FTC Signals Growing Appetite For Greater PBM Oversight

Axios: FTC Rescinds Policy Statements Backing PBMs
The Federal Trade Commission sent another shot across the bow of the pharmacy benefit managers on Thursday, warning the companies against relying on "outdated" agency statements and studies that opposed more regulatory oversight and transparency of PBMs. The move signals the FTC's growing interest in challenging what commissioners characterized as "competitively troubling changes in the PBM market" and its efforts to remove hurdles to state efforts to address concerns with the drug chain middlemen. (Reed, 7/21)

The New York Times: Drugmakers Throw ‘Kitchen Sink’ To Halt Medicare Price Negotiations 
The pharmaceutical industry, which suffered a stinging defeat last year when President Biden signed a law authorizing Medicare to negotiate the price of some prescription medicines, is now waging a broad-based assault on the measure — just as the negotiations are about to begin. The law, the Inflation Reduction Act, is a signature legislative achievement for Mr. Biden, who has boasted that he took on the drug industry and won. Medicare is the federal health insurance program for older and disabled people; the provisions allowing it to negotiate prices are expected to save the government an estimated $98.5 billion over a decade while lowering insurance premiums and out-of-pocket costs for many older Americans. (Gay Stolberg and Robbins, 7/23)

The Hill: Key Drug-Pricing Bill Capping Insulin Costs Faces Hurdles In Congress
Major drug-pricing legislation to cap the cost of insulin is in danger of slipping to the fall, where it risks getting lost amid fights over appropriations bills, abortion and a potential government shutdown. The legislation is a priority for Democrats, and Majority Leader Chuck Schumer (D-N.Y.) said earlier this month that he was hoping to combine the insulin bill and legislation reforming the pharmacy benefit manager (PBM) industry into a package that could get bipartisan support and a vote before the end of summer. (Weixel, 7/23)

Politico: Health Policy Wars Consume Appropriations Bills, Risking Shutdown
House Republicans’ Food and Agriculture spending bill would ban mail delivery of abortion pills and deregulate the tobacco industry. Their Foreign Operations bill would defund the World Health Organization. And multiple bills would bar access to gender-affirming care. Republicans, in coordination with outside conservative groups such as Susan B. Anthony List and the America First Policy Institute, are using must-pass appropriations bills to make their mark on a wide range of health policies, injecting culture wars into the already fraught debate over government spending and raising the chances of a government shutdown. (Miranda Ollstein, 7/23)

Stat: Companies Spend Less On Lobbying After Leaving PhRMA
The three companies that recently left PhRMA all spent less on lobbying following their departures, according to newly released federal disclosures. PhRMA, the brand-drug industry trade group, lost three members over a span of five months following the passage of Democrats’ drug pricing reform law last year. How large members navigate their exits could be instructive to other firms making decisions about their continued membership in the future. Much of PhRMA’s revenue comes from company dues, so exits hurt the group’s bottom line. (Cohrs, 7/24)

In other developments from the Biden administration —

Axios: Dems Press Biden Officials On Medicaid Disenrollments
Congressional Democrats are prodding the Biden administration to do more to prevent Medicaid coverage losses due to the end of the pandemic's continuous coverage provisions. Over 3 million people have been dropped from Medicaid rolls so far, according to KFF, and experts have been alarmed that more than half have lost coverage for "procedural" reasons — meaning a lack of proper paperwork. (Sullivan, 7/21)

Axios: New Merger Guidance Could Stretch Timing Of Health Care Deals
Newly proposed merger guidelines from the Federal Trade Commission could chill dealmaking in the health care sector, as well as increase the costs and time it takes to get transactions to close, experts say. The FTC this month withdrew two antitrust policy statements and with the Department of Justice issued updated guidance for merger reviews, committing to review deals and conduct on a case-by-case basis. (Dreher, 7/24)

ProPublica: Hospices In Four States To Receive Extra Scrutiny Over Concerns Of Fraud, Waste And Abuse
Last week, regulators rolled out enhanced oversight for new hospices in Arizona, California, Nevada and Texas. The Centers for Medicare and Medicaid Services, which pays for most of American hospice care, announced that this change was spurred by “numerous reports of hospice fraud, waste, and abuse” and “serious concerns about market oversaturation.” (Kofman, 7/21)

Stat: NIH’s Translational Research Arm Gets A New Lobbyist
Christopher Austin was the first director of a then-tiny National Institutes of Health department with an opaque name, the National Center for Advancing Translational Sciences. Now, a few years out of the job, he’s got a new task: Make sure Congress doesn’t forget about it. (Owermohle, 7/24)

Politico: The VA’s New Medical Records System Has Gone Haywire. Congress Is Alarmed
The Veterans Affairs Department’s fumbling effort to replace its decadesold electronic health records system has strained its relationship with Congress to the breaking point. Anger about the project — billions over budget, tied to at least four veterans’ deaths, and now, on pause — is responsible for a spate of bill introductions, some aiming to shut the project down, others to boost oversight and accountability. The problems also led Iowa GOP Sen. Chuck Grassley to hold up a confirmation vote on President Joe Biden's nominee for one of the VA's top posts. (Leonard, 7/21)

In news on the FDA —

KFF Health News: FDA Head Robert Califf Battles Misinformation — Sometimes With Fuzzy Facts
Robert Califf, the head of the Food and Drug Administration, doesn’t seem to be having fun on the job. “I would describe this year as hand-to-hand combat. Really, every day,” he said at an academic conference at Stanford in April. It’s a sentiment the FDA commissioner has expressed often. (Tahir, 7/24)

Reuters: U.S. FDA Denies Petition On Chemicals Used In Food Packaging
The U.S. health regulator on Friday denied a petition urging the agency to reconsider its initial denial on a petition seeking a ban of some chemicals used in plastic for food packaging in May last year. The citizen petition to the Food and Drug Administration (FDA) sought a ban on the use of eight ortho-phthalates and revocation of the prior sanctioned uses for five ortho-phthalates in food based on alleged safety concerns. (7/21)

Also —

KFF Health News: Everything Old Is New Again? The Latest Round Of Health Policy Proposals Reprises Existing Ideas
Forget “repeal and replace,” an oft-repeated Republican rallying cry against the Affordable Care Act. House Republicans have advanced a package of bills that could reduce health insurance costs for certain businesses and consumers, partly by rolling back some consumer protections. Rather than outright repeal, however, the subtler effort could allow more employers to bypass the landmark health insurance overhaul’s basic benefits requirements and most state standards. (Appleby, 7/24)