Supreme Court hears case over disproportionate share hospital payments

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Hundreds of millions of dollars in reimbursement are at stake; $3-4 billion from 2005 to 2013.

The Supreme Court was expected to hear oral arguments today over notice and rulemaking requirements for Medicare reimbursement.

The outcome of Azar vs. Allina Health Services could greatly affect reimbursement for hospitals that serve a disproportionate share of low-income patients. The DSH payment calculation is based on the percentage of low-income patients served.

The government wants to add Part C, or Medicare Advantage beneficiaries into the calculation, a move hospitals fear would decrease payments based on their belief that MA members are, on average, wealthier than Medicare Part A beneficiaries.

But the lawsuit is about how the Department of Health and Human Services went about attempting to implement its rule.

The hospitals in the lawsuit argue that HHS is required to conduct notice and comment rulemaking before providing the instructions to a Medicare administrative contractor that makes the initial determinations of payments due under Medicare. Medicare uses private contractors to administer its reimbursements to providers.

The case went to the District of Columbia Circuit Court, which vacated the rule. The hospitals argue that after the circuit court’s decision, CMS simply tried to make the same change without undertaking notice and comment.

The judge in the District of Columbia Circuit Court case was Brett Kavanaugh, who as Supreme Court Justice, is recusing himself in the HHS case Azar vs. Allina Health.

WHY THIS MATTERS

CMS’s proposed rule changes affect hundreds of millions of dollars in reimbursement for hospitals. The government estimates that the DSH payments from 2005 to 2013 totaled $3 to $4 billion, according to SCOTUSblog.

Hospitals suing HHS said the Centers for Medicare and Medicaid Services “botched” attempted rulemaking in 2004, when the department tried to change the standard governing Medicare payment to hospitals nationwide for services furnished to low-income patients.

The Medicare Act requires the agency to engage in notice-and-comment rulemaking, the hospitals argue.

HHS disagrees, saying the Medicare Act does not require HHS to issue formal notice-and-comment rulemaking prior to changing the DSH calculation formula. Doing so would cripple the Medicare program, requiring the agency to use rulemaking for any change in its lengthy and detailed operations manuals, it argues.

The hospitals involved in the lawsuit are Allina Health System and its affiliated hospitals, Abbott Northwestern, United, and Unity; Florida Health Sciences Center; Montefiore Medical Center; Mount Sinai Medical Center, New York-Presbyterian/Queens; New York Presbyterian Brooklyn Methodist Hospital; and New York and Presbyterian Hospital.

ON THE RECORD

“The agency botched that rulemaking: the final rule was not the ‘logical outgrowth’ of the proposed rule, and the D.C. Circuit vacated it,” Allina and other health systems said.

HHS Secretary Alex Azar said in court documents, “As the government has explained, respondents’ theory, if adopted, has the potential to substantially undermine effective administration of the Medicare program, not least because its rationale would encompass not just the Medicare fractions at issue here but nearly every instruction to the agency’s contractors, including those contained in the Provider Reimbursement Manual.”

 

 

Hahnemann University Hospital, St. Christopher’s to share newly-appointed CEO

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Hahnemann, St. Christopher’s were recently sold by Tenet Healthcare to American Academic Health System, a newly-formed affiliate of Paladin Health.

The California healthcare firm that owns both Hahnemann University Hospital and St. Christopher’s Hospital for Children has combined leadership of the two well-known Philadelphia institutions under one new chief executive.

Paladin Healthcare created a new affiliate, American Academic Health System, to own and operate Hahnemann and St. Christopher’s. A memo sent to staff this week said that Southern California hospital executive Suzanne Richards took over as CEO for both hospitals Monday,  according to the Philadelphia Inquirer.

Neither of the previous CEOs, Hahnemann interim CEO Anthony Rajkumar or St. Christopher’s leader George Rizzuto, were mentioned in the memo, the report said.

THE IMPACT

Hahnemann University Hospital is a 496-bed academic medical center affiliated with Drexel University School of Medicine. St. Christopher’s staffs more than 220 pediatric experts and offers both general pediatric care and pediatric specialties including cardiology, ear, nose and throat, gastroenterology, oncology and orthopedics, as well as one of only three Level I pediatric trauma centers in Pennsylvania and the only pediatric burn center in the Philadelphia area.

The hospital also touts an expansive primary and specialty care network that reaches into the Philadelphia suburbs and New Jersey.

THE TREND

The Inquirer report said this is one in a line of management changes American Academic has made since it acquired Hahnemann and St. Christopher’s from Tenet Healthcare in September.

In August, St. Christopher’s laid off 45 people in its physician practices and eliminated an unspecified number of positions also in its physician practices, which amounted to roughly 7 percent of the workforce in the hospital’s practices. Quoting a hospital spokesperson, the report said those being laid off were given severance or offered positions at other American Academic Health System facilities.

Paladin Healthcare formed AAHS to own and operate academic medical centers and general acute care hospitals across the country. Paladin currently manages four Southern California general acute care hospitals as well as the 145-year-old teaching hospital Howard University Hospital in Washington, DC.

Tenet netted roughly $170 million from the sale of Hahnemann and St. Christopher’s, comprised of $152.5 million in cash at closing and a promissory note in the amount of $17.5 million.

ON THE RECORD

At the time of publishing, requests for comment made to Hahnemann, St. Christopher’s and American Academic Health on the change in leadership had not been returned.

On the sale of Hahnemann and St Christopher’s to Paladin/American Academic: “Our leadership team has extensive, first-hand experience in operating hospitals in the Philadelphia market and understands the vital role Hahnemann and St. Christopher’s play in the Philadelphia healthcare delivery system,” said Barry Wolfman, president of Paladin Healthcare. “We appreciate Drexel University College of Medicine’s support and look forward to working closely with the entire physician community to continue the longstanding clinical and academic excellence of both hospitals.”

 

 

FDA to ramp up cell and gene therapy activity as tidal wave of new products approaches

FDA to ramp up cell and gene therapy activity as tidal wave of new products approaches

In a statement, Commissioner Scott Gottlieb said the agency anticipates more than 200 cell and gene therapy INDs per year by 2020, and 10-20 approvals annually by 2025.

The Food and Drug Administration plans to add 50 new staffers to its clinical review group for cell and gene therapies as it anticipates a surge in new products entering the clinic and the market over the next several years.

In a statement Tuesday, FDA Commissioner Scott Gottlieb said that by next year, the agency will receive on an annual basis more than 200 Investigational New Drug applications – used by companies to get regulatory approval to start clinical trials – and approving 10-20 cell and gene products per year by 2025.

“The activity reflects a turning point in the development of these technologies and their application to human health,” Gottlieb’s statement read. “It’s similar to the period marking an acceleration in the development of antibody drugs in the late 1990s, and the mainstreaming of monoclonal antibodies as the backbone of modern treatment regimens.”

That picture stands in stark contrast to the current roster of approved cell and gene therapies. Those consist of two CAR-T cell therapies for blood cancers – Novartis’s Kymriah (tisagenlecleucel) and Gilead Sciences’ Yescarta (axicabtagene ciloleucel) – and one gene therapy, Spark Therapeutics’ Luxturna (voretigene neparvovec-rzyl), for a rare, inherited form of blindness.

For the application review of Kymriah’s initial approval in August 2017, for acute lymphoblastic leukemia in children and young adults, the agency convened the Oncologic Drugs Advisory Committee, a panel of outside experts who offer advice on approvals when the agency requests it. But it did not do so for Yescarta’s approval two months later for diffuse large B-cell lymphoma in adults, nor did it for Kymriah in DLBCL – the relative ease of the latter approvals indicating the agency had quickly become more comfortable approving the then-unprecedented cell therapies.

But Gottlieb noted there are now more than 800 active INDs for cell and gene therapies on file with the FDA. In a panel discussion at last week’s Biotech Showcase in San Francisco, which coincides with the annual J.P. Morgan Healthcare Conference, Iovance Biotherapeutics CEO Maria Fardis noted that competition in CAR-T therapy is heating up at clinical trial centers, making it harder to recruit patients. She was speaking in the context of CAR-Ts for solid tumors, which remain a much less well-established area of the field than blood cancers. Other types of cell therapies are in development as well, including T-cell receptors and tumor-infiltrating lymphocytes, respectively also known as TCRs and TILs.

Of course, the announcement took place against the background of the ongoing government shutdown. As a result, the FDA is currently only able to perform activities covered by user fees paid before the impasse, but is unable to perform many activities for which user fees had not yet been paid.

Several cell and gene therapy products are expected to reach the market in the near term. Celgene anticipates two CAR-T filings: bb2121 in multiple myeloma; and lisocabtagene maraleucel, which it acquired when it bought Juno Therapeutics last year. Both therapies were touted as near-term opportunities in Bristol-Myers Squibb’s recent $74 billion acquisition of Celgene. Separately, bluebird also anticipates approval in the US by next year for LentiGlobin for transfusion-dependent beta-thalassemia. BioMarin Pharmaceutical also anticipates filing for approval of valoctocogene roxaparvovec in hemophilia A.

 

UnitedHealth’s Optum revenues surpass $100B for 1st time

https://www.beckershospitalreview.com/payer-issues/unitedhealth-s-optum-revenues-surpass-100b-for-1st-time.html?origin=cioe&utm_source=cioe

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Growth in UnitedHealth Group’s health services business Optum helped the health insurance company beat Wall Street estimates for the fourth quarter ended Dec. 31, according to Reuters.

Five things to know:

1. Revenues for Optum, which is UnitedHealth’s fastest-growing unit and includes an in-house pharmacy benefits manager, topped $100 billion for the first time in the year ended Dec. 31. Optum grew revenues by 11.1 percent year over year to $101.3 billion, the company said Jan. 15.

2. While Optum may face heightened competition this year after Aetna and Cigna scored deals with large benefit managers, Piper Jaffray analyst Sarah James told Reuters: “We view [the Optum results] as a positive sign given the increasingly competitive nature of the pharmacy benefits management market. We believe 2019 could be a big year at OptumHealth … and see potential for specialty [drugs] to double earnings by 2021.”

3. For the fourth quarter, the country’s largest health insurer posted $27.56 billion in revenues from its Optum unit, up 13 percent year over year. 

4. Still, UnitedHealth’s medical care ratio — or the amount of premiums used to cover medical expenses compared to overhead costs — fell short of expectations at 82.2 percent, according to Reuters. Higher costs in UnitedHealth’s government-sponsored Medicaid business were partially to blame, analysts told the publication.

5. UnitedHealth’s insurance business, UnitedHealthcare, increased sales by 11.1 percent in the fourth quarter, for a total of $46.2 billion. Net earnings to shareholders fell 16 percent to $3 billion in the fourth quarter, compared to $3.6 billion a year prior.