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Monday, October 1, 2018

DaVita unit to pay $270 million to resolve Medicare payments probe


A medical care unit of DaVita Inc (DVA.N) has agreed to pay $270 million to resolve claims it provided inaccurate information about patients that caused Medicare Advantage plans operated by private insurers to obtain inflated payments from the government.
The civil settlement with HealthCare Partners Holdings, which Denver-based DaVita acquired in 2012 and is in the process of selling to UnitedHealth Group Inc (UNH.N), was announced on Monday by the U.S. Justice Department.
HealthCare Partners did not admit wrongdoing. DaVita in a statement said the $270 million will be paid for out of escrow funds that it required HealthCare Partners’ former owners to set aside when DaVita acquired it in 2012.
According to court papers, HealthCare Partners, a California-based independent physician association, contracted with insurers to provide medical services to Medicare Advantage patients.
More than one-third of Medicare recipients receive benefits through Medicare Advantage plans run by private insurers, who the government pays a predetermined monthly sum for each person they cover based on individual diagnostic traits.
Under this part of Medicare, the healthcare program for the elderly, the government makes so-called “risk adjustment” payments based on data it receives regarding the health status of a patient covered by a Medicare Advantage plan.
The case stemmed from a broader investigation into data that insurers who operate Medicare Advantage plans submit to receive “risk adjustment” payments. The probe has already led to the U.S. Justice Department suing UnitedHealth in a similar case.
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The Justice Departments said HealthCare Partners instituted practices that led insurers operating Medicare Advantage plans to submit incorrect information about patients’ diagnoses and obtain inflated payments, which the company shared in.
HealthCare Partners also scoured patients’ records for diagnoses its medical providers failed to record which it then submitted to the insurers for use in obtaining increased Medicare payments, the Justice Department said.
Those allegations stemmed from a whistleblower lawsuit filed in 2009 against various insurers and, later, HealthCare Partners by James Swoben, a former employee of an insurer that did business with DaVita, the Justice Department said.
His lawsuit, pending in federal court in Los Angeles, was filed under the False Claims Act, which allows whistleblowers to sue companies on the government’s behalf to recover funds paid out based on fraudulent claims.
The government may intervene in such cases. For his role in bringing the case, Swoben will receive nearly $10.2 million, the Justice Department said.
The case is U.S. ex rel. Swoben v. Secure Horizons, et al, U.S. District Court, Central District of California, No. 09-5013.

Adial Pharmaceuticals initiated at Dawson James


Dawson James initiated Adial Pharmaceuticals with a Buy and $6 price target.
https://thefly.com/landingPageNews.php?id=2797973

Chiasma completes enrollment for phase 3 CHIASMA OPTIMAL trial


Chiasma announced that it has completed enrollment of its international Phase 3 clinical trial, referred to as CHIASMA OPTIMAL. This trial is being conducted under a special protocol assessment, or SPA, agreement with the FDA to support potential regulatory approval in the United States of its investigational octreotide capsules, conditionally trade-named Mycapssa, for the maintenance therapy of adult patients with acromegaly. Chiasma exceeded target enrollment of 50 patients in the trial with a total of 56 acromegaly patients randomized in 17 countries worldwide, including 21 patients from the U.S.
https://thefly.com/landingPageNews.php?id=2798007

AmerisourceBergen to pay $625M to end charges of distributing unapproved drugs


AmerisourceBergen (ABC +0.7%) has agreed to pay 44 states and the federal government $625M to settle civil charges of distributing unapproved and adulterated drugs related to the alleged misbehavior of an Alabama pharmacy owned by subsidiary AmerisourceBergen Specialty Group (ABSG). It seems that the pharmacy in question was behind a number of false Medicaid claims for unapproved new drugs and defective, contaminated or otherwise compromised medications. There were also instances of double billing for the same product.
The pharmacy supposedly repackaged vials of certain drugs into pre-filled syringes which it shipped to oncology practices and doctors treating cancer patients. The “overfill” scheme enabled the pharmacy to boost profits from the vial formulations, but represented increased risk to patients since the activities were performed in an unsterile environment which resulted in a number of cases of contaminated product.
ABSG agreed to pay $260M in criminal fines and forfeitures.

Novartis-backed cell therapy startup Gamida files for IPO


Gamida Cell has filed to raise $69 million in a Nasdaq IPO. The Novartis-backed cell therapy player wants the money to wrap up a phase 3 trial of its lead candidate in patients with blood cancers.
Cell therapies, in the form of hematopoietic stem cell transplantations (HSCT), are already widely used in the treatment of blood cancers such as acute myeloid leukemia. However, the number of patients who receive HCST is limited by a lack of donor-matched cells. Haploidentical donors and umbilical cord blood partly make up for the shortfall in donor-matched cells, but Gamida still thinks 40% of patients eligible for HSCT never receive the treatment.
Gamida wants to enable these patients to access cell therapy treatments. The biotech’s answer to the problem, NiCord, is made by applying a nicotinamide-based cell expansion technology to cord blood. Gamida thinks the result is an off-the-shelf treatment consisting of cells that quickly engraft and largely avoid attack by the host immune system.
Israel-based Gamida is enrolling patients in a phase 3 trial to test the idea. With the trial not due to deliver top-line data until the first half of 2020 and Gamida’s cash reserves dipping below $30 million, the biotech is seeking up to $69 million from public investors to complete the study.
Some of the money will go toward the build-out of a manufacturing plant in Israel. Manufacturing has posed challenges for the company. During a recent audit of Gamida’s contract manufacturer, Israeli inspectors made critical observations. Gamida is working with the manufacturer to fix the issues but is yet to get the all-clear from regulators.
Novartis was set to buy Gamida for $170 million upfront in 2014, but the deal fell through. Later that year, Novartis invested $35 million in Gamida and secured an option to buy the biotech outright in 2016. However, Novartis turned down the option 10 months later, well before it was due to expire.
The Swiss Big Pharma has continued to invest in Gamida, though. Novartis invested $5 million late in 2015—after turning down its option—and put a further $8 million into Gamida last year. The rounds left Novartis owning more than one-fifth of Gamida, making it the biotech’s biggest shareholder.

Trump Signs Funding Bill Giving NIH $2B Boost in FY19


President Donald Trump on Friday signed into law an appropriations package that included a $2 billion budget increase in fiscal year 2019 for the National Institutes of Health.
The bipartisan legislation increases the NIH’s budget by 5.4 percent over its fiscal 2018 funding level to $39.1 billion. The bill passed the House by a vote of 361 to 61 and passed the Senate in a 93-to-7 vote. It specifically includes an additional $425 million for Alzheimer’s disease research for a total of $2.34 billion; a total of $429.4 million for the BRAIN initiative, a $29 million increase; and $376 million for the All of Us precision medicine study, $86 million more than in FY 2018.

Perrigo confirms patent challenge for generic version of Jublia


Perrigo Company announced that Valeant Pharmaceuticals North America, Valeant Pharmaceuticals Ireland, Dow Pharmaceuticals Sciences and Kaken Pharmaceuticals initiated patent litigation on September 21, 2018 in the United States District Court for the District of New Jersey regarding Perrigo’s Paragraph IV Abbreviated New Drug Application for efinaconazole topical solution 10%, asserting patents listed in the Orange Book for Jublia. This action formally initiates the litigation process under the Hatch-Waxman Act. Jublia Topical Solution 10%, is indicated for the topical treatment of onychomycosis of the toenails due to Trichophyton rubrum and Trichophyton mentagrophytes. Annual market sales for the 12 months ending July 2018 were $276M as measured by IQVIA.
https://thefly.com/landingPageNews.php?id=2797857