Health Care Checkup: July 28, 2023

Health Care Checkup

July 28, 2023

THE BIG PICTURE: KEY CONGRESSIONAL & EXECUTIVE BRANCH DEVELOPMENTS

On Wednesday, the House Ways and Means Committee held a markup on H.R.4822, the Health Care Price Transparency Act of 2023, and H.R.3284, the Providers and Payers COMPETE Act. Both bills were approved on party lines. The Health Care Price Transparency Act of 2023 legislation includes several provisions designed to improve health-care access, quality, and affordability, while providing consumers with a better understanding of their health-care costs.

On Thursday, the Senate Appropriations Committee advanced a $224.4 billion Labor-HHS-Education fiscal year 2024 spending bill, with a 26-1 vote. House GOP appropriators propose funding the Department of Health and Human Services (HHS) $103.3 billion, compared with $117 billion in the Senate. Other agencies under HHS would see cuts under that proposal by staying flat, including the Centers for Disease Control (CDC).

On Tuesday, the President announced a new proposed rule to strengthen mental and physical health parity requirements. The proposed rule, if finalized, would require health plans to evaluate the outcomes of their coverage rules to ensure equivalent access between mental health and medical benefits, bar health plans from using more restrictive prior authorization, and codify Mental Health Parity and Addiction Equity Act (MHPAEA) Congressional changes made to MHPAEA.

What to Expect Next Week: The House and Senate will not be in session next week. The Senate will return to session September 5, and the House will return September 12.

DEEP DIVE

Congressional:

Senate Appropriations Committee Advanced $224.4 Billon FY 24’ Labor-HHS-Educations Spending Bill

On Thursday, the Senate Appropriations Committee advanced, 26-1, the Labor-HHS-Education fiscal year 2024 spending bill. The committee will have to reconcile the bill with the House GOP’s proposed budget cuts and elimination of some agencies, to avoid a partial government shutdown on Oct. 1 and fund the government for the next fiscal year. House GOP appropriators propose funding the Department of Health and Human Services (HHS) $103.3 billion, compared with $117 billion in the Senate. Under the Senate bill, other agencies under HHS would see cuts under that proposal by staying flat, including the Centers for Disease Control (CDC). The National Institutes of Health (NIH) would get a boost of $943 million, and Centers for Medicare and Medicaid Services (CMS) trust fund payments for Medicare and other programs would drop from $548 billion to $477 billion. CMS would also see a bump in appropriations for state grants for Medicaid, from $367 billion to $407 billion, and the appropriators approved increased funding for the Office of the National Coordinator for Health Information Technology (ONC). The plan also includes $135 million for artificial intelligence-enabled research at the NIH. Read the bill summary here, and the Senate Report here.

Congress Passed the Securing the U.S. Organ Procurement and Transplantation Network Act

Earlier this week, the House passed H.R. 2544, the Securing the U.S. Organ Procurement and Transplantation Network Act. Later on Thursday, the Senate used a fast-track agreement to pass the Securing the U.S. Organ Procurement and Transplantation Network Act, which would allow, for the first time, competitive bidding on multiple contracts to manage the Organ Procurement and Transplantation Network (OPTN). OPTN maintains a national registry to help match organ donors with recipients. The legislation, which passed the House by voice vote earlier this week, was adopted by the Senate through unanimous consent. The legislation will now go to Biden’s desk, where he is expected to sign the bill into law soon.

In addition to H.R. 2544, the House also passed H.R. 3203, the Stop Chinese Fentanyl Act of 2023, which would provide the president expanded powers to sanction Chinese entities over fentanyl trafficking. It would allow the president to sanction Chinese officials and businesses that fail to take steps to prevent opioid trafficking, instead of just those who play a significant role in the opioid trade.

Senate Finance Committee Advances Bipartisan Modernizing and Ensuring PBM Accountability Act

On Wednesday, the Senate Finance Committee held a markup and advanced the Modernizing and Ensuring PBM Accountability (MEPA) Act, a series of bipartisan proposals to address pharmacy benefit managers (PBMs) that manage prescription drug coverage. The committee passed legislation 26-1, with the single “no” vote from Sen. Ron Johnson (R-WI). The bill would increase transparency over PBMs, prohibit certain pricing practices and fee collections, and ban spread pricing. The legislation is expected to result in roughly $666 million in savings through 2028, according to the Congressional Budget Office (CBO) report. Read Mehlman Consulting’s markup summary here.

House Ways and Means Committee Advances the Health Care Price Transparency Act of 2023 & the Providers and Payers COMPETE Act

On Wednesday, the House Ways and Means Committee held a markup on H.R.4822, the Health Care Price Transparency Act of 2023, and H.R.3284, the Providers and Payers COMPETE Act. Both bills were approved on party lines, with committee Republicans voting in the majority, while objecting Democrats made up the minority tally. The Health Care Price Transparency Act of 2023 legislation includes several provisions designed to improve health-care access, quality, and affordability, while providing consumers with a better understanding of their health-care costs. Rep. Neal (D-MA) and other Democrats criticized committee Republicans for exempting Medicare Advantage plans from increased disclosure requirements. Democrats also raised concerns that the legislation did not include reporting requirements for health-care entities owned by private equity companies. Read Mehlman Consulting’s markup summary here.

Senate Passed Expansion and Extension of the Radiation Exposure Compensation Act (RECA)

On Thursday, the Senate, passed a bipartisan amendment, to expand and extend RECA, to the fiscal year 2024 National Defense Authorization Act (S. 2226), on a 61-32 vote yesterday. The amendment extends and expands eligibility under the RECA program to those who have suffered from cancers related to fallout from above-ground nuclear weapons testing during the Cold War period of the 1950s and 1960s. The legislation expands the coverage area to allow more potential victims, known as “downwinders,” to file for compensation under RECA to include then-residents of Colorado, Idaho, Montana, and New Mexico, and expand eligibility for certain individuals working in uranium mines, mills or transporting uranium ore. The legislation would also increase the amount of compensation an individual may receive and extend the RECA program another 19 years following enactment.

Senate Veterans’ Affairs Committee Holds Hearing on PACT Act

Marking the one year anniversary of the passage of the Honoring our PACT Act of 2022 the Senate Veterans’ Affairs Committee held a hearing titled “Implementing the PACT Act: One Year Later.” The PACT Act expanded health care for veterans exposed to burn pits and other toxic chemicals during their military service. During the hearing, Committee Chair Jon Tester (D-MT) expressed concerns about the complexity of the VA’s website and said that the department’s burn pit registry, aimed at improving understanding about the impacts of exposure, is difficult to use. Read more on the hearing here.

House Democratic Health Committee Leaders Introduce Lowering Drug Costs for American Families Act

The House Democratic Health Committee leaders introduced the Lowering Drug Costs for American Families Act, to further lower prescription drug prices. This legislation builds upon the provisions in the Inflation Reduction Act. Specifically, the bill would:

Extend the drug price negotiation program to individuals with private coverage;
Prohibit pharmaceutical companies from raising prices faster than inflation by ensuring that the inflation rebates enacted under the Inflation Reduction Act also apply to individuals covered by private health plans; and
Increases the number of prescription drugs selected for negotiation from 20 to 50.

Read the bill text here, and a section-by-section here.

Arrington Introduces Better Deals and Lower Prices Act

On Wednesday, Rep. Jodey Arrington (R-TX) introduced the Better Deals and Lower Prices Act, legislation to provide employers with additional information when making contracting decisions with PBMs. The Better Deals and Lower Prices Act would require PBMs to share net price data from all drugs regardless of class to employers that request it. Read the press release here.

House Energy and Commerce Chair Rodgers Released a Proposal to Address Root Cause of Drug Shortages

Today, House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA) released a discussion draft with policy proposals to address the drug shortages facing the U.S. Key details of the proposal include:

Provide market flexibility giving manufacturers of generic, sterile injectable drugs, more flexibility to respond to market pressures, so they can invest in manufacturing and ramp up production when potential shortage situations arise.
Increase disclosure requirements on group purchasing organizations that control bulk contracts between drug manufacturers and health care providers.
Require Food and Drug Administration (FDA) to exercise the reporting requirement authorities it already possesses, includes reporting on certain active pharmaceutical ingredient (API) metrics for generics, and establishes a pilot program for FDA to conduct preapproval inspections for new domestic sterile manufacturing facilities.
Require a government watchdog to examine how policies interact with drugs that have experienced shortages within the past decade, and data analysis and recommendations from the Department of Health and Human Services (HHS) related to how Medicare reimburses for certain drugs and how to protect against drug shortages, including the use of market-based pricing.

Read the press release here, and the section by section here.

HELP Chair’s Primary Care Legislation Markup Postponed

On Monday, Senator Bernie Sanders (I-VT), chair of the Senate Health, Education, Labor, and Pensions (HELP) Committee, announced the postponement of his Primary Care and Health Workforce Expansion Act markup, stating committee members intend to have a major piece of bipartisan legislation ready by the first week of September. Senator Bill Cassidy (R-LA), ranking member of the HELP Committee, stated the responsible thing to do is consider the bill this week, citing bipartisan legislation which unanimously passed out of committee in the House. Read Sen. Cassidy’s statement here, and Sen. Sanders statement here.

Bicameral Health Committee Leaders Announce Bipartisan Request for Information Regarding FDA-Regulation of CBD

On Thursday, House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA) and Ranking Member Frank Pallone, Jr., (D-NJ), along with Senate Health, Education, Labor, and Pensions Committee Chair Bernie Sanders (I-VT) and Ranking Member Bill Cassidy, M.D. (R-LA), today announced a bicameral Request for Information (RFI) to subject matter experts and stakeholders regarding Food and Drug Administration (FDA) regulation of cannabidiol (CBD). Read the RFI here.

House Energy & Commerce Members Request Answers from HHS on Mpox

Late last week, House Energy and Commerce Committee chair Cathy McMorris Rodgers (R-WA), Health Subcommittee Chair Brett Guthrie (R-KY), and Oversight Subcommittee Chair Morgan Griffith (R-VA) wrote to Health and Human Services (HHS) Secretary Xavier Becerra to give a “final warning” in an investigation into allegations of “risky” mpox, formerly known as monkeypox, research. This follows concerns raised in November 2022, about a purported experiment that apparently made mpox, 1,000 percent more deadly in mice than other variants. The Energy and Commerce Republicans have deemed HHS’ responses inadequate. Read the letter here.

Executive Branch:

President Biden Announces New Rule to Strengthen Mental and Physical Health Parity Requirements

On Tuesday, the President announced a new proposed rule to strengthen mental and physical health parity requirements. The proposed rule, if finalized would:

Require health plans to evaluate the outcomes of their coverage rules to ensure equivalent access between mental health and medical benefits; including evaluating the plan’s provider network, out-of-network provider reimbursement, and how often prior authorization is required and the rate at which prior authorization requests are denied.
Bar health plans from using more restrictive prior authorization, other medical management techniques, or narrower networks, and require health plans to use similar factors in setting out-of-network payment rates for mental health and substance use disorder providers as they do for medical providers.
Close existing Mental Health Parity and Addiction Equity Act (MHPAEA) loopholes and codify Congressional changes made to MHPAEA by requiring more than 200 additional health plans to comply with MHPAEA.

Read the White House fact sheet here, and HHS press release here.

President Biden Announces ARPA-H Program to Improve Cancer Surgery

On Thursday, President Biden announced a first-of-its-kind Advanced Research Projects Agency for Health (ARPA-H) program to develop novel technologies that will allow surgeons to remove cancerous tumors with more precision and accuracy. The Administration hopes this program will accelerate progress toward the goals set by the President and First Lady for the Cancer Moonshot: cutting the cancer death rate in half and improving the experience of cancer patients. ARPA-H wants proposals to address two cancer surgery problems: tumor-edge visualization and critical anatomy visualization. The new agency charged with funding high-risk, high-reward research believes that if surgeons can see tumors' edges more clearly, they'll have a better shot at removing them and avoiding damage to healthy tissue. See the press release here, and ARPA-H proposal request here.

CMS Issued Final Rule for Fiscal Year 2024 Inpatient Rehabilitation Facility Prospective Payment System

On Thursday, the Centers for Medicare & Medicaid Services (CMS) issued a final rule to update Medicare payment policies and rates under the Inpatient Rehabilitation Facility (IRF) Prospective Payment System (PPS) and the IRF Quality Reporting Program (QRP) for fiscal year (FY) 2024. Inpatient rehabilitation facilities will see an additional $355 million in Medicare payments in fiscal 2024 under the rate increase. Read the fact sheet here, and the final rule here.

HHS Invests $11 Million to Expand Medical Residencies in Rural Communities

On Wednesday, the Department of Health and Human Services (HHS), through the Health Resources and Services Administration (HRSA), awarded nearly $11 million to 15 awardees to strengthen the health workforce by establishing new residency programs in rural communities. In response to the declining access to rural maternal health care, three of the 15 awards will be used specifically to develop new family medicine residency programs with enhanced obstetrical training in rural communities. Award recipients will each receive up to $750,000 to establish new rural residency programs. Read the press release here.

DOJ and FTC Seek Comment on Draft Merger Guidelines

Late last week, the Department of Justice (DOJ) and the Federal Trade Commission (FTC) proposed updates to merger guidelines that, if finalized, could free up regulators to stop consolidation in the healthcare industry. The goal of the update is to better reflect how the agencies determine a merger’s effect on competition in the modern economy and evaluate proposed mergers under the law. The comment period will be open until September 18, 2023. Read the press release and fact sheet here, and draft guidelines here.

OIG Report Finds Inappropriate Denial of Coverage

Late last week, the Department of Health and Human Services Office of Inspector General released a report finding 37 states it surveyed had systemic problems with their prior authorization processes, leading to inappropriate denials of coverage. These problems included not informing Medicaid patients of their right to appeal a denial, allowing insufficiently trained staff to make prior authorization decisions, and writing notices in ambiguous, often hard-to-understand language that missed or concealed important information such as the reason for a rejection. Read the fact sheet and report here.