Health Care Checkup
September 22, 2023
THE BIG PICTURE: KEY CONGRESSIONAL & EXECUTIVE BRANCH DEVELOPMENTS
On Thursday, House Republicans delayed plans to take up a stopgap funding measure this week after members of the GOP conference warned there would not be enough votes to pass a continuing resolution to avert a government shutdown at the end of the month. The immediate plan is to prepare more of the chamber's 11 remaining full-year appropriations bills for votes, focusing on passing those to establish a negotiating position for talks with the Senate.

On Thursday, the Senate Health, Education, Labor and Pensions (HELP) Committee held a markup on four bills and advanced the Bipartisan Primary Care and Health Workforce Act out of Committee in a 14-7 vote despite tensions between committee leadership. The $26 billion package reauthorizes key health programs and hospital outpatient payment reforms.

On Monday, House Leaders decided not to proceed with their initial plans to move the Lower Costs, More Transparency Act under suspension of the rules this week. The legislation was released by the House Energy and Commerce, Ways and Means, and Education and the Workforce committees, and would reauthorize the Community Health Center Fund, the National Health Service Corps, and the Teaching Health Center Graduate Medical Education program, all set to expire on September 30. Among other provisions, it would also delay around $16 billion in cuts to hospitals serving a disproportionate number of low-income patients through 2025.

On Thursday, HHS announced it helped half a million children and families regain their Medicaid and Children’s Health Insurance (CHIP) coverage. Following a call to action from CMS, 30 states were required to pause procedural disenrollments for impacted people unless they could ensure all eligible people are not improperly disenrolled due to the issue. 
What to Expect Next Week: The House and Senate are in session next week with much work to do to avoid a government shutdown by September 30. In addition, Congress must reauthorize several health programs and pandemic response legislation. 
DEEP DIVE
Congressional:

House GOP Leaders Delay Stopgap Spending Bill Votes
On Thursday, House Republicans delayed plans to take up a stopgap funding measure this week after members of the GOP conference warned there would not be enough votes to pass a continuing resolution to avert a government shutdown at the end of the month. The immediate plan is to prepare more of the chamber's 11 remaining full-year appropriations bills for votes, focusing on passing those to establish a negotiating position for talks with the Senate. The pivot effectively puts the first move on a Continuing Resolution (CR) to the Senate or a bipartisan group of House lawmakers via a discharge petition. The pivot comes as several House Appropriations subcommittee cardinals spoke with McCarthy and other GOP leaders on Thursday afternoon. Following the meeting, attendees confirmed plans to begin bringing up individual FY24 appropriations measures on the House floor. Leadership is moving forward on a plan to reduce the overall cost of the fiscal 2024 spending bills by $60 billion, with exceptions for Defense, Homeland Security (H.R. 4367) and the Military Construction-VA measure (H.R. 4366), which the chamber has already passed. That would bring the full set of bills into compliance with the new $1.526 trillion topline for fiscal 2024 that the GOP conference largely accepted in a meeting Wednesday night.
 
In the Senate, the focus has shifted from trying to pass a minibus, which stalled over objections from Senator Johnson to Senate Leaders laying the groundwork to take up a stopgap funding measure next week. Senate Majority Leader Charles Schumer (D-NY) filed cloture on a motion to proceed to the House-passed Federal Aviation Administration reauthorization bill (H.R. 3935), which could become the vehicle for the Senate to pass its own CR.
 
Senate HELP Committee Passes Bipartisan Primary Care and Health Workforce Act
On Thursday, the Senate Health, Education, Labor and Pensions (HELP) Committee held a markup of four bills despite tensions between committee leadership. The Committee passed the Bipartisan Primary Care and Health Workforce Act, which reauthorizes key health programs and hospital outpatient payment reforms. This bill passed out of Committee by a vote of 14-7. Three Republicans voted in favor of the legislation, along with all of the Democrats. Senators Bernie Sanders (I-VT) and Roger Marshall (R-KS) stated their $17.4 billion three-year extension for community health centers would be paid for with a mix of policy changes to hospital billing, reforms for pharmacy benefit managers, and several unspecified provisions coming from the Senate Finance and Judiciary committees. Ranking Republican Bill Cassidy (R-LA) remains opposed to the legislation, saying it lacked provisions to offset costs, and the legislation does not explicitly ban funds from paying for abortion services. Given the close Committee vote and the Ranking Member’s strong opposition, whether the bill can pass the full Senate in its current form is unclear. The package is not likely to pass the Republican-controlled House but is significant because it marks the Senate’s negotiating position in reauthorizing several programs that expire on September 30.
Major provisions in the legislation include:
·        $2.3 billion in savings from requiring “honest billing” from hospitals;
  • $2 billion from prohibiting facility fees for telehealth and evaluation and management services;
  • $1.1 billion from banning anti-competitive clauses for commercial insurance;
  • More than $3 billion from PBM reforms like banning spread pricing and de-linking PBM pay from rebate amounts; and
  • $980 million pulled from the Prevention and Public Health Fund.
Read the Mehlman markup summary here.
 
House Vote on The Lower Costs, More Transparency Act, Healthcare Package Delayed
On Monday, House Leaders decided not to proceed with their initial plans to move the Lower Costs, More Transparency Act under suspension of the rules this week. Chair Cathy McMorris Rodgers (R-WA) stated she was “100% committed to getting this bill up for consideration on the floor, passed out of the House, and ultimately onto the president’s desk” but declined to explain further why it was pulled. Among the reasons that the bill is not likely to advance in the near term are the broader challenges the House is encountering to pass spending legislation and keep the government operational past the end of the current fiscal year; the legislation, which has bipartisan support and was approved unanimously by the Energy and Commerce Committee, faced opposition from Ways and Means Ranking Democratic Member Richard Neal (D-MA) and Education and the Workforce Ranking Member Robert Scott (D-VA). The Congressional Budget Office estimates the bill would decrease deficits by $833 million over 10 years. The Legislation includes the following key provisions:
  • Require pharmacy benefit managers to disclose some information and data to plan sponsors and ban "spread pricing" in Medicaid -- a practice in which a PBM charges a health plan more than what is paid to the pharmacy.
  • Reauthorize the Community Health Center Fund, the National Health Service Corps, and the Teaching Health Center Graduate Medical Education program.
  • Delay around $16 billion in cuts to hospitals serving a disproportionate number of low-income patients through 2025.
  • Require Medicare to pay hospital outpatient departments the same prices for drug administration as physician offices are paid. Currently, hospital outpatient departments are paid more for these services.
  • Prevent hospitals from billing group health plans for services provided off-campus unless they obtain and use a unique billing code. Also, it would require off-campus outpatient departments to obtain separate provider identifiers to bill Medicare.
Read the bill here.
 
House Oversight and Accountability Committee Focuses on PBM Practices
On Tuesday, the House Oversight and Accountability Committee held a hearing to examine pharmacy benefit managers (PBMs), with witnesses from industry groups, including JC Scott, the CEO of the PBM trade group, and industry opponents, including PhRMA, which represents brand drugmakers, the National Community Pharmacists Association and the Biosimilars Council. Congress has been increasingly critical of PBMs and is looking to pass bipartisan legislation imposing new transparency requirements or restrictions on PBMs. Read more on the hearing and witness testimonies here.
 
House E&C Health Subcommittee Considers Policies to Improve Seniors’ Access to Innovative Drugs, Medical Devices, and Technology
On Tuesday, the Energy & Commerce Subcommittee on Health held a hearing entitled “Examining Policies to Improve Seniors’ Access to Innovative Drugs, Medical Devices, and Technology” that focused on the following legislation:
  1. H.R. 1691, the Ensuring Patient Access to Critical Breakthrough Products Act of 2023 (Reps. Wenstrup, Bilirakis, Cardenas, Guthrie, Eshoo)
  2. H.R. 2408, the Access to Innovative Treatments Act of 2023 (Reps. Barragan and Joyce) 
  3. H.R. 133, the Mandating Exclusive Review of Individual Treatments (MERIT) Act (Reps. Buchanan and Barragan)
  4. H.R. 2407, the Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act (Reps. Arrington, Hudson, and Ruiz)
  5. H.R. 1199, the Facilitating Innovative Nuclear Diagnostics (FIND) Act of 2023 (Reps. Dunn, Peters, Trahan, Blunt Rochester, Miller-Meeks, Tonko, Joyce, Kuster, and Bucshon)
  6. H.R. 3842, the Expanding Access to Diabetes Self-Management Training Act of 2023 (Reps. Schrier, Bilirakis, DeGette, Bucshon, and Ruiz)
  7. H.R. 4818, the Treat and Reduce Obesity Act (TROA) of 2023 (Reps. Wenstrup, Ruiz, and Miller-Meeks)
  8. H.R. 1458, the Access to Prescription Digital Therapeutics Act of 2023 (Reps. Hern, Johnson, and Matsui)
  9. H.R. 2880, the Protecting Patients Against PBM Abuses Act (Reps. Carter and Blunt Rochester)
  10. H.R. 5074, the Kidney PATIENT Act of 2023 (Reps. Carter and Kuster)
  11. H.R. 4881, To amend title XVIII of the Social Security Act to limit cost sharing for drugs under the Medicare program. (Rep. Malliotakis)
  12. H.R. 5372, the Expanding Seniors’ Access to Lower Cost Medicines Act of 2023 (Reps. Joyce and Peters)
  13. H.R. 5376, the Share the Savings with Seniors Act (Reps. Miller-Meeks and Peters)
  14. H.R. 5371, the Choices for Increased Mobility Act of 2023 (Rep. Joyce)
  15. H.R. 5394, the Expanding Remote Monitoring Access Act (Reps. Balderson and Porter)
  16. H.R. 5386, the Cutting Copays Act (Reps. McGarvey and Bilirakis)
  17. H.R. 5393, the Transparency and Fairness for Pharmacies Act (Reps. Griffith and Carter)
  18. H.R. 5389, the National Coverage Determination Transparency Act (Rep. Guthrie)
  19. H.R. 5395, the Coverage Parity for Medicare Patients Act of 2023 (Rep. Harshbarger)
  20. H.R. 5396, the Coverage Determination Clarity Act of 2023 (Rep. Bucshon)
  21. H.R. 5392, the Timely Access to Coverage Decisions Act of 2023 (Rep. Dunn)
  22. H.R. 5397, the Joe Fiandra Access to Home Infusion Act of 2023 (Reps. Fitzpatrick and Dunn)
  23. H.R. 5385, the Medicare PBM Accountability Act (Reps. Landsman and Harshbarger)
  24. H.R. 5388, the Supporting Innovation for Seniors Act (Rep. Balderson)
  25. H.R. 5380, To amend title XVIII of the Social Security Act to increase data transparency for supplemental benefits under Medicare Advantage. (Rep. Sarbanes)
Read the bills included here, and the Mehlman hearing summary here.

Ways and Means Committee Holds Hearing on Implementation of Surprise Medical Billing Protections
On Tuesday, the House Ways and Means Committee held a hearing to examine the implementation of the No Surprises Act, which was signed into law on December 27, 2020. Republicans and Democrats were united in their criticism of the Biden Administration’s implementation of the law intended to prevent patients from being charged high prices in emergencies and other situations where they cannot control who their medical provider is. Ways and Means Chairman Jason Smith (R-MO) stated the flawed implementation has led to legal challenges, resulting in significant backlogs of disputed cases. Numerous court challenges have been filed by the Texas Medical Association and other provider groups against the administration’s rules governing how payment disputes should be resolved, with major court rulings from the US District Court for the Eastern District of Texas favoring medical providers and finding the rules are contrary to the law. Read the Mehlman hearing summary here.
 
House Oversight and Accountability Committee Focuses on PBM Practices
On Tuesday, the House Oversight and Accountability Committee held a hearing to examine pharmacy benefit managers (PBMs), with witnesses from industry groups, including JC Scott, the CEO of Pharmaceutical Care Management Association (PCMA), and industry opponents, including PhRMA, which represents brand drugmakers, the National Community Pharmacists Association and the Biosimilars Council. Read more on the hearing and witness testimonies here.

House Committee on Veterans’ Affairs Holds Hearing on Scope of Practice Standards
On Tuesday, the House Committee on Veterans’ Affairs, health subcommittee held a hearing examining potential new national standards of practice. The VA is weighing allowing providers like optometrists and certified registered nurse anesthetists to provide other care to help facilities with insufficient staff. The American Medical Association (AMA) has been critical of allowing non-physicians to do procedures beyond their current scope, and the American Society of Anesthesiologists said that allowing nurse anesthetists to do work previously reserved for anesthesiologists could lower the quality of care. Both Democratic and Republican lawmakers have stated concern that providers with less rigorous training who take on more types of care could lead to safety issues. Leaders from groups representing optometrists and nurse anesthetists argued that their clinicians can safely perform more advanced care. The VA is holding the last of several listening sessions on Thursday and is expected to release new data from an independent analysis of nurse anesthetists in the coming weeks. Read more on the hearing and witness testimony here.

House E&C Oversight Subcommittee Hearing on Inflation Reduction Act Exposes Partisan Rifts Over the Law’s Drug Pricing Provisions
On Wednesday, the House Energy and Commerce Oversight Subcommittee held a hearing to discuss the Inflation Reduction Act’s impact on drugmakers. Lawmakers had split views over the issue with Republicans questioning the law’s impact on research and development and Democrats defending its Medicare drug price negotiation provisions. Read more on the hearing and the witness testimonies here.

Lawmakers Call for Progress on Patent Framework
On Tuesday, Rep. Lloyd Doggett (D-TX) and Senators Elizabeth Warren (D-MA) and Angus King, Jr. (D-MA), sent a letter urging Biden’s Health and Commerce secretaries to release a draft framework to keep drug costs down by seizing patents from taxpayer-funded inventions, a procedure called “march-in rights,” to be released immediately for public comment. The Commerce and Health and Human Services Departments are reviewing march-in, an option no federal agency has ever exercised. Read the letter here.

Latta, Dingell Introduce Bipartisan TREAT Act
On Monday, Congressman Bob Latta (R-OH) and Congresswoman Debbie Dingell (D-MI), both members of the U.S. House Energy and Commerce Committee, re-introduced the TREAT Act, which would temporarily waive state reciprocity laws to allow mental telehealth services to be provided across state lines during the event of a public health emergency.  Currently, healthcare professionals must maintain licenses in each state in which they render services. The Temporary Reciprocity to Ensure Access to Treatment (TREAT) Act would provide temporary licensing reciprocity for providers assisting in telehealth services for those suffering from mental health-related issues. Read the press release here.

Thompson and Kuster Introduce Bipartisan Legislation to Improve Access to Telehealth Services In Rural Areas
On Wednesday, Representatives Glenn "GT" Thompson (R-PA) and Ann Kuster (D-NH), introduced the bipartisan Helping Ensure Access to Local TeleHealth, or the HEALTH Act, as part of National Telehealth Awareness Week. The legislation would secure Medicare reimbursement for telehealth services provided by community health centers and rural health clinics. It would also continue to allow providers to utilize audio-only telehealth visits for patients who do not have access to broadband services. Read the press release here.

Rosen, Collins, and Braun Introduce Bipartisan Bill to Address Nursing Shortage
On Wednesday, Senators Jacky Rosen (D-NV), Susan Collins (R-ME), and Mike Braun (R-IN) introduced the bipartisan Train More Nurses Act to address the nursing shortage affecting communities across the nation. The legislation would direct the Secretary of Health and Human Services and the Secretary of Labor to conduct a review of all nursing grant programs to find ways to increase faculty at nursing schools, particularly in underserved areas. It will also increase pathways for Licensed Practical Nurses to become Registered Nurses. Read the press release here

Executive Branch:

HHS Reinstates Coverage for Half a Million Children and Families
On Thursday, HHS announced it helped half a million children and families regain their Medicaid and Children’s Health Insurance (CHIP) coverage. On August 30, the Centers for Medicare & Medicaid Services (CMS) issued a call to action to states about a potential state systems issue where systems were inappropriately disenrolling children and other enrollees. 30 states were required to pause procedural disenrollments for impacted people unless they could ensure all eligible people are not improperly disenrolled due to the issue. CMS offered states strategies to assist in making it easier for people to renew their coverage, and nearly all states have adopted at least some of these strategies. Read the press release here.
 
CFPB Kicks Off Rulemaking to Remove Medical Bills from Credit Reports
On Thursday, the Consumer Financial Protection Bureau (CFPB) announced it is beginning a rulemaking process to remove medical bills from Americans’ credit reports. The CFPB outlined proposals and alternatives under consideration for the CFPB’s medical debt rulemaking. If finalized, they would:
  • Remove medical bills from consumers’ credit reports: Consumer reporting companies would be prohibited from including medical debts and collection information on consumer reports that creditors use in making underwriting decisions.
  • Stop creditors from relying on medical bills for underwriting decisions: The proposal would narrow the 2005 exception and prohibit creditors from using medical collections information when evaluating borrowers’ credit applications.
  • Stop coercive collection practices: As unpaid medical bills would no longer appear on consumers’ credit reports used by creditors in making underwriting decisions, debt collectors would no longer be able to use the credit reporting system as leverage to pressure consumers into paying questionable debts.
Read the press release here.
 
HHS Finalizes Rule to Streamline Enrollment In the Medicare Savings Programs
On Wednesday, the Department of Health and Human Services (HHS), through the Centers for Medicare & Medicaid Services (CMS), finalized a rule to streamline enrollment in the Medicare Savings Programs (MSPs), making coverage more affordable for an estimated 860,000 people. The MSPs, run by state Medicaid programs, currently cover Medicare premiums and, in most cases, cost-sharing for more than 10 million older adults and people with disabilities who also have limited incomes. One of the key changes is to automatically enroll Medicare-eligible people who get Supplemental Security Income (SSI) from Social Security. The rule also expands eligibility for Medicare Part D’s Low-Income Subsidy that helps lower drug costs. The expansion, which could benefit an estimated 300,000 people, was part of the Inflation Reduction Act. Read the rule here.

HHS Awards $600 Million to Bolster US Manufacturing of COVID-19 Tests and Announces the Re-Opening of COVIDTests.gov
On Wednesday, the Department of Health and Human Services (HHS), through the Administration for Strategic Preparedness and Response (ASPR), announced an investment of $600 million across 12 domestic COVID-19 test manufacturers and the reopening of COVIDTests.gov to deliver COVID-19 tests for free to households across the country. These investments in U.S. manufacturing will improve preparedness for COVID-19 and other pandemic threats, strengthen the nation’s capacity to manufacture tests, and secure approximately 200 million new over-the-counter COVID-19 tests for future federal government use. Each household will be able to order four free testing kits via COVIDTests.gov. Read the press release here.

HHS Awards $45 Million in Grants to Expand Access to Care for People with Long COVID
On Wednesday, the Department of Health and Human Services (HHS), through the Agency for Healthcare Research and Quality (AHRQ), announced nine grant awards of $1 million each for up to 5 years to support existing multidisciplinary Long COVID clinics across the country to expand access to comprehensive, coordinated, and person-centered care for people with Long COVID, particularly underserved, rural, vulnerable, and minority populations that are disproportionately impacted by the effects of Long COVID. The grants are designed to expand access and care, develop, and implement new or improved care delivery models, foster best practices for Long COVID management, and support the primary care community in Long COVID education. Read the press release here.

Agencies Propose New Fees for Medical Billing Disputes
On Wednesday, a proposed rule from the Departments of Labor, Health and Human Services, and the Internal Revenue Service proposed a new rule that would set fees for filing arbitration cases under the No Surprises Act to be $150 per dispute. The rule is in response to a ruling in August by the US District Court for the Eastern District of Texas. The court found the prior $350 fee violated the Administrative Procedure Act by not providing parties with notice and an opportunity to comment on administrative fees charged for seeking arbitration in medical billing disputes. The arbitration process has been shut down because of the court’s ruling, causing more backlogs in an already jammed system. More than 330,000 cases have been filed, which prevents medical providers from billing patients more than can be charged for in-network care in emergencies, and in situations where people are treated by out-of-network providers at network facilities. Read the proposed rule here

Legal & Other:

Judge Hears Arguments in Chamber of Commerce Lawsuit Against Drug Pricing Program 
Late last week, a federal judge heard arguments in a case filed by the Chamber of Commerce against the Health and Human Services Department in June, that could determine the future of President Biden's plan to lower drug prices under the Inflation Reduction Act (IRA). The Chamber is asking for a preliminary injunction, claiming the law violates its members’ due process rights by requiring manufacturers to participate in negotiations or face repercussions, including excise taxes or removal of all of its drugs from the Medicare and Medicaid programs. Manufacturers must sign an agreement by Oct. 1 to engage in negotiations or face penalties. United States District Judge Michael Newman of the Southern District of Ohio did not indicate how he might rule, but the U.S. Chamber of Commerce asked that he do so before the Centers for Medicare and Medicaid Services (CMS) deadline. The Department of Justice (DOJ) argued the case should be dismissed because the company cited in the lawsuit, AbbVie, will not be involved in the negotiation process. This is just one of nine lawsuits that have been filed against the Biden administration's drug pricing program, but Friday's hearing marked the first time arguments were heard. The program's timeline could be disrupted by an injunction in any one of these lawsuits. 
CONGRESSIONAL HEARINGS & EVENTS
House Hearings:

No health hearings have been announced for next week.

Senate Hearings:

Senate Budget Committee, Full Committee
Hearing: "Medicare Forever: Protecting Seniors by Making the Wealthy Pay Their Fair Share."
Wednesday, September 27, at 10:00 AM
 
Senate Finance Committee, Full Committee
Hearing: “To Consider the Nominations of Marjorie A. Rollinson, of Virginia, to be Chief Counsel for the Internal Revenue Service and an Assistant General Counsel in the Department of the Treasury, Patricia Hart Neuman, of the District of Columbia, to be a Member of the Board of Trustees of the Federal Supplementary Medical Insurance Trust Fund; to be a Member of the Board of Trustees of the Federal Hospital Insurance Trust Fund; to be a Member of the Board of Trustees of the Federal Old-Age and Survivors Insurance Trust Fund and the Federal Disability Insurance Trust Fund, and Demetrios L. Kouzoukas, of Virginia, to be a Member of the Board of Trustees of the Federal Supplementary Medical Insurance Trust Fund; to be a Member of the Board of Trustees of the Federal Hospital Insurance Trust Fund; to be a Member of the Board of Trustees of the Federal Old-Age and Survivors Insurance Trust Fund and the Federal Disability Insurance Trust Fund.”
Thursday, September 28 at 10:00 AM
ADMINISTRATION ANNOUNCEMENTS
Centers for Medicare & Medicaid Services
Food and Drug Administration
Guidance Documents from the Centers for Disease Control and Prevention
National Institutes of Health
1341 G Street NW
Washington, DC 20005
202-585-0258