Six medical provider organizations have sent an appeal to Congress, asking that they overturn a CMS rule that puts biosimilar drugs of the same kind under one payment code, saying it will discourage innovation and harm patient safety.
On Dec. 9 six groups – the Alliance for Patient Access, the American Association of Clinical Endocrinologists, the American College of Rheumatology, the American Gastroenterological Association, the Biologics Prescribers Collaborative and the Coalition of State Rheumatology Organizations – sent a letter to Senator Orrin Hatch (R-UT), Chairman of the Senate Committee on Finance, to “express our serious and continuing concerns with the CMS decision” in the recent physician fee schedule final rule regarding biosimilars.
A biosimilar is, per the FDA, “a biological product that is approved based on a showing that it is highly similar to an FDA-approved biological product, known as a reference product.”
At issue is CMS’ decision to base biosimilar prices for Medicare “on the ASP [average sales price] of all biosimilar biological products included within the same billing and payment code,” as announced by CMS when the rule was released on Nov. 30. In other words, all biosimilars that mimic the action of a given biologic will take the same code and price. CMS hopes this will help control costs for these drugs in the program.
“Under this policy,” the medical organizations complain, “manufacturers of biosimilars will have no incentive to invest in making improved products with different attributes. The coding policy will also interfere with the ability to track and trace each biosimilar medicine, which could have grave patient safety implications.”
Their complaints track with those of Medicare critics who support a more free-market approach to health care. “Since doctors will be reimbursed at one price under the CMS rule no matter which biosimilar they pick, they may be financially forced to pick the cheapest version, regardless of whether their patient may already be stable and doing well on a different biosimilar,” writes Grace-Marie Turner, president of the Galen Institute (a non-profit that “promotes public debate and education about proposals that support individual freedom, consumer choice, competition and innovation in the health sector”), along with former CMS chief actuary Guy King at Forbes.
The orgs ask Hatch “and other members of Congress to direct CMS to adhere to current law that states that the calculation for reimbursing biosimilars shall be made separately, strongly implying that each biosimilar should have its own unique payment rate and HCPCS code.”