CMS Issues Notice Regarding Barriers to HCV Treatment

By Dalia Deak

Yesterday, the Centers for Medicare & Medicaid Services (CMS) issued a notice that affirmed CMS’s commitment to provide prescription drugs to beneficiaries, specifically highlighting beneficiaries suffering from hepatitis C virus (HCV). The notice comes at a moment of heightened interest in the cost of prescription drugs (particularly on the federal level as an inquiry in the Senate has been initiated regarding rising drug prices).

In the statement, CMS:

  • Reminded the states of their obligation, under the terms of the Social Security Act, that Medicaid programs must cover prescription drugs for medically accepted indications if the manufacturer of the drug is a manufacturer with whom they have rebate agreements with;
  • Discussed the concern regarding costs of direct-acting antiviral (DAA) HCV drugs, emphasizing the role of competition and negotiation in bringing down the drugs’ prices;
  • Expressed concern regarding some states’ policies to restrict access to the DAA HCV drugs that may be contrary to their obligations under the Social Security Act;
  • Encouraged states to ensure that their policies do not unreasonably restrict coverage of effective treatment;
  • Reminded states that drugs available under the states’ fee-for-service programs must also be available to beneficiaries of Medicaid managed care organizations; and
  • Indicated that CMS will monitor state Medicaid policies for DAA HCV drug coverage to ensure that they are compliant with approved state plans, statutes, and regulations.

CMS also followed up its notice with a letter to the CEO of AbbVie asking for additional information regarding the types of value-based purchasing arrangements offered to payers and to state Medicaid agencies by December 31, 2015.

HCV has been a high-stakes topic for the last few years given the cost of the drug and the fact that low-income individuals are disproportionately affected by HCV in the United States. State Medicaid agencies, in particular, have struggled to balance the price of the drug (which can cost ~$84,000 per patient) with their responsibility to provide patients with access to treatments. This has led to a number of coverage restrictions. Yet, as a study out of Harvard Law School’s Center for Health Law Policy and Innovation shows, state Medicaid programs have instituted access restrictions that do not seem to be based on scientific evidence or current treatment guidelines and may act as effective barriers to access for patients. For example, while the Infectious Disease Society of America and the American Association for the Study of Liver Disease have issued guidelines supporting treatment for all HCV-infected individuals (except those with limited life expectancy), 74% of the 42 state Medicaid programs assessed limit treatment to beneficiaries with advanced liver disease. Additionally, 84% of the state Medicaid programs for which information was available include some form of drug or alcohol abuse criterion for eligibility, with half requiring a period of abstinence. This, however, stands in stark contrast to the need this population has from a health outcomes standpoint and the potential to prevent transmission given that the majority of new cases are among people who have injected or inject drugs.

CMS’s notice seems to be responding to similar concerns and certainly has important implications for patients, advocates, and state Medicaid programs. This is particularly true as all parties seek to strike the right balance between patient access to life-saving therapies and sufficient incentives for the development of promising treatments. It will be interesting to see how this debate develops in the coming months.


At the end of her fellowship year, Dalia Deak had completed a MPH in the Department of Health Policy and Management at the Harvard T.H. Chan School of Public Health and was accepted Harvard Law School as a JD candidate ('19). She received her BS in biomedical engineering from the University of Virginia, where she focused primarily on computer science in biomedical engineering and issues at the intersection of technology, health policy, and public health. After receiving her undergraduate education, Dalia joined the Brookings Institution as a Research Assistant where she worked on their medical device evidence and innovation portfolio. While at Brookings, Dalia co-authored a report for the U.S. Food and Drug Administration on the implementation of a unique device identification system that would support postmarket surveillance and enhance patient safety. Dalia’s research interests lay at the intersection of medical device and drug policy and public health law, and her fellowship research paper was entitled "Repurposing Transformative Drugs: Public Health, Policy, and Legal Issues."

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