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Texas Removed Medicaid HCV DAA Treatment Restrictions
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Texas Medicaid Enrollees Sue State For Cure To Hepatitis C Virus......For its part, the federal Centers for Medicare and Medicaid Services issued guidance in November 2015 warning states that exclusions and limitations on public insurance coverage of DAAs may violate federal law. The Texas Health & Human Services Commission ("HHSC") has been challenged by Medicaid enrollees for instituting a policy that rations coverage of prescription drugs to cure Hepatitis C virus ("HCV"). In a class action lawsuit recently filed in federal district court in Austin, Plaintiffs Dorena Coleman, Curtis Jackson and Federico Perez allege that the HHSC has prioritized financial concerns over their health by restricting coverage of HCV cures to only those Medicaid enrollees with severe liver damage, even though the medications result in cure rates approaching 100% for all individuals infected with HCV. "Medicaid is not allowed to discriminate in its coverage of medically necessary prescription medications when someone has an infectious disease like HCV," said Jeff Edwards of Edwards Law, in Austin. "This lawsuit simply enforces the coverage that federal and state law requires to be provided to Medicaid beneficiaries." For its part, the federal Centers for Medicare and Medicaid Services issued guidance in November 2015 warning states that exclusions and limitations on public insurance coverage of DAAs may violate federal law. By withholding coverage for individuals without advanced liver scarring, the Complaint alleges that Texas Medicaid is discriminatory in at least two ways. First, the Texas policy categorically denies coverage from individuals with low fibrosis scores (the level of liver scarring), regardless of their individual circumstances. Under the medical standard of care, Medicaid enrollees blocked from coverage have comparable need to those permitted coverage under the Texas policy. Second, the Complaint alleges that Texas Medicaid singles out HCV patients for rationing on the basis of disease severity in a unique manner that no other chronically ill Texas Medicaid beneficiary in need of treatment coverage is subjected to. Under either view of the Texas policy, it violates federal law. "The policy at issue here, which deprives some of Texas's most vulnerable of vital and curative medical treatment for a chronic illness, is contrary to the federal laws that govern critically important benefits under the Medicaid program," said David Tolley, partner at Latham & Watkins. "We look forward to vigorously pursuing access to treatment for our clients in the State of Texas. And it goes without saying that the real potential of this cure is the eradication of HCV altogether, a goal that is furthered by early treatment of Medicaid beneficiaries that makes further transmission of the virus impossible in their case."."
https://www.chlpi.org/texas-medicaid-enrollees-sue-state-for-cure-to-hepatitis-c-virus/
Medicaid Relaxes Prior Authorization for Hep C Antiviral Drugs
July 14 2021
HHSC Chief Medicaid Director Ryan Van Ramshorst, MD, announced several key changes:
• Treatment with a DAA medication that's on the drug formulary will be available to Medicaid patients "regardless of Metavir fibrosis score," which measures the severity of fibrosis seen on a liver biopsy.
• Specialists such as gastroenterologists are no longer the only physicians who can prescribe DAAs. "General practitioners," including primary care physicians, can also prescribe the medicines, HHSC said.
• Drug screenings are no longer required.
The increased availability of direct antivirals in Medicaid is "huge," Dr. Briggs said.
The state's budget for 2022-23, ironed out during this year's regular legislative session, included $51 million in state and federal funds to increase the availability of direct antiviral agents (DAAs) to treat Medicaid patients with hepatitis C. Although it was less than half of the Texas Health and Human Services Commission's (HHSC's) original $115 million funding request, it was enough to significantly change the game for hepatitis C patients whose condition hasn't progressed to advanced liver fibrosis.
As a result, HHSC in late June announced a policy change significantly curbing prior authorization barriers that prevented patients with hepatitis C from timely access to DAAs. The changes take effect Sept. 1. The budget also specifies that if the DAAs' costs exceed the funding allocated to HHSC, the agency can shift funds to cover the additional costs.
More than half a million Texans are believed to have chronic hepatitis C, according to HHSC's 2020 State Plan for treating the disease.
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Changes to Hepatitis C Prior Authorization Criteria Begin Sept. 1
Published on
August 24, 2021
https://www.txvendordrug.com/about/news/2021/changes-hepatitis-c-prior-authorization-criteria-begin-sept-1
Beginning September 1, 2021, Medicaid will expand coverage of the Hepatitis C virus clinical prior authorization criteria to include all metavir fibrosis scores. HHSC will modify the requirements as follows:
• Treatment with a direct-acting antiviral (DAA) medication on the formulary will be available to Medicaid clients regardless of metavir fibrosis scores.
• HHSC no longer restricts the prescribing of a DDA medication to a specialist provider. These medications can now be prescribed by general practitioners as well.
• A drug screening will no longer be required.
• No additional refill authorization is required to continue DAA treatment.
HHSC requires the clinical prior authorization criteria for all Medicaid clients, both fee-for-service and managed care. Providers should continue using the current criteria and forms until August 31. The following revised Hepatitis C prior authorization forms for Medicaid fee-for-service processing will be available on Sept. 1:
• Antiviral Agents for Hepatitis C Virus - Initial Request (HHS Form 1335)
• Antiviral Agents for Hepatitis C Virus - Initial Request - Addendum (HHS Form 1342)
HHSC will no longer require the Antiviral Agents for Hepatitis C Virus - Refill Request (HHS Form 1336) on Sept. 1.
Each MCO will have its own version of the Hepatitis C prior authorization forms with their specific contact information. Contact each MCO for prior authorization forms and submission instructions.
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Medicaid Relaxes Prior Authorization for Hep C Antiviral Drugs
https://www.texmed.org/Template.aspx?id=57332
For years, Texas Medicaid patients with hepatitis C haven't had access to overwhelmingly effective, often-curative antiviral therapy unless they had advanced liver disease. In many cases, getting the antiviral drugs at that point was too little, too late.
"That's like having a person in the desert that doesn't have access to water, then you've got a bathtub filled with water, and you won't let them drink even a sip," said New Braunfels family physician Emily Briggs, MD. "It just doesn't make any sense. It is a life-altering treatment modality."
The Texas Medical Association and others have advocated for change for years. And this year, the Texas Legislature made it happen.
The state's budget for 2022-23, ironed out during this year's regular legislative session, included $51 million in state and federal funds to increase the availability of direct antiviral agents (DAAs) to treat Medicaid patients with hepatitis C. Although it was less than half of the Texas Health and Human Services Commission's (HHSC's) original $115 million funding request, it was enough to significantly change the game for hepatitis C patients whose condition hasn't progressed to advanced liver fibrosis.
As a result, HHSC in late June announced a policy change significantly curbing prior authorization barriers that prevented patients with hepatitis C from timely access to DAAs. The changes take effect Sept. 1. The budget also specifies that if the DAAs' costs exceed the funding allocated to HHSC, the agency can shift funds to cover the additional costs.
More than half a million Texans are believed to have chronic hepatitis C, according to HHSC's 2020 State Plan for treating the disease.
David Lakey, MD, vice chancellor for health affairs at The University of Texas System and former commissioner for the Texas Department of State Health Services, says the state of hepatitis C care changed rapidly in the recent past, as science developed direct antivirals with overwhelming effectiveness at treating the disease.
"They're much easier to tolerate than [what we had] a decade ago, when you had Interferon-based treatments that weren't really well-tolerated and didn't have this type of effectiveness," Dr. Lakey said.
He says many physicians believe that now the health care system should rethink how it approaches the disease: "Going from where we were before - which was finding the people that were most likely in the near future to develop cirrhosis, and getting those individuals treatment - to ... getting anyone that's infected with it on treatment and getting them cured of hepatitis C."
One barrier between those patients and antivirals was financial because of the high cost of the drugs. But the infusion of funding - a several-years-long cause for TMA and others in organized medicine - largely addressed that.
HHSC Chief Medicaid Director Ryan Van Ramshorst, MD, announced several key changes:
• Treatment with a DAA medication that's on the drug formulary will be available to Medicaid patients "regardless of Metavir fibrosis score," which measures the severity of fibrosis seen on a liver biopsy.
• Specialists such as gastroenterologists are no longer the only physicians who can prescribe DAAs. "General practitioners," including primary care physicians, can also prescribe the medicines, HHSC said.
• Drug screenings are no longer required.
The increased availability of direct antivirals in Medicaid is "huge," Dr. Briggs said.
"We have [had] an unfortunate dichotomy of patients ... that could afford [treatment] and patients that couldn't afford this treatment," she said, adding that patients can see their lives lengthened significantly. "They're not dealing with the uncertainty of a chronic disease versus having it eventually be cured - having something where they're no longer having to be concerned about what their liver is going to do in the long run, becoming cirrhotic or receiving a transplant or something like that, especially from a viral infection."
However, as Dr. Lakey notes, many other patients not in the Medicaid population still need screening and treatment for hepatitis C. And Dr. Briggs adds there are other, nonfinancial barriers still existing between patients and the DAAs that could save their lives.
HHSC addressed one of them in part with its policy removing required drug screenings; Dr. Briggs says right now, patients "have to prove that they are worthy, essentially, of getting treatment" by proving they aren't drinking alcohol or taking illicit substances.
The medical thinking, she says, was that a patient must be free of any other liver-affecting issues before receiving hepatitis C treatment. But whether patients have a substance use problem or not, they still need treatment, Dr. Briggs adds.
"Hepatitis C is not something that is alcohol-related. Yes, alcohol and hepatitis C both affect the liver, so you can imagine that both of those together would be a problem. But only providing treatment to a person that has no other risk factors for liver issues just doesn't fly," she said. "We need to make sure that everybody that has hepatitis C is offered that opportunity to have essentially a cure for it."
The progress made in Medicaid, she said, was due in large part to TMA listening to its membership.
"Clear advocacy of our efforts, but also of the staff helping us to be as well-informed, as well as meeting with the right legislators to get that message out there," she said. "TMA was instrumental in getting this change to happen."
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