This Week in Washington: House Energy and Commerce Committee marks up 13 healthcare bills; House Energy and Commerce Committee Subcommittee on Health holds hearing on CMMI; CMS announces it will recalculate MA Star Ratings.

CONGRESS

HOUSE

• House Energy and Commerce Committee Marks Up 13 Healthcare Bills
• House Energy and Commerce Committee Chairman Releases Discussion Framework for Potential NIH Reforms
• House Appropriations Committee Agriculture, Rural Development, FDA and Related Agencies Subcommittee Marks Up FY2025 Agriculture-FDA Funding Bill
• House Energy and Commerce Committee Subcommittee on Health Holds Hearing on CMMI

SENATE

• Senate Finance Committee Holds Hearing on Youth Residential Treatment Facilities
• MedPAC Releases June 2024 Report to Congress
• MACPAC Releases June 2024 Report to Congress
• Improving Seniors’ Timely Access to Care Act Introduced
• Corporate Crimes Against Health Care Act of 2024 Introduced

ADMINISTRATION

• CMS to Recalculate MA Star Ratings
• CMS Releases Updated State Unwinding Timelines
• CMS Releases Informational Bulletin Concerning Medicaid and CHIP Managed Care Monitoring and Parity Requirements
• FDA Announces Multi-Agency Task Force to Combat Illegal E-Cigarette Sales
• FDA Advisory Committee Recommends Approval of Donanemab
• FDA Approves Leqembi Supplemental Biologics License Application
• HRSA Announces $11 Million Investment to Expand Rural Medical Residencies

PROPOSED RULES

• CMS Proposed Rule Would Establish Increasing Organ Transplant Access Model
• FDA Proposed Rule Establishes Criteria for Drug Products with Demonstrable Compounding Difficulties

FINAL RULES

• CMS Final Rule Implements Changes Related to Standards for Electronic Prescribing and Health IT
• FDA Final Rule Allows Owner of Refused Device to Provide Testimony
• CMS Final Rule Expands Access to Healthcare for DACA Recipients
• HHS OCR Final Rule Strengthens Protections Against Disability Discrimination
• DOL EBSA Final Rule Rescinds 2018 Association Health Plan Rule
• FDA Releases Final Rule Concerning Laboratory Developed Tests
• FTC Final Rule Revises Health Breach Notification Rule
• CMS Releases Final Rule Concerning Nondiscrimination in Health Programs
• CMS Releases Final Rule Concerning Medicaid and CHIP Access to Care
• CMS Final Rule Implements SNF Minimum Staffing Levels
• CMS Releases Final Rule Concerning Access to Medicaid Services
• HHS OCR Releases Rule Concerning HIPAA Reproductive Care Privacy
• HRSA Final Rule Revises 340B Administrative Dispute Resolution Process
• FDA Issues Final Rule Regarding Mammography Quality Standards

REPORTS

• HHS OIG Releases Report Concerning Short Inpatient Stays and Improper Medicare Payments
• CBO Announces Upcoming Health Analysis Division Presentations
• CBO Releases Report Concerning Budgetary Effects of Policies that Would Increase Hepatitis C Treatment
• CBO Releases Cost Estimate of H.R. 7251, Poison Control Centers Reauthorization Act of 2024
• CBO Releases Cost Estimate of S. 150, Affordable Prescriptions for Patients Act of 2023
• CBO Releases Cost Estimate of S. 3775, BOLD Infrastructure for Alzheimer’s Reauthorization Act of 2024
• CMS Releases 2023-2032 National Health Expenditure Projections
• FDA CDER Releases 2023 Report on the State of Pharmaceutical Quality

COURTS

• Supreme Court Unanimously Rules in Case Concerning Mifepristone

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House

The House is in district work week.

House Energy and Commerce Committee Marks Up 13 Healthcare Bills

On June 12, the House Energy and Commerce Committee marked up and reported out of committee 13 healthcare bills concerning maternal health, lung cancer research and Medicare and Medicaid fraud prevention. The committee did not mark up the Telehealth Modernization Act, which would extend telehealth flexibilities for two years because it is waiting for a Congressional Budget Office score.

The bills are:

H.R. 6020, Honor Our Living Donors Act: Eliminates consideration of the income of organ recipients in providing reimbursement of expenses to donating individuals.

H.R. 455, To amend the Controlled Substances Act to fix a technical error in the definitions: Amends the Controlled Substances Act to fix a technical error in the definitions.

H.R. 5012, Stillbirth Health Improvement and Education (SHINE) for Autumn Act of 2023:

Allows the Department of Health and Human Services (HHS) to award grants for data collection and reporting related to stillbirths and requires HHS to issue guidelines and educational materials regarding proper training and processes for the collection of stillbirth data. The bill also requires HHS to establish a perinatal pathology fellowship program within an existing training program.

H.R. 4534, Women and Lung Cancer Research and Preventive Services Act of 2023: Requires the HHS Secretary and Secretaries of Defense and Veterans Affairs, to conduct an interagency review to evaluate the status of and identify opportunities related to research on women and lung cancer.

H.R. 7213, Autism Collaboration, Accountability, Research, Education and Support (CARES) Act of 2024: Enhances activities of the National Institutes of Health with respect to research on autism spectrum disorder and reauthorizes programs relating to autism.

H.R. 8084, LIVE Beneficiaries Act: Requires states to verify certain eligibility criteria for individuals enrolled for medical assistance quarterly.

H.R. 8089, Medicare and Medicaid Fraud Prevention Act of 2024: Requires certain additional provider screening under the Medicaid program.

H.R. 8111, To amend Title XIX of the Social Security Act to ensure the reliability of address information provided under the Medicaid program: Ensures the reliability of address information provided under the Medicaid program.

H.R. 8112, To amend Title XIX of the Social Security Act to further require certain additional provider screening under the Medicaid program: Requires certain additional provider screening under the Medicaid program.

H.R. 4758, Accelerating Kids’ Access to Care Act: Streamlines enrollment under the Medicaid program of certain providers across state lines.

H.R. 5526, Seniors’ Access to Critical Medications Act: Makes permanent a waiver issued by the Centers for Medicare and Medicaid Services that allows Medicare patients to receive medications by mail and allows family members or caregivers to obtain medications on a patient’s behalf.

H.R. 6033, Supporting Patient Education and Knowledge (SPEAK) Act of 2023: Requires the HHS Secretary to establish a task force to improve access to healthcare information technology for non-English speakers.

H.R. 7858, Telehealth Enhancement for Mental Health Act of 2024: Establishes a Medicare incident to modifier for mental health services furnished through telehealth.

For more information, click here.

House Energy and Commerce Committee Chairman Releases Discussion Framework for Potential NIH Reforms

On June 14, the House Energy and Commerce Committee Chairman Cathy McMorris Rodgers (R-WA) released a framework that outlines current challenges facing the National Institutes of Health (NIH) and recommendations for reform proposed by Republican committee members. The proposed reforms intend to:

• Increase accountability, integration and agility of the NIH’s leadership and mission;
• Clarify NIH funding mechanisms and ensure they reflect congressional intent; and
• Enhance NIH grant research to protect against national security risks and ensure it remains independent, innovative, responsive and transparent.

The committee is requesting public comment on the framework. Comments are due by Aug. 16.

In addition, the committee released an interim staff report outlining findings of an investigation into a monkeypox research project planned and/or conducted at the National Institute of Allergy and Infectious Diseases.

For more information on the NIH framework, click here.

For more information on the MPXV report, click here.

House Appropriations Committee Agriculture, Rural Development, FDA and Related Agencies Subcommittee Marks Up FY2025 Agriculture-FDA Funding Bill

On June 11, the House Appropriations Committee Agriculture, Rural Development, Food and Drug Administration and Related Agencies Subcommittee marked up and reported out of committee the fiscal year (FY) 2025 Agriculture-FDA-Rural Development funding bill. It was reported out of committee without amendments.

The bill would provide the FDA with $6.75 billion in FY2025, $22 million less than FY2024 and below top-line funding levels agreed to during debt ceiling negotiations held between the former Speaker and President. The full committee is expected to mark up the bill next month.

For more information, click here.

House Energy and Commerce Committee Subcommittee on Health Holds Hearing on CMMI

On June 13, the House Energy and Commerce Committee Subcommittee on Health held a hearing to discuss value-based care, the challenges facing the Centers for Medicare and Medicaid Innovation (CMMI) and steps Congress can take to alleviate them. Members questioned why CMMI acitivites increased spending despite initial projections showing they would reduce spending. Witnesses were:

• Elizabeth Fowler, Ph.D., J.D., Deputy Administrator and Director of the Center for Medicare and Medicaid Innovation

For more information, click here.

Senate

The Senate is in session except for June 19.

Senate Finance Committee Holds Hearing on Youth Residential Treatment Facilities

On June 12, the Senate Finance Committee held a hearing to discuss youth residential treatment facilities and ways to improve care services they provide. During the hearing, Chairman Ron Wyden (D-OR) announced that he will introduce legislation to increase the oversight, enforcement and health and safety standards of residential treatment facilities (RTFs) and to support community-based services investments.

The chairman’s remarks come after committee staff released a report that outlines findings of an investigation led by the Senate Finance and Health, Education, Labor and Pensions Committees concerning systemic abuse in provider-operated youth RTFs. The report found that:

• Children suffer sexual, physical and emotional abuse in RTFs and face unsanitary and unsafe conditions;
• Children do not get specialized mental and behavioral health treatment advertised by RTF providers;
• Restraint and seclusion are used by RTF staff as punishment;
• RTFs employ unqualified and inadequately trained staff and fail to plan for children’s discharge to the community for ongoing care; and
• State and federal oversight authorities fail to effectively identify and address harm to children in RTFs.

For more information on the hearing, click here.

For more information on the staff report, click here.

MedPAC Releases June 2024 Report to Congress

On June 13, the Medicare Payment Advisory Commission released its June 2024 Report to Congress on Medicare Payment Policy. The report outlines recommendations to improve Medicare payment systems, address Medicare program issues and facilitate the delivery of healthcare services. The six-chapter report focuses on:

• Approaches for updating clinician payments and incentivizing participation in alternative payment models;
• Provider networks and prior authorization in Medicare Advantage;
• Assessing data sources for measuring healthcare utilization by Medicare Advantage enrollees;
• Paying for software technologies in Medicare;
• Considering ways to lower Medicare payment rates for select conditions in inpatient rehabilitation facilities; and
• Medicare’s Acute Hospital Care at Home program.

For more information, click here.

MACPAC Releases June 2024 Report to Congress

On June 11, the Medicaid and Children’s Health Insurance Program (CHIP) Payment and Access Commission released its June 2024 Report to Congress on Medicaid and CHIP. The report outlines recommendations that aim to:

• Increase transparency in Medicaid and State CHIP financing;
• Improve state tools to optimize state Medicaid agency contracts; and
• Enhance enrollment trends in Medicare Savings Programs and demographic data collection in Medicaid.

For more information, click here.

Improving Seniors’ Timely Access to Care Act Introduced

On June 12, Sens. Marshall (R-KS), Sinema (I-AZ), Thune (R-SD) and Brown (D-OH) introduced the Improving Seniors’ Timely Access to Care Act. The legislation would:

• Establish an electronic prior authorization process for Medicare Advantage (MA) plans, including a standardization for transactions and clinical attachments;
• Increase transparency around MA prior authorization use and requirements;
• Clarify Department of Health and Human Services’ (HHS) authority to establish timeframes for e-prior authorizations;
• Expand beneficiary protections to improve enrollee experiences and outcomes; and
• Require HHS to report to Congress on program integrity efforts.

A companion bill was introduced in the House by Reps. DelBene (D-OR), Kelly (R-PA), Bucshon (R-IN) and Bera (D-CA).

For more information, click here.

Corporate Crimes Against Health Care Act of 2024 Introduced

On June 11, Sens. Warren (D-MA) and Markey (D-MA) introduced the Corporate Crimes Against Health Care Act of 2024. The legislation aims to prevent exploitative private equity practices among healthcare entities and would:

• Hold corporate and private equity executives criminally liable if their actions contribute to a triggering event that results in the death or injury of a patient;
• Grant state attorneys general and the Department of Justice the ability to seize all compensation of private equity and company executives within a 10-year period, if an acquired healthcare firm experiences serious, avoidable financial difficulties;
• Prohibit payments from federal healthcare programs to entities that sell assets or use assets as collateral for a loan with a real estate investment trust;
• Require healthcare providers receiving federal funding to publicly report mergers, acquisitions, changes in ownership and financial data, including debt and debt-to-earnings ratios; and
• Mandate a Department of Health and Human Services Office of Inspector General Report to Congress on the harms of healthcare corporatization.

For more information, click here.

Administration

CMS to Recalculate MA Star Ratings

On June 13, the Centers for Medicare and Medicaid Services (CMS) announced that it will recalculate the star ratings of Medicare Advantage (MA) health plans after two federal judges ruled against the agency in lawsuits brought by MA providers who claimed CMS improperly calculated star ratings for the 2024 plan year.

CMS announced it will release plans for bid resubmissions soon and will only apply recalculated star ratings if a plan’s rating goes up under the new methodology.

CMS Releases Updated State Unwinding Timelines

On June 13, the Centers for Medicare and Medicaid Services released updated timelines for when states plan to complete post-pandemic Medicaid redeterminations. States were given 14 months to complete Medicaid coverage redeterminations after COVID-19 Medicaid coverage expansion expired in April 2023.

Nine states and the District of Columbia have announced their unwinding will take longer than the previously scheduled June deadline. The states are: AK, HI, IL, KY, NC, MI, NJ, SC and WI.

CMS Releases Informational Bulletin Concerning Medicaid and CHIP Managed Care Monitoring and Parity Requirements

On June 12, the Centers for Medicare and Medicaid Services released an informational bulletin concerning Medicaid and Children’s Health Insurance Program managed care monitoring, oversight tools and state parity requirements.

For more information, click here.

FDA Announces Multi-Agency Task Force to Combat Illegal E-Cigarette Sales

On June 10, the Food and Drug Administration and Department of Justice announced that they will establish a multi-agency task force to combat the illegal distribution and sale of e-cigarettes. The agencies will collaborate with the Bureau of Alcohol, Tobacco, Firearms and Explosives, U.S. Marshals Service, U.S. Postal Inspection Service and Federal Trade Commission to streamline criminal and civil enforcement actions.

For more information, click here.

FDA Advisory Committee Recommends Approval of Donanemab

On June 10, the Food and Drug Administration Peripheral and Central Nervous System Drugs Advisory Committee recommended the approval of donanemab, a drug used to treat patients with early Alzheimer’s disease. The committee agreed that the benefits of donanemab outweigh its risks.

FDA Approves Leqembi Supplemental Biologics License Application

On June 9, the Food and Drug Administration approved a supplemental biologics license application for monthly Leqembi (lecanemab-irmb) intravenous maintenance dosing. Leqembi is used to treat early Alzheimer’s disease patients with mild cognitive impairment.

HRSA Announces $11 Million Investment to Expand Rural Medical Residencies

On June 13, the Health and Resources Administration announced that it had awarded more than $11 million in awards to organizations in rural communities to establish and support new medical residency programs.

For more information, click here.

Proposed Rules

CMS Proposed Rule Would Establish Increasing Organ Transplant Access Model

On May 8, the Centers for Medicare and Medicaid Services released a proposed rule that would establish the Increasing Organ Transplant Access (IOTA) Medicare payment model. The IOTA Model would be a mandatory, six-year model and would begin on Jan. 1, 2025.

The model aims to:

• Increase access to kidney transplants for end-stage renal disease patients;
• Improve quality of care for people seeking kidney transplants;
• Reduce disparities among individuals undergoing the kidney transplant process; and
• Facilitate the efficiency and capability of transplant hospitals selected to participate.

Public comments will be accepted until July 16, 2024. For more information, click here.

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

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

The proposed rule would:

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

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

Final Rules

CMS Final Rule Implements Changes Related to Standards for Electronic Prescribing and Health IT

On June 13, the Centers for Medicare and Medicaid Services (CMS) Office of the National Coordinator for Health Information Technology (ONC) released a final rule that will revise Medicare Prescription Drug Benefit and ONC regulations to implement changes concerning required electronic prescribing and health information technology (IT) standards.

The final rule will require Part D sponsors, prescribers and dispensers of covered Part D to:

• Comply with standards CMS has adopted directly or is requiring by cross-referencing standards ONC adopts for electronically transmitting prescriptions; and
• Use National Council for Prescription Drug Programs (NCPDP) Formulary and Benefit (F&B) standard version 3.0 or comply with a standard adopted by ONC after Jan. 1, 2027.

The rule will also require Part D sponsor real-time benefit tools to comply with a standard adopted by ONC and will cross-reference the Health Insurance Portability and Accountability Act of 1996 regulations in 45 CFR part 162 for eligibility transactions.

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

FDA Final Rule Allows Owner of Refused Device to Provide Testimony

On May 31, the Food and Drug Administration (FDA) released a final rule that amends a policy that allows the agency to destroy a device valued at $2,500 or less that has been refused admission into the United States (U.S.).

The final rule will allow the owner or consignee of a refused device valued at $2,500 or less to present testimony when the FDA intends to administratively destroy it.

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

CMS Final Rule Expands Access to Healthcare for DACA Recipients

On May 3, the Centers for Medicare and Medicaid Services released a final rule to expand access to healthcare for Deferred Action for Childhood Arrivals (DACA) recipients. The rule will allow DACA recipients to:

• Enroll in a Qualified Health Plan through the Affordable Care Act Health Insurance Marketplace; and
• Obtain coverage through a Basic Health Program.

DACA recipients and other newly eligible individuals will be able to select a health plan through the Marketplace during a 60-day special enrollment period following the implementation of the rule.

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

HHS OCR Final Rule Strengthens Protections Against Disability Discrimination

On May 1, the Department of Health and Human Services (HHS) Office for Civil Rights released a final rule that prohibits discrimination on the basis of disability and strengthens protections for disabled individuals under Section 504 of the Rehabilitation Act. The rule will:

• Ensure that medical treatment decisions are not based on negative biases and stereotypes about disabled individuals or judgements that a disabled individual is a burden on others;
• Prohibit the use of measures, assessments or tools that discount the value of a life extension on the basis of disability;
• Define what accessibility means for websites and mobile applications and ensure that services delivered through these platforms are accessible to and usable by disabled individuals;
• Adopt U.S. Access Board standards for accessible medical diagnostic equipment;
• Outline requirements to ensure nondiscrimination in the services provided by HHS-funded child welfare agencies; and
• Clarify obligations to provide services in integrated services.

In addition, the rule aligns existing requirements with the Americans with Disabilities Act.

The rule will go into effect on July 8, 2024. For more information, click here.

DOL EBSA Final Rule Rescinds 2018 Association Health Plan Rule

On April 30, the Department of Labor (DOL) Employee Benefits Security Administration released a final rule that rescinds a DOL final rule released in 2018, which modified the definition of “employer” under federal law and expanded the availability of Association Health Plans.

The U.S. District Court for the District of Columbia ruled that provisions in the rule were an unreasonable interpretation of the Employee Retirement Income Security Act in 2019.

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

FDA Releases Final Rule Concerning Laboratory Developed Tests

On April 29, the Food and Drug Administration (FDA) released a final rule that will classify laboratory-developed tests (LDTs) and in vitro diagnostic (IVD) products as medical devices subject to rules under the Federal Food, Drug and Cosmetic Act. The rule will phase out the FDA’s general enforcement discretion approach for most LDTs over four years and require compliance with:

• Medical device regulation, correction and removal reporting and compliant file quality system requirements after one year;
• Registration, listing, labeling and investigational use requirements after two years;
• Quality system requirements in 21 CFR Part 820 after three years;
• Premarket review requirements for high-risk IVDs offered as LDTs (unless a premarket submission has been received by the beginning of this stage) after three and a half years; and
• Premarket review requirements for moderate- and low-risk IVDs after four years.

LDTs developed by a healthcare system laboratory that target unmet needs of patients, those approved by New York State’s Clinical Laboratory Evaluation Program and tests first marketed prior to May 6, are exempted from the rule.

The rule will go into effect on July 5, 2024. For more information, click here.

FTC Final Rule Revises Health Breach Notification Rule

On April 26, the Federal Trade Commission (FTC) released a final rule that revises the Health Breach Notification Rule that requires vendors of personal health records (PHR) and related entities not covered by the Health Insurance Portability and Accountability Act, to notify individuals and the FTC of unsecured PHR data breaches. The rule will:

• Modify the definition of PHR identifiable health information and add new definitions for covered healthcare provider and healthcare services or supplies;
• Clarify that a “breach of security” includes an unauthorized acquisition of identifiable health information that occurs as a result of a data security breach or unauthorized disclosure;
• Revise the definition of a PHR-related entity to make clear that the rule applies to entities that offer products and services through online services, including mobile applications;
• Clarify multiple sources of PHR identifiable health information;
• Expand the use of electronic notification and consumer notice content; and
• Require covered entities to report breaches involving 500 or more individuals to the FTC at the same time notices are sent to affected individuals and no later than 60 calendar days after discovery of the breach.

The rule will go into effect on July 29, 2024. For more information, click here.

CMS Releases Final Rule Concerning Nondiscrimination in Health Programs

On April 26, the Centers for Medicare and Medicaid Services released a final rule that revises Section 1557 of the Affordable Care Act to advance health equity and reduce disparities. The rule will:

• Apply nondiscrimination standards to all Department of Health and Human Services (HHS)-administered health programs and activities;
• Reinstate Section 1557’s application to health insurance issuers that receive federal financial assistance;
• Affirm that sex discrimination protections apply to discrimination on the basis of sexual orientation, gender identity, pregnancy and sex characteristics and stereotypes;
• Require state and federally-facilitated exchanges, recipients of federal financial assistance and HHS programs to inform individuals that language assistance services and auxiliary aids are available; and
• Require covered entities to train staff on Section 1557 policies.

The rule also clarifies nondiscrimination requirements for telehealth services and patient care decision support tools.

The rule will go into effect on July 5, 2024. Some provisions of the rule will be phased in to allow covered entities to come into compliance.

For more information, click here.

CMS Releases Final Rule Concerning Medicaid and CHIP Access to Care

On April 22, the Centers for Medicare and Medicaid Services (CMS) released a final rule that will improve access to care, strengthen quality and health outcomes and address health equity issues for Medicaid and Children’s Health Insurance Program (CHIP) managed care enrollees.

The rule will:

• Establish maximum wait times for obstetric, primary care and outpatient mental health and substance use disorder services;
• Require states to implement a remedy plan for managed care organizations that fail to meet required standards;
• Prohibit the use of separate payment terms;
• Remove the requirement that providers must be in-network with managed care plans to receive state-directed payments; and
• Require managed care plans to report any identified or recovered overpayments to states within 30 calendar days.

In addition, the rule will implement revisions concerning In Lieu of Service and Setting, External Quality Review and the Medicaid and CHIP Quality Rating System.

The rule will go into effect on July 9, 2024. For more information, click here.

CMS Final Rule Implements SNF Minimum Staffing Levels

On April 22, the Centers for Medicare and Medicaid Services (CMS) released a final rule that will establish minimum staffing levels for long-term care (LTC) and skilled-nursing facilities (SNFs) and strengthen transparency of worker compensation. The rule will require facilities to:

• Have a registered nurse (RN) on-site 24 hours a day, seven days a week;
• Provide a minimum of 3.48 hours of nursing care per resident day, including a minimum of 0.55 hours of care from a RN and 2.45 hours of care from a nurse aide per resident day;
• Use evidence-based methods when planning care for their residents and the facility assessment when assessing the needs of each resident in the facility;
• Develop staffing plans to maximize recruitment and retention of staff in accordance with Executive Order 14095; and
• Implement new Medicaid Institutional Payment Transparency Reporting provisions.

The rule will be implemented in phases across a three-year period. Nursing homes may apply for a temporary exemption to the rule but must meet certain hardship criteria. Notably, there are two bills in Congress that, if enacted, would prevent the rule from going forward.

The rule will go into effect on June 21, 2024. For more information, click here.

CMS Releases Final Rule Concerning Access to Medicaid Services

On April 22, the Centers for Medicare and Medicaid Services (CMS) released a final rule to improve access to care, service quality and outcomes under Medicaid fee-for-service (FFS), managed care and home and community-based services (HCBS). The rule will require states to:

• Rename and expand the scope of Medical Care Advisory Committees and require states to establish a Beneficiary Advisory Committee;
• Meet nationwide incident management system standards for monitoring HCBS programs;
• Ensure that a minimum of 80 percent of Medicaid payments for homemaker, home health aide and personal care services be spent on compensation for direct-care workers furnishing these services within six years;
• Publicly publish all FFS Medicaid fee schedule payment rates; and
• Establish and manage a grievance process for beneficiaries receiving HCBS in FFS plans.

The final rule will go into effect on July 9, 2024. For more information, click here.

HHS OCR Releases Rule Concerning HIPAA Reproductive Care Privacy

On April 22, the Department of Health and Human Services Office for Civil Rights (OCR) released a final rule concerning Health Insurance Portability and Accountability Act (HIPAA) reproductive healthcare privacy provisions. The rule will:

• Prohibit the use or disclosure of reproductive healthcare protected health information (PHI) when it is requested to investigate or impose liability on patients and providers who seek, obtain or provide lawful reproductive healthcare services;
• Require providers, health plans, clearinghouses and business associates to obtain a signed attestation that acknowledges PHI related to reproductive healthcare is not to be used for prohibited purposes; and
• Require providers, health plans and clearinghouses to modify their Notice of Privacy Practices to support reproductive healthcare privacy.

The final rule will go into effect on June 25, 2024. For more information, click here.

HRSA Final Rule Revises 340B Administrative Dispute Resolution Process

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

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

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

FDA Issues Final Rule Regarding Mammography Quality Standards

On March 9, 2023, the Food and Drug Administration (FDA) issued a final rule that updates the regulations implemented by the Mammography Quality Standards Act of 1992. The FDA has decided to update the regulations due to advancements made in mammography technology and information. The final rule will:

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

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

Reports

HHS OIG Releases Report Concerning Short Inpatient Stays and Improper Medicare Payments

On June 13, the Department of Health and Human Services Office of Inspector General (OIG) released a report examining safeguards established by the Centers for Medicare and Medicaid Services (CMS) to prevent and detect improper payments for short inpatient stays.

After interviewing officials and analyzing Medicare Part A claims, the OIG found that CMS did not have adequate information to identify:

• Short-inpatient stays at risk for noncompliance;
• Prepayment edits for claims at-risk for noncompliance; and
• Adequate policies and procedures to review claims at-risk for noncompliance.

For more information, click here.

CBO Announces Upcoming Health Analysis Division Presentations

On June 13, the Congressional Budget Office (CBO) announced presentations the CBO Health Analysis Division will make at upcoming health research forums and conferences. The presentations include:

• How Does Generic Competition Affect New Prices and Volumes in Part D;
• Net Price Variation in Medicare Part D: Evidence and Implications;
• Formulary Restrictions and Drug Rebates: Evidence from Medicare’s Protected Drug Classes;
• Favorable Selection Into Medicare Advantage and Integrated Plans Among Dual Eligibles; and
• Spending in the 340B Drug Pricing Program, 2010 to 2021.

For more information, click here.

CBO Releases Report Concerning Budgetary Effects of Policies that Would Increase Hepatitis C Treatment

On June 14, the Congressional Budget Office (CBO) released a report concerning budgetary effects of policies that would increase Hepatitis C treatment. The report describes CBO’s analysis of two five-year programs in which treatment rates would peak at increases of 10 percent and 100 percent above the current treatment rate among Medicaid enrollees.

In addition, the CBO announced it is requesting information on the following:

• The effectiveness of outreach and other efforts in increasing testing, treatment initiation and adherence among targeted populations (which would also depend on the specific populations included in the program);
• The costs of treating Hepatitis C with direct-acting antivirals; and
• The costs of treating complications from Hepatitis C if the disease is untreated.

For more information, click here.

CBO Releases Cost Estimate of H.R. 7251, Poison Control Centers Reauthorization Act of 2024

On June 13, the Congressional Budget Office (CBO) released a cost estimate of H.R. 7251, Poison Control Centers Reauthorization Act of 2024. The legislation would reauthorize funding for a national toll-free number and media campaign for poison control centers and a Health Resource and Services Administration grant program to prevent poison and toxic exposure.

The CBO estimates that the bill would cost $124 million over the 2024-2029 period and $23 million after 2029.

For more information, click here.

CBO Releases Cost Estimate of S. 150, Affordable Prescriptions for Patients Act of 2023

On June 13, the Congressional Budget Office (CBO) released a cost estimate of S. 150, Affordable Prescriptions for Patients Act of 2023. The legislation would prohibit drug and biological product manufacturers from engaging in “product hopping.”

The CBO estimates that the bill would reduce direct spending by $2.4 billion and increase revenues by $585 million over the 2024-2034 period.

For more information, click here.

CBO Releases Cost Estimate of S. 3775, BOLD Infrastructure for Alzheimer’s Reauthorization Act of 2024

On June 11, the Congressional Budget Office (CBO) released a cost estimate of S. 3775, Building Our Largest Dementia Infrastructure for Alzheimer’s Reauthorization Act of 2024. The legislation would authorize grants to the Centers for Disease Control and Prevention to support public health awareness and practices related to Alzheimer’s disease and related dementias.

The CBO estimates that the bill would cost $139 million over the 2024-2029 period and $26 million after 2029.

For more information, click here.

CMS Releases 2023-2032 National Health Expenditure Projections

On June 12, the Centers for Medicare and Medicaid Services (CMS) Office of the Actuary released projections of National Health Expenditures (NHEs) and health insurance enrollment for the years 2023-2032. The Office of the Actuary predicts that:

• Average annual Medicare expenditure growth will be 7.4 percent;
• Average rate growth for Medicaid spending will be 5.2 percent;
• Average rate growth for private health insurance spending will be 5.6 percent;
• Out-of-pocket spending growth will average 4.7 percent;
• Hospital average spending growth rate will be 5.7 percent;
• Physician and clinical services average annual growth rate will be 5.6 percent; and
• Retail prescription drug average annual growth will be 6.0 percent.

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FDA CDER Releases 2023 Report on the State of Pharmaceutical Quality

On June 11, the Food and Drug Administration (FDA) Center for Drug Evaluation and Research released the fiscal year 2023 Report on the State of Pharmaceutical Quality. The report provides information about FDA-registered drug manufacturers and the quality of the U.S. drugs and biological products supply chain.

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Courts

Supreme Court Unanimously Rules in Case Concerning Mifepristone

On June 13, the Supreme Court issued a final ruling in the Alliance for Hippocratic Medicine v. FDA case. The court unanimously ruled that the Food and Drug Administration (FDA) did not violate proper regulatory actions when it expanded access to the abortion pill mifepristone.

Plaintiffs suing the FDA argued that the agency failed to follow proper regulatory actions because it did not conduct objective clinical investigations or safety assessments on the effects of mifepristone in patients who took the drug past the original seven-week timeframe it was approved for. The Supreme Court ruled that plaintiffs did not have legal standing to challenge the FDA’s decisions concerning mifepristone regulatory requirements.