Health Policy Report – Aug. 8, 2023

Texas Oncology Hosts Congressman Keith Self (R-TX) 

On Monday, July 24 Texas Oncology hosted Representative Keith Self (R-TX) at its McKinney practice outside Dallas, Texas. Dr. Anand Shivnani and director of practice operations Melissa Rich led Congressman Self on a tour of the practice showcasing the suite of services it offers. 

Congressman Self is a freshman member serving on the House Committee on Veterans’ Affairs and House Committee on Foreign Relations. He met with several imaging staff and patients to learn more about the high-quality community oncology care being delivered in his district.  During the visit, Texas Oncology shared details about its commitment to value-based payment models and the pressures of consolidation from hospitals.  

To read more, CLICK HERE. 

House Ways and Means Committee Passes Health Transparency Legislation 

On July 26, the House Ways and Means Committee held a markup on several healthcare-related bills and voted to advance the Providers and Payers COMPETE Act (H.R. 3284) and the Health Care Price Transparency Act of 2023 (H.R. 4822). Both bills are intended to help increase transparency in the nation’s healthcare system and address growing Medicare spending.  

H.R. 4822, the Health Care Price Transparency Act of 2023 requires additional facilities under Medicare to disclose information regarding charges and prices, provides oversight of Pharmacy Benefit Manager (PBM) services, and requires site neutral payments for Medicare Part B drug administration services. The bill also requires reporting on healthcare transparency tools, data usage and requirements, and integrating these tools into Medicare. The legislation’s primary goal is to increase transparency within Medicare; however, it will also implement changes across the healthcare system. 

H.R. 3284, the Providers and Payers COMPETE Act requires the Secretary of Health and Human Services (HHS) to submit an annual report on the impact Medicare regulations have on provider and payer consolidation. If passed, the bill requires the Secretary of HHS to release the first of these reports by December 30, 2025. Any legislative or structural changes that will impact provider and payer consolidation will also have to be publicly available for feedback before implementation. 

The Alliance for Site Neutral Payment Reform issued a statement applauding the Ways and Means Committee for their work and requesting more action on these issues. “The Alliance strongly urges lawmakers to continue working towards a healthcare landscape that fosters equitable reimbursement for all providers,” the group said in the statement. “The Alliance for Site Neutral Payment Reform stands ready to work alongside the Committee and other policymakers to implement legislation that promotes fair competition, patient choice, and a more cost-effective healthcare system.” 

To read the bill text for the Providers and Payers COMPETE Act (H.R. 3284), CLICK HERE. 

To read the bill text for the Health Care Price Transparency Act of 2023 (H.R. 4822), CLICK HERE. 

To watch the committee markup, CLICK HERE. 

To read the statement from the Alliance for Site Neutral Payment Reform, CLICK HERE. 

Senate Finance Committee Holds PBM Markup 

On July 26, the Senate Finance Committee approved the bipartisan Modernizing and Ensuring PBM Accountability (MEPA) Act through a 25-1 vote.  

The Finance Committee oversees the Medicare & Medicaid programs, which make up a substantial portion of US healthcare spending. Although this is not the only Senate Committee that has passed a pharmacy benefit manager (PBM) reform bill, this is the only bill that aims to delink PBM compensation from the price of drugs, removing an incentive for PBMs to favor higher-priced medications. The bill would also ban spread pricing, ending the practice of charging Medicaid more for prescription drugs than the PBM reimburses the pharmacy. 

During the markup, Senate Finance Committee Chairman Ron Wyden (D-OR) also noted the committee’s intention to look more closely at the 340B program to make meaningful changes, a project he plans to work on with Senator John Thune (R-SD). 

“Pharmacy benefit managers are the middlemen between your health insurance and drug makers that virtually seize every prescription handed from a doctor to a patient,” said Senator Wyden. “Decades ago, PBMs served a role to assemble mountains of claims data and use bargaining power on behalf of insurance companies to negotiate with drug makers for lower prices. But in recent years, these businesses have consolidated into mega-corporations that dominate the market. This consolidation has allowed PBMs to adopt tactics and play games with their data that result in higher profits for themselves and higher costs for everyone else.” 

The Finance Committee has not released the full text of the MEPA Act yet, but a description of the bill and a section by section summary is available HERE. 

To watch the committee markup, CLICK HERE. 

To read more about the bill advancement, CLICK HERE. 

Amid New Pharma Lawsuits, House Democrats Introduce Bill to Expand Medicare Drug Price Negotiations 

Democratic House leaders recently introduced new legislation to expand the drug cost-lowering provisions of the Inflation Reduction Act (IRA). 

On July 26, House Energy and Commerce Committee Ranking Member Frank Pallone, Jr. (D-NJ), Ways and Means Committee Ranking Member Richard Neal (D-MA), and Education and the Workforce Committee Ranking Member Bobby Scott (D-VA) introduced the Lowering Drug Costs for American Families Act. This legislation would extend the drug price negotiation program to all Americans with private health insurance coverage, stop drug companies from raising prices faster than inflation in commercial plans, and increase the annual number of prescription drugs selected for the drug price negotiation program from 20 to 50. If enacted, the provisions would go into effect in 2029.  

This bill differs from the Senate’s S. 1246, SMART Prices Act led by Senators Amy Klobuchar (D-MN) and Peter Welch (D-VT), which was introduced in April 2023 and would expand the drug negotiation program by allowing prescription drugs and biologics to be eligible for negotiation five years after FDA-approval, increase the number of drugs subject to negotiation, and increase the amount by which Medicare can lower prices.  

The Lowering Drug Costs for American Families Act is mostly seen as an aspirational bill, but this may indicate Democrats’ priorities should they regain a majority in 2024.  

To read a press statement from Ranking Member Pallone and view a section by section of the bill, CLICK HERE. 

To read the text of the bill, CLICK HERE.  

To learn more about the legislation, CLICK HERE. 

Bipartisan Lawmakers Send Letter to Congressional Leadership on Urgent Need for Medicare Payment System Reform 

A group of over 90 bipartisan Members of Congress––led by Representatives Ami Bera, M.D. (D-CA), Larry Bucshon, M.D. (R-IN), Kim Schrier (D-WA), Mariannette Miller-Meeks, M.D. (R-IA), Earl Blumenauer (D-OR), and Brad Schneider (D-IL)––recently submitted a letter to House Speaker Kevin McCarthy (R-CA) and Leader Hakeem Jeffries (D-NY) emphasizing the urgent need to establish a stable Medicare payment system.  

Since the Medicare Access and CHIP Reauthorization Act (MACRA) was signed into law in 2015, it has shifted Medicare’s approach to physician payment by paying providers based on quality, value, and the results of care delivered rather than the number or volume of services provided. But payments made to physicians who participate in value-based care models are affected by the Physician Fee Schedule, and revision of the fee schedule has caused some providers to face significant decreases in their reimbursement. The lawmakers’ letter calls on Congress to address the logistical challenges in MACRA and the financial instability it has caused for providers.  

“In order to keep our patients safe, access to care available, and the healthcare workforce strong, Members of Congress must urgently work together to enact MACRA reforms, establishing a stable payment mechanism that appropriately pays for health outcomes. Please work with us to find a solution that ensures we keep our communities healthy,” the members wrote in the letter. 

To read the full letter, CLICK HERE.  

Energy & Commerce Committee Chair Cathy McMorris Rodgers (R-WA) Unveils Drug Shortage Discussion Draft Policy Proposal 

On July 28, House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA) unveiled a discussion draft of policy proposals aimed at addressing drug shortages in the United States. The draft is the result of stakeholder feedback from a request for information from Chair McMorris Rodgers and Senate Finance Committee Ranking Member Mike Crapo (R-ID) issued earlier this summer. 

The key elements of the multifaceted proposal include suspending additional inflationary rebates for certain drugs in Medicaid and exempting certain generic, sterile injectable drugs from the 340B Drug Pricing Program. It would also phase out the inflation rebate amounts for certain drugs in Medicare.  

The discussion draft requires a study on Medicare reimbursement of generic sterile injectable drugs. It also requires the Center for Medicare and Medicaid Innovation (CMMI) to test reimbursement for generic sterile injectable drugs based on commercial net pricing or a drug’s wholesale acquisition cost. It also requires the Medicare Payment Advisory Commission (MedPAC) to make recommendations for changing the add-on payment for Part B drugs to a flat fee-based payment, including ways to ensure physicians are held harmless.  

Additionally, the draft aims to hold the Food and Drug Administration (FDA) accountable by leveraging its reporting requirements and establishing a pilot program for preapproval inspections of new domestic sterile manufacturing facilities.  

“America is the leader in developing innovative treatments and cures. Yet the economics of our convoluted health care system create shortages—particularly of low-cost and generic drugs—that harm patients in need. The responses to our RFI on addressing drug shortages overwhelmingly made clear that we need to address the root causes of shortages with a multifaceted approach. This discussion draft is part of our committee’s thoughtful, deliberative process to offer long-term solutions to these issues so that patients can access the drugs they need. I hope this draft will lead to bipartisan legislation, and I welcome feedback and collaboration from my colleagues across the aisle and chamber, stakeholders, and subject matter experts,” said Chair Rodgers.  

To read Chair McMorris Rodgers’ press release, CLICK HERE. 

To read the section-by-section analysis of the Stop Drug Shortages Act, CLICK HERE. 

White House Announces New Precision Surgery Initiative as Part of Cancer Moonshot 

On July 27, the White House announced a new Advanced Research Projects Agency for Health (ARPA-H) program that will advance the President’s signature Cancer Moonshot initiative. The Precision Surgical Interventions (PSI) program is designed to help accelerate the development of novel technologies that will allow surgeons to remove cancerous tumors with more accuracy and minimize damage to surrounding tissues.  

The program—the first cancer-specific initiative launched by ARPA-H and just the second program ever for the fledgling agency since it was established last year—is intended to develop new tools to enable surgeons to remove cancer through a single operation by better identifying and differentiating between healthy and cancer tissue. Technologies developed through this program will also help surgeons avoid nerves, blood vessels, lymph nodes, and other anatomical structures when performing surgeries to remove cancerous tissues.  

ARPA-H is now soliciting proposals for “methods and techniques to improve visibility of cancer and other critical anatomical structures during surgery.” A Proposers Day for interested research teams is scheduled for September 7, 2023, in Chicago, Illinois. 

To read a White House press release about the Precision Surgical Interventions (PSI) program, CLICK HERE. 

To read more about the announcement, CLICK HERE. 
 

Pandemic Disruptions Slowed Early-Stage Cancer Diagnoses, Led to Increase in Late-Stage Cancers

In early August, The Lancet Oncology published a new study about the impact of the COVID-19 pandemic on cancer diagnoses. The researchers found that early-stage cancer diagnoses decreased by nearly 20% during the first year of the pandemic due to disruptions in care. 

In April 2020, there were approximately half of the number of cancer diagnoses compared to average pre-pandemic levels. The significant drop suggests that cancer has been underdiagnosed, particularly among populations that have been traditionally underserved by the nation’s healthcare system. Hispanic Americans and Asian Americans and Pacific Islanders, for example, were 10%-11% more likely to receive a stage 4 diagnosis in 2020. Ultimately, the disruptions caused by the COVID-19 pandemic have major implications for cancer morbidity, survival, and mortality. 

This is the most comprehensive analysis of cancer diagnoses during the pandemic, using a nationwide registry that captured over 70% of all cancers in the United States. The authors are optimistic that patients will increasingly have their cancers caught early and have better outcomes, but challenges still remain as almost 4 million patients lost their Medicaid insurance since the pandemic-era protections expired in March. 

To read the study in The Lancet Oncology, CLICK HERE.