This Week in Washington: President and Speaker McCarthy to meet on debt limit with 10 days to go, House Energy and Commerce Subcommittee on Health marks up 17 bills, House Appropriations Committee begins moving appropriation bills

Upcoming Hearings

Congress

House

• House Energy and Commerce Health Subcommittee Holds Markup on 17 Bills
• House Appropriations Subcommittee Advances FDA Funding Bill
• Congressional Rare Disease Caucus Urges FDA to Create Rare Disease Task Force
• Telemental Health Services Act Reintroduced
• Black Maternal Health Momnibus Act of 2023 Reintroduced

Senate

• Debt-Ceiling Talks Hit a Pause
• Senate HELP Ranking Member Seeks Feedback on Dually-Eligible Beneficiary Draft Legislation
• NIH Clinical Trial Diversity Act Introduced
• Sen. Sanders Develops Package on Healthcare Workforce
• Medicare for All Act Reintroduced
• Facilitating Access to Innovative Diagnostics Act Reintroduced

Administration

• HHS Awards More Than $65 Million to HRSA-funded Health Centers
• HHS Awards $200 Million to Fund 988 Suicide and Crisis Lifeline Services
• President Nominates NIH Director
• FTC Broadens Look at Pharmacy Benefit Managers
• CMS Releases Comprehensive Guide on Medicaid School-Based Services
• CMS Updates Medicaid and CHIP Unwinding Resources
• FDA Advisors Recommend Approval of Maternal RSV Vaccine
• FDA Approves First Oral Treatment for Crohn’s Disease
• FDA Releases Industry Guidance on Pediatric Drug Study Requirements
• FDA Announces Medical Device Health Equity Advisory Meeting
• FDA Removes Makena and Generic ANDAs from Orange Book
• FDA Approves Drug to Treat Menopause Hot Flashes
• FDA Issues Marketing Denial Orders to 10 E-Cigarette Companies

Proposed Rules

• CMS Proposes Rule Concerning Medicaid Access
• CMS Proposed Rule Seeks to Improve Access to Medicaid Services
• HHS OCR Proposed Rule Modifies HIPAA and HITECH Privacy Rule
• HHS ONC Proposed Rule Updates Electronic Health Information Infrastructure
• CMS Proposed Rule Updates Hospital Inpatient and Long-Term Care Hospital PPS Rates
• CMS Proposed Rule Updates Inpatient Psychiatric Facility (IPF) PPS Rates
• CMS Proposed Rule Updates Skilled Nursing Facility PPS Rates
• CMS Proposed Rule Updates Inpatient Rehabilitation Facility PPS Rates
• CMS Releases Hospice Index, Payment Rate and Aggregate Cap Proposed Rule
• FDA Proposes New Tobacco Product Manufacturing Practices Requirements

Final Rules

• DEA Releases Temporary Rule Extending COVID-19 Telemedicine Flexibilities
• CMS Releases Notice of Benefit and Payment Parameters for 2024 Final Rule
• CMS Finalizes Changes to Medicare Advantage, Part D, Cost Plan and PACE Regulations
• CMS Finalizes 2024 Medicare Advantage and Part C and D Payment Policies
• FDA Issues Final Rule Regarding Mammography Quality Standards
• FDA Delays Tobacco Product Required Warning Final Rule Effective Date
• CMS Issues Correction on Clinical Laboratory Improvement Amendments (CLIA) Final Rule

Courts

• Appeals Court Maintains ACA Provision Coverage of Preventive Medicines

Reports

• GAO Releases Report Regarding VA Health IT System
• GAO Releases Report Regarding Veterans’ Healthcare Staffing Challenges
• GAO Releases Report Regarding Rural Healthcare Access

CBO Cost Estimates

• CBO Releases Analysis on President’s Budget Discretionary Spending Proposals
• CBO Releases Cost Estimate on S. 460, Urban Indian Health Confer Act
• CBO Releases Federal Health Spending Update Presentation

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Upcoming Hearings

May 23

House Veterans’ Affairs Committee Full Committee Oversight Hearing: “COVID-19 Supplemental Funding: Did It Protect and Improve Veteran Care?”
10:00 a.m., Cannon House Office Building 360
Witnesses to be announced.

House Committee on Oversight and Accountability Full Committee Hearing: “The Role of Pharmacy Benefit Managers in Prescription Drug Markets Part I: Self-Interest or Health Care?”
10:00 a.m., Rayburn House Office Building 2154
Witnesses to be announced.

House

House Energy and Commerce Health Subcommittee Holds Markup on 17 Bills

On May 17, the House Energy and Commerce Committee Subcommittee on Health marked up 17 healthcare-related bills and voted to move seven bills forward. They include:

• H.R. 1418, the Animal Drug User Fee Amendments of 2023

This legislation would reauthorize ADUFA and AGDUFA for fiscal years 2024 to 2028. Reauthorization of these programs would include the negotiated agreement on performance goals and procedures between the FDA and industry for the upcoming five-year period. This would be the fifth iteration of ADUFA and the fourth iteration of AGDUFA.

• H.R. 2544, the Securing the U.S. Organ Procurement and Transplantation Network Act

This legislation would amend Section 372 of the Public Health Service Act to allow for additional flexibilities within the Organ Procurement and Transplantation Network (OPTN).

Note: A companion bill was introduced in the Senate on May 17 by Senate Finance Committee Chairman Ron Wyden (D-OR) and Sens. Grassley (R-IA), Cardin (D-MD), Young (R-IN) and Cassidy (R-LA) and referred to the Senate Health, Education, Labor and Pensions Committee.

• H.R. 3281, the Transparent PRICE Act

This legislation would require hospitals to make their standard charges public through machine-readable files as well as payer specific negotiated charges, including for cash-paying patients, for 300 shoppable services. Additionally, the legislation would require health insurance companies to make personalized pricing information available to enrollees and post machine-readable files containing in-network negotiated rates, historical prescription drug prices and out-of-network allowed amounts. Finally, the bill would increase penalties for noncompliance with existing rules and implement policies to improve the quality of data reported by hospitals and insurers to provide actionable information for patients and employers.

• H.R. 2666, the Medicaid VBPs for Patients (MVP) Act

This legislation would codify Medicaid rules that permit the use of varying best price points under value-based purchasing arrangements such as gene therapies.

• H.R. 3285, the Fairness for Patient Medications Act

This legislation would establish deductible and cost-sharing limitations on highly rebated drugs. Specifically, cost-sharing would be capped at the price paid by the insurer for the drug in the previous year to ensure patients are never paying more than the cost of the drug.

• H.R. 3284, Providers and Payers COMPETE Act

This legislation would require the U.S. Department of Health and Human Services (HHS), during each of its annual hospital and other provider payment rules like those for inpatient and outpatient care, to consider the implications that its proposals may have on further consolidating the healthcare system by studying both horizontal and vertical consolidation among both providers and payers.

• H.R. 3290, To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program

This legislation would establish reporting requirements for hospitals participating in the 340B program. Specifically, participating hospitals would be required to report total 340B savings and other key metrics to the Health Resources and Services Administration on an annual basis.

• H.R. 2559, the Strengthening Community Care Act of 2023

This legislation would extend funding for the Community Health Center Fund and National Health Service Corps.

• H.R. 2547, the Special Diabetes Program for Indians Reauthorization Act of 2023

This legislation would extend funding for the Special Diabetes for Indians program.

• H.R. 2550, the Special Diabetes Program Reauthorization Act of 2023

This legislation would extend funding for the Special Diabetes Program.

• H.R. 1613, the Drug Price Transparency in Medicaid Act of 2023

This legislation would require pass-through pricing and prohibit spread-pricing for payment arrangements with pharmacy benefit managers under Medicaid.

• H.R. 2665, the Supporting Safety Net Hospitals Act

This legislation would eliminate the disproportionate share hospital payment reductions under the Medicaid program for fiscal years 2024 and 2025.

• H.R. 2679, the PBM Accountability Act

This legislation would require pharmacy benefit managers (PBMs) regularly to furnish employers with detailed data on prescription drug spending, including the cost of drugs, total out-of-pocket spending, formulary placement rationale and aggregate rebate information. Additionally, the Comptroller General of the United States would be required to submit a report to Congress on pharmacy networks of group health plans, health insurance issuers and entities providing pharmacy management services under such group health plans or group or individual health insurance coverage.

• H.R. 3248, Diagnostic Lab Testing Transparency Act

This legislation would require diagnostic laboratories to disclose three data points for clinical diagnostic laboratory tests included on the list of shoppable services specified by the Centers for Medicare and Medicaid Services: the discounted cash price of each test, the de-identified minimum rate for each test and the de-identified maximum rate for each test.

• H.R. 3262, Ownership Transparency

This legislation would require hospitals, freestanding emergency centers, ambulatory surgical centers, physician practices with more than 25 physicians, physician practices owned by hospitals, insurance companies and other entities to report to the Department of Health and Human Services (HHS) upon changes in ownership. HHS would be required to use this data to submit annual reports on trends in healthcare consolidation.

• H.R. 3282, The Promoting Transparency and Healthy Competition in Medicare Act

This legislation would increase transparency into the effects of vertical integration in healthcare by requiring Medicare Advantage Organizations and Part D plan sponsors to report data with respect to how these companies interact with healthcare providers that they share common ownership with—like physician groups, pharmacy benefit managers (PBMs) and pharmacies—compared to those that they do not.

• H.R. 3237, To amend title XVIII of the Social Security Act to require each off campus outpatient department of a provider to include a unique identifier on claims for items and services, and to require providers with a department of a provider to submit to the Centers for Medicare & Medicaid Services an attestation with respect to each such department

This legislation would require that each department of a provider include a unique identification number on claims for services, and require hospitals with an outpatient department of a provider to submit to the Centers for Medicare and Medicaid Services an attestation with respect to each outpatient department.

For more information, click here.

House Appropriations Subcommittee Advances FDA Funding Bill

On May 18, the House Appropriations Committee’s Agriculture, Rural Development, and Food and Drug Administration (FDA) Subcommittee convened to mark up the fiscal year (FY) 2024 Agriculture, Rural Development, FDA, and Related Agencies Appropriations Bill. The bill, also referred to as the FDA Funding Bill, was forwarded by the subcommittee with no amendment. House Democrats strongly oppose the bill, stating that it would override important FDA decisions and negatively impact public health. In addition, House Republicans omitted from the bill a longstanding policy rider that for years has blocked FDA from using appropriations funding to finalize a rule that would require pharmaceutical prescribing information to be shared electronically, rather than in paper format. The bill would:

• Provide the FDA with $6.6 billion in funding in FY 2024;
• Reverse the FDA decision to allow mifepristone to be dispensed by certified pharmacies;
• Prevent the FDA from banning flavored cigars and menthol cigarettes;
• Prevent the FDA from imposing nicotine limits on cigarettes; and
• Delay any plans to impose population-wide sodium reduction targets;

For more information, click here.

Congressional Rare Disease Caucus Urges FDA to Create Rare Disease Task Force

On May 12, the Congressional Rare Disease Caucus urged the Food and Drug Administration (FDA) to improve reliability and consistency of the agency’s rare disease therapy review process. Caucus cochairs Klobuchar (D-MN), Wicker (R-MS), Bilirakis (R-FL) and Matsui (D-CA) led a group of 25 senators and representatives in sending a letter to FDA Commissioner Robert Califf, in which they asked the commissioner to establish a task force to review and address shortcomings in FDA rare disease policies and guidance. The members are requesting that the task force release a public report by December 2024 that would:

• Explain how FDA advisory committees have addressed rare disease applications;
• Identify inconsistent processes and policies;
• Review how the accelerated approval pathway is used for rare disease therapies;
• Clarify how real-world evidence can be used in regulatory approvals;
• Include tracking metrics on rare disease policy implementation issues; and
• Highlight FDA statutory changes and new authority.

For more information, click here.

Telemental Health Services Act Reintroduced

On May 16, Reps. Matsui (D-CA) and Johnson (R-OH) reintroduced the Telemental Health Services Act. The bill would remove a Medicare provision that requires beneficiaries who receive treatment for mental or behavioral health concerns via telehealth to see a doctor in-person within six months of receiving their virtual treatment.

For more information, click here.

Black Maternal Health Momnibus Act of 2023 Reintroduced

On May 15, Reps. Underwood (D-IL) and Adams (D-NC) reintroduced the Black Maternal Health Momnibus Act of 2023. The bill would increase investments to address social determinants of health and provide funding for community-based organizations. It would also diversify and expand the perinatal health workforce, broaden access to maternal mental health care, increase funding for veteran maternal healthcare services, improve maternal health crisis data collection processes and more.

For more information, click here.

Senate

Debt-Ceiling Talks Hit a Pause

On May 16, President Biden met with House Speaker Kevin McCarthy (R-CA), Senate Majority Leader Chuck Schumer (D-NY) and House Minority Leader Hakeem Jeffries (D-NY) to discuss the debt-ceiling.

Despite the ongoing gridlock, Tuesday’s meeting signaled a shift from Democratic leaders, as they acknowledged that the only way forward is through negotiations. However, negotiations while the President has been out of the country hit a snag with each side saying the other wanted a package that was unrealistic. The President and Speaker McCarthy will meet today with ten days to go until the debt limit and Treasury’s exhaustive measures will run out. Democrats are urging the President to use an untried measure involving the Fourteenth Amendment. In the House, democrats are also seeking the use of a discharge petition, but that would require some republicans also signing on.

Senate HELP Ranking Member Seeks Feedback on Dually-Eligible Beneficiary Draft Legislation

On May 18, Senate Health, Education, Labor and Pensions (HELP) Committee Ranking Member Bill Cassidy (R-LA) announced that he is seeking feedback on draft legislation that would impact dually-eligible Medicare and Medicaid beneficiaries. The draft legislation would, among other things:

• Direct states to choose an integrated care model to provide comprehensive care for full-benefit dual beneficiaries;
• Require integrated plans that enroll dually-eligible beneficiaries to regularly update provider directories and collect quality measures data;
• Require the Department of Health and Human Services (HHS) to review the processes states use to determine whether someone is a full-benefit or partial-benefit dual beneficiary;
• Require HHS to identify legislative changes needed to align billing codes for Medicare, Medicaid and state integrated-dual beneficiary programs;
• Direct the Centers for Medicare and Medicaid Services (CMS) to issue guidance for brokers on how to enroll dual beneficiaries;
• Require states to make the Program of All-Inclusive Care for the Elderly (PACE) available to all Medicare beneficiaries under the age of 55; and
• Direct CMS to review the hospital star rating program.

NIH Clinical Trial Diversity Act Introduced

On May 18, Sens. Menendez (D-NJ) and Collins (R-ME) introduced the NIH Clinical Trial Diversity Act. The bill would require the National Institutes of Health (NIH) to ensure the availability of less burdensome clinical trial follow-ups, to increase participation of underrepresented populations and to develop clear recruitment and retention objectives with clinical trial sponsors. The bill would also require the NIH to launch a public awareness campaign to highlight research opportunities across federal agencies.

A companion bill was introduced in the House by Reps. Kelly (D-IL) and Fitzpatrick (R-PA).

For more information, click here.

Sen. Sanders Develops Package on Healthcare Workforce

Chairman of the Senate Health, Education, Labor and Pensions (HELP) Committee announced a new package that would over five years provide $130 billion for community health centers and $60 billion in funding to grow the healthcare workforce. Within that $60 billion, the package would set aside $15 billion for graduate medical education programs with an emphasis on primary care. Overall the $200 billion package is the chairman’s response to the months-long discussion the committee members have had about how to address healthcare workforce shortages and concerns about community health centers in the wake of the pandemic.

Medicare for All Act Reintroduced

On May 17, Senate Health, Education, Labor, and Pensions (HELP) Committee Chairman Bernie Sanders (I-VT) led 14 senators in introducing the Medicare for All Act. The bill would establish a Medicare-for-all health insurance program that would be implemented over a four-year period. The Medicare eligibility age would be reduced to 55 in the first year, and Medicare Part A, B and D deductibles would be eliminated. By the fourth year, all Americans, including children, would be entitled to Medicare benefits and comprehensive healthcare services.

A companion bill cosponsored by more than 110 members was introduced in the House by Reps. Jayapal (D-WA) and Dingell (D-MI).

For more information, click here.

Facilitating Access to Innovative Diagnostics Act Reintroduced

On May 16, Sens. Blackburn (R-TN) and Baldwin (D-WI) reintroduced the Facilitating Access to Innovative Diagnostics Act. The bill would improve patient access to diagnostic radiopharmaceuticals and technologies used to detect diseases such as cancer and Alzheimer’s. It would also revise payment policies for imaging diagnostics that use innovative technologies and promote further research and development opportunities. The bill is supported by a large number of prostate cancer, Alzheimer’s and Parkinson’s stakeholder groups.

For more information, click here.

Administration

HHS Awards More Than $65 Million to HRSA-funded Health Centers

On May 19, the Department of Health and Human Services (HHS) announced that it awarded more than $65 million to 35 health centers that are funded through the Health Resources and Services Administration (HRSA). The funds will be used to implement new approaches to reduce disparities for patients who are at high risk of maternal mortality, particularly Black, American Indian and Alaska Native women.

For more information, click here.

HHS Awards $200 Million to Fund 988 Suicide and Crisis Lifeline Services

On May 17, the Department of Health and Human Services (HHS) announced that it administered $200 million through the Substance Abuse and Mental Health Services Administration (SAMHSA) to improve the 988 Suicide and Crisis Lifeline and other crisis services among states, territories and tribes. The funding will be used to enhance crisis workforce recruitment and training and to improve coordination with emergency service providers.

For more information, click here.

President Nominates NIH Director

On May 15, President Biden nominated Dr. Monica Bertagnolli to be the next director of the National Institutes of Health (NIH). Dr. Bertagnolli is the current director of the National Cancer Institute (NCI) and previously served as the Richard E. Wilson Professor of Surgery at Harvard Medical School. She also worked as a surgeon at Brigham and Women’s Hospital.

For more information, click here.

FTC Broadens Look at Pharmacy Benefit Managers

On May 17, the Federal Trade Commission (FTC) ordered two group purchasing organizations to submit information and records concerning their business practices as the FTC continues its investigation of pharmacy benefit managers (PBMs) and their business operations as they related to prescription drug prices. The two GPOs are responsible for the negotiation of rebates with drug manufacturers on behalf of PBMs and maintain the rebate contracts.

CMS Releases Comprehensive Guide on Medicaid School-Based Services

On May 18, the Centers for Medicare and Medicaid Services (CMS) released a comprehensive guide on Medicaid school-based services (SBS). The guide intends to clarify how payments can be made to school-based entities under Medicaid and the Children’s Health Insurance Program (CHIP), and discusses how rural schools and local educational agencies (LEAs) can simplify their billing process and reduce administrative burdens. The guide also outlines best payment practices used by state Medicaid agencies, provides examples of the types of providers that can participate in Medicaid and CHIP in school settings, and explains unaddressed SBS policies and practices.

For more information, click here.

CMS Updates Medicaid and CHIP Unwinding Resources

On May 18, the Centers for Medicare and Medicaid Services (CMS) Office of Minority Health announced that it had updated its resources on the Medicaid and Children’s Health Insurance Program (CHIP) continuous enrollment unwinding, and post-COVID-19 public health emergency (PHE) testing and telehealth services. The resources are available on the CMS Office of Minority Health Coverage to Care (C2C) website.

For more information, click here.

FDA Advisors Recommend Approval of Maternal RSV Vaccine

On May 18, the Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 14-0 in favor of approving Pfizer’s maternal respiratory syncytial virus (RSV) vaccine. The committee voted in favor of the vaccine after reviewing clinical trial data that showed the vaccine effectively preventing RSV in infants during the first six months after their birth. The committee’s vote comes two weeks after the FDA approved the first RSV vaccine for adults aged 60 and older.

FDA Approves First Oral Treatment for Crohn’s Disease

On May 18, the Food and Drug Administration (FDA) approved Rinvoq (upadacitinib), the first oral treatment for adults with moderate to severe Crohn’s disease. Crohn’s disease is a chronic inflammatory bowel disease that can cause symptoms such as cramping, diarrhea and weight loss. The FDA decided to grant Rinvoq approval after a randomized clinical study showed the drug reducing intestinal inflammation in trial participants.

For more information, click here.

FDA Releases Industry Guidance on Pediatric Drug Study Requirements

On May 17, the Food and Drug Administration (FDA) released a guidance for industry regarding the development of pediatric drugs. The guidance is intended to help pediatric drug manufacturers comply with pediatric drug study requirements, and it covers topics such as pediatric drug assessments, plans, waivers and deferrals, compliance issues and exclusivity provisions. The guidance also explains statutory changes that were made to pediatric study plans (PSPs), deferral extensions and noncompliance.

For more information, click here.

FDA Announces Medical Device Health Equity Advisory Meeting

On May 18, the Food and Drug Administration (FDA) announced that the FDA Center for Devices and Radiological Health (CDRH) Patient Engagement Advisory Committee will hold a public advisory committee meeting to discuss how medical device health equity can be advanced. The committee will discuss how access to medical devices can be improved at home and other locations outside a hospital or clinical care setting, and how comprehension of FDA patient and caregiver communications can be improved across diverse demographic groups. The committee will also discuss when medical devices should be evaluated in diverse populations to support marketing authorizations.

The meeting will be held virtually on Sept. 6, 2023, and public comments will be accepted until Aug. 10, 2023.

For more information, click here.

FDA Removes Makena and Generic ANDAs from Orange Book

On May 15, the Food and Drug Administration (FDA) announced that it had removed MAKENA (hydroxyprogesterone caproate) and eight abbreviated new drug applications (ANDAs) that reference MAKENA as a reference listed drug (RLD), from the FDA Orange Book. The FDA had previously withdrawn approval from MAKENA and the eight ANDAs on April 6.

For more information, click here.

FDA Approves Drug to Treat Menopause Hot Flashes

On May 12, the Food and Drug Administration (FDA) approved Veozah (fezolinetant), an oral medication that is intended to treat moderate to severe hot flashes caused by menopause. Approximately 80 percent of menopausal women experience hot flashes, which can be a serious physical burden and impact to their quality of life. Veozah was shown to effectively treat hot flashes in two 12-week, randomized, placebo-controlled, double-blind clinical trials. The FDA warned that Veozah can raise the risk of liver damage and is urging patients to get blood work done before taking the drug.

For more information, click here.

FDA Issues Marketing Denial Orders to 10 E-Cigarette Companies

On May 12, the Food and Drug Administration issued marketing denial orders (MDOs) to 10 e-cigarette companies. The companies in question include Imperial Vapors LLC, Savage Enterprises and Big Time Vapes, among others. The 10 companies collectively manufacture approximately 6,500 flavored e-cigarette and e-liquid products. The FDA issued the MDOs after the premarket tobacco product applications (PMTAs) submitted by the companies failed to provide evidence that the marketing of the products would prove appropriate for public health.

For more information, click here.

Proposed Rules

CMS Proposes Rule Concerning Medicaid Access

On May 3, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule that seeks to strengthen and improve access to care, quality and health outcomes for Medicaid and Children’s Health Insurance Program (CHIP) managed care enrollees. Among the changes in the Ensuring Access to Medicaid Services are requirements to:

• Establish national maximum standards for certain appointment wait times for Medicaid and CHIP managed care enrollees;
• Establish stronger state monitoring and reporting requirements related to access and network adequacy for Medicaid and CHIP managed care plans;
• Establish a quality rating system for Medicaid and CHIP managed care plans;
• Require states to conduct annual enrollee experience surveys for Medicaid managed care plans;
• Implement new standards for states that use in lieu of services and settings (ILOSs) to promote effective utilization; and
• Specify medical loss ratio (MLR) requirements.

Public comments will be accepted until July 3, 2023. For more information, click here.

CMS Proposed Rule Seeks to Improve Access to Medicaid Services

On May 3, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule that seeks to improve access to Medicaid fee-for-service (FFS), managed care delivery system, and in-home and community-based services (HCBS) programs. The proposed rule would:

• Increase program transparency and accountability;
• Standardize program data and monitoring;
• Create opportunities for states to promote active beneficiary engagement; and
• Strengthen how states use state Medical Care Advisory Committees.

Public comments will be accepted until July 3, 2023. For more information, click here.

HHS OCR Proposed Rule Modifies HIPAA and HITECH Privacy Rule

On April 12, the Department of Health and Human Services (HHS) Office for Civil Rights (OCR) released a proposed rule that would modify the Standards for Privacy of Individually Identifiable Health Information “privacy rule” under the Health Insurance Portability and Accountability Act of 1996 (HIPPA) and the Health Information Technology for Economic and Clinical Health (HITECH) Act of 2009. The proposed rule would limit the use and disclosure of an individual’s protected health information (PHI) if it relates to an individual accessing lawful reproductive healthcare services. It would specifically prohibit the disclosure of such information for criminal, civil or administrative investigations or proceedings against individuals or regulated entities.

Public comments will be accepted until June 19, 2023. For more information, click here.

HHS ONC Proposed Rule Updates Electronic Health Information Infrastructure

On April 11, the Department of Health and Human Services (HHS) Office of the National Coordinator for Health Information Technology (ONC) released a proposed rule that would make several changes to the nationwide health information technology infrastructure. The proposed rule would:

• Implement the Electronic Health Record Reporting Program and make it a requirement for health information technology (Health IT) developers who are seeking certification;
• Modify and expand exceptions in information blocking regulations;
• Make revisions to the ONC Health IT Certification Program criteria;
• Adopt the United States Core Data for Interoperability (USCDI) Version 3 as standard for the ONC Health IT Certification Program; and
• Update implementation specifications and standards.

Public comments will be accepted until June 20, 2023. For more information, click here.

CMS Proposed Rule Updates Hospital Inpatient and Long-Term Care Hospital PPS Rates

On April 10, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule that would update the hospital inpatient prospective payment system (PPS) and long-term care hospital PPS for fiscal year (FY) 2024. The proposed rule would:

• Increase inpatient PPS payment rates by a net 2.8 percent;
• Increase the cost outlier threshold by 4.8 percent;
• Increase the federal capital by 4.5 percent;
• Exclude “dual reclass” hospitals from the rural wage index policy;
• Consider rural reclassified hospitals as geographically rural when calculating the wage index;
• Support graduate medical training in rural areas by allowing graduate medical education payments to go toward rural emergency hospitals;
• Restore program integrity restrictions on “high Medicaid facilities”;
• Add 15 and remove 16 Medicare Severity Diagnosis Related Groups (MS-DRGs);
• Allow web-based surveys to be used for Hospital Consumer Assessment of Healthcare Providers and Systems; and
• Seek public comment and information on supporting safety-net providers.

Public comments will be accepted until June 9, 2023. For more information, click here.

CMS Proposed Rule Updates Inpatient Psychiatric Facility (IPF) PPS Rates

On April 4, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule that would update the Inpatient Psychiatric Facility (IPF) Prospective Payment System’s (PPS) Medicare payment policies and rates, as well as the IPF Quality Reporting Program (QRP), for fiscal year (FY) 2024. The proposed rule would:

• Result in a 1.9 percent (approximately $55 million) payment increase for IPFs in FY 2024, based on a 3.0 percent increase in the IPF PPS payment rate;
• Adopt a 2021-based IPF market basket;
• Update and increase the labor-related share (LRS) to 78.5 percent;
• Make it easier for hospitals to open new IPF units, by allowing them to open new units at any time during the cost reporting period, so long as they notify their CMS Regional Office and Medicare Administrative Contractor within 30 days; and
• Make changes to the IPF QRP measures.

Public comments will be accepted until June 5, 2023. For more information, click here.

CMS Proposed Rule Updates Skilled Nursing Facility PPS Rates

On April 4, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule that would update the Skilled Nursing Facility (SNF) Prospective Payment System’s (PPS) Medicare payment policies and rates, as well as the SNF Quality Reporting Program (QRP) and SNF Value-Based Purchasing (VBP) Program, for fiscal year (FY) 2024. The proposed rule would:

• Result in a 3.7 percent (approximately $1.2 billion) Medicare Part A payment increase for SNFs in FY 2024, based on a 2.7 percent market basket update; a 3.6 percent increase in the market basket forecast error adjustment; a 0.2 percent decrease in the productivity adjustment; and a 2.3 percent decrease in the FY 2024 SNF PPS rates; and
• Make multiple changes to the SNF QRP measures.

Public comments will be accepted until June 5, 2023. For more information, click here.

CMS Proposed Rule Updates Inpatient Rehabilitation Facility PPS Rates

On April 3, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule that would update the Inpatient Rehabilitation Facility (IRF) Prospective Payment System’s (PPS) Medicare payment policies and rates, as well as the IRF Quality Reporting Program (QRP), for fiscal year (FY) 2024. The proposed rule would:

• Result in a 3.0 percent payment increase for IRFs, based on the proposed market basket update of 3.2 percent minus the 0.2 percentage point productivity adjustment;
• Increase IRF outlier payments by 0.7 percent;
• Make it easier for hospitals to open IRF units by allowing them to immediately start billing under the IRS PPS at any time during the cost reporting period, so long as they notify the CMS Regional Office and Medicare Administrative Contractor in writing within 30 days; and
• Make changes to the IRF QRP measures.

Public comments will be accepted until June 2, 2023. For more information, click here.

CMS Releases Hospice Index, Payment Rate and Aggregate Cap Proposed Rule

On March 31, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule that would make changes to hospice wage index rates, payment rates and aggregate cap amounts for fiscal year (FY) 2024. The proposed rule intends to inform patients and caregivers on hospice utilization trends, hospice center ownership information and Medicare hospice and non-hospice spending amounts. The proposed rule will:

• Codify the Hospice Quality Reporting Program (HQRP) data completion threshold policy;
• Provide an update on future Quality Measures (QM) development and health equity efforts;
• Provide an update on the Consumer Assessment of Healthcare Providers and Systems, Hospice Survey Mode Experiment; and
• Require physicians who order or certify hospice services for Medicare beneficiaries to be enrolled in Medicare or validly opted-out.

Public comments will be accepted until May 30, 2023. For more information, click here.

FDA Proposes New Tobacco Product Manufacturing Practices Requirements

On March 8, the Food and Drug Administration (FDA) released a proposed rule that would improve the manufacture, design, packing and storage of tobacco products. The proposed rule seeks to ensure that tobacco products comply with the Federal Food, Drug, and Cosmetic (FD&C) Act. The FDA has noted that it will help minimize and prevent tobacco product contamination, as well as inconsistencies in e-cigarette liquid concentrations and labeling. The proposed rule will also:

• Establish tobacco product design and development controls;
• Ensure that tobacco products meet established specifications;
• Crack down on tobacco products that do not meet specifications;
• Require manufacturers to take action in cases of product contamination;
• Require investigations of products that do not meet specifications; and
• Establish the ability to trace all components, ingredients, additives, and materials used by tobacco product manufacturers.

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

Final Rules

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 allows 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 Releases Notice of Benefit and Payment Parameters for 2024 Final Rule

On April 19, the Centers for Medicare and Medicaid Services (CMS) released a final rule that will finalize standards for issuers that offer qualified health plans (QHPs) through federally-facilitated exchanges (FFEs) and state-based exchanges on the federal platform (SBE-FPs), and changes made to the payment parameters and provisions of the Department of Health and Human Services (HHS)-operated risk adjustment and risk adjustment data validation programs. The final rule will:

• Make it easier for individuals losing Medicaid or Children’s Health Insurance Program (CHIP) coverage to obtain health coverage by granting them a special enrollment period (SEP) 60 days before or 90 days after losing coverage;
• Grant healthcare plan assisters permission to provide enrollment assistance to individuals;
• Add Substance Use Disorder Treatment Centers and Mental Health Facilities to the essential community provider (ECP) list;
• Extend the requirement to contract with at least 35 percent of available ECPs in a service area to Federally Qualified Health Centers and Family Planning Providers;
• Refine health plan designs for standardized plan options; and
• Limit the number of non-standardized plan options offered by issuers of qualified health plans (QHPs) to four in each service area.

The rule will go into effect on June 18, 2023. For more information, click here.

CMS Finalizes Changes to Medicare Advantage, Part D, Cost Plan and PACE Regulations

On April 5, the Centers for Medicare and Medicaid Services (CMS) released a final rule that will finalize revisions made to the Medicare Advantage (MA), Prescription Drug Benefit and Cost Plan program regulations, as well as the Programs of All-Inclusive Care for the Elderly (PACE) regulations, for calendar year (CY) 2024. The final rule will:

• Require that MA plans comply with national coverage determinations (NCDs), local coverage determinations (LCDs), and general coverage and benefit conditions included in Traditional Medicare regulations;
• Require that coordinated care plan prior authorization policies may only be used to confirm the presence of diagnoses or other medical criteria and/or ensure that an item or service is medically necessary;
• Require coordinated care plans to provide a minimum 90-day transition period to enrollees who are undergoing treatment and switch to a new MA plan;
• Require all MA plans to establish a Utilization Management Committee and review policies to ensure consistency with Traditional Medicare guidelines;
• Require that approval of a prior authorization request be valid for as long as medically reasonable and necessary;
• Prohibit MA plan television ads from using words, imagery or names that may mislead or confuse beneficiaries;
• Expand access to behavioral healthcare by adding clinical psychologists and licensed clinical social workers to the list of evaluated specialties;
• Promote equitable care by adding a health equity index to the Star Ratings program and require MA and Part D plans to provide care to underserved populations; and
• Implement certain provisions of the Inflation Reduction Act (IRA), the Consolidated Appropriations Act (CAA) of 2021 and the Bipartisan Budget Act (BBA) of 2018.

The rule will go into effect on June 5, 2023. 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.

CMS Issues Correction on Clinical Laboratory Improvement Amendments (CLIA) Final Rule

On Nov. 17, the Centers for Medicare and Medicaid Services (CMS) corrected a technical error that was found in a final rule published in the Federal Register on July 11, 2022. The final rule updates proficiency testing (PT) regulations under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), to address analytes and newer technologies.

The rule goes into effect July 11, 2024. For more information, click here.

Courts

Appeals Court Maintains ACA Provision Coverage of Preventive Medicines

On May 15, the U.S. Court of Appeals for the Fifth Circuit blocked a previous ruling issued by the Federal District Court for the Northern District of Texas that sought to nullify a provision in the Affordable Care Act (ACA) that allows Americans to obtain a variety of free preventive healthcare services. The ACA provision grants approximately 150 million people who are covered under private employer-sponsored or ACA marketplace health insurance plans, access to preventive services, such as cancer and diabetes screenings, HIV tests and HIV prophylaxis medications, at no-cost. The case, Braidwood v. Becerra, remains under review, and could make its way to the U.S. Supreme Court. In the meantime, health insurers are legally required to continue covering certain preventative services.

Reports

GAO Releases Report Regarding VA Health IT System

On May 18, the U.S. Government Accountability Office (GAO) released a report regarding challenges the Department of Veterans Affairs (VA) has faced in implementing the Electronic Health Record (EHR) program, an information technology (IT) program used to manage healthcare for its patients. The VA has been working toward fully implementing the program since June 2017.

After analyzing VA implementation activities, organizational change management practices and EHR system issues, the GAO determined that the VA was not consistent with seven of its leading practices, and that it had inadequately identified and addressed system issues. The GAO conducted this study because prior VA appropriation bills contained provisions asking the GAO to review the VA’s implementation of the EHR program.

For more information, click here.

GAO Releases Report Regarding Veterans’ Healthcare Staffing Challenges

On May 17, the U.S. Government Accountability Office (GAO) released a report regarding staffing challenges within the Veterans Health Administration (VHA). The VHA operates the nation’s largest healthcare system and has more than 370,000 employees. Despite a large workforce, the VHA has struggled to keep up with increasing demand for its services.

This report outlines previous recommendations the GAO has made to the VHA regarding how it can adequately address and resolve certain staffing challenges. The GAO has asked the VHA to better identify facility needs, integrate mental healthcare within primary care settings and improve onboarding data for new hires.

For more information, click here.

GAO Releases Report Regarding Rural Healthcare Access

On May 16, the U.S. Government Accountability Office (GAO) released a two-page memo highlighting obstacles to accessing healthcare in rural areas. The memo lists previous reports the GAO has released, which examined the challenges rural individuals face in accessing healthcare services, and reiterates recommendations the GAO has made regarding how they can be resolved. Common barriers faced by rural individuals include the lack of broadband internet, long travel distances between clinics and fewer healthcare providers.

For more information, click here.

CBO Cost Estimates

CBO Releases Analysis on President’s Budget Discretionary Spending Proposals

On May 18, the Congressional Budget Office (CBO) released a report that analyzes the discretionary spending proposals in the president’s 2024 budget. The report looks at how discretionary spending proposals in the budget differ from the CBO’s most recent baseline budget projections for 2023 through 2033. CBO identified the following main differences:

• Under the president’s budget, funding would be $70 billion below baseline amounts in 2024 and $25 trillion below baseline amounts from 2024 through 2033;
• The president’s budget contains less funding designated as an emergency requirement than CBO’s baseline; and
• Funding in the president’s budget that is not designated as an emergency requirement is $28 billion higher in 2024 and $819 billion lower over the 2024-2033 period, compared to CBO baseline amounts.

For more information, click here.

CBO Releases Cost Estimate on S. 460, Urban Indian Health Confer Act

On May 17, the Congressional Budget Office (CBO) released a cost estimate on S. 460, the Urban Indian Health Confer Act. The bill would require the Department of Health and Human Services (HHS) to confer with urban Indian organizations on matters related to the Indian Health Care Improvement Act and other issues that impact Indian healthcare.

The CBO estimates that S. 460 would not affect direct spending or revenues and that it would have an insignificant impact on spending subject to appropriation.

For more information, click here.

CBO Releases Federal Health Spending Update Presentation

On May 16, the Congressional Budget Office (CBO) released a presentation that provides an update on the federal government’s spending on healthcare. The presentation analyzes how healthcare spending trends have changes since 1960 and covers topics such as net interest outlays, primary deficits, total deficits, national health expenditures, federal outlays and more.

For more information, click here.