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Tuesday, April 30, 2019

Judge recuses self from UnitedHealthcare proton therapy lawsuits

At least two lawsuits have been filed against UnitedHealthcare in the last two months alleging the insurance company improperly denied patients coverage for a certain type of cancer treatment that insurers have long been reluctant to pay for.
On Monday, U.S. District Judge Robert Scola recused himself from deciding one of the lawsuits filed this month in Miami because of personal experience with the cancer treatment, writing in an order of recusal that denying a patient the treatment “is immoral and barbaric.”
“It is undisputed among legitimate medical experts that proton radiation therapy is not experimental and causes much less collateral damage than traditional radiation,” Scola wrote. “To deny a patient this treatment, if it is available, is immoral and barbaric.”
The treatment, called proton beam therapy, is a radiation therapy used by oncologists to kill cancerous tumors. Compared with traditional radiation, proton therapy is used to target a specific site on the body, limiting damage to surrounding tissues.
According to the complaints, UnitedHealthcare denied coverage for the proton beam therapy for one patient’s prostate cancer and another patient’s cervical cancer, in both instances determining that the treatment is experimental and unproven. But the patients, who are seeking class action status for their lawsuits, argue that proton therapy is a decades-old effective and established cancer treatment. It was approved by the Food and Drug Administration in 1988 and is paid for by Medicare, according to the complaints.
“Instead of acting solely in the interests of the participants and beneficiaries of its health insurance plans, upon information and belief, UHC denied coverage for PBRT to treat prostate cancer because, on average, PBRT is significantly more expensive than traditional Intensity Modulated Radiotherapy or other treatments,” one complaint alleged.
UnitedHealthcare said Monday that it “bases its medical policies and coverage decisions—including for proton beam therapy—on the prevailing published clinical and scientific evidence.”
UnitedHealth isn’t the only insurer that has denied coverage of proton beam therapy for certain cancers. Last year, an Oklahoma jury told Aetna to pay $25.5 million to a patient’s estate after the insurer denied to pay for the treatment based on grounds that it was experimental. Other insurers and policy experts have warned in recent years that there’s a lack of evidence showing proton therapy produces better outcomes than other types of radiation. Despite that, hospitals and other companies have rushed to build expensive proton-beam therapy centers.
Richard Cole, the plaintiff in the amended complaint filed last week in a federal district court in Miami, was diagnosed with prostate cancer in April 2018 and his physicians at Baptist Health South Florida recommended proton therapy as an alternative to another type of radiation called intensity modulated radiation therapy, or IMRT, because of the likelihood of a better health outcome, according to the complaint.
UnitedHealthcare, which administered medical benefits on behalf of Cole’s self-funded employer, denied his prior authorization request and subsequent appeals for coverage of proton therapy on the grounds that it fell under an exclusion for experimental, investigational or unproven services for patients over 19 years old. Cole paid for the treatment out of pocket.
UnitedHealthcare then changed its policy effective Jan. 1, 2019, to cover proton beam therapy for prostate cancer, acknowledging that proton therapy and IMRT are “proven and considered clinically equivalent for treating prostate cancer,” the complaint stated. Still, UnitedHealthcare’s independent reviewer continued to deny Cole coverage of the treatment as recently as February 2019.
In the other case filed in March, patient Kate Weissmann, whose employer contracted with UnitedHeathcare for benefits administration, similarly alleged that the insurer repeatedly denied coverage for proton therapy to treat her cervical cancer in 2016 based on a policy that relied on “outdated medical evidence, ignores contemporary medical evidence, and relies more heavily on actuarial calculation of risk pools” because it covers the therapy for patients younger than 19 and older than 65.
She also alleged that UnitedHealthcare relies on an “inadequate review of clinical records” by medical directors who are unqualified to make coverage determinations.
The insurer denied coverage despite recommendations by her physicians at Mass General and the Dana-Farber Cancer Institute that proton therapy was essential for Weissman’s treatment for reasons including IMRT put her at risk for bowel and gastrointestinal toxicity while proton therapy reduced that risk. Weissman shelled out $95,000 out of pocket for proton therapy.
The complaints do not state how many patients might be affected by UnitedHealthcare’s coverage policy for proton beam therapy. However, the lawsuit filed in Miami noted that 5,000 patients within prostate cancer were treated using proton therapy nationwide in 2018.
Judge Scola wrote in his recusal order that UnitedHealthcare denied coverage of proton radiation treatment requested by his close friend in 2015. UnitedHealthcare agreed to pay for the $150,000 treatment when threatened with litigation. The judge also wrote that he personally was diagnosed with prostate cancer in 2017 and the experts he consulted throughout the country determined that proton therapy was the “wiser course of action” if he opted for radiation.

Medicaid contract losses weigh on Molina’s top line

Long Beach, Calif.-based insurer Molina Healthcare reported lower revenue but higher profit in the first quarter of 2019 compared with the same period a year ago as it served fewer patients but had fewer expenses.
Molina’s membership decreased by almost 700,000 from the first quarter last year after losing its managed Medicaid contracts in New Mexico and Florida last year. While the company successfully protested the loss in Florida, it still is serving only two regions in the state, whereas it served eight regions previously.
The contract losses, coupled with lower membership in its Medicare and Affordable Care Act exchange plans, brought total membership down to 3.4 million, a decrease of 16.4%. Molina collected less premium revenue for the same reasons. Its total revenue was $4.1 billion, down 11.3%.
Even so, Molina said it had lower expenses in the first quarter, including lower medical care costs, general and administrative expenses, and restructuring costs. Its medical loss ratio, which represents the percentage of premiums spent on medical claims and quality improvement activities, dropped to 85.3% from 86.1% largely because of “improvements” in the company’s temporary assistance for needy families and aged, blind or disabled programs, the company reported.
Molina’s net income increased about 85% to $198 million from $107 million in the first quarter of 2018. Its profit margin after taxes was 4.8% compared with 2.3% a year ago.
“These results are a testament to the achievability of the second phase of our strategy, which is to sustain the attractive margin position we had built in 2018,” Molina CEO Joseph Zubretsky said in the announcement. “While certainly not conclusive, our first quarter results validate our position that durable financial and operational improvement can and should allow us to sustain these margins, all while we begin to grow the top line again.”

Civica Rx will allow hospital members to use wholesalers, CEO says

Generic-drug company Civica Rx pledged that it will deliver drugs to member hospitals and will accommodate hospitals if they use wholesalers to purchase the products.
So far more than 800 U.S. hospitals have joined the organization founded by Intermountain Healthcare, SSM Health, Trinity Health and Ascension, which has since left the group.
The company is expected to have its first generic drug on the market this year. Civica Rx CEO Martin VanTrieste told the World Health Care Congress in Washington on Monday that the organization will deliver the generic drugs it makes directly to the member hospitals.
“We will not use the standard middleman approach,” he said.
However, Civica Rx will accommodate a health system if it still wants to use a wholesaler to get the drug if that could be more convenient.
“Our member will know what price we charge the wholesaler,” VanTrieste said, adding that the price it charges a wholesaler would be the same as a hospital.
“If a wholesaler takes a container that I sell for $1 and at the end of the system it comes out at $3 then the health system knows that they paid $2 for that convenience,” said VanTrieste, a former executive with the pharmaceutical manufacturer Amgen. “We will force transparency.”
Civica Rx is targeting 14 hospital-administered generic drugs that are in short supply, and it hasn’t announced what drug will go to market first. It remains unclear which drug will be the first to reach the market. The company is contracting with private manufacturing facilities to make its first products.

HCA Healthcare tops analysts’ bets on revenue, earnings

In what’s become a familiar refrain, for-profit HCA Healthcare easily came out ahead of analysts’ estimates for its revenue and earnings in the first quarter of 2019, and executives ticked up their guidance for the year.
“We typically don’t address guidance after just one quarter, but given our performance, we believe it was appropriate,” HCA Chief Financial Officer Bill Rutherford said in an investor call.
The Nashville-based hospital chain reported Tuesday it drew $12.5 billion in revenue in the quarter ended March 31, up 9.6% compared with $11.4 billion in the first quarter of 2018. Expenses grew at an even faster clip, jumping 11.9% to $11 billion in the recently ended quarter.
Those metrics easily exceeded predictions from analysts with Zacks Investment Research, which pegged revenue in the quarter at $12.3 billion. HCA drew earnings per share in the quarter of $2.97, considerably higher than Zacks’ prediction of $2.31.
HCA’s adjusted earnings before interest, taxes, depreciation and amortization was $2.5 billion in the first quarter of 2019, up nearly 20% from $2.1 billion in the prior-year period.
That better-than-expected performance prompted leadership to increase the company’s full-year guidance, including adjusted EBITDA between $9.45 billion and $9.85 billion. The company now expects revenue to fall between $50.5 billion and $51.5 billion.
A dark spot on the results was the 9.2% decline in net income to $1 billion in the quarter. Cash flows from operating activities were down 24% in the quarter, from $1.3 billion in the first quarter of 2018 to $974 million in the first quarter of 2019.
Last week, fellow for-profit chain Universal Health Services reported a 0.4% year-over-year decline in revenue per adjusted acute-care admission, which leadership blamed on weak surgical acuity and volumes. HCA appears to have dodged that fate, reporting a 5.2% increase in inpatient revenue per admission year-over-year.
Same-facility admissions grew 0.9% in the quarter compared with the prior-year period, which HCA CEO Sam Hazen noted on the earnings call marks 20 consecutive quarters of same-facility inpatient admission growth for HCA.
Same-facility emergency department visits declined 2.3% in the quarter year-over-year, which Rutherford said is partly due to a weakened flu season. He noted all of the declines were among lower acuity emergency department visits, while higher acuity visits increased during the quarter.
Same-facility inpatient surgeries fell 0.3%, and same-facility outpatient surgeries grew 1.3%. Hazen attributed the weak inpatient surgical volumes to fewer cesarean sections and one less surgical day in the quarter. He noted volume performance was stronger across HCA’s hospital-based outpatient surgery centers.
Hazen said HCA is constantly looking to gain efficiencies and improve profitability. On the supply chain side, the company recently signed a contract with Optum to take over as its pharmacy benefit manager in 2020 in place of CVS. HCA’s pending acquisition of the Galen College of Nursing, expected to close by year-end, is also expected to help control expenses, Hazen said.
“We do think it’s going to create opportunities for us to enhance the pipeline of nurses into our company,” he said, although he declined to share a specific expense impact projection.
HCA had expected recent acquisitions, including Asheville, N.C.-based Mission Health and Memorial Health in Savannah, Ga., to contribute roughly 3% EBITDA growth in 2019. That was achieved in the first quarter, Rutherford said.
While Hazen didn’t announce any new acquisitions on Tuesday’s call, he said HCA is talking with several appealing not-for-profit health systems.
“I do think we are entering a period of time where we would see more (deals) than we’ve seen in the past,” he said.

Tenet Healthcare CEO is ‘bullish’ on Conifer deal

While Tenet Healthcare Corp. on Tuesday touted an earnings bump for its revenue cycle subsidiary Tuesday, it didn’t divulge new details on the ongoing process to offload that business.
Tenet’s Conifer Health Solutions generated $99 million in adjusted earnings before interest, taxes, depreciation and amortization in the first quarter of 2019, which ended March 31, up 1% compared to the prior-year period, the company announced Monday. Revenue in the segment, however, plunged 13.6% to $349 million in the quarter due to divestitures by Tenet and other clients.
Dallas-based Tenet announced in February it had entered exclusive talks over a potential deal. On the company’s earnings call Tuesday, Tenet CEO Ron Rittenmeyer said the discussions continue, but did not share an estimated date for an announcement.
“I’m as bullish on that as I was in the past,” he said.
Not counting $10 million in customer termination fees, Tenet reported Conifer’s EBITDA grew 12.5% in the quarter.
Tenet pulled in $4.54 billion in revenue in the quarter, just squeaking by the $4.53 billion estimate from analysts at Zacks Investment Research. That’s compared with $4.7 billion in the prior-year period, a 3.3% decline. The company said a similar 2.2% operating revenue decline in its hospital segment was because of divestitures. On a same-hospital basis, net patient service revenue grew 1.9% year-over-year during the quarter, the company said.
Tenet’s earnings per share of $0.26 per diluted share fell below Zacks’ estimates, which pegged earnings per share at $0.30 in the quarter. That metric was down from $0.95 in the prior-year period.
Tenet’s share price was down roughly 4% Tuesday afternoon following the company’s earnings call.
Tenet’s adjusted earnings before interest, taxes, depreciation and amortization was $613 million in the first quarter, down 7.8% from $665 million in the prior-year period. Tenet wrote that the decline was due to a $38 million increase in malpractice expense, $11 million in losses generated by a risk-based contracting business in California and the $7 million divestiture of the company’s former operations in the U.K., Aspen Healthcare.
Tenet’s same-hospital adjusted admissions increased 0.6% in the quarter year-over-year, while admissions declined 0.1%.
Revenue per adjusted admission to Tenet’s hospitals increased 2.4% in the quarter year-over-year. That puts it ahead of fellow for-profit chain Universal Health Services, which last week posted a 0.4% decline in revenue per adjusted acute-care admission in the quarter.
Dan Cancelmi, Tenet’s CFO, said on Tuesday’s call that revenue per adjusted admission was in line with expectations from a pricing perspective. He noted the metric was negatively affected by “incredibly strong” acuity in the first quarter of 2018.
UHS’ CFO, Steve Filton, similarly said last week that high acuity at the beginning of 2018 negatively affected UHS’ revenue per acute-care admission in the recently ended quarter.
Tenet reported a net loss from continuing operations of $27 million in the first quarter of 2019, compared with $98 million in net income in the prior-year period. A number of factors contributed to the loss, including a $47 million pre-tax loss from the early extinguishment of debt. The company said the prior-year-period’s figure was inflated from the sale of MacNeal Hospital and other operations.
A.J. Rice, an analyst with Credit Suisse, remarked on the company’s earnings call Tuesday that as Tenet sells hospitals, the buyers don’t seem to be keeping Conifer as their revenue-cycle provider.
“I would assume if it’s doing a good job, you’d have a better chance at holding on to it,” he said.
Cancelmi responded that some buyers are more comfortable using their own internal revenue cycle processes.
“It sort of cuts both ways,” he said.
Tenet paid $21 million in the first quarter of 2019 to settle various medical malpractice claims, contributing to a $65 million year-over-year decline in EBITDA in its hospital segment.
Raymond James analyst John Ransom pointed out on Tenet’s earnings call that the company seems to pay out more in malpractice claims than other for-profit hospital chains.
“I know you can’t speak to your peers, but it does stand out as something Tenet struggles with a bit more than the other guys,” he said.
The amounts paid out in a quarter depend on whether Tenet decides to resolve large cases rather than proceed to trial, Cancelmi said, adding that some of Tenet’s markets are more challenging from a litigation perspective than others.

Exact Sciences raises FY19 revenue view to $725M-$740M from $710M-$730M

Consensus is for FY19 revenue $729.45M.
https://thefly.com/landingPageNews.php?id=2900405

Stealth Biotherapeutics reports ‘positive’ results for elamipretide

Stealth BioTherapeutics recently presented positive results from its ophthalmic programs in dry age-related macular degeneration and Leber’s hereditary optic neuropathy. The data, which were presented at the Association for Research in Vision and Ophthalmology 2019 Annual Meeting, being held April 28 – May 2 in Vancouver, British Columbia, demonstrated significant improvements in visual function following treatment with elamipretide, an investigational drug, in its ReCLAIM study of patients with dry AMD and in the open-label portion of its ReSIGHT study of patients with LHON.
https://thefly.com/landingPageNews.php?id=2900419