(1/27/2023): WARREN CALLS FOR FTC SCRUTINY OF PHARMA MERGERS
— Sen. Elizabeth Warren wants the Federal Trade Commission to more closely scrutinize major pharmaceutical mergers — especially the pending deals between Amgen and Horizon Therapeutics, and Indivior and Opiant. The Massachusetts Democrat urged the antitrust agency to use Section 7 of the Clayton Act more rigorously to “remedy the FTC’s historically lax approach” to pharmaceutical deals.
(1/27/2023): WYDEN: REINING IN PBMS ‘HUGELY IMPORTANT’
— Senate Finance Committee Chair Ron Wyden (D-Ore.) told reporters Thursday he has talked with several lawmakers on both sides of the aisle about moving forward legislation to target pharmacy benefit managers this Congress, POLITICO’s Megan R. Wilson and Ben Leonard report.
(1/27/2023): BUCHANAN TO CHAIR W&M HEALTH SUBCOMMITTEE
— Rep. Vern Buchanan (R-Fla.) will serve as chair of the Ways and Means Health Subcommittee, as well as vice chair of the full panel, Ben also reports.
(1/27/2023): NIH LAUNCHES NEW RESEARCH CENTER
— The NIH’s National Institute of Biomedical Imaging and Bioengineering announced Wednesday it is establishing the Center for Biomedical Engineering Technology Acceleration to speed development and distribution of new biotechnologies. Manu Platt — who previously worked at the Georgia Institute of Technology and Emory University — will be the center’s first director.
(1/26/2023): GUTHRIE TO FOCUS ON PRICE TRANSPARENCY, FENTANYL CRISIS, TELEHEALTH
— Rep. Brett Guthrie (R-Ky.) will chair the Energy and Commerce Health Subcommittee, the full panel's chair, Cathy McMorris Rodgers (R-Wash.), announced Wednesday.
(1/26/2023): Government Input Sought in Oklahoma Pharmacy Benefit Law Appeal
- An appeals court tasked with deciding whether Oklahoma’s law regulating pharmacy benefit managers interferes with federal statutes asked the federal government to give its views on the topic.
(1/26/2023): Drug company middlemen likely to be a focus in 118th Congress
- Factions of the health care system and members of Congress are turning their fire on an oft-maligned part of the drug pricing system — the middlemen who negotiate discounts with drug companies on behalf of health plans.
(1/26/2023): FROM CONGRESS TO CHILDREN’S HOSPITAL ASSOCIATION
— Former Rep. Jaime Herrera Beutler (R-Wash.), fresh out of Congress, has joined the Children’s Hospital Association as a strategic adviser, POLITICO’s Megan R. Wilson and Caitlin Oprysko report.
(1/25/2023): TELEHEALTH: MAYBE NOT A MIRACLE CURE
— Despite widespread belief that telehealth would make it easier for people to access treatment for opioid use disorder, a new study has found no evidence to back up that view, Ben writes.
(1/25/2023): Hospital price transparency: fines or full compliance?
- As of September, 65% of hospitals had posted their negotiated rates with commercial insurers, but some claim full compliance with CMS isn’t worth it.
(1/24/2023): FDA: ORPHAN DRUG APPROACH STAYING THE SAME
— The FDA announced Monday it intends to continue to tie orphan-drug exclusivity to indications approved by the agency instead of an entire disease area.
(1/24/2023): Drugmakers Spent Record Highs to Block Drug Bill
: Drugmakers spent record amounts on lobbying in 2022 in an unsuccessful bid to block Democrats’ sweeping drug pricing legislation. Pfizer, Merck, and AbbVie all spent more on lobbying in 2022 than in any previous year with data available, according to federal lobbying data posted this week, Alex Ruoff reports.
(1/24/2023): Pharma CEOs Among Likely Targets of Democrats’ Subpoenas
: Senate Democrats plan their own political counter-programming to House Republicans’ threats of wide-ranging probes into the Biden administration. With an expanded majority, they now have the threat of subpoenas to haul corporate executives before their committees—and the drug industry is among the anticipated early targets. Read more from Laura Litvan.
(1/24/2023): Amazon rolls out generic drug subscription service
- At $5 a month to Amazon Prime members, the generic drug subscription service is aimed at treating patients with multiple chronic conditions.
(1/23/2023): HAIL TO THE NEW CHIEF
— Jeff Zients is on his way back to the White House as President Joe Biden’s new chief of staff, where the managerial prowess he showed as Covid czar will be put to the test, POLITICO’s Adam Cancryn reports.
(1/23/2023): Biden Set to Name Jeff Zients as White House Chief of Staff
: Biden is set to name Jeff Zients as his next White House chief of staff Monday, according to people familiar with the matter, elevating the administration’s former Covid-19 czar to one of the highest-profile roles in Washington. Jennifer Jacobs, Jenny Leonard and Josh Wingrove have more.
(1/23/2023): Zoom in on the omnibus "health" law
- The year-end spending package Congress cleared in December could also be thought of as an omnibus health bill for all the changes it's setting off through the medical system, argues the New York Times' Margot Sanger-Katz.
(1/20/2023): PALLONE: AGENCIES MUST ENFORCE TRIAL REPORTING REQUIREMENTS
— The FDA and NIH must do a better job policing companies that do not comply with requirements to report clinical trial information to ClinicalTrials.gov, said Rep. Frank Pallone (D-N.J.), the top Democrat on the House Energy and Commerce Committee.
(1/20/2023): Omnibus Law Sparks State Medicaid Scramble
- State Medicaid programs are racing to make sure they’re prepared to help as many people as possible keep health coverage once income eligibility checks resume in the coming months.
(1/20/2023): SANDERS BRINGS HELP ONTO HELP
— Incoming Senate HELP Committee Chair Bernie Sanders (I-Vt.) is building up his health policy staff with several longtime aides and alums, POLITICO’s Megan R. Wilson scoops.
(1/20/2023): JANUARY DRUG PRICE HIKES DRAW CSRxP IRE
— A basket of 587 brand-name drugs saw an average price increase of 5.5 percent for 2023, according to data from AnalySource. The data drew fresh calls from the Campaign for Sustainable Rx Pricing — whose members include hospitals, insurers and pharmacy benefit managers — for policymakers to take further action to curb the cost of prescription drugs.
(1/20/2023): FEMALE CANCER SURVIVORS FACE FASTER AGING
— Women who survive cancer experience key aging factors faster, according to a new Kaiser Permanente study published in JAMA Oncology.
(1/19/2023): Doctors in Congress Hunt Medicare Pay Fix
- The doctors in the House want to revamp how Medicare pays physicians, potentially giving health-care providers a boost in pay in coming years.
(1/19/2023): Hospitals still not posting prices
- Only 19% of hospitals fully comply with the Centers for Medicare and Medicaid Services rule that requires facilities to post estimated costs for items and services, an analysis published in the Journal of General Internal Medicine has found, Axios' Arielle Dreher writes.
(1/19/2023): Clinical Trial Diversity at FDA Gets a Boost From New Law
: Drug and device companies should prepare now for new legal requirements aimed at improving clinical trial diversity—even as they wait for more action from the FDA. The 2023 omnibus spending bill (Public Law 117-328) enacted last month requires diversity action plans for the clinical trials used by the FDA to decide whether drugs are safe and effective. Read more from Jeannie Baumann.
(1/18/2023): PUSH ON TELEHEALTH CODING
— Lobbying group the Alliance for Connected Care wrote to the Centers for Medicare and Medicaid Services calling on the agency to roll out an interim final rule to preserve telehealth access, Ben reports.
(1/18/2023): HARRIS TO LEAD HOUSE FDA SPENDING PANEL
— Conservative Rep. Andy Harris (R-Md.) will take the gavel of the House Appropriations Committee’s panel governing Agriculture Department and FDA spending, he said in a statement.
(1/18/2023): Senate Spending Lineups in Flux
- Change is coming to the Senate Appropriations Committee as a new chair and ranking member at the top could translate into revamped subcommittee leaders on both sides of the aisle.
(1/18/2023): Patients delaying care over cost reached all-time high in 2022: survey
- Nearly 40% of respondents said they or a family member delayed medical care because of cost last year, the highest share Gallup has ever recorded.
(1/17/2023): Granger Announces Appropriations Chairs
: House Appropriations Chair Kay Granger (R-Texas) Monday announced the House Republican Steering Committee had approved her slate of subcommittee chairs for the panel, including Reps. Robert Aderholt (R-Ala.) for Labor-HHS-Education and Andy Harris (R-Md.) for Agriculture-FDA, according to a press release.
(1/13/2023): CMS RELEASES KEY DATES FOR MEDICARE NEGOTIATION
— CMS Administrator Chiquita Brooks-LaSure announced Wednesday that the first 10 Medicare Part D drugs selected for price negotiations will be made public by Sept. 1 — a key step toward implementation of the Inflation Reduction Act.
(1/13/2023): Debt ceiling fight looms over Medicare, Medicaid
- House Republicans don't have much of a path to get major health care changes passed with a Democratic Senate and president, with one possible exception: the debt ceiling fight, Axios' Peter Sullivan writes.
(1/13/2023): Data du jour: Cancer deaths fall
- U.S. cancer death rates have fallen by a third since 1991, with about 3.8 million deaths averted in that time, according to study published Thursday in CA: A Cancer Journal for Clinicians.
(1/13/2023): Drugmakers Say New Law Puts Them in Limbo
- Drugmakers say a new US law aimed at cutting prices on top-selling medicines after they have been on the market for several years has them stuck in limbo.
(1/13/2023): House GOP Plans New Slate of Appropriations Leaders
: House Republicans are weighing changes to the leadership of most Appropriations subcommittees, as term-limited “cardinals” plan to take new roles on the influential panel. The top Republicans on some of the biggest spending panels will swap positions, members said. Those changes are up to Appropriations Chair Kay Granger (R-Texas), who would then need approval through a House Republican Steering Committee vote.
(1/13/2023): CALIFF: CAN’T HAVE SEPARATE CLINICAL TRIAL RESPONSE FOR EMERGENCIES
— FDA Commissioner Robert Califf on Thursday called for the U.S. to consider setting up a governance structure for clinical trials — which does not yet exist — that can help identify the “most important questions for public health and make sure that those questions get answered.”
(1/13/2023): NEW GOP E&C MEMBERS
— The House Republican Steering Committee selected nine new members to serve on the House Energy and Commerce Committee: Reps. Randy Weber (Texas), Rick Allen (Ga.), Troy Balderson (Ohio), Russ Fulcher (Idaho), August Pfluger (Texas), Diana Harshbarger (Tenn.), Mariannette Miller-Meeks (Iowa), Kat Cammack (Fla.) and Jay Obernolte (R-Calif.).
(1/13/2023): HHS EXTENDS COVID PUBLIC HEALTH EMERGENCY
— On Wednesday, HHS Secretary Xavier Becerra extended the Covid-19 public health emergency for the 11th time since it was first declared in January 2020. It could be the last time the administration extends the emergency, as federal health officials eye a potential spring end date, POLITICO’s Adam Cancryn writes.
(1/12/2023): HOUSE GOP CIRCULATES ‘CARDINALS’ LIST
— Newly installed House Appropriations Chair Kay Granger (R-Texas) has selected her dozen subcommittee chiefs, known colloquially as “cardinals,” for the next two years, POLITICO’s Olivia Beavers and Sarah Ferris report.
(1/12/2023): Dems increase pressure on march-in rights
- Lawmakers led by Sens. Elizabeth Warren and Angus King and Rep. Lloyd Doggett are pressing the Biden administration on taking control of patents of drugs developed with the government's backing, in order to lower prices, Axios' Caitlin Owens writes.
(1/12/2023): A TIMELINE FOR DRUG PRICE NEGOTIATIONS
— The first 10 Medicare Part D drugs selected for price negotiations will be made public by Sept. 1, POLITICO’s David Lim reports.
(1/12/2023): McMorris Rodgers Announces Nine New GOP E&C Panel Members
: House Energy and Commerce Chair Cathy McMorris Rodgers (R-Wash.) announced nine new Republican members to serve on the panel, pending approval by the House Republican Conference.
(1/12/2023): Drugmakers to Get Spring Medicare Guidance on Price Negotiations
: The Medicare agency plans to issue guidance in the coming months on how it will work with manufacturers of the first 10 high-spending prescription drugs subject to government price negotiations.
(1/11/2023): Medical Research Girds for GOP Funds Cut
- Health research funding will face some of the steepest cuts in a decade if Congress sticks with House Republicans’ agreement to cap sets next year’s spending at 2022 levels, potentially slashing billions of dollars in medical research.
(1/11/2023): Judges Hands Decisions On Disputed 340B Payments To HHS
- A federal judge ruled that the Department of Health and Humans Services will put a plan in place to address more than $1 billion in underpayments to hospitals under the federal drug discount program.
(1/11/2023): Judge orders HHS to resolve 340B underpayments
- A federal court ordered the Health and Human Services Department to devise a plan to implement the 2022 Supreme Court ruling invalidating modifications to the 340B drug discount program that cost hospitals billions of dollars.
(1/6/2023): FDA EXPECTED TO PUBLISH 38 RULES IN 2023
— This week, the Office of Information and Regulatory Affairs released the Fall 2022 Unified Agenda containing rules that agencies government-wide hope to finalize this spring.
(1/6/2023): A banner year for drugs brings cost concerns
- A series of pricey breakthrough prescription drugs are poised to shake up the market this year — including an Alzheimer's treatment that could be approved today by the FDA, Axios' Caitlin Owens writes.
(1/6/2023): Top lawmakers to watch on health care this Congress
- The House Cathy McMorris Rodgers (R-Wash.): In 2021, McMorris Rodgers stepped into the top GOP slot on the Energy and Commerce Committee. She’s now poised to lead the panel for the first time and has laid out an agenda that includes probing the Biden administration’s covid policies and the high rate of deaths from fentanyl. She’s also planning oversight into how the federal health department decides to implement Democrats’ new drug-pricing policies and transparency into how much hospitals charge, the latter of which has been bipartisan.
(1/6/2023): FDA Readies Action on Clinical Diagnostics
- The FDA will likely rekindle its efforts to oversee laboratories’ diagnostic tests after lawmakers failed to act on legislation requiring the agency to regulate them, former Food and Drug Administration officials and policy analysts say.
(1/6/2023): PATIENT PORTAL DISPARITY
— White patients are more likely to know about and use online patient portals than are Black and Hispanic patients, POLITICO’s Ben Leonard reports.
(1/5/2023): New Biden Rules Agenda Released With Health Measures
: The Biden administration released its next regulatory to-do list on Wednesday, with several health-related highlights. HHS is ramping up efforts to stop discrimination against disabled people by way of a proposed rule scheduled to drop in March. Also on deck is a proposed HHS rule that would craft disincentives aimed at health-care providers who interfere with the exchange or sharing of electronic health records.
(1/5/2023): Hardliners Angle for Plum Posts as Price of McCarthy Support
: The demands from House Republicans who back someone other than Kevin McCarthy (Calif.) to be speaker continue to grow. Rep. Matt Gaetz (Fla.), who questions if Covid-19 originated from a Chinese lab, wants to lead a House Armed Services subcommittee, and Rep. Andy Harris (Md.), an ardent opponent of abortion, wants to lead the Appropriations HHS panel. Billy House has more.
(1/4/2023): Drugmaker Pricing Data Lacks Medicare Scrutiny, Watchdog Says
: Gaps in Medicare oversight on the average sale price of certain cancer drugs and others administered in outpatient settings has led to millions in lost savings to beneficiaries, the HHS Inspector General’s office said. Two reports released Tuesday identified issues at the Centers for Medicare & Medicaid Services that the watchdog office said helped allow inaccurate data to impact Medicare Part B payments.
(1/4/2023): Medicare Part B oversight gaps costs millions
- Medicare and its enrollees were unable to realize millions in savings because of gaps in CMS' oversight of the Part B program, according to a federal watchdog report released Tuesday.
(1/3/2023): THE BERNIE EFFECT
— Lobbyists across the health care sector are steeling themselves for when Sen. Bernie Sanders becomes chair of the Senate’s Health, Education, Labor and Pensions Committee, POLITICO’s Megan R. Wilson reports.
(1/3/2023): DEMS BANK ON DRUG PRICING LAW
— Democrats are hoping last year’s passage of the Inflation Reduction Act will pave the way for more government action in the coming years, writes POLITICO’s Alice Miranda Ollstein.
(1/3/2023): What’s ahead for healthcare in 2023?
- Modern Healthcare spoke with industry stakeholders about their 2023 forecasts, and how leaders can best prepare for the next 12 months.
(1/3/2023): Drug Prices in Crosshairs for New Congress
- Overseeing Medicare’s new authority to negotiate prices of the country’s highest-spending drugs is among the top priorities for lawmakers as Congress returns to Washington.
(1/3/2023): Medicare lost millions in savings due to spotty oversight: federal watchdog
- A federal watchdog has found that Medicare lost out on millions of potential savings due to spotty oversight of the average sales price of medications, impacting how much Medicare Part B beneficiaries pay for coverage.