(5/5/2023): FDA’s advisory committee process scrutinized as more novel treatments seek approvals
- One of the only public windows into the FDA’s medical product approval process needs to be modernized to match the novel and complex drugs they’re reviewing, Katherine reports. The FDA’s advisory committees are tasked with providing the agency with outside scientific expertise on drugs or other medical products. They’ve been a part of the agency’s regulatory decisions for more than 50 years. In addition to objective views, the committees provide a layer of transparency into the regulatory process — key for maintaining public trust in the FDA’s authority. But in recent years, the FDA has steadily decreased the number of advisory committee meetings it holds. Between 2010 and 2021, the number of FDA drug approvals after an advisory committee meeting plummeted from 55 percent to 6 percent
The Boston Globe
(5/5/2023): Massachusetts makes its case to host coveted federal health research agency
- A firm representing Governor Maura Healey’s administration filed its pitch with the ARPA-H site selection committee last month. State officials expect to learn next week if they make it to the next round, which will involve site visits to the semifinalists. State officials aren’t sharing the details of their bid, saying this is competitive info that could hurt their chances to win. But they’ve assuredly highlighted the strengths of the Massachusetts life sciences sector — all the biotechs, research hospitals, universities and venture capitalists, primarily in and around Boston and Cambridge. Leaders in the region’s healthcare and biotech industries are helping with the pitch. There really is no other place in the country, their argument goes, that’s as strong as Massachusetts when it comes to this kind of research.
(5/5/2023): Bill Aims to Prevent Medicare Overpayment on Drugs
- Legislation proposed Thursday by Sens. Sanders and Amy Klobuchar (D-Minn.) would prevent Medicare from paying more for prescription drugs than does the Department of Veterans Affairs, Celine Castronuovo reports. “There’s no rational reason other than greed for Medicare to pay twice as much for the same exact prescription drugs as the VA,” Sanders said. The bill
, called the ‘‘Cutting Medicare Prescription Drug Prices in Half Act,” would save an estimated $835 billion over the next 10 years, the Senate duo said in a release. The bill comes after a Government Accountability Office report
in 2021 found the Veterans Affairs Department paid 54% less per unit for nearly 400 brand name prescription drugs or generic counterparts than Medicare Part D in 2017. Last year’s Inflation Reduction Act
gave Medicare the ability for the first time to negotiate the prices of some of the highest spending drugs. The Centers for Medicare and Medicaid Services must publish by September the first 10 Part D drugs that will get negotiated prices starting in 2026.
(5/4/2023): Biden’s NIH Budget Plan Draws Bipartisan Fire in Senate Hearing
- Senate Democrats and Republicans alike are voicing concerns about President Joe Biden’s modest fiscal 2024 medical research spending proposal for the National Institutes of Health. The White House proposed $51.1 billion for the NIH in in its fiscal 2024 request. However, most of that would be devoted to the Advanced Research Projects Agency for Health, and the cancer moonshot program. Medical research spending would increase by $920 million, or 1.7%, for NIH’s base programs in 2024. Lawmakers on both sides of the dais signaled during a Senate Appropriations subcommittee hearing Thursday that they thought the request wasn’t enough. Medical research spending has generally garnered support from both chambers, but a plan to increase NIH’s base level potentially sets up a clash with the House Republican plan to cut $4.8 trillion in budget deficit cuts over a decade as part of a proposal to raise the debt ceiling.
(5/4/2023): R.I.P. PHE
- The end of the Covid-19 public health emergency - and the return to some semblance of pre-pandemic health care — is one week away. The PHE began during the Trump administration and came to affect nearly all parts of American health care, Ben writes, with the government appropriating $4.6 trillion to fight the virus. Though some policies originally from the emergency declaration are here to stay, many patients, providers and health companies are preparing to readjust to the old ways of doing things.
(5/4/2023): The Senate Finance Committee will hold a hearing next week on the impact U.S. international tax policy has on the pharmaceutical industry
- Chair Ron Wyden
(D-Ore.) said the hearing will focus on the effects of the Tax Cuts and Jobs Act of 2017, which Democrats widely criticize, and what he characterizes as the drug industry’s “tax avoidance schemes”
(5/3/2023): DEA backs off plan to end telehealth access to common medications, for now
- The Drug Enforcement Administration will continue to allow doctors to prescribe controlled substances by telehealth while the agency finalizes rules on prescribing now that the Covid-19 public health emergency is ending, the agency said in a statement Wednesday. The agency’s announcement may signal it’s rethinking regulations it proposed in February that would have restricted telehealth access once the Biden administration ends the emergency on May 11.
(5/3/2023): DEA seeks to temporarily extend COVID telehealth prescribing rules
- The Drug Enforcement Administration has asked the White House for more time to finalize draft rules that proposed reinstating stricter limits requiring doctors to evaluate patients in-person before prescribing certain drugs — like Adderall and opioid use disorder treatment — via telehealth.
(5/2/2023): Sanders Threatens to Oppose Biden Health Picks on Drug Costs
- Sen. Bernie Sanders (I-Vt.) has indicated he could block President Joe Biden’s likely pick to head the National Institutes of Health if she doesn’t commit in nomination hearings to using her position to help lower drug prices. Sanders, who leads the Senate Health, Education, Labor, and Pensions Committee, stopped short of saying he would block cancer surgeon Monica Bertagnolli, but she is certain to face tough questioning if she receives the formal nomination. Sanders made his remarks about two weeks after the White House was reportedly gearing up to nominate Bertagnolli for the top NIH job. A researcher and surgeon who’s currently undergoing her own treatment for cancer, she’s been director of the National Cancer Institute since October.
(5/2/2023): Senate drug pricing bill markup devolves, postponed until May 11
- A Senate HELP Committee hearing to consider legislation aimed at lowering drug costs screeched to a halt on Tuesday and was postponed until next week amid allegations of reneging on agreements made while crafting the package. The panel had planned to advance four bipartisan measures
that would increase access to generic drugs and rein in pharmacy benefit managers as part of an overall effort to lower health care costs — but a bristling opening statement from ranking member Bill Cassidy
(R-La.) set off a cross-party debate over whether the bill markup should continue. “The chair seems to be inclined to abandon a carefully balanced, bipartisan piece of legislation we negotiated over the last several weeks,” Cassidy said. Cassidy said that he and Chair Bernie Sanders
(I-Vt.) had agreed on what would be included in the package — with each making concessions — and to table certain issues. But, Cassidy said Sanders had gone back on his word when it became clear that the chair would allow a number of bipartisan amendments to move forward. Cassidy chastised his Democratic peer for failing to share FDA technical assistance on the amendments and cost scores from the Congressional Budget Office. He acknowledged that he generally supported the content of the amendments and may have even co-sponsored them in the past.
(5/2/2023): The FTC’s Health Data Mission
- The Federal Trade Commission has made protecting online health data a priority of its enforcement agenda in the absence of new federal data privacy legislation, POLITICO’s Ruth Reader reports. The FTC plans to propose a rule that would more directly regulate online commercial surveillance and data security. The agency has received 1,250 comments
on the advanced notice it released last year. In the meantime, the agency has said it will continue policing companies that deal in unfair and deceptive data practices — but it needs more money. The FTC recently requested funding in a hearing
before the House Energy and Commerce Subcommittee on Innovation, Data and Commerce.
(5/2/2023): Senate HELP Committee to Mark Up Generic Drug and PBM Bills
- The Senate HELP Committee considers today a slate of legislation
that aims to promote competition for generic drugs and reins in pharmacy benefit managers, Megan reports. The measures are largely bipartisan and part of a growing number of congressional measures
to help lower drug costs. One bill, led by committee chair Bernie Sanders
(I-Vt.) and ranking member Bill Cassidy
(R-La.), takes swipes at PBMs, including prohibiting their ability to charge health plans more for a drug than they reimburse pharmacies for dispensing it, a practice known as spread-pricing.
(5/1/2023): High Hopes on Capturing Health Momentum
- Reining in the cost of health care — and medicines, in particular — remains a priority for lawmakers in both parties. What happens on Capitol Hill over the next few weeks could be pivotal for how the battle over prices plays out over the rest of the year, Megan reports
. Looking toward the 2024 elections, Senate Majority Leader Chuck Schumer is evidently hoping to seize the bipartisan moment to bring a package of drug pricing bills to the floor this month. The New York Democrat is interested in legislation that would cap the cost of insulin, make pharmacy benefit managers less opaque and bolster access to generic drugs.
(5/1/2023): Nursing shortages show no signs of slowing, survey finds
- Nearly a third of nurses nationwide say they will likely leave nursing for another career due to the pandemic, a new survey
found. Some sectors of the health care industry plagued by significant labor shortages during the pandemic appear to be rebounding
, but the AMN Healthcare survey, published on Monday, suggests a shortage of nurses may continue to be a major challenge for health care providers for years to come.
(4/28/2023): Medicaid Managed Care Under the Microscope
- MS issued two proposed regulations aimed at ramping up scrutiny of Medicaid managed care plans, including a requirement for plans to follow mandatory appointment wait times, Robert reports. The proposed rules come amid concerns from industry groups around a lack of transparency in managed care, which are private plans that oversee state Medicaid programs. Recent data shows more than two-thirds of Medicaid beneficiaries are in a managed care plan.
(4/28/2023): Republican Says NIH Research Funds at Risk
- At the same time that lawmakers are calling for research to combat drug-resistance, the lead Republican on a House oversight panel hinted he wants to end NIH funding for high-level biocontainment research, part of GOP scrutiny into how the agency handled coronavirus research grants in Wuhan.
(4/28/2023): Reading Between the Lines of the DEA's Proposed Rules on Telemedicine
- In February, the DEA proposed permanent rules for the prescribing of controlled medications via telemedicine. A significant concern is that the rules will require an in-person exam in addition to telemedicine exams for any prescribing of controlled substances, including medications commonly used to treat substance use disorder, anxiety, and ADHD in children. With a continuing psychiatrist shortage and more than 150 million Americans living in federally designated mental health professional shortage areas, this change means the stakes couldn’t be higher for mental health clinicians and patients everywhere. The in-person requirement will limit access for rural and underserved communities with inadequate access to in-person providers without the substantive burden of distance, financial status, health insurance, childcare, and transportation. These rules are contrary to the recommendations of the bodies that create the clinical best practices for psychiatry, the American Psychiatric Association and the American Academy of Child and Adolescent Psychiatry. The comment period is now closed, and the consensus in behavioral health circles is that there is a high likelihood that these proposed rules will become final. On one hand, it is essential to recognize that these rules represent progress: the DEA is giving mental health prescribers a clearer pathway for approved teleprescribing. The proposed rules provide greater clarity amid a gray area the industry has been operating in since 2008.
(4/28/2023): Telehealth bill would permanently extend eased Medicare rules, lobbyists say
- Telehealth advocates expect new Senate legislation to drop in the coming weeks that would permanently extend rules that have allowed Medicare patients to access virtual care during the pandemic. Congress extended those rules through 2024 in December’s fiscal 2023 omnibus spending law
. But a congressional aide and four telehealth lobbyists, whom POLITICO granted anonymity to discuss legislative deliberations, said they expect the latest version of Sen. Brian Schatz
’s CONNECT for Health Act to eliminate that sunset date. The lobbyists said the Hawaii Democrat's plans to reintroduce the bill after incorporating some of their asks.
(4/28/2023): CMS proposes accountability standards for Medicaid plans
- The Centers for Medicare and Medicaid Services on Thursday proposed new reporting rules for Medicaid and the Children's Health Insurance Programs health plans, that would, among other things, set national standards for appointment wait times and require disclosure of provider payment rates.
(4/28/2023): Dems Push for IRA Expansion
- Nearly two dozen Democrat senators introduced legislation this week that would empower CMS to select drugs and biologics for Medicare price negotiations five years after FDA approval and increase the number of products that can be negotiated starting in 2026. Under current law, drugs can be selected into the program seven years after market entry and biosimilars after 11 years, and just 10 Medicare Part D drugs are subject to price negotiation for 2026.
(4/27/2023): CMS on Transparency
- The House Energy and Commerce Health Subcommittee held a sweeping hearing Wednesday about competition and transparency in the health care system, Megan reports. CMS Administrator Chiquita Brooks-LaSure answered questions about CMS’ approach to a number of policies, including its Alzheimer’s drug coverage — as Katherine reported Wednesday — and price-transparency legislation. At the hearing, Brooks-LaSure said the agency would strengthen its enforcement of hospital price-transparency rules — including moving bad-faith actors straight to a corrective action plan. CMS later released additional details.
(4/27/2023): GOP’s Medicaid Rules Risk Patchwork Impact
- House legislation to change work rules for social and health care safety net programs would hit red and blue states in different ways, broadening existing inequalities nationwide. The work-related proposals under Speaker Kevin McCarthy’s (R-Calif.) debt ceiling bill (H.R. 2811), which passed yesterday on a 217-215 vote, would directly hit relatively small groups of recipients of Medicaid health insurance and the Supplemental Nutrition Assistance Program. Research shows most adults on Medicaid are already working. And proposed SNAP rules, which would tighten work requirements for adults in their early 50s who receive the food assistance, wouldn’t apply in multiple states across the US that implement state and local waivers.
The Washington Post
(4/27/2023): Rep. Jamie Raskin (D-Md.) says his cancer is in remission
- Rep. Jamie B. Raskin (D-Md.) has “rung the bell” after finishing chemotherapy — and has been told by doctors that his cancer is in remission, he announced in an open letter on Thursday. Raskin was diagnosed with diffuse large B-cell lymphoma in December. He had since been undergoing chemotherapy treatment at MedStar Georgetown University Hospital and the Lombardi Comprehensive Cancer Center — while handling his duties as a congressman and the top Democrat on the House Oversight Committee, one of the most high-profile roles in Congress.
(4/26/2023): PBMs Brace for Impact
- Pharmacy benefit managers, which negotiate rebates on drugs with pharmaceutical companies and decide which medicines insurance plans will cover, are preparing for a congressional bashing, Megan writes. Lawmakers have become increasingly interested in PBMs, with some on Capitol Hill saying they aren’t transparent enough about how they operate and are incentivized to favor expensive drugs. Multiple committees in the House and Senate have begun to focus on PBMs — and the Senate Finance Committee wants to have a bipartisan PBM bill by the summer. Yesterday, the Senate HELP Committee announced it would mark up a 91-page bill next week that takes aim at their business practices.
(4/26/2023): Hospitals Push Back as Congress Eyes Cuts
- Congress is weighing whether to reduce some Medicare payments to hospitals and beef up price transparency rules, sparking a pushback from the industry. A slate of House bills, including three to lower Medicare and Medicaid payments to hospitals for certain services to what doctor’s offices and outpatient labs are typically paid, will come up for debate before the Energy and Commerce Committee today. The hearing will also discuss codifying and expanding federal regulations requiring hospitals to post their prices online.
(4/25/2023): E&C Launches Probe into NIH Comms Money
- The House Committee on Energy and Commerce announced it’s investigating how the NIH has been spending its communication dollars. The committee seeks information about a contract awarded to 10 public relations and consulting firms in 2018, which is due to expire in December. In 2021, the NIH requested that the ceiling for the potential contract amount be raised from $500 million to $1 billion, citing the unprecedented need for communication services because of the pandemic. Citing past concerns over how federal health agencies managed media consulting contracts and the size of contracts, an E&C committee spokesperson said the goal of the new probe is to “determine how the NIH uses contract public relations firms and whether these are an appropriate use of taxpayer dollars.”
(4/25/2023): Rare Disease Bill Would Uphold FDA’s Use of Law, Avert Suits
- Rare disease drugmakers would retain their special status when pursuing treatments especially for children under legislation scheduled to be marked up by a Senate panel next week. The legislation aims to head off future lawsuits like the one Catalyst Pharmaceuticals Inc. won last year, granting them exclusive rights to market a drug to treat a rare disease. Sen. Tammy Baldwin’s (D-Wis.) Retaining Access and Restoring Exclusivity Act, or RARE, Act (S. 1214) is one of a package of drug pricing bills the Senate Health, Education, Labor and Pensions will consider May 2. Baldwin’s bill aims to solidify incentives that have been in place for four decades to increase treatments for rare diseases. It would clarify that the protections under the Orphan Drug Act apply to the use or indication approved by the agency and not across the entire disease space.
(4/24/2023): AHIP Hits At ‘Big Pharma’
- America’s Health Insurance Plans, the leading insurance lobby, is launching a seven-figure ad campaign touting the industry and accusing drugmakers as the culprits of high drug prices, Megan R. Wilson reports. The ads, which feature caricatures of high-powered drug lobbyists, will appear on television and social media, targeting outlets in Washington — and effectively bringing a war between insurers and the pharmaceutical industry into the open. PhRMA has been hammering insurers and pharmacy benefit managers — the pharmaceutical middlemen that negotiate drug discounts with drugmakers and design prescription drug benefits for health plans — in ads for years, saying the industries don’t pass the savings from the discounts negotiated with drugmakers onto consumers. Congress is mulling a slew of proposals that take aim at PBMs, the largest of which are owned by insurance companies.
(4/24/2023): What's next on the No Surprises Act
- The No Surprises Act may have shielded patients from unexpected medical bills, but it's left a bureaucratic mess, with providers and insurers fighting over who'll cover the costs and Congress weighing whether to step back in.
(4/21/2023): Pulse Newsletter, Sanders Sets Sight on Insulin, PBMs
- Senate HELP Committee Chair Bernie Sanders (I-Vt.) is summoning executives from top insulin makers and pharmacy benefit managers as part of his efforts to rein in drug prices, Megan reports
. The hearing, slated for May 10, comes after major drugmakers Eli Lilly, Novo Nordisk and Sanofi announced they would be slashing insulin prices. It will feature testimony from those CEOs, plus executives from the three largest PBMs, which negotiate discounts on drugs like insulin with drugmakers and decide which medicines insurance plans will cover.
(4/21/2023): More care at home could save Medicare, lawmakers believe
- House lawmakers backed by a wide array of industries think they have a solution to Medicare’s approaching insolvency: moving more care from the hospital to the home. A new bill from Reps. Adrian Smith
(R-Neb.) and Debbie Dingell
(D-Mich.) that aims to reduce care in hospitals and other health care facilities and increase it in living rooms marks a rare, bipartisan collaboration on a potential solution to Medicare’s financing problem
. And it has drawn support from tech companies, insurers, venture capitalists, providers and telehealth advocates.
(4/21/2023): Rep. Jamie Raskin shares update in cancer battle: ‘Chemotherapy has extinguished the cancer cells’
- Rep. Jamie Raskin shares update in cancer battle: ‘Chemotherapy has extinguished the cancer cells’ In December, Raskin was diagnosed with diffuse large B-cell lymphoma, which is a “serious but curable” cancer. It’s a type of disease in which over 18,000 people are diagnosed with it each year, according to the Lymphoma Research Foundation.
Bloomberg (4/21/2023): R&D Spending to Decline Further Under GOP Debt Plan -
Federal spending on research and development would fall by $442 billion—roughly 19% over the next decade—with even steeper cuts projected for the pool of cash that affects biomedical research spending, according to an analysis
by the Federation of American Scientists.
(4/20/2023): Pulse Newsletter, Work Requirements and Cash Recalls
- The GOP plan for raising the debt ceiling is here — with goals of adding work requirements for Medicaid
and clawing back unspent Covid funds, POLITICO’s David Lim reports. The proposed health provisions of the bill, unveiled Wednesday by House Speaker Kevin McCarthy, would require Medicaid recipients to work 80 hours a month and rescind Covid-19 relief funds that haven’t been spent or were obligated to be spent.
(4/20/2023): GOP Plan Could Cut NIH Research Grants:
The NIH would have to cut about 5,000 new research grants if a House GOP proposal to freeze next year’s discretionary spending at fiscal 2022 levels kicked in, acting director Lawrence A. Tabak told House appropriators. Scientists also would see cuts to existing grants, he said, Jeannie Baumann reports. Appropriations ranking member Rosa DeLauro (D-Conn.) said she’s “very much concerned” about what she described as “massive funding cuts.” The National Institutes of Health’s fiscal 2023 budget is around its 2003 spending level in real dollars, after Congress provided $2.5 billion to elevate the agency’s budget to $47.5 billion. The Biden administration proposed a $920 million, or 1.7% increase for the NIH in fiscal 2024.
(4/19/2023): Biden picks cancer surgeon to run NIH
- The White House is planning to nominate Monica Bertagnolli to run the National Institutes of Health, two people familiar with the matter told POLITICO. The decision would end a lengthy vacancy atop the health research agency, and vault Bertagnolli, a Boston cancer surgeon, into the role just months after being appointed as director of the government’s National Cancer Institute. She became the first woman to occupy the position when she took over that position in October.
(4/19/2023): Bipartisan Senators Make Drug Pricing Push
- The leaders of two key Senate health committees are trying to strike a deal on a slate of drug-pricing bills, including ones to spur generic drug approvals, cut fees from pharmaceutical middlemen, and cap the cost of insulin. The Democratic and Republican heads of the Senate Finance and Health, Education, Labor and Pensions committees say they’re trying to mark up drug-pricing legislation in the coming weeks and assemble a package of bills that would also include some drug patent changes already approved by two other panels.
(4/19/2023): Pulse Newsletter, Fallout of Privacy Crackdown
- A series of federal data privacy crackdowns is complicating how health care companies market their services online
, POLITICO’s Ruth Reader reports. New action from both the FTC and HHS to protect customer health data is upending longstanding business practices and sending the health care industry scrambling. In some cases, firms are cutting ties with tech giants like Google and Facebook as they try to understand the regulatory landscape and measure the fallout to their bottom lines.
(4/19/2023): VA indefinitely delays troubled electronic health records rollout
- The VA will once again delay its troubled electronic health records modernization project, this time indefinitely, agency officials announced Friday. It’s another significant blow to the troubled rollout. The VA had previously paused deployment to new sites till June.
(4/18/2023): Groups Slam GOP Push for Stricter Medicaid
- Over a dozen chronic care groups—including the American Cancer Society, Cancer Action Network, American Lung Association, and Cystic Fibrosis Foundation—urged House Republicans to abandon any plan to add work requirements to Medicaid, noting that in the past they have resulted in people losing benefits for failing to complete the proper paperwork. “Our organizations strongly oppose any policies that jeopardize coverage in the Medicaid program,” the groups said in a joint statement to Congress.
(4/18/2023): Pulse Newsletter, How a Health Equity Tool Might Backfire
- The government relies, in part, on the Area Deprivation Index to adjust payments to providers, and it’s an important part of the Biden administration’s ACO REACH program, a Medicare pilot that offers provider groups a set amount of money each month to treat a roster of underserved patients. The ADI uses several factors, including home value, to measure socioeconomic disadvantage in every census block in America. But in parts of the country where extreme wealth and poverty live side by side, the ADI metric can produce distorted results. Home values tend to be higher in urban areas, even in places rife with poverty and poor health outcomes.
(4/17/2023): Pulse Newsletter, A Step Forward for a Cancer Vaccine
- Moderna and Merck said Sunday a combination of immunotherapy and a personalized cancer vaccine prevented cancer recurrence
better than standard immunotherapy treatment alone, POLITICO’s Katherine Ellen Foley reports. The results, a new application of Moderna’s mRNA platform used in its Covid-19 vaccine and boosters, are a major step forward for getting the first cancer-recurrence vaccine approved.
(4/14/2023): Pulse Newsletter, Lawmakers want answers on generics
- Lawmakers want to know how the FDA is ensuring that generic medicine — which comprises the vast majority of prescriptions written in the U.S. — is safe. In a letter to FDA chief Robert Califf on Wednesday, Reps. Buddy Carter (R-Ga.), Mariannette Miller-Meeks (R-Iowa), Randy Weber (R-Texas), Ronny Jackson (R-Tex.) and Diana Harshbarger (R-Tenn.) noted that the U.S., which heavily depends on generics from China and India, has at times allowed drugs to be imported from overseas facilities with a history of FDA violations amidst drug shortages.
(4/14/2023): CMS readies for price negotiation feedback
- Public comments on CMS’ implementation plan for its Medicare Drug Price Negotiation Program are due today. In a letter sent Wednesday, a trio of Republican lawmakers hued closely to complaints the pharmaceutical industry is signaling it will file with the agency — CMS’ definition of “qualifying single-source drugs,” consideration of research and development costs, the prohibition of disclosure of information shared during negotiations, and limitations on judicial and administrative review.
(4/14/2023): Electronic health records rule sets up "bridge to nowhere" insurers say
- A Biden administration effort stemming from the 21st Century Cures Act to make health data sharing more transparent is facing pushback from health insurers.
(4/14/2023): Medicare advisers say it’s too soon to judge telehealth’s performance -
Congress’ Medicare advisory panel reported Friday that expanded access to telehealth during the pandemic boosted access to care. But the panel said that the limited data that’s available doesn’t show that telehealth improved the quality of care or reduced costs. Specifically, Medicare doesn’t have data on lab results or patient-reported outcomes, and Covid-19 surges confounded the results.
(4/13/2023): Pulse Newsletter, changes for generics trade
– The Association for Accessible Medicines has lost some members or reduced dues to keep others, contributing to the need for more than $4 million in budget cuts that culminated in layoffs of top public affairs, trade policy and advocacy executives, as previously reported by POLITICO
, and its smallest overall revenue in seven years. It comes as the organization attempts to raise its profile with the public and policymakers — including pushing for expanded access to generics and biosimilars — and it searches for a permanent CEO.
(4/13/2023): Pulse Newsletter, Drug Pricing Policy Delays
- The Senate HELP Committee is postponing a bipartisan hearing on a drug pricing bill to gather more information, Megan reports. The panel, led by Sen. Bernie Sanders (I-Vt.), hoped to mark up the yet-to-be-seen legislation focused on pharmaceutical middlemen and generic drug policy on April 19, shortly after the spring recess.
(4/13/2023): Personalized Immunotherapy to Fight Deadly Brain Tumors
- Researchers are testing a new personalized immunotherapy approach that is designed to work similarly to a vaccine by training the immune system to fight glioblastoma brain cancer.
(4/13/2023): Biden to open up Medicaid, Obamacare plans to DACA recipients
- President Joe Biden on Thursday announced a plan to expand federal health care to hundreds of thousands of immigrants who came to the United States as children but do not qualify for government insurance plans because they lack legal status. Under the proposed rule, nearly 580,000 people enrolled in the Deferred Action for Childhood Arrivals program will be able to obtain health coverage through Medicaid or the marketplace, two public health insurance programs for which undocumented immigrants are currently ineligible.
(4/13/2023): GOP Budget Blueprint Would Target Medicare
- A large group of conservative House Republicans are preparing a proposed budget that could exacerbate rifts within the party with proposals to reduce Social Security and Medicare benefits.The blueprint by the Republican Study Committee, whose membership includes three-fourths of the House GOP, comes as party leaders are struggling to reach consensus on spending reductions which they want to tie to raising the debt limit in negotiations with the White House. The plan is expected to be released in early May.
(4/12/2023): Pulse Newsletter, Will expanded health worker roles help patients?
- A decades long debate among health providers of all kinds over who can deliver what type of care is taking on new urgency amid health worker shortages and eased regulations spurred on by the pandemic, your host reports. In what many groups believe is a unique opportunity to change policy, health providers are pushing for — or against — nearly 200 bills across state governments that would change the licensing or supervision requirements for certain types of care.
(4/12/2023): Safety net clinics still rely on audio-only telehealth
- Technology barriers and payment policies have kept safety net clinics relying on audio-only telehealth for primary care and behavioral health when its use has declined elsewhere, according to a RAND study published in JAMA
(4/12/2023): National Cancer Institute, FDA Eye Clinical Trial Modernization -
NCI’s latest cancer study is straying from the typical approach for testing new treatments in a way that aims to remove common roadblocks to accessing these trials. The announcement is part of a broader federal effort to modernize clinical trials and is focused on lung cancer, one of the most common cancers in the US.
(4/11/2023): Pulse Newsletter, End to National Emergency
- President Joe Biden signed on Monday a House bill immediately ending the Covid-19 national emergency, first enacted during the Trump administration in 2020, POLITICO’s Kelly Garrity reports. The White House initially announced plans to extend
the national emergency, as well as the Covid public health emergency, until May 11. But shortly after, House Republicans put forth bills
to end both imminently. The bill Biden signed Monday ended only the national emergency.
(4/11/2023): Hospitals get a slight pay boost
- Hospitals are in line for a 2.8% pay increase, or $3.3 billion in additional funding in fiscal year 2024, under a proposed inpatient payment rule
Medicare administrators released on Monday.
(4/11/2023): EPA targets cancer-causing gas from medical sterilizers
- EPA proposed a rule on Tuesday aimed at slashing emissions of a cancer-causing gas used at facilities that sterilize medical equipment. Billions of medical devices and equipment are sterilized annually using ethylene oxide, a gas that is colorless and at low concentrations odorless but can cause cancer in people who face chronic exposure. Ethylene oxide has emerged as an environmental justice issue in recent years as communities that sit close to sterilizer facilities raised health concerns.
(4/11/2023): HHS proposes new standards for artificial intelligence in health care
- HHS’ Office of the National Coordinator for Health IT will formally propose new rules next week to require makers of artificial intelligence used in health care, as well as health technology developers that incorporate other companies' AI, to open up those algorithms to scrutiny if they want HHS’ certification.
CMS Press Release
(4/10/2023): The Centers for Medicare and Medicaid Services has released a proposed policy for inpatient and long-term care hospitals’ payments for fiscal year 2024.
(4/10/2023): Bristol-Myers, Cancer Institute Settle Patent Ownership Lawsuit
- The Dana-Farber Cancer Institute Inc. and drugmakers Bristol-Myers Squibb Co.
and Ono Pharmaceutical Co.
have reached a truce, settling a four-year legal feud over whether the pharma firms cut the institute out of ownership rights for lucrative cancer immunotherapy patents.
(4/10/2023): For Uninsured People With Cancer, Securing Care Can Be Like Spinning a Roulette Wheel
– Uninsured women that develop breast or cervical cancer likely qualify for insurance coverage under a federal law that extends Medicaid eligibility to lower-income patients diagnosed with those two malignancies. For female patients with other types of cancer, as well as pretty much all male patients, the options are scant, especially in South Carolina and the 11 other states that haven’t yet implemented Medicaid expansion, according to cancer physicians and health policy experts who study access to care.
Clinical Trials Arena
(4/10/2023): Sumitomo Pharma nabs fourth FDA Orphan Drug Designation in past year
- TP-1287 earned an FDA Orphan Drug Designation amid an industry-wide surge in the regulatory program’s popularity. In the past decade, the FDA has doubled the number of new designations granted
compared to the preceding decade. Therapies for oncology, and in particular rare genetic cancers, have made up the majority of orphan drug designations
(4/7/2023): Pulse Newsletter, Drug Pricing Legislation
- The Senate HELP Committee plans to mark up yet-to-be-seen drug pricing legislation focused on policies related to pharmaceutical middlemen and generic drugs on April 19, POLITICO’s Megan R. Wilson and David Lim report.
(4/7/2023): BGOV Healthcare Briefing
- Republican lawmakers are calling on the Centers for Medicare & Medicaid Services (CMS) to ensure that Medicaid enrollees meet strict eligibility requirements and to perform eligibility checks quickly and accurately to prevent improper payments. Democrats, on the other hand, are urging the CMS to crack down on states that wrap up Medicaid eligibility checks too quickly during the Covid-19 public health emergency. The House Oversight Committee has also written a letter to CMS Administrator Chiquita Brooks-LaSure to reverse the agency's opposition to states that cut people off early in the redetermination process to avoid improper payments due to errors or fraud. Meanwhile, the Congressional Progressive Caucus criticized the Biden administration for its recent decisions to delay changes to Medicare Advantage and lower the cost of the cancer drug Xtandi. They called on the administration to do more to protect seniors and people with disabilities in Medicare from the greed of health insurance companies.
(4/7/2023): Sanders, Cassidy game out drug pricing package
- April 19 is the day Senate HELP Chair Bernie Sanders (I-Vt.) wants to mark up a yet-to-be-seen bipartisan bill focused on policies related to generic drugs and pharmacy benefit managers, more than a half-dozen lobbyists tell Megan and David.
(4/7/2023): Hospitals' off-site fees draw lawmakers' scrutiny
- More than two years after Congress acted to shield patients from surprise medical bills, lawmakers are turning to another source of unexpected medical costs: the fees that hospitals tack on for services provided in clinics they own.
(4/6/2023): Pulse Newsletter, A crackdown on ‘misleading’ Medicare Advantage ads
- The Biden administration looks to prohibit insurers from advertising their Medicare Advantage plans in misleading ways, POLITICO’s David Lim reports.
(4/6/2023): BGOV Healthcare Briefing House GOP’s Push to Overhaul CDC Kicks Off
- A House Republican effort to reform the CDC has started, with Rep. Mariannette Miller-Meeks (R-Iowa) leading the work by seeking guidance, feedback, and information on how to reform, improve, and authorize the CDC and its programs.
(4/6/2023): National Cancer Plan Eyes Data, Tech in Cancer Moonshot Goals
- A new interagency collaborative plan that tackles cancer prevention and treatment is harnessing the power of the cloud, data, and other technologies as part of the reignited Cancer Moonshot effort. The National Cancer Institute released the National Cancer Plan this week with an outline for the long-term plan coordinating a national response to create better outcomes for cancer patients.
(4/6/2023): To make immunotherapy safe for brain tumors, researchers will have to tackle new risks
- The success of CAR-T immunotherapies against blood cancers has raised hope that CAR-T can bring breakthroughs to brain cancers, which haven’t had new treatments for decades. The initial clinical trials have yielded progress against brain tumors and new, potentially fatal, risks.
NYU Langone (4/6/2023): Artificial Intelligence Meets the World’s Largest Database of Brain Scans
- NYU Langone’s Department of Neurosurgery Leverages It's Vast Repository of MRI Images to Help Advance the Scientific Understanding of Metastatic Brain Cancer.
(4/6/2023): Privacy is at risk as HIPAA fails to keep pace with digital health
- Phones were still 11 years away when Congress passed HIPAA. But it hasn't been substantially modified since, and the bewildering pace of technological change has left vast amounts of sensitive data outside the scope of the law, threatening basic consumer privacy.
(4/5/2023): Pulse Newsletter, CALLING ON WEINGARTEN
- The House subcommittee investigating the federal response to the pandemic wants Randi Weingarten, president of the American Federation of Teachers, to explain what role — if any — the union had in shaping CDC guidance on school reopenings during the pandemic.
(4/5/2023): BGOV Healthcare Briefing, Democrats Urge US to Keep Covid Tests Free
- Lawmakers are pressing the HHS Secretary Xavier Becerra to extend Medicare coverage of at-home Covid tests after the public health emergency ends May 11.
(4/5/2023): J&J proposes $8.9B settlement fund for baby powder cancer claims
- The proposal would settle more than 60,000 lawsuits and any future ones filed alleging the company's asbestos-contaminated baby powder caused cancer.
(4/5/2023): These 40 drugs could be first up for Medicare price negotiations
- Medicare will begin negotiating the price of Part D drugs next year for prices effective in 2026, as called for in the Inflation Reduction Act signed by President Joe Biden last year. Starting in 2028, Medicare Part B drugs will also become eligible for price negotiation.