legislation & regulation

News Briefs: FTC Ratchets Up Regulatory Pressure on PBMs, Targeting Rebate Practices and Insulin

The Federal Trade Commission (FTC) ratcheted up regulatory pressure on PBMs once again, announcing that it will apply more scrutiny to PBMs' rebating practices, particularly regarding insulin. The move follows the agency's announcement earlier this month that it would investigate PBM business practices and consolidation. In an official policy statement, the agency wrote that “some have suggested that high rebates and fees to PBMs and other intermediaries may incentivize higher list prices for insulin” and that “rebate and fee agreements may incentivize PBMs and other intermediaries to steer patients to higher-cost drugs over less expensive alternatives.” Actions the agency said it would pursue include cracking down on exclusionary rebates and intensifying scrutiny of formulary design.

Researchers Find Overspending in Generic Drug Market, Advocate for More Transparency

Researchers from the USC Leonard D. Schaeffer Center for Health Policy & Economics are pushing for more transparency in the pharmaceutical supply chain and policy changes in the generic drug sector. Their recommendations, published in a white paper on May 31, were based on their findings that PBMs and health insurers cost patients, employers and the federal government billions of dollars per year in the generic drug market.

Karen Van Nuys, Ph.D., one of the paper’s authors and executive director of the Center’s Value of Life Sciences Innovation Project, tells AIS Health, a division of MMIT, that she recommends changes in the way pharmacies set their cash prices as well as in some formularies that favor branded drugs over generics and so-called spread pricing, where PBMs reimburse pharmacies one price, charge health plans a higher price and pocket the difference.

Plans Are Likely to Treat Paxlovid Like Other Drugs if U.S. Isn’t Paying

With COVID-19 infections surging once again, the Biden administration has stepped up efforts to increase the supply of Paxlovid, the Pfizer Inc. antiviral that garnered emergency use authorization as a therapeutic treatment for the coronavirus. However, increased availability for Paxlovid might end in coming months — Congress has stalled on providing the increased COVID-19 response funding that the administration requested, and experts say health plans are likely to treat the drug like any other if the federal government isn’t picking up the tab for treatments.

The Biden administration has pushed in recent weeks to increase the availability of Paxlovid, free of charge, to COVID-19 patients. On May 26, the White House released a statement touting the rollout of more than 2,500 “test-to-treat” sites where free testing and Paxlovid courses are available, along with 40,000 locations where antivirals are available for patients. The administration also noted that it had “increased the number of people benefiting from oral antivirals in the last seven weeks, from about 27,000 prescriptions filled each week to more than 182,000 last week.”

News Briefs: California fines Anthem

The Supreme Court ruled that HHS incorrectly altered the 340B drug program, with Justice Brett Kavanaugh finding that “absent a survey of hospitals’ acquisition costs, HHS may not vary the reimbursement rates only for 340B hospitals; HHS’ 2018 and 2019 reimbursement rates for 340B hospitals were therefore unlawful.” Kavanaugh’s opinion found in favor of the American Hospital Association, which brought a suit against HHS over the changes. “When the original [changes] went into effect in 2018, CMS cut Medicare 340B reimbursements by ~30% for most outpatient drugs, leading to ~$1.6B in savings for the first year,” wrote Citi analyst Jason Cassorla in a note to investors. HHS may have to make retroactive payments to hospitals to make up for the savings, Cassorla noted.


New State Regs, Lawsuit Increase Heat on Health Care Sharing Ministries

Scrutiny of health care sharing ministries (HCSMs) is growing, with Colorado becoming the second state to require the entities to submit health care financial data to insurance departments amid stepped-up scrutiny from regulators nationwide. Meanwhile, a Florida health system filed a lawsuit challenging the common practice among HCSMs of pushing members to conceal their sharing ministry enrollment when dealing with providers’ billing departments, which Orlando Health contends is an effort to “illegitimately secure the reduced ‘charity rate.’”

HCSM supporters contend that the religious organization-affiliated ministries provide a less expensive alternative to health insurance for members who agree to comply with faith-based lifestyle restrictions and pledge to “share” medical costs among members. But critics say the programs provide no guarantees of coverage and are exempt from much insurance oversight, while still being marketed in many cases by brokers with terminology such as provider networks and benefit design names that mimic traditional insurance.


South Dakota Seems Poised to Expand Medicaid

South Dakota voters just moved their state one step closer to expanding Medicaid through a ballot initiative, with over 67% of voters rejecting a proposed amendment to the state constitution that would have made Medicaid expansion prohibitively difficult to pass. The founder of a pro-expansion ballot initiative campaign tells AIS Health, a division of MMIT, that he’s optimistic about Medicaid expansion’s chances when it finally comes to a definitive vote in November.

If South Dakota does vote to expand Medicaid in the fall, more than 27,000 people could gain eligibility for the safety-net health insurance program, according to estimates from the Kaiser Family Foundation.


CMS Fines 2 Georgia Hospitals for Non-Compliance with Price Transparency Rule

In the first enforcement action since CMS’s Hospital Price Transparency rule went into effect at the start of last year, the agency on June 7 fined two hospitals in Georgia a total of more than $1 million for non-compliance with price transparency requirements. Health policy experts tell AIS Health, a division of MMIT, that they hope CMS ramps up its enforcement efforts, which could help payers, patients, employers and other stakeholders benefit from price comparison and greater competition.

CMS levied an $883,180 penalty against Northside Hospital in Atlanta and a $214,320 fine against Northside Hospital in the Atlanta suburb of Canton, Ga. The penalties were announced the same week that a research letter published in JAMA revealed that only 5.7% of hospitals had complied with the federal transparency rule between six and nine months after the legislation was enacted on Jan. 1, 2021 — the latest in a series of studies drawing similar conclusions.


Judge Strikes Down ‘Accumulator Rule,’ Ending Potential Threat to Patient Assistance

A U.S. district court judge has struck down a CMS rule that would have narrowed the exclusions from Medicaid best price for manufacturer-provided patient-assistance programs. The rule, which was set to go into effect on Jan. 1, would have required drugmakers to determine exactly where their patient assistance is going. If 100% of it was not reaching the patient — particularly via copayment accumulators and maximizers when payers are taking this assistance rather than allowing it to count toward patients’ deductibles and out-of-pocket maximums — that assistance would need to have been included in Medicaid best price and average manufacturer price (AMP) calculations for prescription drugs. This decision, as well as a recent pharma lawsuit against a maximizer company, may spur more pushback against these copay programs, one industry expert tells AIS Health, a division of MMIT.

The Medicaid rebate rule allows state Medicaid programs to get the same discounts on drug prices that manufacturers offer commercial plans purchasing prescription drugs. Manufacturers pay rebates to Medicaid programs that are calculated based on drugmakers’ best price, which is the lowest price the manufacturer gives to most providers of health care services or items, including hospitals, HMOs and MCOs — but not patients. It includes any price adjustments, such as discounts and rebates, but not manufacturer-provided assistance to patients.

FTC to Investigate PBM Business Practices, Consolidation

The Federal Trade Commission (FTC) said on June 7 that it will investigate the business practices and consolidation of PBMs, following months of pressure from health care stakeholders.

The FTC’s investigation, which is just the latest escalation in a nationwide regulatory push to clamp down on PBMs’ most controversial methods, was praised by plan sponsors and pharmaceutical groups.

The FTC’s leadership, a panel of five commissioners, voted unanimously to launch the investigation under section 6(b) of the Federal Trade Commission Act of 1914. The commissioners are a mix of two Democrats and two Republicans, with the fifth seat filled by the party that holds the White House.

FTC Files Lawsuits to Block Hospital Deals in N.J. and Utah

The Federal Trade Commission (FTC) on June 2 said it had filed lawsuits to block hospital mergers in New Jersey and Utah. Health policy experts tell AIS Health that health insurers and other payers likely will welcome the FTC’s actions as mergers limit competition and lead to higher prices.

The FTC is looking to block HCA Healthcare, Inc.’s acquisition of five hospitals that Steward Health Care owns in Utah. The agency is also aiming to deny RWJBarnabas Health’s purchase of Saint Peter’s Healthcare System, a non-profit that operates a hospital in New Brunswick, N.J. The Utah trial is scheduled to begin on Dec. 13 and the New Jersey trial is scheduled to start on Nov. 29.