More TB transmitted via bone grafting

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Jul 27, 2023 View in browser   By Daniel Payne Presented by Driving the Day The CDC reports that five TB cases in the U.S. have been traced to bone graft material manufactured by Aziyo Biologics. | David Goldman/AP Photo MORE POSITIVE TB TESTS — Contaminated bone graft materials have been linked to three more patients testing positive for tuberculosis, POLITICO’s Alice Miranda Ollstein and Lauren Gardner report. The CDC announced the new cases Wednesday, adding to two cases — of which one was fatal — previously identified by health officials. But the materials suspected to be contaminated have been used in other surgical or dental procedures for patients outside of the known five cases, with at least 36 people being treated as if they have TB. The CDC said the materials were sent to California, Michigan, New York, Oregon, Texas and Virginia. Aziyo Biologic issued a recall earlier this month of its bone matrix products — materials made from human tissue typically used in orthopedic and spinal surgeries. Two years ago, Aziyo issued a voluntary recall for a different bone-repair product contaminated with the bacteria that causes TB after it was linked to the death of eight patients. Aziyo said in a July 13 statement that samples from the donor lot in question tested negative for TB at an independent lab. The company did not respond to requests for additional comment. An FDA spokesperson said in a statement Tuesday that the agency is collaborating with the CDC “to fully understand the impact of this recall.” The FDA can take “a number of enforcement actions” when human cell and tissue products don’t comply with its requirements, the spokesperson said, though it typically focuses on voluntary compliance first. WELCOME TO THURSDAY PULSE, where we want to know which health concerns your agency is tracking. Let us know — and send other health news and tips — at dpayne@politico.com. TODAY ON OUR PULSE CHECK PODCAST, host Katherine Ellen Foley talks with Paul Demko, who explores why Mississippi’s new medical marijuana market, with more than 280 licensed businesses but fewer than 20,000 enrolled patients, is trying to balance robust competition with attracting enough patients to sustain the businesses. Listen to today’s Pulse Check podcast   A message from PhRMA: Research and development of cancer medicines after their initial FDA approval can help expand treatment populations, find new ways of treating a cancer or help patients earlier in their cancer battle. Unfortunately, provisions in the Inflation Reduction Act put this progress in jeopardy by selecting medicines for price setting before many of these critical advancements can be fully realized. Read the new report.   In Congress The Senate Finance Committee, led by Chair Ron Wyden, advanced a bill that would require pharmacy benefit managers to be more transparent. | Kevin Dietsch/Getty Images PBM BILL ADVANCES — The Senate Finance Committee approved a legislative package Wednesday that aims to require more transparency from pharmacy benefit managers, POLITICO’s David Lim reports. The bill, which advanced 26-1, would place new requirements on contracts between Medicare Part D plan sponsors and pharmacy benefit managers, the so-called pharmacy middlemen who negotiate drug prices between manufacturers, insurers and government health providers like Medicare and Medicaid. The lone holdout was Sen. Ron Johnson (R-Wis.). If passed, the new requirements would mandate that payments to PBMs must be for a “bona fide service fee” not linked to a drug list price. Rebates, discounts and price concessions that result in a lower net cost for covered Part D drugs would still be allowed. ANOTHER TRANSPARENCY PACKAGE ADVANCES — The House Ways and Means Committee approved a health care package Wednesday on a party-line vote, POLITICO’s Megan Wilson reports. The partisan vote came after talks between Republicans and Democrats broke down last week. The 150-page bill includes proposals that would promote price transparency among hospitals, health plans and PBMs; require prior authorizations from Medicare Advantage plans to be handled electronically; and usher in site-neutral payment policies that ensure patients pay the same for a service regardless of where it’s performed. But Democrats were upset at the last-minute removal of a provision that aimed to reveal private equity ownership of hospitals and nursing homes after months of talks with Republicans on the issue. SENATE TO VA: DO MORE ON PACT ACT — Nearly a year after the PACT Act massively expanded health care for veterans exposed to burn pits and other toxic chemicals, key Senators say the VA needs to go further, POLITICO’s Ben Leonard reports. At a Wednesday hearing, Senate Veterans’ Affairs Committee Chair Jon Tester (D-Mont.) raised concerns about the complexity of the VA’s website. He and ranking member Jerry Moran (R-Kan.) said they hope to expand care for veterans who have had other types of chemical exposures not covered by the legislation. Moran raised concerns about claim backlogs. As of mid-July, the agency had received nearly 745,000 PACT Act–related claims. At the hearing, the VA touted “aggressive” hiring to help process the incoming claims but said there was a backlog of 243,000 as of June 30. The agency expects the backlog to grow into fiscal 2024 and then stabilize around 100,000 or less by 2025. “It’s a constant tension … to deliver timely benefits … while delivering them in a quality and accurate manner,” said Joshua Jacobs, VA under secretary for benefits. VA officials said they’re examining whether the department can establish new conditions covered under the act.   YOUR TICKET INSIDE THE GOLDEN STATE POLITICAL ARENA: California Playbook delivers the latest intel, buzzy scoops and exclusive coverage from Sacramento and Los Angeles to Silicon Valley and across the state. Don't miss out on the daily must-read for political aficionados and professionals with an outsized interest in California politics, policy and power. Subscribe today.     At the Agencies BECERRA DEFENDS HHS ON MIGRANT CHILDREN — HHS Secretary Xavier Becerra decried migrant children being placed in dangerous jobs Wednesday while defending HHS’ vetting process for releasing them into sponsor care, Nick Niedzwiadek and your host report. He made the remarks as he testified before the House Energy and Commerce Oversight and Investigations Subcommittee. Lawmakers have repeatedly targeted the agency over reports of children under government care ultimately being exploited. The hearing comes as the Department of Labor announced child-labor violations are up 44 percent in FY23, which the department attributed to the Biden administration’s stepped-up enforcement efforts. IN THE STATES IT’S A DATE — North Carolina Gov. Roy Cooper’s administration Wednesday set a date for Medicaid expansion: Oct. 1. But POLITICO’s Megan Messerly reports that the announcement comes even as lawmakers have yet to approve the funding for the expansion. The unusual move, agreed to by the Biden administration, puts additional pressure on the state’s Republican-controlled legislature to either pass a budget or fund Medicaid expansion separately — something the Democratic governor and his health and human services secretary, Kody Kinsley, have been calling for since lawmakers failed to reach a spending deal earlier this month. The state’s plan gives lawmakers until Sept. 1 to fund the proposal. State health officials said by starting their work now, they can reduce the lead time needed to implement the program from 90 or 120 days after the legislature gives its final approval to 30 days.   A message from PhRMA:   HEALTH TECH COSTS OF CYBER ATTACKS MOUNT — The cost of data breaches in health care — which have surged — is higher than in any other sector, per a new report from IBM and the Ponemon Institute. They put that cost per breach, on average, at $10.93 million, nearly double what breaches typically cost the next-highest cost group, the financial sector, at $5.90 million. Breaches in the pharmaceutical industry ran $4.82 million, the report said. It’s the 13th year in a row that health care topped the list, according to IBM’s figures. Why it matters: Cyber threats like ransomware can disrupt patient care, putting lives at risk and hurting health care organizations financially, and they’re increasingly posing issues. So far, more than 43 million people have had their sensitive health data breached in 2023, closing in on 2022’s total of more than 52 million, according to a POLITICO analysis of HHS data.   JOIN 7/27 FOR A TALK ON WOMEN LEADERS IN THE NEW WORKPLACE: In the wake of the pandemic, U.S. lawmakers saw a unique opportunity to address the current childcare system, which has become increasingly unaffordable for millions of Americans, but the initial proposals went nowhere. With the launch of the Congressional Bipartisan Affordable Childcare Caucus in May, there may be a path to make childcare more affordable. Join Women Rule on July 27 to dive into this timely topic and more with featured speakers Rep. Nancy Mace (R-S.C.), Rep. Ro Khanna (D-Calif.) and Reshma Saujani, Founder & CEO of Moms First and Founder of Girls Who Code. REGISTER HERE.     What We're Reading The Washington Post reports on the rarity of doctors being punished over Covid misinformation. The Wall Street Journal reports that a group of hedge funds is devising a plan to cut off nearly $1 billion meant for those with opioid use disorder. STAT reports on Asian American doctors often being left out of leadership positions.   A message from PhRMA: A new report showcases the vital role of post-approval R&D in nine critical oncology treatments. This research can help expand treatment populations, find new ways of treating a cancer or help patients earlier in their cancer battle. Unfortunately, provisions in the Inflation Reduction Act put this progress in jeopardy by selecting medicines for price setting before many of these critical advancements can be fully realized. See how post-approval R&D in cancer is at risk.     Follow us on Twitter Dan Goldberg @dancgoldberg Katherine Ellen Foley @katherineefoley Lauren Gardner @Gardner_LM Kelly Hooper @kelhoops Robert King @rking_19 Ben Leonard @_BenLeonard_ David Lim @davidalim Megan Messerly @meganmesserly Alice Miranda Ollstein @aliceollstein Carmen Paun @carmenpaun Daniel Payne @_daniel_payne Ruth Reader @RuthReader Erin Schumaker @erinlschumaker Megan R. Wilson @misswilson   Follow us

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