed Medicaid single audit data and interviewed CMS officials and state auditors from seven selected states.

The GAO found that some state auditors face challenges when conducting Medicaid audits, including a lack of resources and training. Additionally, the GAO found that CMS had not yet used its analysis of audit trends to inform its oversight over state auditors. The GAO conducted this study because it was asked to examine CMS and state auditor coordination.

For more information, click here.

GAO Releases Report Regarding COVID-19 Provider Relief Fund Payments

On Sept. 21, the Government Accountability Office (GAO) released a report regarding the COVID-19 Provider Relief Fund (PRF). The report analyzes how effective the Health Resources and Services Administration (HRSA) has been at recovering PRF payments that were made inappropriately. The GAO analyzed data on PRF payments, interviewed agency officials and reviewed information and documentation on payment integrity activities.

The GAO found that as of May 2023, HRSA had successfully recovered half of the $2.6 billion in PRF payments that were identified for recovery. The GAO also discovered that HRSA has established clear time frames to recover most of the remaining payments. The GAO conducted this study because a provision in the Coronavirus Aid, Relief, and Economic Security (CARES) Act required it to monitor and report on the federal response to the COVID-19 pandemic.

For more information, click here.

CBO Cost Estimates

CBO Releases Presentation Explaining the Federal Budget Process and the Role of CBO

On Sept. 19, the Congressional Budget Office (CBO) released a presentation that explains the federal budget process and the role of the CBO. The presentation outlines how the CBO conducts analysis of budgetary and economic issues, analyzes healthcare legislation and prepares budget estimates.

For more information, click here.