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Politico (10/15/2021): BIDEN EYEING FDA VETERAN ROBERT CALIFF TO LEAD THE AGENCY — President Joe Biden is likely to nominate former Food and Drug Administration Commissioner Robert Califf to return to the top role at the sweeping regulatory agency, people with knowledge of the situation told POLITICO.

Bloomberg (10/15/2021): Democrats Prep Shift on Drug Pricing Push - Democratic leaders say they’re eyeing a less aggressive drug pricing proposal in their broad tax and social spending package, which may offer some relief to drugmakers concerned about the original plan.

Bloomberg (10/15/2021): Bills to Avoid ‘Telehealth Cliff’ Delayed by Higher Priorities - Lawmakers are struggling to push widely supported legislation that would end the “telehealth cliff” through a logjam created by their intense focus on more divisive priorities—such as the Democratic spending package, bipartisan infrastructure bill, addressing the debt ceiling and funding the government. “There’s not much oxygen in the room, even for an issue of agreement,” said Kyle Zebley, vice president of public policy for the American Telemedicine Association. Read more from Allie Reed.

Bloomberg (10/13/2021): Progressives Press for Medicare Benefits - New vision, dental, and hearing benefits under Medicare must be included in Democrats’ social spending package if it’s going to win support from progressives, lawmakers said yesterday.

Bloomberg (10/13/2021): Democrats Divided Over How Best to Slice Biden’s Economic Agenda - Democrats are coalescing around a tax and spending plan totaling about $2 trillion, but the party’s progressives and moderates remain divided over which pieces of Biden’s agenda to pay for -- and how long to pay for them.

Bloomberg (10/13/2021): Poll Shows Drug Pricing Negotiation Support - A new poll from the Kaiser Family Foundation shows Americans of all party affiliations want government to negotiate for better drug prices—an effort being debated in Congress—even after hearing common arguments about it, Alex Ruoff reports. Eighty three percent of the public in the survey said they favored allowing government to negotiate to lower drug prices, including 76% of Republicans. After hearing key arguments being made for and against that plan, “little” change was seen overall, with Republican s upport overall dipping to 71%, Alex Ruoff reports.

Politico (10/12/2021): SINEMA NOT SOLD ON A DRUG PLAN, STILL — Senate Democrats still haven’t agreed on a key component of President Joe Biden’s sweeping social spending package — drug pricing reform.

Bloomberg (10/12/2021): Biomedical Agency’s Future is Complicated - President Joe Biden’s proposed new biomedical research agency may fall short of funding or approval from Congress this year after Senate Democrats signaled they’ve booted the initiative from their pending social spending and tax package.

Modern Healthcare (10/11/2021): Cancer care must crack the diversity code - We can credit clinical trials for great improvements made in cancer care in recent years. But there's a large hole in these gains—the lack of diversity.

Politico (10/1/2021): BUTTERFIELD, BILIRAKIS BILL AIMS TO BOOST CANCER TEST COVERAGE — Two lawmakers are making a bipartisan push to require Medicare, Medicaid and the Children’s Health Insurance Program to provide coverage of molecular cancer diagnostics when individuals are diagnosed with cancer. The new bill, H.R. 5377, introduced by Reps. G.K. Butterfield (D-N.C.) and Gus Bilirakis (R-Fla.), also would require HHS to run a national education campaign to raise awareness of the role of genetic testing and counseling.

Politico (10/1/2021): FDA ISSUES DRAFT GUIDANCE ON USING REAL-WORLD DATA FOR DRUG REGULATION — The Food and Drug Administration on Wednesday released draft guidance for industry on using real-world evidence, including electronic health records and other medical records, to evaluate novel therapies, Katherine reports. These kinds of real-world data show insight that clinical trials can’t, like how well drugs work in patients with additional conditions or how they fare after being on the drugs for long periods of time.

Modern Healthcare (10/1/2021): As Democrats bicker over massive spending plan, here’s what’s at stake for Medicaid - With Democrats controlling both chambers of Congress and the White House, health experts say this could be the only time such a fix to the “Medicaid gap” will be possible for many years.

Modern Healthcare (10/1/2021): HHS kills Trump-era 340B rule targeting community health clinics - The rule would have required community health clinics to pass on insulin and Epi-Pen savings directly to patients.

Modern Healthcare (10/1/2021): HHS lays out surprise billing resolution process in new rule - The Biden administration gave new details on the independent dispute resolution process that out-of-network providers and plans can use to settle surprise billing disputes.

Politico (10/1/2021): AMERICANS WANT DRUG PRICE NEGOTIATION — … Even if many lawmakers don’t. Americans support letting the government negotiate drug prices above all the other major priorities in the infrastructure and social spending packages now before Congress, according to a new POLITICO-Harvard poll.

Politico (10/1/2021): ‘SURPRISE’ BILL BAN ON DECK — The Biden administration is finalizing a key element of its ban on surprise medical bills , laying out new procedures for how insurers and providers should settle pay disputes for out-of-network care.

Politico (10/1/2021): DEMS’ DOMESTIC AMBITIONS SLAM INTO REALITY — Top Democrats dreamed of making generational progress this year on health coverage, drug pricing, family leave and all manner of other big priorities — and doing it in a single masterful stroke.

Axios (10/1/2021): Proteins give clearer picture of cancer growth - Unique networks of hundreds of proteins may drive the growth of breast, head and neck cancers, according to three new studies, Axios' Eileen Drage O'Reilly reports.

Axios (10/1/2021): More details on surprise billing ban - Insurers are happy with the Biden administration's planned implementation of Congress' ban on surprise medical bills. Hospitals are not.

Politico Pro (9/29/2021): Democrats dial back drug-pricing plans to win over moderates - Top congressional Democrats are acknowledging for the first time that they’ll have to scale back their drug pricing plans to win centrist votes for their giant social spending package.

Politico (9/29/2021): House approves doomed debt limit extension but hurdles loom - The House on a mostly party-line vote approved an extension of the debt ceiling through 2022 Wednesday, but Republican opposition in the Senate will almost certainly doom the measure.

Axios (9/29/2021): Democrats' tough choices - Democrats may soon have to decide whether to shrink their health policy ambitions or pick fights with more of the industry, Axios' Caitlin Owens writes.

Politico (9/29/2021): THE FIGHT FOR MEDICAID TAKES ON ‘RACIAL COMPONENT’ — The ongoing struggle on Capitol Hill over how to allocate scarce resources in Democrats’ social spending bill ramped up Tuesday, with a member of House leadership arguing to his caucus that prioritizing older adults on Medicare at the expense of low-income people on Medicaid is racially discriminatory.

Politico (9/29/2021): NEXT PHASE OF PROVIDER FUNDING OPENS — In other funding news, HHS today opened its application portal for $25.5 billion available through the Provider Relief Fund. This is the fourth installment of PRF cash after it was established in the CARES Act and includes money from the American Rescue Plan.

Politico (9/27/2021): Democrats grapple with cuts to health care priorities - Top House Democrats are voicing a new willingness to pare down their ambitious health care proposals within the sweeping $3.5 trillion social spending bill as they scramble to build consensus ahead of a potential vote this week.

Axios (9/27/2021): 1 big thing: Health policies at stake in Dems' infrastructure bet - Democrats are at a pivotal moment in their quest to expand health care coverage, slash the cost of prescription drugs and create a social structure that prioritizes people's health, Axios' Caitlin Owens writes.

Modern Healthcare (9/24/2021): Centene, Humana sue Merck over alleged 'pay-for-delay' drug deal - The lawsuits come just three months after the Kaiser Foundation Health Plan sued the pharmaceutical giant over allegedly anticompetitive actions.

Modern Healthcare (9/24/2021): Federal government should advise on drug negotiations, not run them - Rather than relying on policies that will further distort incentives in healthcare markets, it is time to start aligning health prices with value and innovation.

Modern Healthcare (9/24/2021): Six drugmakers face fines for 340B contract pharmacy violations - Eli Lilly, AstraZeneca, Novartis, Novo Nordisk, Sanofi and United Therapeutics could pay more than $5,000 for each violation.

Politico (9/23/2021): BIDEN’S ‘GOOD FRIEND’ HATES HIS DRUG PLAN — When Biden kicked off Wednesday’s global Covid-19 summit, he went out of his way to laud one person: Pfizer CEO Albert Bourla, who he hailed as a “good friend” and a leader in the pandemic fight.

Politico (9/22/2021): HOUSE LEADERS TO JAM DEM HOLDOUTS ON DRUG PRICING — Top House Democrats are still planning to include the party’s signature drug pricing plan in their forthcoming reconciliation package — even after four Democrats voted against it in committee last week.

Axios (9/21/2021): Democrats' case for prioritizing health care - Health care advocates are making the case that the pieces of Democrats' legislative agenda that lower health care costs and expand coverage are the most popular with voters — and should thus be prioritized, Axios' Caitlin Owens writes.

Politico (9/21/2021): SANDERS RALLIES OUTSIDE PhRMA OVER DRUG PRICING — Sen. Bernie Sanders (I-Vt.) is hosting a rally outside PhRMA headquarters today to press lawmakers on drug pricing provisions now in jeopardy under the reconciliation talks.

Axios (9/20/2021): Voters' top health care priorities - Seven in 10 voters — no matter their political, geographic or demographic background — say cost is their biggest concern regarding health care, according to a poll from liberal advocacy group United States of Care.

STAT News (9/20/2021): Senate proposes expanding pharma penalties for hiking drug prices - A key Senate panel is expanding its plans to punish drug makers that hike prices faster than inflation, according to an internal Senate document described to STAT.

Politico (9/19/2021): Sinema tells White House she’s opposed to current prescription drug plan - The White House has a new headache as it struggles to get its multitrillion-dollar party-line spending bill passed: Sen. Kyrsten Sinema's objections to drug pricing reforms that are already struggling to make it through the House.

Open Secrets (9/17/2021): Pharmaceutical industry backs Democratic holdouts on drug pricing plan - House Democrats who voted Wednesday against a key provision that would lower prescription drug prices in the $3.5 trillion reconciliation plan received large campaign contributions from pharmaceutical industry PACs and CEOs.

Modern Healthcare (9/16/2021): House panel rejects drug pricing plan in setback to Biden - A House committee dealt an ominous setback Wednesday to President Joe Biden's social and environment package, derailing a money-saving plan to let Medicare negotiate the price it pays for prescription drugs.

Axios (9/16/2021): Pharma still isn't in the clear - A key congressional committee rejected Democrats' signature drug pricing bill yesterday, but that doesn't mean the party's push to lower drug prices is anywhere near over, Axios' Caitlin Owens writes.

Politico (9/16/2021): CENTRISTS JAM UP DEMS’ DRUG PLAN — A key plank of House Democrats’ health agenda is suddenly in deep jeopardy , after three centrist lawmakers blocked a plan to authorize direct negotiation of drug prices and help pay for the party’s $3.5 trillion reconciliation bill.