Chipping Away at Medicaid Restrictions to DAA Coverage

A recent Notice from the Centers for Medicare and Medicaid Services outlined policies surrounding coverage and access to hepatitis C drugs for Medicaid beneficiaries. The authors were sympathetic to ongoing concerns about the high cost of direct-acting antiviral therapies and expressed cautious optimism that market forces will ultimately drive those costs down.

However, the statement contained information about restrictions to coverage and qualifications for initiating therapy that prompted objections from a number of sectors in and around the clinical community.

The three key areas of contention include restrictions based on fibrosis score, mandatory sobriety for active drug and alcohol users before receiving treatment and limitations on what type of clinician can prescribe HCV medications. In short, there are stipulations for coverage of HCV drugs by Medicaid, stipulations that did not exist for previous HCV regimens, and stipulations that do not exist for drugs to treat other diseases.

Robert Greenwald, JD, clinical professor of law and faculty director of the Center for Health Law and Policy Innovation at Harvard Law School, detailed some of the objections in an interview with HCV Next. “We have seen unprecedented restriction in coverage and access to medications for a communicable disease,” he said. “These restrictions are unlike any we have seen before.”

Rebecca Cope, PharmD, assistant professor of Pharmacy Practice at Touro College of Pharmacy and ambulatory care pharmacotherapy specialist at The Brooklyn Hospital Center, agreed. “Restrictive policies for access to DAA drugs certainly continue to be an important barrier for HCV treatment,” she said.

Greenwald pointed out that access to interferon was nearly unrestricted, despite the fact that the drug was relatively expensive, far less effective and associated with a host of adverse events.

“In DAA therapies, we now have a cure which is transformative, that is easy to tolerate, and so of course the expectation is that utilization will increase. Isn’t that great news? We could actually eliminate this disease forever,” he said. “But that is not the response we have seen from insurers, both public and private.”

Although the restrictions have grabbed headlines and attention within the HCV community and the mainstream media, there are a host of other issues at hand, according to Christina Mangurian, MD, MAS, associate professor in the Department of Psychiatry at the UCSF School of Medicine. She has conducted research primarily in improving the medical treatment of Medicaid recipients with mental health issues.

“There is a career’s worth of work in any of these areas,” she said. “People like me do research to highlight the problems, and hopefully larger groups of people will come together to make changes.

Setting the Stage

The CMS Notice contained information about the Medicaid drug rebate program. “The Centers for Medicare & Medicaid Services (CMS) remains committed to Medicaid beneficiaries continuing to have access to needed prescribed medications, a commitment we know that states share,” they wrote. The authors noted that although coverage of these drugs is optional, all 50 states currently provide such benefits. “States that provide assistance for covered outpatient drugs of manufacturers that have entered into, and have in effect, rebate agreements described in section 1927(b) of the Social Security Act (the Act) under their Medicaid fee-for-service (FFS) programs or Medicaid managed care plans are required to comply with the requirements of section 1927(d)(1) and (2) of the Act.”

Greenwald put this information in context. “This is not a suggestion,” he said. “States that are not complying are doing so in violation of a range of provisions within the Medicaid Act.”

Many experts in both the legal and medical fields, like Greenwald, serve as unofficial enforcers of the law. “The government sets the rules of the game, so we have tried to work with states who have seen and are obligated to comply with the CMS notice,” he said. “We offer a warning or a reminder to states that they must comply with the law.”

He argued that this is mostly a socioeconomic issue. “Medicaid is the primary source of coverage for low-income populations that are disproportionately impacted by HCV,” he said. “This is where they get their treatment. Under the Medicaid Act, states are obligated to cover and include on its formulary any drug whose manufacturer participates in the drug rebate program. Straight off the top, Medicaid gets a 23.1% discount on the drugs. In exchange, the drug must be provided by the Medicaid formulary.”

Many states also negotiate with pharma for supplementary rebates, according to Greenwald. “While states have to cover the drugs, there is latitude in terms of prior authorization, utilization and management. We have seen different states employ different strategies for utilizing these drugs and managing patients. In general, though, most of these drugs are only being prescribed when it is an absolute medical necessity.”

The good news is that the Notice, while imperfect, is a work in progress, according to Greenwald. Changes can be made, and the law can be more effectively enforced. “We will continue to push CMS,” he said. “But we are in a situation where people living with HCV have no choice but to pursue legal action. We have filed a class action lawsuit in the state of Washington. Washington was very transparent about not covering the drugs because of politics and cost. They indicated that they were not going to change that policy in the near future. We recently filed the suit. It is working its way up through the justice system and we expect to win.”

But for Greenwald, the issue is not just one of laws or cost. It has to do with who these patients are: low-income, unstably housed, disenfranchised individuals. “I don’t believe this would be happening if we were talking about a cure for Alzheimer’s, multiple sclerosis or cancer,” he said. “We would not be tolerating this situation if they were not poor people. If we had to say to fully employed, fully housed people: ‘You have to wait until your grandfather or wife progresses to a certain state of disease before we can treat them.’ That just would not happen.”

And Greenwald is not the only person investigating these issues. Trooskin and colleagues recently published a paper in Clinical Infectious Diseases in which they discussed advances in HCV therapy and the potential for DAA drugs to eradicate the disease. “Medicaid, however, is rationing these drugs, and other insurers have restricted coverage due to their exorbitant costs and the large size of the population in need,” they wrote. “These access barriers and disparities have resulted in national patient advocacy mobilization, U.S. congressional inquiry, and legal challenges. The U.S. Department of Health and Human Services has been urged to intervene. We propose the establishment of a federal program, analogous to AIDS Drug Assistance Programs, to reduce access barriers and facilitate focused price negotiations. The federal government may further undertake a non-voluntary acquisition of the pharmaceutical patents pursuant to federal statutory authority and principles of eminent domain. Projections indicate this proposal could lower costs by 90% and eliminate rationing.”

Fibrosis Restrictions

Under the Medicaid Act, states may only use reasonable criteria, such as safety and efficacy to restrict coverage. Many advocates assert that using fibrosis score is not a reasonable criterion by which to restrict access. “For example, several state Medicaid programs are limiting treatment to those beneficiaries whose extent of liver damage has progressed to metavir fibrosis score F3, while a number of states are requiring metavir fibrosis scores of F4,” the authors of the Notice wrote.

HCV Next reached out to sources at CMS for comment. “CMS is concerned that some states are restricting access to DAA HCV drugs contrary to the statutory requirements in section 1927 of the Act by imposing conditions for coverage that may unreasonably restrict access to these drugs,” they said in a statement.

Cope addressed this issue. “Most providers are currently finding it extremely difficult to obtain insurance authorization for patients with F0 to F1 fibrosis, despite studies such as CDC CHeCS, which demonstrate the risk of delaying HCV treatment,” she said. “Regardless of fibrosis score — although coverage is arguably even more important in advanced disease — we need to ensure that the patient is able to maintain a reasonable level of medication adherence in order to prevent treatment failures and emergence of resistance. These factors will only complicate care down the road.”

Clinicians should work to gain coverage for patients with early fibrosis, according to Cope. Unfortunately, this can be an uphill battle. “I don’t have any tricks for getting F0 to F1 patients covered, but it always seems beneficial to justify earlier treatment based on patient factors associated with accelerated fibrosis progression — such as diabetes or obesity — consistent with Table 1 in When and in Whom to Initiate HCV Therapy in the HCV Guidelines. From the perspective of eliminating socioeconomic barriers, we suggest seeking to emulate integrated care models which have been shown to facilitate achievement of SVR in traditionally underserved populations.”

Substance Abuse Restrictions

In another section of the CMS Notice, the authors note that state Medicaid programs require a period of abstinence from drugs and alcohol as a condition for reimbursement of the drugs. Some states require at least 6 months and up to 1 year of sobriety before treatment can be initiated.

CMS also addressed this issue in an interview. “Certain states are also requiring a period of abstinence from drug and alcohol abuse as a condition for payment for DAA HCV drugs,” CMS sources said.

“Although we are still learning more about treating active substance users in the DAA era, the AASLD/IDSA/IAS-USA HCV Guidelines suggest that interventional strategies can be used to successfully achieve SVR in this population,” Cope said. “Medicaid restrictions, however, essentially force providers to continue to view active substance use as a contraindication to HCV therapy. The decision to treat in this population should be based on the provider’s assessment of the patient’s ability to adhere to treatment, as well as the treatment setting. The HCV Guidelines cite Ho and colleagues, which utilized multidisciplinary care coordination and patient case management to safely and effectively treat HCV-infected individuals with substance use or psychiatric illness.”

Greenwald said that none of the restrictions are based on safety or efficaciousness. “What we are seeing is discriminatory restrictions on the use of these drugs,” he said. “It is cost and politics, as there are no legitimate grounds by which Medicaid can restrict access. This is happening in Medicaid programs across the country.”

Prescriber Limitations, Prior Authorization

The Notice also deals with what type of clinician may prescribe HCV medication. “In addition, several states are requiring that prescriptions for DAA HCV drugs must be prescribed by, or in consultation with specific provider types, like gastroenterologists, hepatologists, liver transplant specialists, or infectious disease specialists in order for payments to be provided for the drug,” the authors of the CMS Notice wrote. “As such, the effect of such limitations should not result in the denial of access to effective, clinically appropriate, and medically necessary treatments using DAA drugs for beneficiaries with chronic HCV infections. States should, therefore, examine their drug benefits to ensure that limitations do not unreasonably restrict coverage of effective treatment using the new DAA HCV drugs.”

Greenwald said that there are practical implications to prescriber restrictions. “There are fewer gastroenterologists and hepatologists in many rural communities and even in some urban communities,” he said. “These restrictions exclude many experienced primary care providers from prescribing HCV treatment and restrict access by unfairly limiting the pool of eligible providers.”

Cope and colleagues conducted a retrospective analysis that included emergency medical records and prior authorization records for 128 patients at a Ryan White-funded HIV/HCV coinfection clinic. Eligible participants visited the clinic at least once after January 2013. The researchers identified patients who were actively considered for treatment and those who actually followed through and were treated. Medicaid insurance holders were less likely to initiate therapy, according to the results (RR = 1.90; 95% CI, 0.95-3.82)

“The availability of IFN-free DAA regimens has yet to increase HCV treatment uptake in our HIV/HCV co-infected population,” the researchers concluded. “Barriers to HCV treatment initiation have shifted from medical contraindications to socioeconomic variables.”

“What was interesting in our study was that Medicaid insurance did not seem to affect an individual’s chances of being actively considered for DAA therapy, which one might expect due to the often high burden of socioeconomic barriers in this population,” Cope said. “It was within the group of patients who actually had a prior authorization initiated where Medicaid insurance holders tended to be less likely to begin treatment than those with private insurance or Medicare. This may be a direct result of Medicaid restrictions related to fibrosis score, active substance use or provider specialty. This is an important finding because it points to the need to eliminate disease-state and other restrictions if we hope to improve access to treatment.”

It may be worth noting states with managed care organizations tend to be more restrictive than states with fee for service programs. However, the authors of the CMS document also wrote that, “While managed care plans may place appropriate limits on DAA HCV drugs using criteria applied under the state plan, such as medical necessity, the managed care plan may not use a standard for determining medical necessity that is more restrictive than is used in the state plan.”

“In our study, we highlight the burden in terms of time and effort that the prior authorization process places on practicing clinicians who treat HCV infection,” Cope said. “We found that the average time between initial evaluation for HCV therapy and prior authorization approval was over 2 months. As many providers do not have the resources to employ a clinical pharmacist in their practice, it is often beneficial to partner with a specialty pharmacy that can assist with completing prior authorizations to cut down on time and paperwork for the staff. Once a practice has identified what information will be routinely requested by the primary insurers for their patient population, we also suggest working with an IT department to build an electronic note template which will pull in the appropriate labs and prompt the clinician to document the necessary criteria during the initial visit. This note may then be sent in as part of the prior authorization. We think the key is to be systematic in your approach to HCV treatment and to streamline the process as much as possible.”

Although the results from Cope and colleagues painted a harsh picture for gaining prior authorization, there is some indication that improvement could be forthcoming. Do and colleagues retrospectively reviewed charts for patients treated with sofosbuvir/ledipasvir (Harvoni, Gilead) between Oct. 11 and Dec. 31, 2014. They aimed to investigate factors surrounding drug authorization, including predictors of approval. There were 174 patients prescribed HCV therapies, including 129 requests for sofosbuvir/ledipasvir therapy. One hundred of those patients (77.5%) received initial approval for the combination, while another 13.9% were finally approved after appeal. Patients with Medicare/Medicaid coverage were approved at a higher rate than those with other insurance, 92.2% vs. 71.4% (P = .002). This trend continued through multivariate analysis, with Medicare/Medicaid coverage proving to be a predictor of initial approval (OR = 5.96; 95% CI, 1.66-21.48). “Having Medicare/Medicaid and advanced liver disease resulted in a higher likelihood of approval as well as earlier decision and approval times,” the researchers concluded. “More studies are needed to determine factors resulting in higher likelihood of denial and to evaluate approval rates and times after implementation of restrictive prior authorization guidelines.”

Real-World Consequences

Although only a few years have passed since the DAA era emerged, a body of evidence is taking shape, one that sheds light on how the Medicaid rules play out in real-world situations.

Barua and colleagues undertook a systematic evaluation of Medicaid reimbursement policies for the treatment of HCV with sofosbuvir (Sovaldi, Gilead) in all 50 states and the District of Columbia. Databases were analyzed between June 23 and Dec. 7, 2014. At that time, 42 states had reimbursement criteria for the drug. Categories associated with coverage included liver disease stage, HIV co-infection, prescriber type and drug or alcohol use. Results indicated that 74% of states limited access for patients with F3 or F4 fibrosis, one-quarter required active antiretroviral therapy or suppressed HIV RNA levels in coinfected patients and two-thirds placed restrictions on prescriber type. Other findings indicated that 88% of states included criteria regarding drug or alcohol use, 50% required a period of abstinence and 64% required urine drug testing.

“Restrictions do not seem to conform with recommendations from professional organizations, such as the Infectious Diseases Society of America and the American Association for the Study of Liver Diseases,” the researchers wrote. “Current restrictions seem to violate federal Medicaid law, which requires states to cover drugs consistent with their U.S. Food and Drug Administration labels.”

In another study, Younossi and colleagues assessed a cohort of 3,841 patients from the TRIO health care network. They looked at patients who were treated with regimens containing sofosbuvir between December 2013 and September 2014, but they also looked at non-start patients, or those who failed to initiate therapy. Eight percent of the cohort were in the non-start category. Of this 141 patients, 44% were primarily covered by Medicaid and 5% were primarily covered by Medicare, according to the results. The researchers wrote that a number of reasons were cited for failure to begin therapy. However, processes related to insurance coverage and financial reasons were cited in 81% of the non-start patients. Patients covered by Medicaid had the highest rates of failure to initiate therapy. Moreover, more than half of the non-start group had F3 or F4 fibrosis and should have been prioritized for treatment. Results of a matched analysis indicated that patients with commercial insurance coverage were 6.5 times more likely to begin sofosbuvir-based therapy as their counterparts who were covered by Medicaid. “As better treatment for HCV with high efficacy and low side effect rates become available, the disparity in access to treatment, as evidenced by the high non-start rate in the Medicaid-covered group, must be resolved,” the researchers concluded.

“What we are seeing here is use of utilization and management stipulations to preclude access,” Greenwald said. “Officially, the drugs are covered. But the reality is that there are limitations. It’s almost like they’re saying, ‘We have these great drugs, but you can’t use them.’”

Mental Health, Incarceration

Because HCV occurs in about 17% of individuals with severe mental illness, compared with about 1% of the general population. Trager and colleagues conducted a cross-sectional study that included 57,170 Medicaid enrollees with severe mental illness in California. The study occurred between October 2010 and September 2011. HCV screening was reported in 4.7% of this cohort. Individuals in the health care system who were being treated with non-psychiatric care were more likely to be tested, as were patients with comorbid substance use.

Mangurian, who was the senior researcher on the Trager study, put the findings in context. “This population has a high prevalence but a low testing rate,” she said.

The questions surrounding Medicaid coverage are “complicated” for people with severe mental illness, according to Mangurian. “The main issue is that the mental health system is completely separate from the primary care health care system,” she said. “It is separate geographically, electronically, financially and culturally. People with mental health issues receive most of their medical care in mental health settings. We have been trying to integrate mental health and physical health care, but there are many barriers.”

Given the myriad complications that can arise in a patient with mental health, screening, diagnosis and treatment of HCV are not generally on the radar of the clinicians managing mental health. “This is not usually recognized as something that we [as psychiatrists] need to check on, even though we often serve as their primary doctor,” Mangurian said. “Psychiatry can do a better job of meeting patients where they are and doing health care screening.”

The most troubling aspect of the situation for Mangurian pertains to the nature and quality of DAA therapies. “We battled mental health issues with interferon for so long,” she said. “Now that we have therapies that don’t come with those side effects it feels like a missed opportunity when we are unable to secure coverage for our patients.”

Unfortunately, mental health issues often go hand-in-hand with incarceration. The findings from Cope and colleagues included data on these individuals, as well.

“Our study found that the presence of socioeconomic variables, such as unstable housing and incarceration, prevented patients from being actively considered for DAA therapy,” Cope said. “In other words, providers were not ready to even begin pursuing the prior authorization process to obtain coverage in such patients. While this line of thought may have been influenced by knowledge of insurance restrictions, I think it is more reflective of provider concerns about patients’ ability to adhere to HCV treatment in light of unpredictable social situations. I think this is an issue many clinicians are currently contending with: How do you approach the patient who you aren’t sure will be able to complete DAA therapy as prescribed?”

Market Forces

No discussion of HCV medications would be complete without a reference to the hope, or the eventuality, that the cost of drugs will ultimately decrease. CMS asserts that competition in the marketplace will drive costs down. “This competition may enhance the ability of states to negotiate supplemental rebates or other pricing arrangements with manufacturers to obtain more competitive prices for both their [fee for service] and managed care programs, thereby reducing costs,” the authors of the Notice wrote. They encouraged states to capitalize on these opportunities and urged manufacturers to keep states aware of value-based purchasing arrangements.

Greenwald is optimistic, at least in terms of the likelihood that drug costs will come down. “This conversation may very well be over in the next few years,” he said, noting a recent announcement from Gilead that the average rebate would increase to 46%. The entry of Viekira Pak (AbbVie) into the market has had a positive impact as may the subsequent entry in January 2016 of Zepatier (Merck) “Competition will lead to a decrease in cost. But the issue is so much bigger than that. What this really is about is HCV treatment access and how we, as a nation, respond to an era when diseases are cured.”

The current era can be called the “age of pharma,” according to Greenwald. He is considerably less enthusiastic about the response to the DAA era, and what this signifies for other paradigm-shifting regimens that may hit the market in the ensuing years. “What this has taught us is that we are relying on market forces to arrive at fair drug prices,” he said. “This approach is unlike any other industrialized nation in the world. We choose not to regulate drug pricing as a country. We believe in letting the market dictate cost. That is how we arrived at the current situation. If this is what our government chooses, then we can’t have a government health care program complaining about cost and restricting access in violation of its own laws.”

Greenwald added that the issue may be larger than HCV and DAA therapies. “If HCV is any indication of how it is going to go, we are in trouble,” he said. “Our government program did not react well at all. Our government did not say, ‘We can eradicate a communicable disease, and this will have positive public health implications for everyone.’ No. They chose to bury their head in the sand.”

For Mangurian, the complicated scenarios are actually quite simple. “Whatever can be done to improve access to HCV therapies for all populations with HCV, we should be doing,” she said. “It is critical.”

Cope is realistic about what this might entail. “Our study findings also support the need for multidisciplinary strategies to address these kind of treatment barriers in real-world settings,” she said.

The authors of the CMS Notice also appreciate the challenges. “CMS recognizes the challenges of defining policies in the face of new and innovative drug treatments,” they wrote. “It will monitor the policies and conditions states impose for the coverage of DAA HCV drugs to ensure compliance with the requirements of the Act and access to effective, clinically appropriate, and medically necessary treatments for beneficiaries. CMS will monitor state compliance with their approved state plans, the statute, and regulations to assure that access to these medications is maintained.”

Greenwald urged the clinical community to remember the big picture. “We are ignoring all of the lessons we learned about HIV,” he said. “Give patients early access, early intervention, get them screened, linked and engaged in care. Suppress the virus so they can live long lives, not transmit the virus, and go back into the population without any increased health risk. We need to take steps to make this happen.”

• References:
• Barua S, et al. Ann Intern Med. 2015;doi:10.7326/M15-0406.
• Cope R, et al. AIDS Patient Care STDS. 2016;doi:10.1089/apc.2015.0222.
• Do A, et al. PLoS One. 2015;doi:10.1371/journal.pone.0135645. eCollection 2015.
• Ho SB, et al. Clin Gastroenterol Hepatol. 2015;doi:10.1016/j.cgh.2015.02.022.
• Statement from CMS: https://www.medicaid.gov/Medicaid-CHIP-Program-Information/By-Topics/Benefits/Prescription-Drugs/Downloads/Rx-Releases/State-Releases/state-rel-172.pdf
• Trager E, et al. Am J Pub Health. 2015;doi:10.2105/AJPH.2016.303059.
• Trooskin SB, et al. Clin Infect Dis. 2015;doi:10.1093/cid/civ677.
• Younossi ZM, et al. J Viral Hepat. 2016;doi:10.1111/jvh.12506.
• Zhang S. AIDS Care. 2015;doi:10.1080/09540121.2015.1021745.

• For more information:
• Rebecca Cope, PharmD, can be reached at 2090 Adam Clayton Powell Blvd., Office 630I, New York, NY 10028; email: rebecca.cope@touro.edu.
• Robert Greenwald, JD, can be reached at Harvard Law School, 1563 Massachusetts Avenue, Cambridge, MA 02138; email: rgreenwa@.law.harvard.edu.

Disclosures: Cope serves on the advisory boards of Gilead Sciences, Inc. She was awarded research grants, paid to her institution, from Gilead Sciences Inc. Greenwald reports his institution has received grants from numerous public and private sources including the Ford Foundation, MAC AIDS Funds, Elton John AIDS Foundation, Bristol-Myers Squibb Foundation, Janssen Viiv Health Care and Gilead Sciences. Mangurian reports funding from the NIH.