Free subscription to the Capitol Journal keeps you current on legislative and regulatory news.
Flurry of Bills Targeting Vaccine Makers and Mandates:
Already this year lawmakers in 18 states have introduced over 80 measures dealing with vaccine policy, according to Dorit Reiss, a professor at...
With so much of our world online, data privacy has become a major concern for American policymakers. But in the absence of comprehensive federal legislation addressing data privacy, states are leading...
U.S. Rep Introduces Unique Measure Calling for Regulation of AI
U.S. Rep. Ted Lieu (D-CA) introduced a resolution last week calling on Congress to establish a nonpartisan commission to make recommendations...
CA’s New Fast-Food Industry Law on Hold
Implementation of a landmark law passed last year in California ( AB 257 ) aimed at improving working conditions for fast-food employees and potentially...
U.S. Hospital Use of Volunteers May Violate Federal Rules:
Volunteer workers have become an integral part of the labor force at hospitals across the country. According to analysis of federal and other...
The U.S. Food and Drug Administration’s decision last June to grant accelerated approval for Aduhelm, Biogen’s new treatment for Alzheimer’s disease, sparked considerable controversy. Many -- including the FDA’s own advisory panel, which recommended against approval nearly unanimously - contended there was little evidence the drug, which targets the amyloid plaques that accumulate in the brains of Alzheimer’s sufferers, actually slows the progression of the disease.
The controversy only deepened in January when the Center for Medicare and Medicaid Services announced that Medicare would only cover the drug’s $28,200 per year cost if it was being used in a clinical trial to assess its benefit.
Critics of Big Pharma praised the decision.
“If the FDA were doing its job, CMS wouldn’t have had to step in. But good for the CMS, they are helping to protect the public from drugs whose harms outweigh benefits,” said Dr. Adriane Fugh-Berman, a professor of pharmacology at Georgetown University and director of PharmedOut, an organization that draws public attention to what it considers poor industry practices.
But the decision also put the pharmaceutical industry on high alert. It has spent decades cultivating its relationship with the FDA and fears CMS now using its power to effectively keep drugs that receive FDA approval off the market.
Aduhelm may seem unworthy of a fight. Concerns about the drug’s cost, effectiveness and safety have depressed sales so much that Biogen cut its initial $56,000 a year price in half.
But Fugh-Berman said the industry was right to be nervous about the CMS decision.
“The drug companies are worried that this could be a precedent for other drugs. And it should be,” she said. “This isn’t just about money; it’s about protecting the public.” (KAISER HEALTH NEWS, FOOD AND DRUG ADMINISTRATION)
Nonprofit and for-profit hospitals had similar unreimbursed Medicaid costs as a share of expenses, at 2.51 percent and 2.53 percent, respectively, according to a study published in JAMA Open Network. But unreimbursed Medicaid costs should be higher for nonprofit hospitals, given the community benefits they must provide - including unreimbursed care for Medicaid recipients - in return for the various tax exemptions they receive. (STAT)
Minnesota EMS workers and the state’s Emergency Medical Services Regulatory Board are asking state lawmakers to temporarily waive some regulations that apply to them in order to free up staff time. Nearly 60 percent of the state's 10,465 certified EMTs provided no patient care last year, indicating they may have left the workforce. (MINNEAPOLIS STAR TRIBUNE)
The Department of Health and Human Services awarded 29 community health centers roughly $55 million to provide telehealth, remote patient monitoring and other virtual care services to their underserved populations. The awards are the latest of the more than $7.3 billion in COVID-19-related funding community health centers have received under the American Rescue Plan Act over the past year. (FIERCE HEALTHCARE)
For almost a decade, the Centers for Medicare and Medicaid Services has overpaid hospitals that run nursing schools, amounting to an estimated $310 million. Many of those hospitals will have to pay back the Medicare overpayments this summer, barring a successful effort in Congress to forgive the debts. (MODERN HEALTHCARE)
The Biden administration has told key members of Congress it will probably need an additional $30 billion in COVID-19 funding. That sum would include $17.9 billion for vaccines and treatments, $4.9 billion for testing, $3 billion for coronavirus-related health care costs for the uninsured, and $3.7 billion for future variant preparation. (CNN POLITICS)
A resolution (SR 48) in the New Jersey Senate cosponsored by Sen. Nia Gill, a Democrat, and Joseph Pennachio, a Republican, would establish a special legislative committee with subpoena power to investigate the thousands of COVID-19 deaths at the state’s nursing homes. But with longstanding accusations from Republicans that the administration of Gov. Phil Murphy (D) mismanaged the pandemic response at long-term care facilities, the measure seems unlikely to advance in the Democrat-controlled chamber. (NJ.COM, STATE NET)
LTL Management, a subsidiary of Johnson & Johnson came under fire in bankruptcy court last week for seeking to use the bankruptcy process to resolve thousands of claims that J&J baby powder and other talc products caused cancer. The company employed a legal move called the “Texas two-step,” allowing companies to split valuable assets from liabilities through a divisive merger. Lawyers for the plaintiffs argue that letting the LTL bankruptcy go forward would unjustly limit J&J’s potential payout to $2 billion. Democrats in the U.S. House proposed a bill last July that would block the two-step maneuver. (INSURANCE JOURNAL)
In a 50-46 largely party-line vote, the U.S. Senate confirmed Duke University cardiologist Dr. Robert Califf as head of the Food and Drug Administration. It will be Califf’s second stint as commissioner, having briefly led the agency in 2016. (NATIONAL PUBLIC RADIO, WASHINGTON POST)
-- Compiled by KOREY CLARK