Courts Push Medicaid to Cover Costly Hepatitis C Treatments

A series of recent court rulings and settlements, including one last week in Indiana, have found that states cannot withhold potentially life-saving but expensive medications from Medicaid beneficiaries and prison inmates who have chronic hepatitis C.

Hepatitis C kills far more Americans than any other infectious disease. But when new antiviral drugs that for the first time promised a cure for hepatitis C hit the market in 2014, states blanched at their eye-popping prices and took steps to sharply limit the availability of those treatments for Medicaid beneficiaries and inmates. According to one recent survey, only 3 percent of inmates in state penitentiaries with hepatitis C receive the cure.The antiviral drugs have since become cheaper, but judicial decisions and settlements have consistently found that states cannot deny treatment because of cost in any case.

In the latest ruling, U.S. District Judge Jane Magnus-Stinson, chief judge of the U.S. Southern District of Indiana, said that withholding or delaying treatment from hepatitis C-infected inmates was unconstitutional, amounting to cruel and unusual punishment in violation of the Eighth Amendment. The U.S. Constitution requires state penitentiaries to provide health care to prisoners.

The ruling follows a similar decision in Florida last year and settlements reached this year in Massachusetts and Colorado that require correctional systems in those states to provide treatment to virtually all infected inmates. Colorado has set aside $41 million over two years to treat all inmates with the virus. Similar lawsuits are pending in Pennsylvania, Minnesota, Missouri and Tennessee.

Likewise, states have been on the losing end of lawsuits involving Medicaid beneficiaries who have been denied hepatitis C treatments in Colorado, Michigan, Missouri and Washington, forcing changes in policies to make the cure more broadly available. And settlements have been reached elsewhere, including in Pennsylvania, Massachusetts and Florida, according to the Center for Health Law and Policy Innovation at Harvard University. States run Medicaid agencies, which provide health care to the poor, and split the costs with the federal government.

While providing the treatments will cost states tens of millions of dollars, health policy experts insist the spending will provide an overall economic and public health benefit. Attacking hepatitis C in prisoners and in Medicaid patients, they say, will go a long way toward eradicating the disease while also saving money by preventing patients with untreated hepatitis C from progressing to liver failure and cancer.

“The most important thing to remember about cost-effectiveness is that something that is really expensive can still be cost-effective if it is really, really effective,” said Mark Roberts, chairman of the University of Pittsburgh department of health policy and management who has written studies about the new hepatitis C medications. “And these drugs are very, very effective.”

A Cure Arrives

The new antivirals, approved by the U.S. Food and Drug Administration late in 2013 and first sold the following year, represented a giant leap from previous treatments. The treatment period for the old drugs lasted as long as 48 weeks, entailed severe side effects, and delivered a cure rate lower than 50 percent.

By contrast, the new antivirals usually require 12-week treatment periods, carry virtually no side effects and boast an effective rate above 95 percent. For the estimated 3.5 million Americans with hepatitis C, the new drugs promise a pain-free cure. Hepatitis C is particularly prevalent among baby boomers, who were susceptible to the disease at a time when infection controls were less prevalent, and among drug users who share contaminated needles.

When the drugs first hit the market, a single course of treatment cost as much as $84,000.

“States were terrified by their cost exposure,” said Matt Salo, executive director of the National Association of Medicaid Directors. “And they had no idea how many people would show up on Day One demanding the cure. Would it be 75 percent? Twenty-five percent? One percent? They had no idea what their exposure was.”

The prevalence of hepatitis C is thought to be higher among Medicaid beneficiaries than the general population, Salo said, with estimates ranging from 700,000 to 1 million Medicaid patients infected. And the rate is higher still in prisons because of illicit drug use and do-it-yourself tattooing common in penitentiaries. The Centers for Disease Control and Prevention estimates that 1 in 3 prisoners in U.S. jails and prisons has hepatitis C.

In response to the high prices, state Medicaid agencies and prisons decided to essentially ration the new drugs.

They relied on blood tests to determine the severity of a patient’s disease, measuring the level of fibrosis, or liver scarring. Patients were given scores, from F0 (no fibrosis) to F4 (cirrhosis, or late-stage scarring of the liver).

In the corrections and Medicaid systems, only patients with higher scores were eligible for treatment. Many states also denied treatment to active drug users, and in Medicaid programs, they limited the numbers of doctors who could prescribe the new antivirals.

Nationwide, at least 144,000 inmates at state prisons with hepatitis C (97 percent) aren’t getting the cure, according to a new survey by Siraphob “Randy” Thanthong-Knight at Columbia University’s Graduate School of Journalism.

In Vermont, according to VTDigger, one state lawmaker called it “appalling” when he learned at a legislative hearing last week that in 2017, of 258 state prisoners with hepatitis C, only one had received the cure.

Stigma

Those restrictions drew a firestorm of criticism, not only from advocates for Medicaid beneficiaries and prisoners, but from human rights and medical organizations, such as the Infectious Diseases Society of America and the World Health Organization. Many argued that policymakers stigmatized patients with hepatitis C in a way they would never consider with other diseases.

“If there were a cure for breast cancer or Alzheimer’s or diabetes, people would be storming the White House to make sure those medicines were available to everyone, you can be sure of that,” said Robert Greenwald, a professor at Harvard Law School and the faculty director of the school’s Center for Health Law and Policy Innovation. “But we’ve responded completely differently with the cure for hepatitis C because of the stigma associated with that disease.”

Greenwald and others insist that treating prisoners with hepatitis C is an indispensable step toward eradicating the disease in the whole population.

(Stateline contacted communications offices for a dozen state Medicaid offices that restrict hepatitis C antivirals to those patients with fibrosis scores of F3 or F4. None responded.)

In 2015, the Obama administration urged state Medicaid agencies to lift restrictions on the drugs. By 2017, at least 17 states lifted restrictions based on severity. Many others retained the restrictions but loosened them to make the drugs available to beneficiaries with less severe liver damage.

The movement in prisons has been slower, nudged along mainly by the lawsuits. “They have been slow to respond,” said Tina Broder, interim executive director of the National Viral Hepatitis Roundtable, a coalition working to eradicate hepatitis B and C.

Kellie Wasko, deputy executive director at the Colorado Department of Corrections, said the settlement the state reached with the American Civil Liberties Union last month only formalized what the state had decided to do on its own, which was to treat all the estimated 2,200 Colorado prisoners with hepatitis C.

“As a health care professional, I do believe it is right to treat everybody,” said Wasko, who is a nurse.

She acknowledged that the drugs’ lower costs made the decision easier for the prison administrators and the legislators who appropriated the $41 million for treatment.

Originally, she said, the price for a single course of treatment was $56,000. Because of contract requirements, she said she couldn’t reveal the price Colorado pays now, but “it is significantly less.”

Other experts say that with discounts, Medicaid and corrections systems can now pay as little as $10,000 for a course of treatment.

“Even at those prices,” Harvard’s Greenwald said, “states are waiting for us to litigate before they’ll remove these restrictions. And the only explanation for that is the stigma.”

http://www.governing.com/topics/health-human-services/sl-hepatitis-c-treatments-courts-states-medicaid-inmates.html

Medicare eases readmission penalties for safety-net hospitals

Penalties will total $566 million for all hospitals. But many that serve a large share of low-income patients will lose less money than they did in previous years.

On orders from Congress, Medicare is easing up on its annual readmission penalties on hundreds of hospitals serving the most low-income residents, records released last week show.

Since 2012, Medicare has punished hospitals for having too many patients end up back in their care within a month. The government estimates the hospital industry will lose $566 million in the latest round of penalties that will stretch over the next 12 months. The penalties are a signature part of the Affordable Care Act’s effort to encourage better care.

But starting next month, lawmakers mandated that Medicare take into account a long-standing complaint from safety-net hospitals. They have argued that their patients are more likely to suffer complications after leaving the hospital through no fault of the institutions, but rather because they cannot afford medications or don’t have regular doctors to monitor their recoveries. The Medicare sanctions have been especially painful for this class of hospitals, which often struggle to stay afloat because so many of their patients carry low-paying insurance or none at all.

In a major change to its evaluation, the federal Centers for Medicare & Medicaid Services (CMS) this year ceased judging each hospital against all others. Instead, it assigned hospitals to five peer groups of facilities with similar proportions of low-income patients. Medicare then compared each hospital’s readmission rates from July 2014 through June 2017 against the readmission rates of its peer group during those three years to determine if they warranted a penalty and, if so, how much it should be.

The broader issue is whether medical providers that serve the poor can be fairly judged against those that care for the affluent. This has been a continuing topic of contention as the government seeks to accurately measure health care quality. It is particularly a concern in efforts to consider patient outcomes in setting pay rates for doctors, nursing homes, hospitals and other providers.

Overall, Medicare will dock payments to 2,599 hospitals — more than half in the nation— throughout fiscal year 2019, which begins Oct. 1, a Kaiser Health News analysis of the records found. The harshest penalty is 3 percent lower reimbursements for every Medicare patient discharged in fiscal year 2019. The number of hospitals and the average penalty — 0.7 percent of each payment — are almost the same as last year.

But the new method shifted the burden of those punishments. Penalties against safety-net hospitals will drop by a fourth on average from last year, the analysis found.

“It’s pretty clear they were really penalizing those institutions more than they needed to,” said Dr. Atul Grover, executive vice president of the Association of American Medical Colleges. “It’s definitely a step in the right direction.”

Safety-net hospitals that will see their penalties cut by half or more include many urban institutions, such as Sutter Health’s Alta Bates Summit Medical Center in Oakland, Calif.; Providence Hospital in Washington, D.C.; and Hurley Medical Center in Flint, Mich. Sixty-five safety-net hospitals — including Franklin Medical Center in Winnsboro, La., Astria Toppenish Hospital in Toppenish, Wash., and Emanuel Medical Center in Swainsboro, Ga. — that had been penalized last year escaped punishment entirely this year.

Conversely, the average penalty for the hospitals with the fewest low-income patients will rise from last year, the analysis found.

Before the program began, roughly 1 in 5 Medicare beneficiaries were readmitted within a month. Hospitals were paid the same amount regardless of how their patients fared after being discharged. In fact, a readmission was financially advantageous as hospitals would be paid for the second hospital stay, even if it might have been avoidable.

Since the sanctions began, Medicare has evaluated each year rates for readmitted patients who had originally been treated for heart failure, heart attacks and pneumonia. And it has reduced its payments to more than half of hospitals based on those rates. The evaluations have since expanded to cover chronic lung disease, hip and knee replacements and coronary artery bypass graft surgeries.

Medicare counts patients who returned to a hospital within 30 days, even if it is a different hospital than the one that originally treated them. The penalty is applied to the first hospital.

Medicare exempts hospitals with too few cases, those serving veterans, children and psychiatric patients, and critical-access hospitals, which are the only hospitals within reach of some patients. In addition, Maryland hospitals are excluded because Congress lets that state set its own rules on how it distributes Medicare money.

In its revised method this year, Medicare distinguished hospitals that serve a high proportion of low-income patients by looking at how many of the hospital’s Medicare patients were also eligible for Medicaid, the state-federal program for the poor. American Hospital Association officials say that while they considered this an improvement, it isn’t a perfect reflection of poor patients. For one thing, they say, hospitals in states with more restrictive Medicaid coverage do not appear through this formula to have as challenging patient populations as do hospitals in states with higher Medicaid eligibility.

Akin Demehin, the association’s director of quality policy, said CMS might consider linking its records to Census records that show income and education level of patients.

“It might give you a more precise adjuster,” he said.

The hospital industry remains critical of the overall program, saying that stripping hospitals of revenue because of poor performance only makes it harder for them to care for patients.

Congress’ Medicare Payment Advisory Commission in June concluded that the penalties from previous years successfully pressured hospitals to reduce the numbers of returning patients — and helped save Medicare about $2 billion a year.

In its analysis of the approach’s effectiveness, Congress’ advisory commission rejected some of the hospital industries’ complaints about Medicare’s Hospital Readmissions Reduction Program: that hospitals may have tried to get around the penalties by keeping patients under “observation status” and that discouraging rehospitalizations may have led to extra deaths.

The commission found that between 2010 and 2016 readmission rates fell by 3.6 percentage points for heart attacks, 3 percentage points for heart failure and 2.3 percentage points for pneumonia. At the same time, readmissions caused by conditions that do not factor into the penalties fell on average 1.4 percentage points, indicating hospitals were focusing on lowering unnecessary readmissions that could hurt them financially.

The commission wrote: “We conclude that the [penalties] contributed to a significant decline in readmission rates without causing a material increase in ED [emergency department] visits, a material increase in observation stays, or a net adverse effect on mortality rates.”

This fall, Medicare will attack the readmissions from another angle by issuing penalties on skilled nursing facilities that send recently discharged residents back to the hospital too frequently.

https://www.healthleadersmedia.com/finance/medicare-eases-readmission-penalties-against-safety-net-hospitals

Antibody combo controls HIV for months

Antiretroviral therapy (ART) is the gold standard for HIV treatment. But patients need to take their medicines every day or risk a rapid virus rebound. That makes the drugs hard to adhere to in a lifelong battle. Scientists at Rockefeller University now suggest that combining HIV antibodies could keep the virus in check for months, potentially relieving patients of their daily pill-taking routine.

In a small phase 1b trial, the researchers combined two broadly neutralizing antibodies (bNAbs), dubbed 3BNC117 and 10-1074. These antibodies were found in “elite controllers,” or people whose bodies successfully fight off HIV without the help of drugs. They work by targeting proteins on HIV’s surface so that the body’s immune system can seek out and destroy the virus.

Participants whose viral load had already been controlled stopped taking their antiretroviral drugs and received three infusions of the bNAbs three weeks apart.

Among nine individuals who had viruses that were sensitive to both antibodies, the treatment suppressed their viral load for a median of 21 weeks—or 15 weeks after their last injection. Two of them maintained virologic control at the 30-week follow-up. The team reported the results in the journal Nature.

In a separate study, seven patients who hadn’t received ART and had viruses still circulating in their bloodstream were treated with bNAbs and maintained significant viral reduction for up to three months, according to results published in Nature Medicine.

The new findings from the Rockefeller researchers were encouraging, because previous studies using a single bNAb only reduced the levels of virus for a short time. By contrast, 3BNC117 and 10-1074 attack HIV from two different angles, so administering them together might reduce the likelihood of resistance, the researchers believe.

The two antibodies offer other advantages, too. “The expectation is that these new variants will have three- to four-fold longer half-lives,” said Rockefeller’s Michel Nussenzweig, a co-leader in both bNAb studies, in a statement. “So we may be able to give the antibodies once or twice a year.”

Moreover, Nussenzweig said that bNAb therapy could help the body produce HIV-fighting antibodies on its own, much like anti-cancer antibody therapies that boost the natural immune system.

Other efforts are underway in the HIV community to develop safe therapies that require less frequent dosing. A partnership between GlaxoSmithKline’s HIV unit ViiV Healthcare and Johnson & Johnson’s Janssen has demonstrated in a phase 3 trial that a combination of cabotegravir and rilpivirine could be a monthly ART, and the two companies are also testing the regimen as a bi-monthly injectable.

Of course, the once-and-for-all approach would be to clear “reservoirs” where HIV hides from ARTs and bide its time to bounce back. Scientists at the University of North Carolina at Chapel Hill recently showed that a T-cell therapy was well tolerated in a small group of patients, teeing up further studies that combine it with latency-reversing drugs.

According to the Rockefeller researchers, bNAbs also hold the potential to prevent HIV. Gilead Sciences’ Truvada is approved for pre-exposure prophylaxis (PrEP) but requires daily administration. A team from the International AIDS Vaccine Initiative and the Scripps Research Institute recently identified potent bnAbs that could block most HIV strains by targeting a “site of vulnerability.”

Promising as they are, bNAb treatments do have their limitations. HIV virus has many variants and is prone to mutation especially when it’s not properly suppressed. In some patients, antibodies are unable target all of them. In the Nature study, for example, two participants who experienced viral rebound at 12 weeks were found to host HIV variants that were resistant to at least one bNAb.

“These two antibodies are not going to work for everyone,” said the studies’ co-leader, Marina Caskey, in a statement. “But if we start to combine this therapy with other antibodies or with antiretroviral drugs, it could be effective in more people—and that’s something we hope to look at in future studies.”

https://www.fiercebiotech.com/research/combination-antibody-therapy-controls-hiv-for-months

Education Can Up Emotional Intelligence in Med Residents

Following an educational intervention, residents from pediatrics and med-ped residency programs have an increase in total emotional intelligence (EI), according to a study published online Sept. 20 in Advances in Medical Education and Practice.

Ramzan Shahid, M.D., from the Loyola University Medical Center in Maywood, Ill., and colleagues examined whether educational intervention increases the overall EI of residents. A total of 21 residents from pediatrics and med-ped residency programs volunteered to complete an online self-report EI survey before and after an educational intervention. The intervention focused on developing four EI skills: self-awareness, self-management, social awareness, and social skills.

The researchers found that, compared with before the intervention, there was a significant increase in total EI median scores after the educational intervention (114 versus 110; P < 0.004). There was also a significant increase in the stress management composite median score (111 versus 105; P < 0.001) and in the resident’s overall wellness score (111 versus 104; P = 0.003).

“Teaching EI skills related to the areas of self-awareness, self-management, social awareness, and social skill may improve stress management skills, promote wellness, and prevent burnout in resident physicians,” the authors write.

Abstract/Full Text (subscription or payment may be required)

http://www.physiciansbriefing.com/Article.asp?AID=738000

Most People Don’t Know if They Have Genetic Risk for Cancer

Most people carrying genes that put them at risk for cancer don’t realize it, new research suggests.

Genetic screenings of more than 50,000 people found that more than 80 percent of those who carry a known gene variant for breast, ovarian, prostate or pancreatic cancer were unaware of their risk.

Researchers noted that most people carrying cancer-associated variants in the BRCA1 or BRCA2 genes only realize they’re at increased risk for cancer when a friend’s or relative’s diagnosis prompts them to undergo screening.

“It usually takes a tragedy for people to get tested,” said study senior author Michael Murray, a professor of genetics at Yale School of Medicine. “Our reliance on a documented personal or family history as a trigger to offer testing is not working. Hopefully, one day we can change that with effective DNA-based screening for everyone.”

Screening found that about 270 of the study participants carried a BRCA gene variant. Only 18 percent knew about it before the study, the researchers found.

About 17 percent of the living BRCA-positive patients had a related cancer. Of the small group of BRCA-positive patients who died before the study ended, about 48 percent had a BRCA-associated cancer, the researchers found.

The findings were published Sept. 21 in the journal JAMA Network Open.

“Once risk is identified, we can apply proven tools for early diagnosis and prevention, and we believe that the 31 percent difference in cancer incidence in these two groups is a window into an opportunity to decrease cancer and cancer deaths through genomic screening approaches,” Murray said.

More information

The American Cancer Society provides more on cancer and genetics.

SOURCE: Yale University, news release, Sept. 21, 2018

https://consumer.healthday.com/cancer-information-5/breast-cancer-news-94/most-people-don-t-know-if-they-have-genetic-risk-for-cancer-737965.html

Euro Meds Agency feeling better about drug supply interruptions from Brexit

The European Medicines Agency says concerns over drug shortages stemming from Brexit have eased, but not all drugmakers feel the same.

The EMA reported this week that it has revised its list of drugs whose supplies might be disrupted by the separation of the U.K. from the European Union next year to 39 from its previous estimate of 108.

Noël Wathion, EMA’s deputy executive director, said in a statement that the agency has been assured by many of the makers of the 108 medicines it was uncertain about that they have taken needed steps to minimize supply risks.

Of the remaining 39 drugs, 25 are for humans and the other 14 are veterinary drugs. The EMA said it is trying to figure out how to reduce the impact if there are difficulties with supplies of those.

Many Big Pharmas have invested to ensure that even if no trade agreements have been hammered out ahead of the March separation, drugs keep flowing across borders seamlessly.

But AstraZeneca CEO Pascal Soriot told the Sunday Times that he is worried about problems getting drugs across borders. The U.K. drugmaker is increasing its medicine stockpiles by 20% in hopes of having plenty of approved drugs ready for patients. Meanwhile, he said the company “wasted” £40 million to duplicate laboratories in Sweden so that it can test and authorize its drugs in Europe to meet EU rules that could result from a so-called hard Brexit.

“I hope more and more people get worried,” he told the newspaper.

Drug and vaccine makers are making logistics plans, assuming long lines at checkpoints if the U.K. and EU negotiators can’t hammer out a deal on trade. Sanofi has committed to stockpiling 14 weeks’ worth of drugs and said it’d consider flying flu vaccines into the U.K. because of tight timelines required to deliver the products. If the parties could agree, Sanofi also said it would consider marking trucks to make a fast pass through customs.

Other top players in the pharma industry have been detailing their Brexit plans, as well. Pfizer and GlaxoSmithKline have both said changes to their supply chains will cost $100 million each to ensure supply. Merck, for its part, plans a 6-month drug supply. Novo Nordisk says it’ll more than double its normal 7-week stockpile to 16 weeks’ worth of insulin. The company supplies more than half of the U.K.’s insulin, according to The Independent.

https://www.fiercepharma.com/manufacturing/ema-feeling-better-about-drug-supply-interruptions-from-brexit

Histogenics to Meet With FDA to Discuss NeoCart Phase 3 Clinical Trial

Histogenics Corporation (Histogenics) (Nasdaq:HSGX), a leader in the development of restorative cell therapies that may offer rapid-onset pain relief and restored function, today announced that the U.S. Food and Drug Administration (the FDA) has granted a Type C meeting on October 30, 2018 to discuss the top-line results from the NeoCart Phase 3 clinical trial and Histogenics’ planned Biologics License Application submission.  Histogenics submitted its briefing materials regarding the top-line data of the NeoCart Phase 3 clinical trial to the FDA in mid-September 2018, and has been working closely with the FDA to schedule the meeting.  Histogenics expects to provide an update following this meeting in early November 2018, with meeting minutes expected by late November 2018 or early December 2018.  During the third quarter of 2018, Histogenics has sold an aggregate of 3,550,416 shares of common stock in at-the-market offerings pursuant to Histogenics’ equity distribution agreement with Canaccord Genuity Inc. for aggregate net proceeds of $2.72 million after deducting sales agent fees and expenses.  Histogenics believes that its existing cash and cash equivalents will be sufficient to fund its projected cash needs late into the fourth quarter of 2018.

https://www.nasdaq.com/press-release/histogenics-to-meet-with-fda-to-discuss-neocart-phase-3-clinical-trial-data-and-potential-20180926-01038