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Monitoring of Adverse Effects

August 30, 2023

September 2023

Camille Puronen, MD, MPH

Camille Puronen, MD, MPH

The American Society of Hematology (ASH) selected Camille Puronen, MD, MPH, as its 2022–2023 ASH Congressional Fellow. The Congressional Fellow program aims to connect hematologists to the policy-making process and educate congressional members and staff about issues that are important to hematologists and their patients.


Early summer is a busy time on the Hill. With the drama of the debt ceiling behind it, Congress has swiftly moved on to other topics, including many health policy issues. My office (Brian Higgins, NY-26) has been working on several cancer-related bills. I helped revise and reintroduce a bill on improving access to cancer screening and assisted with a bipartisan bill to address clinical trial diversity. A few months ago, with the support of hematologists from the Roswell Park Comprehensive Cancer Center in Buffalo, New York, I secured Rep. Higgins’s co-sponsorship of the Sickle Cell Comprehensive Care Act, which was particularly gratifying. I have continued to meet with constituents who bring a wide range of perspectives on the current issues before Congress; I have learned that legislation championed by one constituent is often denounced by another.

Hematologists are familiar with unintended consequences in clinical medicine (the patient who develops bleeding while on anticoagulation, for example). Such “adverse effects” are equally common in health policy because of the complexity of our health care system and the competing needs of stakeholders. Some may be familiar: expanded screening programs may catch disease earlier but can also lead to overdiagnosis and increased cost. Other unintended consequences of health policy may be less familiar but still affect our work. For example, 340B programs, which allow hospitals that serve vulnerable populations to purchase drugs at discounted prices, serve as a lifeline for many community health centers and safety-net hospitals, in addition to many centers for bleeding disorders. 340B programs also help increase access to oncology services in rural areas.1 However, the program may incentivize the use of more expensive drugs over biosimilars to maximize hospital revenue, ultimately increasing cost.2

Higher reimbursement for hospital-based procedures, designed to compensate for hospitals’ operating costs, can result in significant discrepancies in the price of chemotherapy infusions administered in a hospital-affiliated clinic versus a physician’s office.3 The potential for increased reimbursement may create a financial incentive for hospitals to purchase local practices and rebrand them as hospital outpatient departments, increasing consolidation and driving up prices.4 Proposed legislation on site-of-care neutrality would make reimbursement independent of the care location, potentially saving Medicare hundreds of billions of dollars.5 However, the decreased revenue could negatively affect rural or safety-net clinics that maintain affiliations with local or regional hospitals for this very purpose. Additionally, many comprehensive cancer centers have benefitted from hospital-based reimbursement rates, which they obtain by establishing dedicated beds in their affiliated hospitals.

The list of health policy “adverse effects” goes on. Medicare Advantage, a private-sector alternative to Medicare, began more than 20 years ago on the promise of increased coverage at lower cost. The government adjusts payments to Medicare Advantage plans based on how complex or “sick” a patient is. Consequently, this risk-adjustment system has led to high-profile reports of organizations attempting to inflate risk-​adjustment data and make patients appear “sicker” to drive revenue.6 Oral parity laws, which require that patient copays for oral anticancer treatments be similar to copays for intravenous medications, seek to improve access to oral drugs by decreasing out-of-pocket costs to patients. However, studies have shown only limited impact in states that have enacted these laws, which tend to disproportionately benefit higher-income, well-insured patients.7,8 Litigation around the Affordable Care Act requirement to cover HIV prophylaxis could affect coverage of other preventive care services, including mammograms, colonoscopies, and routine immunizations.9,10 Over and over, the complexity of our health care system and its diverse stakeholders lead to unintended consequences that can be difficult to reverse.

As I write, we are in the midst of a severe shortage of basic, essential, and cheap chemotherapies. The very affordability of these drugs makes them vulnerable to supply chain disruption in the U.S. market because domestic manufacturers favor higher-margin drugs. In response to advocacy from patients, physicians, and smaller cancer centers, Congress has introduced several bills to prevent future shortages, including legislation to improve drug origin transparency (H.R. 3810), tighten U.S. Food and Drug Administration (FDA) reporting requirements (H.R. 3008), increase drug safety monitoring (H.R. 2500), and extend shelf life (H.R. 3793). In partnership with other offices, my office is drafting legislation to increase the FDA’s authority to address and prevent drug shortages, improve supply chain redundancy, and create a national stockpile for essential medicines. We also hosted a cancer caucus briefing on chemotherapy shortages, bringing together policy experts, physicians, and patient advocates.11

Just as we balance therapeutic benefit and adverse effects in clinic, policymakers must thread the needle of improving health care while ensuring access and controlling costs. Input from stakeholders, including hematologists and their patients, is critical to that process. There are many ways to learn and engage: join the ASH Grassroots Network, sign up for advocacy action alerts, or get involved with your state or local medical society. The ASH Leadership Institute offers a unique opportunity to learn about health policy, advocacy, and the legislative process, not to mention meet like-minded hematologists. The more informed we are as a hematology community, the more effectively we can advocate for our field and patients.

As I wind down my fellowship and prepare to return to clinical medicine, I am again filled with gratitude for this unforgettable experience. I have been fortunate to work with smart, kind, and dedicated staffers who generously shared their expertise, time, and energy. I am grateful for the support of my colleagues at Kaiser Permanente Washington, who recognized this fellowship as an extraordinary opportunity, encouraged me to apply, then cheered me on and cared for my patients in my absence. I am grateful for the kindness of my patients, who forgave me for being away and kept asking when I would be back. And, of course, I am indebted to ASH for allowing me to serve as the 2022-2023 Congressional Fellow. I look forward to passing the torch to the next ASH Congressional Fellow, Shakira Grant, MBBS, to continue bringing hematology to the Hill.

References

  1. Owsley KM, Bradley CJ. Access to oncology services in rural areas: influence of the 340B drug pricing program. Health Aff (Millwood). 2023;42(6):785-794.
  2. Bond AM, Dean EB, Desai SM. The role of financial incentives in biosimilar uptake in Medicare: evidence from the 340B program. Health Aff (Millwood). 2023;42(5):632-641.
  3. Medicare Payment Advisory Commission (MedPAC). Report to the Congress: Medicare Payment Policy. March 2019, Chapter 4. https://www.medpac.gov/wp-content/uploads/import_data/scrape_files/docs/default-source/reports/mar19_medpac_entirereport_sec_rev.pdf.
  4. Post B, Norton EC, Hollenbeck B, et al. Hospital-physician integration and Medicare’s site-based outpatient payments. Health Serv Res. 2021;56(1):7-15.
  5. Committee for a Responsible Federal Budget. Equalizing Medicare payments regardless of site-of-care. Feb. 23, 2021. Accessed 29 June 2023. https://www.crfb.org/papers/equalizing-medicare-payments-regardless-site-care.
  6. Schulte F, Hacker HK. Hidden audits reveal millions in overcharges by Medicare Advantage Plans. National Public Radio. Nov. 21, 2022. https://www.npr.org/sections/health-shots/2022/11/21/1137500875/audit-medicare-advantage-overcharged-medicare.
  7. Dusetzina SB, Huskamp HA, Winn AN, et al. Out-of-pocket and health care spending changes for patients using orally administered anticancer therapy after adoption of state parity laws. JAMA Oncol. 2018;4(6):e173598.
  8. Winn, AN, Dusetzina, SB. More evidence on the limited impact of state oral oncology parity laws. Cancer. 2019;125(3):335-336.
  9. S. District Court, Northern District of Texas, Fort Worth Division. Braidwood Management Inc. v. Xavier Becerra. Civil Action No. 4:20-cv-00283-O. March 30, 2023. https://storage.courtlistener.com/recap/gov.uscourts.txnd.330381/gov.uscourts.txnd.330381.114.0.pdf.
  10. Levitt L, Cox C, Dawson L, et al. Q&A: Implications of the ruling on the ACA’s preventive services requirement. Kaiser Family Foundation. Apr. 4, 2023. https://www.kff.org/policy-watch/qa-implications-of-the-ruling-on-the-acas-preventive-services-requirement/.
  11. Duke University School of Medicine. House Cancer Caucus briefing on chemotherapy shortages. Jun. 6, 2023. https://obgyn.duke.edu/news/house-cancer-caucus-briefing-chemotherapy-shortages.

The content of Notes from the Hill is the opinion of the author and does not represent the official position of the American Society of Hematology unless so stated.

 

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