The Big Picture

Call to Action: Physicians Needed to Alleviate HCV Treatment Restrictions

In conducting our national review of Medicaid restrictions for hepatitis C virus treatments, it became obvious that people living with HCV and the broader HCV advocacy community need help from you — the physicians who treat HCV.

For the first time ever we have new curative treatments that offer the potential to eliminate HCV. Yet current access restrictions in Medicaid programs keep the cure out of reach for many people who are in desperate need of it. To address this crisis, we need health care providers to demand the elimination of life-threatening restrictions to HCV treatment to promote access to needed health care for their patients and our public health.

Progress and Continued Challenges

In our report, Hepatitis C: The State of Medicaid Access, co-written and produced by the Center for Health Law and Policy Innovation of Harvard Law School and the National Viral Hepatitis Roundtable, we examined coverage of all HCV treatment regimens in state Medicaid fee-for-service programs and managed care organizations. What we found is some improvement in treatment access since 2014, but that many Medicaid programs continue to restrict access to HCV treatments using medically unjustifiable requirements.

Robert Greenwald

It remains common for state Medicaid programs to limit access to only those individuals living with HCV that has caused serious liver damage, as evidenced by advanced fibrosis or cirrhosis of the liver. Similarly, states often require long periods of sobriety before providing access to treatment and many severely limit which providers can prescribe treatment. Such restrictions do not exist for the treatment of most other health conditions, go against the standard of HCV care, and certainly should not exist for treating a serious and communicable yet curable disease such as HCV.

While the cost of treatment is a legitimate concern, the reality is that with increased competition, the cost of treatment is far, far lower than it was even 2 years ago. Regardless, cost concerns cannot supersede clear guidance from the Centers for Medicare and Medicaid Services and Courts that have made clear that treatment access restrictions often violate federal law. We must heed recent court decisions, which in response to advocates suing Medicaid programs to expand access, have found that current Medicaid restrictions on HCV treatment are unfair and discriminatory. Medicaid programs must follow established treatment guidelines as published by the American Association for the Study of Liver Diseases and the Infections Disease Society of America, which call for unrestricted access to HCV treatment for almost all people living with HCV. There is no legal basis for preventing access to curative HCV treatments for Medicaid enrollees across the country.

The good news is that our recent report shows that we are making progress in reducing HCV treatment access restrictions in Medicaid. Overall, from 2014 to 2016, 16 states either eased or eliminated restrictions based on fibrosis or liver disease stage requirements, including one state that moved from requiring evidence of cirrhosis of the liver to dropping the fibrosis requirement all together. From 2014 to 2016, seven states decreased their sobriety restrictions, with three of those states removing sobriety restrictions altogether. Lastly, from 2014 to 2016, seven states eased their prescriber limitations.

However, while progress has been made in securing treatment access for many people living with HCV, it is counterbalanced by many states retaining medically unjustified treatment restrictions that continue to threaten the lives of millions of people living with HCV in the United States.

Provider Restrictions, the Advocacy Role of Specialists

Unfortunately, prescriber restrictions remain widespread across state Medicaid programs. In the fee-for-service programs, only two states do not limit which medical providers may prescribe HCV treatments. Most states require prescribing by specialists — generally, gastroenterologists, hepatologists and infectious disease specialists — or prescribing in consultation with a specialist.

We have made some progress in easing these restrictions. In 2016, 64% of states allowed general practitioners to prescribe HCV treatment “in consultation with a specialist,” up from 52% in 2014. Yet, given the simplicity of these new curative HCV treatment regimens, compared with the interferon era, the restrictions on providers are still unreasonable. Serving as gatekeepers puts specialist in a very difficult situation, as without them, in most states, no one living with HCV can be treated.

Many specialists are not willing or able to dedicate their practice to a relatively easy 8 to 12 week course of treatment. Also, the restrictions are over-inclusive in that there are many health care providers who have significant experience treating patients with HCV who do not fall into the specialist category. By making specialists the gatekeeper to care, state Medicaid programs have created a bottleneck that saves them money by keeping individuals from receiving the curative HCV treatment they need.

There is clear a solution to this gatekeeping problem. Specialists could play a leading role in a successful effort to end unfair and discriminatory treatment access restrictions, including the prescriber limitations in their state’s Medicaid programs. In particular, specialists could make it clear to state policymakers that these restrictions are unjustified, defy established treatment standards and violate federal Medicaid law. The restrictions also often violate state law.

Specialists should join people living with HCV and patient advocates who are testifying before state Medicaid Pharmacy and Therapeutics Committees to eliminate restrictions. They should participate in meetings with key elected and appointed officials to put an end to unfair access restrictions.

Where public advocacy falls short and lawsuits are filed against state Medicaid programs (and private insurers), specialists should serve as expert witnesses, providing courts with the information needed to understand how these restrictions are a threat to both individual and the public health.

Next Steps

Specialists are the experts and it makes sense for them to play a leading role in promoting HCV treatment access and eliminating HCV in our communities.

While specialists have busy schedules and many primary responsibilities, what is more important than protecting and promoting the health of the people they are trained to serve? Specialists must work with their patients and the advocacy community to build on the progress that has been made in holding federal and state Medicaid officials and insurance regulators accountable for ensuring that people living with HCV have access to treatment in keeping with established treatment guidelines and relevant federal and state laws.

Working together, we must insist that state Medicaid programs across the country ensure that all people living with HCV have access to life-saving, curative treatment regimens.

Disclosure: Greenwald reports no relevant financial relationships. The Center for Health Law and Policy Innovation of Harvard Law School is funded by multiple sources including non-profit health organizations, individual donors, state/local governments, non-profit foundations (eg, Ford Foundation, Elton John AIDS foundation), pharmaceutical companies (eg, Gilead, Janssen and ViiV) and Harvard Law School.

In conducting our national review of Medicaid restrictions for hepatitis C virus treatments, it became obvious that people living with HCV and the broader HCV advocacy community need help from you — the physicians who treat HCV.

For the first time ever we have new curative treatments that offer the potential to eliminate HCV. Yet current access restrictions in Medicaid programs keep the cure out of reach for many people who are in desperate need of it. To address this crisis, we need health care providers to demand the elimination of life-threatening restrictions to HCV treatment to promote access to needed health care for their patients and our public health.

Progress and Continued Challenges

In our report, Hepatitis C: The State of Medicaid Access, co-written and produced by the Center for Health Law and Policy Innovation of Harvard Law School and the National Viral Hepatitis Roundtable, we examined coverage of all HCV treatment regimens in state Medicaid fee-for-service programs and managed care organizations. What we found is some improvement in treatment access since 2014, but that many Medicaid programs continue to restrict access to HCV treatments using medically unjustifiable requirements.

Robert Greenwald

It remains common for state Medicaid programs to limit access to only those individuals living with HCV that has caused serious liver damage, as evidenced by advanced fibrosis or cirrhosis of the liver. Similarly, states often require long periods of sobriety before providing access to treatment and many severely limit which providers can prescribe treatment. Such restrictions do not exist for the treatment of most other health conditions, go against the standard of HCV care, and certainly should not exist for treating a serious and communicable yet curable disease such as HCV.

While the cost of treatment is a legitimate concern, the reality is that with increased competition, the cost of treatment is far, far lower than it was even 2 years ago. Regardless, cost concerns cannot supersede clear guidance from the Centers for Medicare and Medicaid Services and Courts that have made clear that treatment access restrictions often violate federal law. We must heed recent court decisions, which in response to advocates suing Medicaid programs to expand access, have found that current Medicaid restrictions on HCV treatment are unfair and discriminatory. Medicaid programs must follow established treatment guidelines as published by the American Association for the Study of Liver Diseases and the Infections Disease Society of America, which call for unrestricted access to HCV treatment for almost all people living with HCV. There is no legal basis for preventing access to curative HCV treatments for Medicaid enrollees across the country.

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The good news is that our recent report shows that we are making progress in reducing HCV treatment access restrictions in Medicaid. Overall, from 2014 to 2016, 16 states either eased or eliminated restrictions based on fibrosis or liver disease stage requirements, including one state that moved from requiring evidence of cirrhosis of the liver to dropping the fibrosis requirement all together. From 2014 to 2016, seven states decreased their sobriety restrictions, with three of those states removing sobriety restrictions altogether. Lastly, from 2014 to 2016, seven states eased their prescriber limitations.

However, while progress has been made in securing treatment access for many people living with HCV, it is counterbalanced by many states retaining medically unjustified treatment restrictions that continue to threaten the lives of millions of people living with HCV in the United States.

Provider Restrictions, the Advocacy Role of Specialists

Unfortunately, prescriber restrictions remain widespread across state Medicaid programs. In the fee-for-service programs, only two states do not limit which medical providers may prescribe HCV treatments. Most states require prescribing by specialists — generally, gastroenterologists, hepatologists and infectious disease specialists — or prescribing in consultation with a specialist.

We have made some progress in easing these restrictions. In 2016, 64% of states allowed general practitioners to prescribe HCV treatment “in consultation with a specialist,” up from 52% in 2014. Yet, given the simplicity of these new curative HCV treatment regimens, compared with the interferon era, the restrictions on providers are still unreasonable. Serving as gatekeepers puts specialist in a very difficult situation, as without them, in most states, no one living with HCV can be treated.

Many specialists are not willing or able to dedicate their practice to a relatively easy 8 to 12 week course of treatment. Also, the restrictions are over-inclusive in that there are many health care providers who have significant experience treating patients with HCV who do not fall into the specialist category. By making specialists the gatekeeper to care, state Medicaid programs have created a bottleneck that saves them money by keeping individuals from receiving the curative HCV treatment they need.

There is clear a solution to this gatekeeping problem. Specialists could play a leading role in a successful effort to end unfair and discriminatory treatment access restrictions, including the prescriber limitations in their state’s Medicaid programs. In particular, specialists could make it clear to state policymakers that these restrictions are unjustified, defy established treatment standards and violate federal Medicaid law. The restrictions also often violate state law.

PAGE BREAK

Specialists should join people living with HCV and patient advocates who are testifying before state Medicaid Pharmacy and Therapeutics Committees to eliminate restrictions. They should participate in meetings with key elected and appointed officials to put an end to unfair access restrictions.

Where public advocacy falls short and lawsuits are filed against state Medicaid programs (and private insurers), specialists should serve as expert witnesses, providing courts with the information needed to understand how these restrictions are a threat to both individual and the public health.

Next Steps

Specialists are the experts and it makes sense for them to play a leading role in promoting HCV treatment access and eliminating HCV in our communities.

While specialists have busy schedules and many primary responsibilities, what is more important than protecting and promoting the health of the people they are trained to serve? Specialists must work with their patients and the advocacy community to build on the progress that has been made in holding federal and state Medicaid officials and insurance regulators accountable for ensuring that people living with HCV have access to treatment in keeping with established treatment guidelines and relevant federal and state laws.

Working together, we must insist that state Medicaid programs across the country ensure that all people living with HCV have access to life-saving, curative treatment regimens.

Disclosure: Greenwald reports no relevant financial relationships. The Center for Health Law and Policy Innovation of Harvard Law School is funded by multiple sources including non-profit health organizations, individual donors, state/local governments, non-profit foundations (eg, Ford Foundation, Elton John AIDS foundation), pharmaceutical companies (eg, Gilead, Janssen and ViiV) and Harvard Law School.