This Week in Washington: Senate Finance Committee releases discussion draft for Nov. 8 markup; White House issues executive order on AI; House passes two appropriations bills; Senate passes minibus.

Upcoming Hearings

Congress

House

• House Passes Two Appropriations Bills and Continues to Discuss a Continuing Resolution
• House Energy and Commerce Chairmen Send Letters Concerning Improper Medicaid Payments and Budget Neutrality Requirements
• House Energy and Commerce Chairmen Threaten to Subpoena FDA Over Laboratory Safety Rules Violations

Senate

• Senate Passes Minibus
• Senate Finance Committee Chairman and Ranking Member Release Discussion Draft Containing PBM, MA and Mental Health Proposals
• Senate HELP Committee Ranking Member Launches Healthcare Cybersecurity Working Group
• Senate HELP Committee Ranking Member Pushes for Oversight on School-Based Health Centers
• Senate HELP Committee to Hold Subcommittee Hearing on Role of AI in Healthcare

Administration

• White House Issues Executive Order on AI
• White House OMB Reviewing CMS Prior Authorization and Interoperability Final Rule
• HHS OIG Releases Report Regarding HHS’ Oversight of Provider Relief Fund Payments
• HHS Secretary Sends Letter Concerning COVID-19 Drug Stakeholder Partnerships
• CMS Extends Medicare Diabetes Prevention Program Flexibilities
• CMS Releases New Alert on MSP
• FDA Issues Guidance Regarding PMA and HDE Submission Supplements
• FDA Revises Paxlovid EUA
• FDA Approves Inflammatory Disease Interchangeable Biosimilar

Proposed Rules

• CMS Proposes Rule to Penalize Providers Who Block Electronic Health Information
• CMS Proposes Rule Regarding Federal IDR Process
• FDA Proposes Rule Regarding Laboratory Developed Tests
• FDA Proposes Rule to Broaden Prescription Drug Labeling Regulations
• OCR Proposed Rule Strengthens Protections Against Disability Discrimination

Final Rules

• CMS Final Rule Outlines Remedy for 340B Payment Cuts Deemed Unlawful Between CYs 2018-2022
• CMS Final Rule Updates 2024 Medicare Physician Fee Schedule
• CMS Final Rule Updates 2024 Hospital OPPS and ASC Payment System
• CMS Final Rule Updates 2024 Home Health Prospective Payment System
• CMS Final Rule Updates 2024 ESRD Prospective Payment System
• CMS Final Rule Specifies When and How CMS Imposes Civil Money Penalties
• CMS Final Rule Streamlines Medicare Savings Program Enrollment Process
• CMS Final Rule Mandates Medicaid and CHIP Program Core Set Measures Reporting
• CMS Finalizes 2024 Medicare Advantage and Part C and D Payment Policies
• FDA Issues Final Rule Regarding Mammography Quality Standards

Courts

• AHA Sues HHS OCR Over Data Privacy Rule

CBO Cost Estimates

• CBO Releases Working Paper Projecting Short- and Long-Term Fiscal Effects of Medicaid Spending on Children

Upcoming Hearings

Nov. 7

Senate Committee on the Judiciary Subcommittee on Privacy, Technology and the Law Hearing: “Social Media and the Teen Mental Health Crisis”
10:00 a.m., Dirksen Senate Office Building 226
Witnesses to be announced.

Nov. 8

Senate Committee on Appropriations Full Committee Hearing: “A Review of the President’s Supplemental Request for the Departments of Health and Human Services and Homeland Security”
9:00 a.m., Dirksen Senate Office Building 106
Announced witnesses are:

• The Honorable Xavier Becerra, Secretary of the Department of Health and Human Services
• The Honorable Alejandro Mayorkas, Secretary of the Department of Homeland Security

Senate Health, Education, Labor and Pensions Committee Subcommittee on Primary Health and Retirement Security Hearing: “Avoiding a Cautionary Tale: Policy Considerations for Artificial Intelligence in Health Care”
2:30 p.m., Dirksen Senate Office Building 430
Announced witnesses are:

• Thomas Inglesby, Director of the Johns Hopkins Center for Health Security
• Kenneth D. Mandl, Harvard Professor and Director of the Boston Children’s Hospital Computational Health Informatics Program
• Christine Huberty, Supervising Attorney of the Greater Wisconsin Agency on Aging Resources
• Keith Sale, Vice President and Chief Physician Executive of Ambulatory Services at the University of Kansas Health System

Congress

House

House Passes Two Appropriations Bills and Continues to Discuss a Continuing Resolution

Last week, the House passed the Legislative Branch and Interior-Environment appropriations bills. It is unclear if the Senate will accept these bills and they will likely have to be conferenced. On Nov. 2, the House was scheduled to vote on the Transportation-HUD funding bill but the vote was postponed.

The Speaker of the House continues to discuss a continuing resolution (CR) with the Republican Caucus. On Nov. 2, Speaker Johnson proposed a “laddered CR,” which would set staggered funding deadlines for each appropriations bills. This would likely force Congress to pass appropriations bills on an individual basis instead of combining and passing them together in an omnibus package as has typically been done.

Please see Senate story on the minibus.

House Energy and Commerce Chairmen Send Letters Concerning Improper Medicaid Payments and Budget Neutrality Requirements

On Oct. 31, House Energy and Commerce Committee Chairman Cathy McMorris Rodgers (R-WA) and two subcommittee chairmen, Brett Guthrie (R-KY) and Morgan Griffith (R-VA), sent a letter to Department of Health and Human Services (HHS) Inspector General Christi Grimm and Centers for Medicare and Medicaid Services (CMS) Administrator Chiquita Brooks-LaSure concerning the prevalence of improper payments within the Medicaid program. The chairmen are requesting information on the steps the agencies have taken to address them.

In addition, the chairmen sent letters to CMS Administrator Chiquita Brooks-LaSure and Government Accountability Office (GAO) Comptroller General Gene Dodaro regarding changes made to budget neutrality requirements for Medicaid demonstrations. The chairmen are concerned about the potential for fraud in the calculation of state budget neutrality limits under Section 1115 Medicaid waivers.

For more information on the letter to HHS, click here.
For more information on the letter to CMS on improper payments, click here.
For more information on the letter to CMS on budget neutrality, click here.
For more information on the letter to the GAO, click here.

House Energy and Commerce Chairmen Threaten to Subpoena FDA Over Laboratory Safety Rules Violations

On Nov. 1, House Energy and Commerce Committee Chairman Cathy McMorris Rodgers (R-WA) and two subcommittee chairmen, Brett Guthrie (R-KY) and Morgan Griffith (R-VA), sent a letter to Food and Drug Administration (FDA) Commissioner Robert Califf, warning that the committee could subpoena the FDA if it fails to provide information regarding federal laboratory safety rules violations. The chairmen are concerned about the FDA’s noncompliance with federal workplace safety regulations and its delays in addressing laboratory safety recommendations from the Government Accountability Office.

The committee began this Congress with an oversight hearing that investigated the origins of the COVID-19 pandemic and in April, it held a subcommittee hearing on biosafety and risky research practices.

For more information, click here.

Senate

Senate Passes Minibus

On Nov. 1, the Senate passed the mini-omnibus funding package by an 82-15 vote. The minibus contains the Agriculture-FDA, Military Construction-VA and Transportation-HUD appropriations bills.

Please see House story on appropriations.

Senate Finance Committee Chairman and Ranking Member Release Discussion Draft Containing PBM, MA and Mental Health Proposals

On Nov. 2, Senate Finance Committee Chairman Ron Wyden (D-OR) and Ranking Member Mike Crapo (R-ID) released a discussion draft that includes legislative proposals aimed at addressing Medicare and Medicaid mental health and substance use disorder providers, prescription drug costs, funding for primary care physicians and access to telehealth mental health services. It also includes extenders for Medicare and Medicaid provisions that are set to expire this year.

The committee will mark up the discussion draft on Nov. 8 alongside legislation concerning pharmacy benefit manager (PBM) reforms that was reported favorably by the committee in July. The Chairman and Ranking Member have been focused on reforming PBMs and lowering prescription drug costs since releasing a legislative framework in April.

For more information, click here.

Senate HELP Committee Ranking Member Launches Healthcare Cybersecurity Working Group

On Nov. 2, Senate Health, Education, Labor and Pensions (HELP) Committee Ranking Member Bill Cassidy (R-LA), Senate Intelligence Committee Chairman Mark Warner (D-VA) and Sens. Cornyn (R-TX) and Hassan (D-NH) established a bipartisan healthcare cybersecurity working group.

The working group will examine cybersecurity proposals under HELP committee jurisdiction and will work towards crafting legislation aimed at strengthening cybersecurity within the healthcare and public health sectors.

For more information, click here.

Senate HELP Committee Ranking Member Pushes for Oversight on School-Based Health Centers

On Oct. 17, Senate Health, Education, Labor and Pensions (HELP) Committee Ranking Member and Senate Finance Committee member Bill Cassidy (R-LA) sent a letter to HELP Committee Chairman Bernie Sanders (I-VT) regarding school-based health centers (SBHCs).

The Ranking Member is requesting that the Chairman establish a process to review and evaluate SBHCs within the HELP Committee, and schedule a hearing on the SBHC Program and the Full-Service Community Schools Program.

For more information, click here.

Senate HELP Committee to Hold Subcommittee Hearing on Role of AI in Healthcare

On Nov. 8, the Senate Health, Education, Labor and Pensions (HELP) Committee Subcommittee on Primary Health and Retirement Security will hold a hearing on the role of artificial intelligence (AI) in healthcare.

The hearing comes after the White House issued an executive order on AI that directs federal agencies to develop AI standards and oversight strategies. On Oct. 31, the subcommittee held a hearing to examine the role of AI in the workforce.

For more information, click here.

Administration

White House Issues Executive Order on AI

On Oct. 30, the White House issued an executive order on the development and use of artificial intelligence (AI) systems. It directs federal agencies to set AI data privacy and cybersecurity standards and develop strategies to address discrimination, fairness and innovation concerns.

The executive order requires the Department of Health and Human Services to:

• Establish a task force to draft a strategic plan concerning the responsible use of AI;
• Determine the applicable uses of AI in drug and device safety, research and public health;
• Evaluate whether AI could discriminate against patients; and
• Identify the benefits public-private partnerships could have on drug development.

For more information, click here.

White House OMB Reviewing CMS Prior Authorization and Interoperability Final Rule

On Oct. 25, the Centers for Medicare and Medicaid Services sent a final rule concerning Medicare and Medicaid prior authorization and interoperability to the White House Office for Management and Budget for review.

The final rule would require Medicare fee-for-service, Medicare Advantage and Medicaid plans to establish an electronic prior authorization system to allow for the sharing of patient clinical and claims data.

HHS OIG Releases Report Regarding HHS’ Oversight of Provider Relief Fund Payments

On Nov. 1, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) released a report regarding HHS’ oversight of automatic Provider Relief Fund (PRF) payments. The PRF was established to provide funds to healthcare providers who lost revenue due to the COVID-19 pandemic.

The OIG found that HHS was mostly effective in overseeing the distribution of PRF automatic payments but that it failed to ensure the proper calculation of $2.16 billion in payments and did not stop the disbursal of $247 million to ineligible providers.

For more information, click here.

HHS Secretary Sends Letter Concerning COVID-19 Drug Stakeholder Partnerships

On Oct. 27, Department of Health and Human Services (HHS) Secretary Xavier Becerra sent a letter to COVID-19 drug manufacturers, distributors and insurers, urging them to maintain strong partnerships with HHS and the Centers for Medicare and Medicaid Services during the transition period of COVID-19 drugs to the commercial market.

For more information, click here.

CMS Extends Medicare Diabetes Prevention Program Flexibilities

On Nov. 2, the Centers for Medicare and Medicaid Services released a final rule that updates the Medicare Physician Fee Schedule (PFS) payment rates for calendar year 2024. The final rule also extends Medicare Diabetes Prevention Program (MDPP) enhancements and will allow MDPP suppliers to continue using specific COVID-19 public health emergency flexibilities through Dec. 31, 2027.

For more information, click here.

CMS Releases New Alert on MSP

On Nov. 2, the Centers for Medicare and Medicaid Services released a new alert regarding Medicare Secondary Payer and Certain Civil Money penalties.

For more information, click here.

FDA Issues Guidance Regarding PMA and HDE Submission Supplements

On Nov. 2, the Food and Drug Administration issued guidance concerning supplements medical device manufacturers must generally submit following the modification of a device approved under the Premarket Approval (PMA) and Humanitarian Device Exemption (HDE) programs.

The guidance clarifies that the FDA will allow manufacturers to forego submission of supplements when making limited modifications to devices aimed at alleviating manufacturing shortages and supply chain issues.

For more information, click here.

FDA Revises Paxlovid EUA

On Nov. 1, the Food and Drug Administration announced that it had revised the emergency use authorization (EUA) for Paxlovid. The revised EUA clarifies that EUA-labeled Paxlovid may continue to be used to treat COVID-19 adult and pediatric patients during Paxlovid’s transition to the commercial market.

For more information, click here.

FDA Approves Inflammatory Disease Interchangeable Biosimilar

On Oct. 31, the Food and Drug Administration approved Wezlana (ustekinumab-auub), a biosimilar used to treat inflammatory diseases including plaque psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitis. Wezlana is interchangeable with Stelara (ustekinumab).

For more information, click here.

Proposed Rules

CMS Proposes Rule to Penalize Providers Who Block Electronic Health Information

On Oct. 30, the Centers for Medicare and Medicaid Services released a proposed rule that would establish disincentives for healthcare providers who knowingly interfere with the access, exchange or use of electronic health information except when required by law or regulatory exception. The proposed rule would:

• Under the Medicare Promoting Interoperability Program, penalize hospitals that block information by reducing their annual market basket increase by 75 percent and reducing a critical access hospital’s payment to 100 percent of reasonable costs;
• Under the Merit-based Incentive Payment System Promoting Interoperability performance category, penalize clinicians or groups by awarding them a zero score for the category; and
• Under the Medicare Shared Savings Program, penalize accountable care organizations (ACO) and ACO participants, providers or suppliers by deeming them ineligible to participate in the program for at least one year.

Public comments will be accepted until Jan. 2, 2024. For more information, click here.

CMS Proposes Rule Regarding Federal IDR Process

On Oct. 27, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule that would amend requirements for the federal independent dispute resolution (IDR) process. The proposed rule would:

• Require group health plans and insurers to provide additional information at the time of an initial payment or notice of denial of payment for certain items and services covered by surprise billing protections;
• Implement changes to the IDR open negotiation process to incentivize stronger communication between disputing parties;
• Revise the process for initiating the federal IDR process; and
• Modify requirements related to IDR dispute eligibility review and the payment and collection of administrative and certified IDR entity fees.

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

Public comments will be accepted until Jan. 2, 2024. For more information, click here.

FDA Proposes Rule Regarding Laboratory Developed Tests

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

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

FDA Proposes Rule to Broaden Prescription Drug Labeling Regulations

On May 30, the Food and Drug Administration (FDA) released a proposed rule that would amend human prescription drug product labeling regulations for medication guides. The proposed rule would require prescription drug and biological product applicants to include a new one-page medication guide known as the Patient Medication Information (PMI) along with products that are used, dispensed or administered in an outpatient setting. Blood and blood components transfused in an outpatient setting would also require a PMI. The PMI would include essential information such as the product’s name, important safety information, common side effects and directions for use.

Public comments will be accepted until Nov. 27, 2023. For more information, click here.

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 Outlines Remedy for 340B Payment Cuts Deemed Unlawful Between CYs 2018-2022

On Nov. 2, the Centers for Medicare and Medicaid Services (CMS) released a final rule that outlines how it will pay back hospitals that participate in the 340B Drug Pricing Program and were impacted by payment cuts between calendar years (CYs) 2018 and 2022, which were deemed unlawful. The final rule clarifies that:

• CMS will repay impacted 340B hospitals in a single lump-sum payment equal to the difference in what CMS paid hospitals for 340B drugs between CYs 2018-2022 and the amount they would have paid if the payment cuts had not been implemented; and
• CMS will establish a policy to recoup funds from hospitals that received higher rates for non-drug services. CMS intends to achieve this by annually adjusting the outpatient prospective payment system conversion factor by minus 0.5 percent beginning in CY 2026 until the full amount is offset. This is projected to take 16 years.

The final rule will go into effect on Jan. 7, 2024. For more information, click here.

CMS Final Rule Updates 2024 Medicare Physician Fee Schedule

On Nov. 2, the Centers for Medicare and Medicaid Services released a final rule that updates the Medicare Physician Fee Schedule (PFS) payment rates for calendar year 2024. The final rule will:

• Decrease the PFS conversion factor by 3.4 percent from $33.89 to $32.74;
• Decrease overall PFS payment rates by 1.25 percent;
• Finalize separate coding and payment for new caregiver and health equity services;
• Allow eligible marriage and family therapists and addiction counselors to enroll in Medicare starting Jan. 1, 2024;
• Allow payments to be made for certain dental services linked to specific cancer treatments; and
• Enhance the Medicare Diabetes Prevention Program (MDPP) Expanded Model and allow MDPP suppliers to continue using COVID-19 public health emergency flexibilities and offer services virtually through Dec. 31, 2027.

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

CMS Final Rule Updates 2024 Hospital OPPS and ASC Payment System

On Nov. 2, the Centers for Medicare and Medicaid Services released a final rule that updates the hospital outpatient prospective payment system (OPPS) and the ambulatory surgical center (ASC) payment system for calendar year 2024. It also finalizes changes to the Hospital Outpatient Quality, ASC Quality and Rural Emergency Hospital Quality reporting programs. The final rule will:

• Increase hospital OPPS and ASC payment rates by 3.1 percent, based on an inpatient hospital market basket percentage increase of 3.3 percent and a 0.2 percent reduction in the final productivity adjustment;
• Modify and adopt new quality reporting measures;
• Establish payments for intensive outpatient program services under Medicare;
• Update payment rates for partial hospitalization program services;
• Modify community mental health center conditions of participation; and
• Establish the Rural Emergency Hospital (REH) provider type.

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

CMS Final Rule Updates 2024 Home Health Prospective Payment System

On Nov. 1, the Centers for Medicare and Medicaid Services released a final rule that updates payment policies and rates for Medicare Home Health Agencies for calendar year 2024. It also finalizes changes to the Home Health Quality Reporting and Value-based Purchasing Programs. The final rule will:

• Increase home health payments by 0.8 percent, based on a projected 3.0 percent increase in home health payments, a 2.6 percent decrease in the permanent behavior assumption adjustment and a 0.4 percent increase in the fixed-dollar ratio for outlier payments adjustment;
• Implement a permanent prospective payment adjustment of minus 2.89 percent;
• Increase the home health market basket percentage by 3.0 percent;
• Establish an informal dispute resolution and special focus program for hospice programs; and
• Add new and updated quality reporting measures.

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

CMS Final Rule Updates 2024 ESRD Prospective Payment System

On Oct. 27, the Centers for Medicare and Medicaid Services released a final rule that updates the payment policies and rates for the end-stage renal disease (ESRD) prospective payment system (PPS) for renal dialysis services covered under Medicare for calendar year (CY) 2024. It also updates the acute kidney injury dialysis payment rate and requirements for the ESRD Quality Incentive Program. The final rule will:

• Increase the ESRD PPS base rate by 2.1 percent to $271.02;
• Implement new ESRD PPS claims reporting requirements;
• Finalize a new transitional add-on pediatric ESRD dialysis payment adjustment for CYs 2024, 2025 and 2026;
• Discuss the responses CMS received to a request for information it issued related to a low-volume payment adjustment; and
• Implement a payment adjustment for new renal dialysis drugs and biological products after the Transitional Drug Add-on Payment Adjustment (TDAPA) period.

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

CMS Final Rule Specifies When and How CMS Imposes Civil Money Penalties

On Oct. 11, the Centers for Medicare and Medicaid Services (CMS) released a final rule that specifies how and when it will calculate and impose civil money penalties (CMPs) when group and non-group health plan responsible reporting entities (RREs) fail to meet their Medicare Secondary Payer (MSP) reporting requirements. It also outlines CMP amounts and clarifies under which circumstances penalties will and will not be imposed.

The final rule will go into effect on Dec. 11, 2023. For more information, click here.

CMS Final Rule Streamlines Medicare Savings Program Enrollment Process

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

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

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

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

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

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

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

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

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

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

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

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

FDA Issues Final Rule Regarding Mammography Quality Standards

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

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

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

Courts

AHA Sues HHS OCR Over Data Privacy Rule

On Nov. 2, the American Hospital Association (AHA) filed a lawsuit against the Department of Health and Human Services Office of Civil Rights (OCR) over a rule it released in Dec. 2022 that prohibits Health Insurance Portability and Accountability Act of 1996 (HIPAA)-covered entities from using online third-party web technologies to capture the internet protocol (IP) addresses of visitors on public-facing hospital webpages that address health conditions and healthcare providers.

The ACA is arguing that the OCR exceeded its statutory authority under HIPPA and the Administrative Procedure Act in releasing the rule and that it failed to follow required notice-and-comment rulemaking processes. The Texas Hospital Association, Texas Health Resources and United Regional Health Care System are also suing over the rule.

For more information, click here.

CBO Cost Estimates

CBO Releases Working Paper Projecting Short- and Long-Term Fiscal Effects of Medicaid Spending on Children

On Nov. 1, the Congressional Budget Office (CBO) released a working paper concerning the short- and long-term fiscal effects of Medicaid spending on children. The working paper specifically examines how different levels of Medicaid spending on children may impact their income earnings as adults. It also describes the model the CBO used to conduct its analysis.

The CBO estimates that enrollment in Medicaid during childhood increases income in adulthood as well as taxes net of transfers. The CBO also predicts that long-term fiscal effects of Medicaid spending on children could offset half or more of the Medicaid program initial outlays.

For more information, click here.