| | | | |  | | By Chelsea Cirruzzo and Ben Leonard | | | | | 
Reactions to HHS' proposed rule to shield abortion-related data from mandatory sharing has been mixed. | Jacqueline Larma/AP | WEIGHING IN ON A PRIVACY RULE — Providers, health IT groups and reproductive health care advocates largely support a proposed HHS rule to make health data, including public health information, easier to share while protecting patient privacy. But they disagree on the specific wording needed to protect reproductive health care data. Background: The rule, proposed in July, would standardize how public health departments transmit data among each other and to the CDC via certified protocols. It also creates an exception to the agency’s rules against information blocking for reproductive health care data — meaning providers who refuse to share reproductive data due to a “good faith belief” won’t be penalized. Key context: Getting an HHS health IT certification for public health systems would be voluntary. More than 200 groups and individuals submitted comments, largely agreeing with the rule, though some, including local public health leaders, worried that costs to update IT systems might be prohibitive. Provider groups also agreed with a proposal that would let patients request that certain information be withheld from their patient portal but asked HHS to allow patients to make requests verbally, not just in writing. The idea is to help avoid patients coming across serious diagnoses before doctors can speak with them. Providers and abortion-rights activists largely approved of an exception that would allow providers to withhold reproductive health information. But some groups couldn’t agree on how to word the exception, which HHS wrote as a “good faith belief” that the information would expose the patient or provider to legal action. The American Medical Association suggested “good faith belief” be changed to “belief,” which it said would reduce confusion. Others, including the American Medical Informatics Association, Federation of American Hospitals and the American College of Obstetricians and Gynecologists, urged HHS to issue clear guidance. Some abortion-rights groups called on HHS to go further: The ACLU, for example, asked that the exception be extended to gender-affirming care, and Pregnancy Justice wants “reproductive-health” information to include pregnant people undergoing substance use treatment. WELCOME TO TUESDAY PULSE. Are there any interesting health care initiatives on the ballot in your state? Let us know at ccirruzzo@politico.com and bleonard@politico.com and follow along @ChelseaCirruzzo and @_BenLeonard_.
| | |  Vice President Kamala Harris is expected to propose a new Medicare benefit to help families care for aging adults. | Pool photo by Evelyn Hockstein | HARRIS’ HOME CARE BOOST — Vice President Kamala Harris is expected to unveil a new Medicare home care benefit proposal during her appearance on “The View” today, aiming to ease the financial burden on families caring for aging adults, POLITICO’s Megan Messerly reports. The proposal would help older Americans age at home and avoid the costly expenses of in-facility care. It would cover various home care services, including in-home health aides, according to a senior campaign official granted anonymity to share details of the proposal. Harris plans to fund the new benefit by expanding Medicare drug price negotiations, increasing discounts on certain brand-name drugs and reducing costs associated with the pharmacy benefit managers that negotiate drug prices for insurers and large employers. Why it matters: The proposal addresses a significant need, as studies show that more than 40 percent of Americans provide unpaid care. It also aims to appeal to the “sandwich generation” — those raising children while caring for aging parents — a demographic that includes many undecided voters, according to Harris campaign data, the campaign official said.
| | | HOSPITALS ASK FOR IV HELP — The American Hospital Association asked federal officials on Monday to declare a shortage of IV fluids and allow them to use certain flexibilities, such as preparing sterile solutions in their own pharmacies. The request, sent to President Joe Biden, comes as a North Carolina factory responsible for producing most of the IV solution sent to hospitals across the country remains offline due to damage from Hurricane Helene. Baxter International, which owns the factory, said Monday it resumed shipments to hospitals with limited allocations and is working with the FDA to receive a special license to bring in products from sites outside the U.S. In its letter, AHA said its members are “already reporting substantial shortages of these lifesaving and life-supporting products. Patients across America are already feeling this impact, which will only deepen in the coming days and weeks unless much more is done to alleviate the situation.” Rep. Debbie Dingell (D-Mich.) made a similar plea to HHS on Friday, asking in a letter to HHS Secretary Xavier Becerra how federal officials might prevent a national shortage of IV fluids and meet hospital demand. She also asked whether officials plan to invoke the Defense Production Act, which would compel manufacturers to prioritize IV fluid production. AHA also asked HHA to invoke the act. A senior Biden administration official told Pulse that HHS officials held a briefing Friday and are working with Baxter to confirm how much product is available. “This could include reviewing potential temporary imports or expediting reviews of the cleaned and restored manufacturing lines,” the official said. An FDA spokesperson also told Pulse the agency has not yet declared any shortages.
| | | | US TO SCREEN FOR MARBURG — Travelers arriving in the U.S. from Rwanda — which is battling an outbreak of the lethal Marburg virus — will be redirected to certain U.S. airports to be screened, POLITICO’s Carmen Paun reports. Officials haven’t specified which airports. The screenings will also include people who have been in the African country within the past 21 days, HHS said. Why it matters: The screening of travelers from Rwanda aims to reduce the risk of Marburg virus cases arriving and spreading into the U.S., HHS said. So far, no other country has confirmed Marburg cases, but the World Health Organization has assessed the risk of the virus spreading to Rwanda’s neighboring countries as high. The virus, which is similar to Ebola and has a fatality rate of up to 88 percent, has caused 12 deaths in Rwanda out of 56 confirmed cases. Eight people have recovered from it, according to the Rwandan health ministry. No drugs or vaccines have been approved for the disease, but some are in development. DOCS TO SCOTUS: CRACK DOWN ON ‘GHOST GUNS’ — Major physician groups, including the American Medical Association, filed an amicus brief to the Supreme Court on Monday, urging them to allow regulation keeping unregistered firearms away from people who have committed crimes. The brief, part of a SCOTUS case that asks the court to allow federal regulators to apply background checks and licensing laws to homemade guns, comes as more providers refer to gun violence as a public health issue — including the U.S. Surgeon General. The AMA declared gun violence a public health crisis in 2016. Homemade firearms, the brief says, “are designed to evade [federal regulation] and restore the unregulated firearms markets that preceded [regulation.]” Without regulations, the AMA warns, ghost guns could fall into the hands of criminals or children, potentially causing harm. What’s next? The case is part of SCOTUS’ October term, which began Monday.
| | KID DRUG TRIAL LAW UNDERUSED: STUDY — A 2003 law aimed to make sure clinical trials for new drugs took children into account resulted in around a third of new drugs approved from 2015 to 2021 having a pediatric trial requirement — but the law’s implementation may have been limited by an exclusion on rare diseases, according to a new research letter. The study published Monday in JAMA analyzed the impact of the Pediatric Research Equity Act, which required pediatric clinical testing for new drugs before they entered the market. The law, however, excluded drugs for rare diseases. Congress has since eliminated the exception for certain adult cancer drugs. Researchers from the University of Illinois at Chicago and Brigham and Women’s Hospital found that, of 323 new FDA-approved drugs between 2015 and 2021, 38 percent didn’t have pediatric testing due to a rare disease designation, and 22 percent had the testing waived. Thirty percent, or 97 drugs, had pediatric studies assigned for the post-approval period. More than half of the required studies are ongoing, researchers said. Why it matters: The percentage of rare disease drugs approved has grown in recent years, from 15 percent of new approvals between 1999 and 2003 to about one-half of new drugs between 2015 and 2021, according to the study. What’s next? A Senate bill introduced this year would eliminate the rare disease exemption from the law, which researchers say might increase pediatric testing requirements for new drugs, but additional reforms may be needed.
| | Courtney Laydon is now managing director of health care strategy at Rational 360. She previously was executive vice president and head of strategic communications for Edelman’s global practices and sectors team. Jason Stenta is joining Walgreens as SVP and chief commercial officer. He previously was SVP of payer sales at Optum, a UnitedHealth Group company. Dori Zweig Young has rejoined Crosscut Strategies as a strategic communications manager. She was previously director at 120/80 MKTG, a digital health agency.
| | The New York Times reports on the discoveries in microRNA, which helps determine how cells function, that led to two scientists’ Nobel Prize. The Wall Street Journal reports on the troubled background of the company taking over the bankrupt Steward hospitals. | | | | Follow us on Twitter | | | | Follow us | | | | |
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