On July 26, 2023, the Community Oncology Alliance (COA) sued HHS on behalf of its members and their patients to reverse a recent federal policy change that blocks oncology cancer practices from delivering drugs to patients. In a statement, COA called said the suit calls the change “an unconstitutional and dangerous display of government overreach that presents real and irreparable injury to patients.”
Filed in US District Court in the District of Columbia, the suit responds to a Frequently Asked Questions (FAQ) document issued by CMS, which told practices that they would be violating the Stark law if they delivered oral cancer medications to their patients, even if a caregiver picks up a drug for a patient. The guidance took effect on May 11, 2023, in advance of the end of the COVID-19 Public Health Emergency (PHE).
“HHS has blatantly and clearly overreached with this FAQ and cancer patients are suffering because of it. COA filed this lawsuit because we cannot let the government simply make unconstitutional rule changes whenever it wants,” said Ted Okon, executive director of COA. “By allowing this FAQ to silently become official policy, CMS has courted disaster for cancer patients and others with serious diseases across the country. The clinical best practices and procedures for patient care, that practices followed forever, are now being upended by bureaucratic edict and putting Medicare seniors at risk.”
The case states that the result of the FAQ has been serious disruptions in care for patients with cancer. In some cases, CMS’ guidance has forced patients to rely on pharmacy benefit manager (PBM) mail order pharmacies; COA has long complained that these pharmacies cause delays and have delivery problems. The CMS guidance also makes no exception for patients with cancer who are too to pick up their drugs, especially in rural or underserved areas, and low-income patients who are now forced to travel, often by public transportation, to collect their oral drugs from the clinic because they can no longer be mailed or shipped.
COA believes that the rule change quietly issued through an FAQ on a website violates the federal rulemaking process for a “substantive amendment” to existing rules, in addition to the 10th Amendment to the United States Constitution. “The Medicare Act and Administrative Procedure Act require formal notice and comment periods so that stakeholders can be adequately notified and allowed to express their concerns before such major changes to existing rules,” COA said in its statement. In addition, the group states, the 10th Amendment “should protect those States with preexisting physician-dispensed medication mailing rules from interference by the federal government.”
The case, Community Oncology Alliance v Becerra et al, is case number 1:23-cv-02168, in the US District Court for the District of Columbia. Jonathan Levitt, Jason Silberberg and Matthew Modafferi of Frier Levitt LLC represent COA.
The Senate Finance Committee has introduced bipartisan legislation that proposes using Medicaid and Medicare programs to help prevent and reduce generic drug shortages; US indicators for COVID-19, flu, and respiratory syncytial virus (RSV) declined further last week; findings from a recent study reveal growing disparities in child death rates across racial and ethnic groups.
Read More
Tackling Health Inequality: The Power of Education and Experience
April 30th 2024To help celebrate and recognize National Minority Health Month, we are bringing you a special month-long podcast series with our Strategic Alliance Partner, UPMC Health Plan. Welcome to our final episode of this limited series and our conversation with Janine Jelks-Seale, MSPPM, director of health equity at UPMC Health Plan.
Listen
A new federal rule will enable thousands of immigrants in the Deferred Action for Childhood Arrivals (DACA) program to obtain health care through the Affordable Care Act; a forthcoming CMS rule is expected to lower home-based care wait times and raise caregiver wages; the HHS Office for Civil Rights has finalized 2 rules that strengthen the ACA’s health care discrimination ban.
Read More
Empowering Community Health Through Wellness and Faith
April 23rd 2024To help celebrate and recognize National Minority Health Month, we are bringing you a special month-long podcast series with our Strategic Alliance Partner, UPMC Health Plan. In the third episode, Camille Clarke-Smith, EdD, MS, CHES, CPT, discusses approaching community health holistically through spiritual and community engagement.
Listen
Shelly Lanning on How Employers Can Reduce Costs by Bridging Gaps in Women's Health Care
May 3rd 2024In a presentation at the Greater Philadelphia Business Coalition on Health Women’s Health Summit, Shelly Lanning, cofounder and president of Visana Health, addressed the need for comprehensive approaches in women’s health care and their coverage options.
Read More