Medicaid DAA restrictions withhold care from HCV patients in need

A notice from CMS delivered in November 2015 outlined policies surrounding coverage and access to hepatitis C virus drugs for Medicaid beneficiaries. The authors were sympathetic to ongoing concerns about the high cost of direct-acting antiviral therapies, or DAAs, and expressed cautious optimism that market forces will ultimately drive those costs down. However, the statement also acknowledged many states’ restrictions to DAA coverage related to fibrosis score, mandatory drug and alcohol sobriety, and the qualifications of the prescribing clinician.

These restrictions — which did not exist for previous HCV regimens and have not been applied to drugs treating other diseases — have prompted objections from a number of sectors in and around the clinical community.

“These restrictions are incredibly challenging from the public health standpoint,” Vincent Lo Re III, MD, MSCE, assistant professor of medicine and assistant professor of epidemiology in biostatistics and epidemiology at the Perelman School of Medicine at the University of Pennsylvania, told Infectious Disease News. “WHO, CDC and the National Academies of Medicine have all begun to discuss strategies to eliminate HCV infection, particularly since highly efficacious direct-acting antiviral treatments are available, but it’s going to be hard to eliminate HCV as a public health problem if the patients who need these therapies cannot get access to them.”

Photo by Phil Farnsworth

Infectious Disease News spoke with HCV and health policy experts to explore the driving factors behind these drug restrictions and their impact on clinical care.

Setting the stage

According to the CMS notice, the service “remains committed to Medicaid beneficiaries continuing to have access to needed prescribed medications, a commitment we know that states share.” The authors noted that although coverage of these drugs is optional, all 50 states currently provide such benefits and are required to meet established criteria in order to remain eligible for federal government-funded rebates.

Robert Greenwald, JD, clinical professor of law and faculty director of the Center for Health Law and Policy Innovation at Harvard Law School, said this notice was “not a suggestion,” and that he and other legal medicine experts are often required to serve as unofficial enforcers for states that may not be complying with the tenets of the 1965 Medicaid Amendment to the Social Security Act.

“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.”

The level of coverage for Medicaid patients varies by state, Greenwald explained, as many states negotiate with pharmaceutical companies for supplementary rebates when determining coverage policy.

“While states have to cover the drugs, there is latitude in terms of prior authorization, utilization and management,” he said. “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.”

There is, however, evidence of and avenues for improving HCV drug coverage. Earlier this year, the Department of Veterans Affairs announced that DAAs would be available to all patients under its care throughout the 2016 fiscal year. Further, Greenwald noted that changes may still be made to the CMS notice, and that lawsuits against states unwilling to provide coverage should improve adherence to policy.

“We will continue to push CMS,” he said. “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.”

Greenwald said his lawsuit and other efforts to improve drug access are especially imperative when considering those who are affected: low-income, unstably housed, disenfranchised individuals who are disproportionately affected by HCV.

“I don’t believe this would be happening if we were talking about a cure for Alzheimer’s [disease], 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.”

Fibrosis restrictions

Concerns about unreasonable restrictions have been fueled by several state programs limiting treatment to beneficiaries with advanced disease, according to Rebecca Cope, PharmD, assistant professor of pharmacy practice at Touro College of Pharmacy and ambulatory care pharmacotherapy specialist at The Brooklyn Hospital Center.

“Most providers are currently finding it extremely difficult to obtain insurance authorization for patients with F0 to F1 fibrosis, despite studies such as CDC’s CHeCS [Chronic Hepatitis B and C Cohort Study], which demonstrate the risk of delaying HCV treatment,” Cope told Infectious Disease News. “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.”

CMS officials also expressed concerns about state programs limiting treatment to F3 or F4 fibrosis scores, and noted that some of these and other restrictions could be contrary to statutory requirements of the Social Security Act. For clinicians providing care within these states, Cope said it is important to continue working toward early coverage.

“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,” she said. “From the perspective of eliminating socioeconomic barriers, we suggest seeking to emulate integrated care models, which have been shown to facilitate achievement of [sustained virologic response (SVR)] in traditionally underserved populations.”

Substance abuse restrictions

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

“Although we are still learning more about treating active substance users in the DAA era, [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.”

Greenwald said none of the restrictions is based on safety or efficacy.

“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 [to nonabstinent patients].”

Prescriber limitations, prior authorization

According to the notice, “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.” Although the authors emphasized that these requirements cannot hamper patient access to treatment, Greenwald said prescriber restrictions are fraught with practical implications.

“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.”

The logistical complexity of this and other restrictions may become the deciding factor of whether a patient initiates therapy. Recently, 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. The researchers identified patients who were actively considered for treatment and those who actually followed through and were treated, and found that Medicaid insurance holders were more likely not to initiate therapy (RR = 1.9; 95% CI, 0.95-3.82).

“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.”

Cope also explained that the average time between initial evaluation for HCV therapy and prior authorization approval was more than 2 months, and represents a lengthy process that she and Lo Re each argued places a substantial burden on patients and care providers.

“You have to complete a prior authorization request when prescribing DAA therapies, you have to acquire all of the required information, complete the request form, submit it, potentially get a denial, file an appeal and perhaps talk to the insurer’s medical liaisons to plead the patient’s case,” Lo Re said. “It’s all been a very laborious process for health care providers, and it’s been very, very frustrating for patients.”

Recent results from Lo Re and colleagues also demonstrated the difficulties and infrequent success of Medicaid HCV patients. Among a cohort of 2,321 patients in four northeastern states prescribed DAAs, 46% of Medicaid patients were denied treatment as opposed to 5% and 10% of Medicare and privately insured patients, respectively.

But while Cope and Lo Re paint a harsh picture of the prior authorization process for Medicaid beneficiaries, there is some indication of improvements to treatment access. Albert Do, MD, MPH, internal medicine resident at Yale University, and colleagues retrospectively reviewed charts for patients treated with DAAs between Oct. 11 and Dec. 31, 2014. Among the 174 patients prescribed HCV therapies, including 129 requests for Harvoni (sofosbuvir/ledipasvir, Gilead Sciences) therapy, 77.5% received initial approval for the treatment, 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), with Medicare/Medicaid coverage proving to be a predictor of initial approval in multivariate analysis (OR = 5.96; 95% CI, 1.66-21.48).

Real-world consequences

Although only a few years have passed since the DAA era emerged, a body of evidence is describing how the Medicaid rules play out in real-world situations.

In their 2015 study, Greenwald and colleagues undertook a systematic evaluation of Medicaid reimbursement policies for the treatment of HCV with Sovaldi (sofosbuvir, Gilead Sciences) in all 50 states and the District of Columbia. During the 2014 analysis period when 42 states had reimbursement criteria for the drug, results indicated that 74% of states limited access for patients with F3 or F4 fibrosis, one-quarter required active ART 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.

“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.’ ”

In another study, Zobair M. Younossi, MD, MPH, vice president for research and chairman of the department of medicine at Inova Health System in Falls Church, Virginia, and colleagues assessed a cohort of 3,841 patients from the TRIO health care network. Of the 141 patients in this cohort who failed to initiate therapy, 44% were primarily covered by Medicaid, and 5% were primarily covered by Medicare. Processes related to insurance coverage and financial reasons were cited in 81% of the nonstart patients, they wrote, and patients covered by Medicaid had the highest rates of failure to initiate therapy. Further, 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.

Along with disease progression and unimpeded transmission, Lo Re said these failures to initiate therapy frequently lead to extrahepatic complications, including diabetes, bone disease, kidney disease and cardiovascular disease. Unfortunately, he continued, not all of these underserved patients are willing to return to care after being turned away.

“This is an opportunity for these patients to engage in care,” he said. “They’re motivated to do that, and issuing a denial can have a really extreme effect and impair their ability to be linked into care down the road. It could potentially disrupt or destroy the patient-provider relationship.”

Mental health, incarceration further complicate access

While HCV occurs in about 17% of individuals with severe mental illness, compared with about 1% of the general population, only about 5% of Medicaid enrollees with severe mental illness reported screening for HCV, according to a cross-sectional study conducted by Christina Mangurian, PhD, associate professor in the department of psychiatry at the University of California, San Francisco School of Medicine, and colleagues. These low testing rates within such a highly affected population are troubling, especially when DAAs remove many of the mental health side effects commonly associated with older, interferon-based therapies.

“We battled mental health issues with interferon for so long,” Mangurian told Infectious Disease News. “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.”

The questions surrounding Medicaid coverage are especially complicated for people with severe mental illness, according to Mangurian, as it often occurs outside of standard care and is not an immediate concern for physicians specializing in mental health.

“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. This is the case for a number of reasons ranging from billing, to stigma, to culture. We have been trying to integrate mental health and physical health care, but there are many barriers.”

Unfortunately, mental health issues often go hand-in-hand with incarceration. The findings from Cope and colleagues also implicated incarceration as a key factor preventing patients from DAA therapy consideration.

“In other words, providers were not ready to even begin pursuing the prior authorization process to obtain coverage in such patients,” Cope said. “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.”

Lo Re agreed, but argued that the prison population could be uniquely adherent to DAA therapy and should be targeted by policymakers.

“That is a high HCV prevalence group that has had difficulty getting antiviral therapies,” he said. “But, [it’s] one place where you can be sure people are going to adhere to therapy, and could substantially reduce HCV prevalence and transmission. We need to do more to address HCV infection in the prison population.”

‘Relying on market forces’

While Medicaid coverage is complicated by numerous factors, restricted access to HCV treatment is primarily driven by the exorbitant cost of DAAs and the difficulties many state programs face in balancing their annual budgets, Michael S. Saag, MD, director of the Center for AIDS Research, University of Alabama at Birmingham, told Infectious Disease News.

“What if these drugs cost $100 a treatment course as opposed to $90,000 a treatment course? There’s no question that they wouldn’t have any of these restrictions — it’d be just the opposite. We’d be aggressively going out, testing people and linking them to care just like we do for syphilis, with case finding and [types] of public health activity.”

CMS asserts that competition in the marketplace will drive costs down, and it encouraged states to capitalize on opportunities for value-based purchasing arrangements.

“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.

Greenwald also was optimistic about future pricing, and mentioned that “this conversation may very well be over in the next few years.” However, he was considerably less enthusiastic about the market’s response to the DAA era and what the past few years of HCV care could mean for other expensive, paradigm-shifting regimens to come.

“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. ... 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.”

Although CMS will continue to “monitor the policies and conditions states impose for the coverage of DAA HCV drugs,” Greenwald urged the clinical community to remember the big picture, and not to repeat the same mistakes of prior epidemics.

“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.” – by Rob Volansky and Dave Muoio

Editor’s note: A version of this article originally appeared in HCV Next.

• References:
• Barua S, et al. Ann Intern Med. 2015;doi:10.7326/M15-0406.
• CMS. Medicaid Drug Rebate Program Notice. November 5, 2015. https://www.medicaid.gov/Medicaid-CHIP-Program-Information/By-Topics/Benefits/Prescription-Drugs/Downloads/Rx-Releases/State-Releases/state-rel-172.pdf. Accessed August 15, 2016.
• 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.
• Ho SB, et al. Clin Gastroenterol Hepatol. 2015;doi:10.1016/j.cgh.2015.02.022.
• Lo Re V, et al. Clin Gastroenterol Hepatol. 2016;doi:10.1016/j.cgh.2016.03.040
• Trager E, et al. Am J Pub Health. 2016;doi:10.2105/AJPH.2016.303059.
• Younossi ZM, et al. J Viral Hepat. 2016;doi:10.1111/jvh.12506.
• Zhang S, et al. AIDS Care. 2015;doi:10.1080/09540121.2015.1021745.

• For more information:
• Rebecca Cope, PharmD, can be reached at rebecca.cope@touro.edu.
• Robert Greenwald, JD, can be reached at rgreenwa@law.harvard.edu.
• Vincent Lo Re III, MD, MSCE, can be reached at vincentl@mail.med.upenn.edu.
• Christina Mangurian, MD, MAS, can be reached at Christina.Mangurian@ucsf.edu.
• Michael S. Saag, MD, can be reached at msaag@uabmc.edu.

Disclosures: Cope reports serving on the advisory boards of Gilead Sciences and being awarded research grants, paid to her institution, from Gilead Sciences. Greenwald reports that 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, Gilead Sciences, Janssen and ViiV Healthcare. Mangurian reports receiving funding from the NIH. Saag reports institutional grants from AbbVie, Bristol-Myers Squibb, Gilead Sciences, Merck and ViiV Healthcare and serving on advisory boards for Bristol-Myers Squibb, Gilead Sciences and Merck. Lo Re reports no relevant financial disclosures.