On Monday, Senate Appropriations Committee leaders reached an agreement to add nearly $14 billion in additional fiscal 2024 spending in the bills set to be marked up on July 27. Of the $14 billion, the Labor-HHS bill would get another $2 billion. At the same time, the House of Representatives continues to move appropriations bills that contain much lower spending levels than their Senate counterparts, setting up a clash this fall over funding federal government programs.

On Thursday, The Senate Health, Education, Labor, and Pensions (HELP) Committee approved bipartisan legislation to reauthorize the Pandemic and All-Hazards Preparedness Act (PAHPA), which is set to expire at the end of the fiscal year in September. Six of the ten Republican members of the committee, including Ranking Member Bill Cassidy (R-LA), voted with all committee Democrats a day after the House Energy and Commerce Committee approved a narrower version along party lines.

On Monday, the House Energy and Commerce Committee held a markup of 15 health care bills, all of which were agreed to—some bipartisan and some along party lines with GOP-only votes. The bills included legislation that would permanently allow telehealth to be a standalone benefit (H.R. 824), and a sweeping pandemic preparedness package and the reauthorization of the SUPPORT Act.

Late last week, the Federal Trade Commission (FTC) announced that it is withdrawing two guidance documents, signaling tougher stance on antitrust issues in health care, saying they’re “outdated,” and the health care market has significantly changed in the past 30 years, making the old guidance no longer appropriate.

On Tuesday, the Biden Administration announced that it will allocate an additional $50 million in grant money toward substance use and treatment and will be awarded by the Substance Abuse and Mental Health Services Administration (SAMHSA).

1. H.R. 824, the Telehealth Benefit Expansion for Workers Act of 2023 (Rep. Walberg)

– AGREED TO 29-20

2. H.R. 3226, the Prematurity Research Expansion and Education for Mothers who deliver Infants Early (PREEMIE) Reauthorization Act of 2023 (Rep. Eshoo)

– AGREED TO 48-0

3. H.R. 3838, the Preventing Maternal Deaths Reauthorization Act of 2023 (Rep. Burgess)

– AGREED TO 50-0

4. H.R. 3843, the Action for Dental Health Act of 2023 (Rep. Kelly)

– AGREED TO 50-0

5. H.R. 3884, the Sickle Cell Disease and Other Heritable Blood Disorders Research, Surveillance, Prevention, and Treatment Act of 2023 (Rep. Burgess)

– AGREED TO 50-0

6. H.R. 3821, the Firefighter Cancer Registry Reauthorization Act of 2023 (Rep. Pascrell)

– AGREED TO 51-0

7. H.R. 3391, the Gabriella Miller Kids First Research Act 2.0 (Rep. Wexton)

– AGREED TO 50-0

8. H.R. 3836, the Medicaid Primary Care Improvement Act (Rep. Crenshaw)

– AGREED TO 51-0

9. H.R. 4531, the Support for Patients and Communities Reauthorization Act (Rep. Guthrie)

– AGREED To 49-0

10.  H.R. 4529, the Public Health Guidance Transparency and Accountability Act of 2023 (Rep. Rodgers)

– AGREED TO 25-21

11.  H.R. 4381, the Public Health Emergency Congressional Review Act (Rep. Murphy)

– AGREED TO 28-21

12.  H.R. 3813, the CDC Leadership Accountability Act of 2023 (Rep. Guthrie)

– AGREED TO 27-20

13.  H.R. 4421, the Preparing for All Hazards and Pathogens Reauthorization Act (Rep. Hudson)

– AGREED TO 28-23

14.  H.R. 4420, the Preparedness and Response Reauthorization Act (Rep. Hudson)

– AGREED TO 27-22

15.  H.R. 3887, the Children’s Hospital GME Support Reauthorization Act of 2023 (Rep. Crenshaw)

– AGREED TO 27-17

On Tuesday, The House Veterans’ Affairs Committee’s health subcommittee held a markup, advancing several bills aimed at boosting veterans’ health care, including H.R.3520, the Veteran Care Improvement Act of 2023, and H.R. 1774, the VA Emergency Transportation Act. Two of the bills were also discussed at a Senate Veterans Affairs Committee hearing last week:

1.  The Expanding Veterans’ Options for Long Term Care Act (S.4169), which moved forward on a voice vote, would create a three-year pilot program to offer assisted living to veterans who need the services but aren't eligible for nursing home care. The VA does not directly cover assisted living room and board. The agency supports the Senate version, with some caveats, as do veterans groups.

2.  The VA Zero Suicide Demonstration Project Act (S.853), would establish pilot programs at five VA sites. The VA didn’t support the Senate companion, arguing that “existing suicide prevention efforts and strategies are more robust.” Rep. Derrick Van Orden (R-WI) called the legislation “redundant” on Tuesday.

On Thursday, The Senate Health, Education, Labor, and Pensions Committee approved bipartisan reauthorize the Pandemic and All-Hazards Preparedness Act (PAHPA), set to expire at the end of September. Six Republicans voted with committee Democrats a day after the House Energy and Commerce Committee approved a narrower version along party lines. The Senate panel also adopted an amendment from Senator John Hickenlooper (D-CO) that would create an FDA program focused on reviewing new medical countermeasures for emerging pathogens. Chair Bernie Sanders (I-Vt.) and ranking member Bill Cassidy (R-La.) were largely aligned on the package. The pair were divided over including changes to price controls and vouchers for drugmakers, but both were removed from the base text before the hearing. Read the bill here, and Mehlman Consulting markup summary here.

On Wednesday, the House Energy and Commerce Health Subcommittee held a hearing to hear from experts and trade lobbies on the Medicare coverage process for novel medical devices and drugs. Witnesses included Natalia Rost, the American Academy of Neurology’s president-elect; Thomas MacGillivray, president of the Society of Thoracic Surgeons; and Todd Brinton, advanced technology chief scientific officer at Edwards Lifesciences. Lawmakers questioned CMS’ coverage policy for novel Alzheimer’s treatments and the agency’s recent notice of a Transitional Coverage for Emerging Technologies (TCET) pathway for breakthrough medical devices, which aims to speed coverage of breakthrough devices. Read Mehlman Consulting’s summary here.

On Thursday, the Senate Finance Committee, Health Care Subcommittee held a hearing titled “The Cost of Inaction and the Urgent Need to Reform the U.S. Transplant System.” The panel questioned United Network for Organ Sharing, the private nonprofit that manages the organ transplant system under contract with the federal government, and the panel vowed to move quickly on passing legislation to help end the group’s monopoly power. The nonprofit faces intense criticism from lawmakers and patient advocates, claiming they lack accountability, failures with technology and general mismanagement of the system. Hearing witnesses included Molly J. McCarthy Vice Chair & Region 6 Patient Affairs Committee Representative, Organ Procurement and Transplantation Network (OPTN); Matthew Wadsworth President And CEO, Life Connection of Ohio; Raymond J. Lynch, MD, MS, FACS Professor Of Surgery And Director Of Transplantation Quality And Outcomes, Penn State Health Milton S. Hershey Medical Center; and Donna R. Cryer, JD Founder And CEO, Global Liver Institute. Read more information on the hearing here, and Mehlman Consulting’s summary here.

Last week, Senate Finance Committee Chair Ron Wyden (D-OR) and Ranking Member Mike Crapo (R-ID) announced that the committee will mark up legislative proposals to modernize and enhance federal prescription drug programs on Wednesday, July 26^th at 2 p.m. The committee package will focus on addressing pharmacy benefit manager practices (PBM) including the Modernizing and Ensuring PBM Accountability Act (at-yet-unnumbered bill). In addition, the Senators sent a letter to the Congressional Budget Office (CBO) requesting budgetary estimates in advance of the markup for the following policies: (1) Strengthening Part D patient access to pharmacies of their choice in their communities; (2) Reducing patient out-of-pocket costs and abating perverse incentives caused by prescription drug rebates; (3) Mitigating PBM steering on specialty medicines; (4) Bolstering transparency and reporting requirements for PBM-owned pharmacies; and (5) Increasing patient access to lower cost biosimilar and generic medicines. Read the press release here and the bill draft here.

On Wednesday, Sen. Bernie Sanders (I-Vt.), chairman of the Senate Health, Education, Labor, and Pensions (HELP) Committee, introduced The Primary Care and Health Workforce Expansion Act (As-yet-unnumbered bill), legislation which if passed would invest $100 billion a year over a five-year period to expand community health centers. Senator Bill Cassidy (R-LA) opposes the bill. He introduced a Senate version (S.2308) of the bipartisan package advanced in the House, which also reauthorized some of these programs but at much lower levels. The markup of the bill is scheduled for Wednesday, July 26, at 10:30 AM. Read the bill here, and a summary here. Read Senator Cassidy’s statement here.

Late last week, House Energy and Commerce chair Cathy McMorris Rodgers (R-WA) and Ways and Means chair Jason Smith (R-MO) led a letter to CMS Friday calling for more transparency from CMS on how it weighs Medicare national coverage determination (NCD) requests. NCDs set out how Medicare will cover certain items and care nationally and leans on evidence review. The lawmakers asked CMS for a list of items awaiting a national coverage determination and a plan for updating the NCD dashboard, which they say hasn’t been updated in nearly three years. The request comes as lawmakers have been critical of the agency’s limited national coverage determination for Alzheimer’s treatments and takes their scrutiny to another level. Read the letter here. 

Late last week, the Federal Trade Commission (FTC) announced that it is withdrawing two guidance documents on antitrust issues in health care, saying they’re “outdated.” The two withdrawn documents were jointly written by the Department of Justice (DOJ) and FTC, and are the 1996 Statements of Antitrust Enforcement Policy in Health Care; and a 2011 statement on Antitrust Enforcement Policy Regarding Accountable Care Organizations Participating in the Medicare Shared Savings Program. The FTC said the health care market has significantly changed in the past 30 years, making the old guidance no longer appropriate. Instead, it will lean on general antitrust principles. Read the FTC press release here.

On July 14, the Department of Health and Human Services announced that it would re-establish verification of eligibility to enroll in Affordable Care Act plans and receive subsidies. A “matching program” between the Centers for Medicare & Medicaid Services and the Social Security Administration will be re-established for an initial term of 18 months from September 9 to March 8, 2025, and may be renewed for an additional year if no changes are made. This follows the previous administration’s decision to restrict automatic re-enrollment in the Affordable Care Act plans in 2020 to maintain program integrity. The notice under the Privacy Act of 1974 said the program will “Verify match findings before suspending, terminating, reducing, or making a final denial of an individual’s benefits or payments or taking other adverse action against the individual.” Read the notice here.

On Monday the Department of Labor (DOL) announced a final rule, which will require employers in high-risk industries, including healthcare, with 100 or more employees to electronically file injury and illness reports to the Occupational Safety and Health Administration (OSHA). The rule will apply to organizations across the health care sector, including hospitals, ambulatory care providers, nursing care, mental health, and substance abuse facilities. The rule mandates that organizations submit two detailed documents on work-related injuries and illnesses and individual incident reports on top of other reporting requirements. The rule is set to take effect on January 1, 2024. See the press release here, and final rule here.

On Monday, the Food and Drug Administration (FDA) approved AstraZeneca and Sanofi’s drug Beyfortus, known as nirsevimab, is a long-acting monoclonal antibody designed to protect newborns and infants against respiratory syncytial virus (RSV) during their first year of life. RSV results in as many as 80,000 pediatric hospital visits annually. The green light from the FDA came ahead of the US RSV season, which normally picks up in the fall. Read the press release here.

On Tuesday, Vice President Kamala Harris announced that the Biden Administration will allocate an additional $50 million toward substance use and treatment, following on the heel of the National Response Plan announced July 11. The money, which will come as grants, will be awarded by the Substance Abuse and Mental Health Services Administration (SAMHSA) on Wednesday. In a meeting with eight attorneys general on illicit fentanyl, Harris stressed the importance of naloxone, the opioid overdose reversal drug, in saving lives nationwide as overdose deaths remain at record levels, driven mainly by illicit fentanyl, a powerful synthetic opioid. Read the White House press release here, and the HHS press release here.

On Thursday, the Federal Trade Commission (FTC) unanimously voted to issue a statement cautioning against relying on prior advocacy statements and studies related to pharmacy benefit mangers (PBMs) that no longer reflect current market realities. The move follows bipartisan legislation moving through Congress to require PBMs to disclose more about how they do business. The FTC is studying PBMs’ influence on the drug industry as pharmaceutical companies and lawmakers in both parties blame PBMs for rapid drug price inflation. The Pharmaceutical Care Management Association, the leading trade association for pharmacy benefit managers, said it agrees with the FTC that the market has changed, but not with its decision to disavow its prior guidance. Read the press release here, and the statement here.

On Thursday, the Federal Trade Commission (FTC) and the U.S. Department of Health and Human Services' Office for Civil Rights (OCR) cautioned hospitals and telehealth providers about the privacy and security risks related to the use of online tracking technologies integrated into their websites or mobile apps that may be impermissibly disclosing consumers’ sensitive personal health data to third parties. The two agencies sent a joint letter to 130 hospital systems and telehealth providers to alert them about the risks and concerns about the use of technologies that can track a user’s online activities. Read the press release here, and the letter here.

White House Launches Office of Pandemic Preparedness and Response Policy (OPPR)

Today, the White House announced the launch of the Office of Pandemic Preparedness and Response Policy (OPPR), a permanent office in the Executive Office of the President (EOP) charged with leading, coordinating, and implementing actions related to preparedness for, and response to, known and unknown biological threats or pathogens that could lead to a pandemic or to significant public health-related disruptions in the United States. Major General (ret) Paul Friedrichs will serve as the inaugural Director of OPPR and Principal Advisor on Pandemic Preparedness and Response. Read the press release here. 

On Monday, The Federal Trade Commission (FTC) announced it is seeking to block IQVIA, the world’s largest health care data provider and owner of advertising technology company DeepIntent, from acquiring Propel Media, Inc. (PMI), alleging in an administrative complaint that the proposed acquisition would give IQVIA a market- leading position in programmatic advertising for health care products, namely prescription drugs, to doctors and other health care professionals. The merger would also increase IQVIA’s incentive to withhold key information to prevent rival companies and potential entrants from effectively competing, the complaint states. The FTC’s complaint alleges that the proposed transaction would eliminate head-to-head competition, driving up prices and reducing quality and choice. Read the press release here.

Hearing:  "VA Disability Exams: Are Veterans Receiving Quality Services?"

Markup: To consider an original bill entitled, "Primary Care and Health Workforce Expansion Act", and other pending calendar business.

Hearing: Executive Session Hearing: "S. _, The Primary Care and Health Workforce Expansion Act."

Markup: Markup of Pharmacy Benefit Manager Proposals (PBMs)

Markup: Full Committee Markup of Fiscal Year 2024 Defense, Interior and Environment, Labor, Health and Human Services, Education, and Homeland Security Appropriations Acts