Court Case

Health care fraud was the largest driver of False Claims Act recoveries last year, the Dept. of Justice (DOJ) recently reported. Of the more than $5.6 billion in settlements and judgments from civil cases involving fraud and false claims against the government for the fiscal year ending Sept. 30, 2021, more than $5 billion related to matters involving the health care industry, including drug and medical device manufacturers, managed care providers and hospitals, the DOJ estimated. Medicare Advantage-related recoveries included a $90 million settlement with Sutter Health to resolve allegations that it submitted unsupported diagnosis codes that led to inflated payments to MA plans and the health system and a $6.3 million settlement with Kaiser Foundation Health Plan of Washington (formerly Group Health Cooperative) over similar allegations.

Teva Pharmaceuticals Ltd. launched the first generic version of Bristol Myers Squibb unit Celgene Corp.’s Revlimid (lenalidomide) in 5 mg, 10 mg, 15 mg and 25 mg strengths in the United States on March 7. The FDA approved the drug from Teva U.S. affiliate Arrow International Ltd. and Natco Pharma Ltd. on May 21, 2021. The companies have tentative approval for the 2.5 mg and 20 mg strengths due to an exclusivity issue: The FDA has approved Dr. Reddy’s Laboratories Ltd.’s lenalidomide for those dosages. The product is approved for three indications: (1) multiple myeloma in combination with dexamethasone, (2) transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with a deletion 5q abnormality with or without additional cytogenic abnormalities and (3) mantle cell lymphoma that has relapsed or progressed after at least two treatments, including bortezomib. The launch is limited, and through an agreement with Celgene, the companies are allowed to sell “mid-single-digit percentages” of Revlimid’s total volume this month, a figure that gradually will increase to one-third of the volume. Beginning Jan. 31, 2026, Teva can sell the drug without volume limitation. Multiple companies are expected to launch Revlimid generics in the U.S. this year.

With UnitedHealth Group poised to battle the U.S. Dept. of Justice in court over the fate of its proposed purchase of Change Healthcare, Inc., there’s still a host of unknowns about how that legal case will play out. However, one thing does appear to be clear to industry observers: UnitedHealth will be just fine no matter how the fight to salvage its transaction plays out.

In the credit rating world, “if the deal is ultimately stopped by the DOJ, it would be credit positive for UnitedHealth” because it would require the company to take on less debt, “but long-term growth prospects would be incrementally diminished,” Moody’s Investors Service wrote in a Feb. 28 report.

The U.S. Dept. of Justice (DOJ) on Feb. 24 sued to block UnitedHealth Group’s proposed $13 billion acquisition of Change Healthcare Inc., arguing that the deal would stymie competition not only in commercial health insurance markets but also the market for technology that allows insurers to process claims and reduce health care costs.

UnitedHealth has already indicated that it will challenge the legal action taken by the DOJ and attorneys general from Minnesota and New York — setting the stage for the first legal fight to save a major deal involving a health insurer since the failed Anthem/Cigna and Humana/Aetna tie-ups.

Texas providers have notched their first win in the legal battle over the No Surprises Act (NSA), the federal law that bans surprise billing — though the Biden administration can appeal the decision. In a lawsuit brought by the Texas Medical Association (TMA), Judge Jeremy Kernodle of the federal Eastern District of Texas on Wednesday struck down regulations issued by the Biden administration that providers allege favor insurers at their expense in balance-billing scenarios.

The NSA requires payers and providers to work out the balance billing disputes between themselves. If that fails, an HHS-approved independent arbitrator will decide between two payment amounts: one submitted by the provider and one by the insurer. Arbitrators then pick between one of the two proffered amounts using criteria designed by the Biden administration.

CMS on Feb. 24 released plans to revamp the Global and Professional Direct Contracting model, which allows participants to share risk and receive capitated payments for serving fee-for-service Medicare beneficiaries. Democrats like Washington Rep. Pramila Jayapal and Massachusetts Sen. Elizabeth Warren have criticized the model for transforming “the care of a traditional Medicare beneficiary to care typically seen in a private Medicare Advantage (MA) plan despite the fact that the patient chose not to enroll in an MA plan,” in Jayapal’s words. However, in good news for insurers like Clover Health, which are counting heavily on direct contracting revenue, CMS appears to still allow health insurers to apply for the renamed ACO Realizing Equity, Access, and Community Health (REACH) Model. As part of the overhaul, CMS promised greater “participant vetting, monitoring and transparency,” more promotion of provider leadership and governance, and a larger focus on health equity, among other changes.

Gilead Sciences, Inc. said on Jan. 14 that it is voluntarily withdrawing two indications for Zydelig (idelalisib): for the treatment of relapsed follicular B-cell non-Hodgkin lymphoma (FL) and small lymphocytic leukemia (SLL), both of which had accelerated approval. “As the treatment landscape for FL and SLL has evolved, enrollment into the confirmatory study has been an ongoing challenge,” said the company in a press release. Along with the FL and SLL approvals on July 23, 2014, the FDA granted traditional approval to the drug for the treatment of relapsed chronic lymphocytic leukemia. Zydelig will remain on the U.S. market for this indication.

Due to a Jan. 27 federal court order, CVS Health Corp.’s Aetna health insurance division could be the defendant in a class-action lawsuit regarding Aetna’s restrictive coverage decisions in breast and prostate cancer treatment. In a lawsuit filed in Florida district court, a federal judge found that Aetna improperly denied coverage of proton therapy to cancer patients who ultimately had to pay for the treatment out of pocket.

Proton beam radiation therapy (PBRT) is a type of cancer treatment “that uses high-powered energy to treat cancer and some noncancerous tumors,” according to the Mayo Clinic, which also notes that “studies have compared proton radiation and X-ray radiation, so it’s not clear whether proton therapy is more effective at prolonging lives.” The therapy isn’t widely available, although new proton therapy centers are being built in the U.S. and in other countries.

New drugs are becoming less expensive to bring to market and more profitable at launch, according to a new Deloitte Ltd. white paper. “Cost to bring an asset to market has declined over the past three years, as peak sales forecasts increase,” the report says. “The combined cohort’s average cost to develop an asset was $2,006 million, a decrease of $370 million from 2020....This decrease in 2021 compared to 2020 is due mainly to the overall increase in the number of assets in the late-stage pipeline.” However, the report also notes that this figure is “an increase of $710 million from 2013.” In addition, the cycle time for drug development has increased, especially since the start of the pandemic.

New Hampshire is the latest state to settle its suit against Centene Corp, accepting $21 million from the Medicaid-focused carrier. More than a dozen states have sued the health insurer, accusing Centene of mismanaging their Medicaid programs’ pharmacy benefits. As with the other settlements, in the New Hampshire agreement Centene denied it was liable for any wrongdoing or violations of federal or state statute. The insurer has paid out more than $241 million in settlements with Arkansas, Illinois, Kansas, Mississippi and Ohio out of the $1.25 billion it set aside earlier this year to settle such suits.

Centene Corp. will pay the state of Kansas $27.6 million, the fifth such settlement reached between the insurer and state Medicaid programs. More than a dozen states have sued the health insurer, accusing Centene of mismanaging their Medicaid programs’ pharmacy benefits. The insurer has paid out $214 million in settlements with Arkansas, Illinois, Mississippi and Ohio out of the $1.25 billion it set aside earlier this year to settle such suits. According to a press release from the office of Republican Kansas Attorney General Derek Schmidt, “In the settlement, Centene guarantees that it will improve transparency by providing the state with access to all data necessary to track pharmaceutical transactions, from the point of sale through reimbursement.” Centene is in the process of consolidating its $30 billion in pharmacy spend and hopes to bid out that business to one vendor in 2022.