Sneaky Medicare Price Hike; Docs Forced to Work Sick; Fewer FDA Ad Comms

Welcome to the latest edition of Investigative Roundup, highlighting some of the best investigative reporting on healthcare each week.

Sneaky Medicare Price Hike

Linda Griffith, a retired construction company accountant from California, witnessed something strange happen between the time she signed up for a new Medicare prescription drug plan during last fall’s enrollment period and when she tried to fill her first prescription at the beginning of the year, Kaiser Health News reported.

Griffith, who had selected a Humana drug plan for its low prices, was expecting to pay $70.09 for dextroamphetamine, a medication used to treat attention-deficit/hyperactivity disorder, KHN reported. However, the 73-year-old’s pharmacist told her she in fact owed $275.90.

“To me, when you purchase a plan, you have an implied contract,” Griffith told KHN. “I say I will pay the premium on time for this plan. And they’re going to make sure I get the drug for a certain amount.”

But it didn’t work that way for Griffith, and she’s hardly alone, KHN reported.

As soon as 3 weeks after Medicare’s drug plan enrollment period ends on Dec. 7, insurance plans can change what they charge members, KHN reported. For Griffith, her prescription out-of-pocket cost has varied each month. And through March, she paid $433 more than she expected to.

“Medicare’s prescription drug benefit, which began in 2006, was supposed to take the surprise out of filling a prescription,” KHN wrote. “But even when seniors have insurance coverage for drugs, advocates said, many still can’t afford them.”

Now, surprises could increasingly happen, with more insurers eliminating copayments and instead charging members a percentage of the drug price, or coinsurance, KHN reported, citing Chiquita Brooks-LaSure, the top official at CMS. “And that is one of the reasons why we’re asking Congress to give us authority to negotiate drug prices,” Brooks-LaSure told KHN.

CMS also is looking at other ways to make drugs more affordable, KHN reported. In the meantime, Griffith gave in and paid the unexpectedly hefty cost for her medication that she told KHN she couldn’t function without. Her plan denied a number of requests for a price reduction — despite help from a program manager for a number of California counties served by the Health Insurance Counseling and Advocacy Program — and they are now appealing directly to CMS.

Physicians with COVID-19 Urged to Work While Sick, Lawsuit Says

A number of emergency room physicians in Texas have filed a lawsuit, alleging that representatives for their employer, American Physician Partners (APP), urged against testing for COVID-19 and pressured them to work while sick, Becker’s reported. The Houston Chronicle first reported the news.

The physicians claim that Brentwood, Tennessee-based APP has been underpaying them and engaging in “unethical practices,” such as urging doctors with COVID to work in order to boost revenues, Becker’s reported. Their lawsuit further states that APP is placing “profit over patients,” and that its protocol “discourages testing and disregards physician, staff, and patient safety when a doctor does test positive for COVID-19.”

APP, however, told the Chronicle that it has been in discussions with the physicians since they first raised their concerns 4 months ago, Becker’s reported. The company added the following in a statement provided to the Chronicle: “We advised [the physicians] at that time that their concerns do not reflect the facts known to APP and otherwise appear to be based on misinformation. Thus we are disappointed these physicians — who represent a very small minority of the physicians APP partners within the Houston area — have decided to move forward with this litigation. We remain open to continuing our dialogue with these physicians outside of the litigation, which, again, APP believes is without merit.”

A spokesperson for Houston Methodist, which is not involved in or named in the lawsuit, told Becker’s that, “We are unaware of any ER doctor who came to work after testing positive for COVID-19.”

Fewer FDA Advisory Committee Meetings

About 10 years ago, half of newly approved drugs were brought before an FDA advisory committee, Endpoints News reported. However, by 2021, that figure had dropped to just 6%.

“It’s hard to say why fewer new drugs are seeing advisory committee review before approval, because FDA doesn’t have to explain that decision,” Harvard’s Joseph Daval, first author of a new paper published in Health Affairs, told Endpoints News. “One concern is that FDA might be trying to avoid the risk of a negative vote, if it’s shepherding a drug to approval.”

FDA advisory committees consist of a group of outside experts who review data presented by both the drugmaker and the agency, Endpoints News noted. Robert Califf, MD, FDA Commissioner, has recently announced plans to amend the advisory committee process, the outlet reported.

The authors of the new paper in Health Affairs suggested the FDA provide a formal statement when it makes a decision in contrast to an advisory committee’s recommendation, Endpoints News reported. The authors noted the one exception they found in which the agency explained itself was following the accelerated approval of Biogen’s controversial Alzheimer’s drug. (One of the authors of the paper, Harvard’s Aaron Kesselheim, MD, JD, MPH, resigned from the advisory committee that voted against Aduhelm following the FDA’s approval of the drug.)

“Inconsistency in the sometimes leading questions posed to the committee and the FDA’s response to a negative vote… invites scrutiny into the role of advisory committees in the FDA’s decision-making process,” Endpoints News wrote.