|
Presented by Arnold Ventures: Delivered every Tuesday and Friday by 12 p.m., Prescription Pulse examines the latest pharmaceutical news and policy. | | | | |  | | By Katherine Ellen Foley and Lauren Gardner | Presented by Arnold Ventures | | | | | | 
CMS wants to prevent agents and brokers from earning more than they should from Medicare Advantage insurers for plans they sell to older Americans. | Justin Sullivan/Getty Images | TAMING HEALTH CARE ‘MIDDLEMEN’ — The Biden administration wants to cap the amount insurers can pay Medicare Advantage brokers and agents per enrollee, POLITICO’s Robert King reports. The administration also took another step toward reducing drug prices for older Americans. CMS proposed a rule late Monday limiting the amount paid to brokers and agents to $632 per enrollee — $31 more than the current limit. But the new cap would include any external fees that companies pay brokers and agents as incentives to sell more expensive plans. “Many people with Medicare rely on agents and brokers to help them make the best choice about their health care coverage,” said CMS Administrator Chiquita Brooks-LaSure during a call with reporters Monday. “However, we are concerned that some Medicare Advantage plans are compensating agents and brokers in a way that circumvent existing payment rules.” Caps per enrollee are nothing new. CMS annually limits how much an insurer can pay a broker and agent for each Medicare Advantage plan sold. But now, insurers can compensate those who sell plans with unrelated fee payments not calculated as part of the cap. The proposed rule comes less than two weeks after more than a dozen Democratic senators raised the alarm about such marketing strategies, which they critically characterized as “middlemen” in a letter to CMS. The senators additionally asked CMS to prohibit Medicare Advantage marketers from selling beneficiary information to each other. The rule would also give Medicare Part D enrollees easier access to biosimilars, which would lower patient drug costs. Biosimilars are typically much cheaper than the first-approved biologic drugs they mimic. Right now, Part D beneficiaries must get CMS approval for biosimilar alternatives, but the proposed rule would eliminate the requirement. IT’S TUESDAY. WELCOME BACK TO PRESCRIPTION PULSE. The CDC is expanding its Traveler-Based Genomic Surveillance program to randomly test for more respiratory illnesses — including RSV and the flu — at pilot programs at international airports in Washington, Boston, New York City and San Francisco. Send news and tips to Lauren Gardner (lgardner@politico.com or @Gardner_LM), David Lim (dlim@politico.com or @davidalim) and Katherine Ellen Foley (kfoley@politico.com or @katherineefoley). TODAY ON OUR PULSE CHECK PODCAST, host Kelly Hooper talks with POLITICO health care reporter Chelsea Cirruzzo, who reports on a proposed update to the CDC's infection-control guidelines, which would better help clinicians limit transmission of viral infections in health care facilities.
| | | | | | | A message from Arnold Ventures: The United States patent system is designed to promote science and innovation, but drug manufacturers are gaming the system to stifle competition. As a result, already-high prescription drug prices continue to rise, leaving tens of millions of Americans without access to lower cost, life-saving treatments. Learn more about the effects of anticompetitive behaviors that block competition: https://www.arnoldventures.org/work/drug-prices | | | | | | | 
VA's process for drug negotiations is different than the process CMS must follow. | AP Photo | AP Photo | CMS VS. VA DRUG PRICE NEGOTIATIONS — CMS won’t be able to look to the Department of Veteran Affairs for a negotiations roadmap as it begins talks with drug manufacturers over drug prices due to distinctions in the way Congress granted the agencies their abilities, Robert reports. The agencies have three key differences in the way they must negotiate prices: — The VA has set prices with drugmakers for nearly 30 years, resulting in a sophisticated way in which drug prices are negotiated. The Inflation Reduction Act includes many rules CMS must follow that don’t apply to the VA. — The VA can negotiate entire classes of drugs from competing drugmakers vs. Medicare, which was required to select 10 drugs to discuss with each manufacturer as a platform for lowering prices. — Medicare serves 64 million beneficiaries compared with the VA’s 9 million-strong population. The huge Medicare market could factor into why nine lawsuits seeking to halt the negotiations have been filed, Dr. Mariana Socal, an associate scientist at Johns Hopkins Bloomberg School of Public Health, told POLITICO. Drug companies could take a greater hit to their bottom line if they negotiate the price of a product that reaches a much larger market than at the VA. FIRST IN RxP: OLDER VOTERS ON DRUG COSTS — An AARP survey coming out later this week shows that Americans ages 50 and older will consider drug costs when voting for candidates in the 2024 presidential election. Results shared first with Prescription Pulse found that 42 percent of those polled said prescription drug costs are “extremely” or “very” important when weighing how they’ll vote next November when party control of the White House and Congress will be up for grabs. More than a third of respondents said the issue is “somewhat” important to them, and adults 65 and older are more likely to consider those costs important to their voting decisions than those in the 50-64 age bracket. And awareness of Medicare’s new authority to negotiate lower drug prices is perhaps not as high as you might think, with 39 percent of people 50 and older saying they knew “a great deal” or “some” thing about the Inflation Reduction Act that empowers the federal government to set drug prices.
| | | | JOIN US ON 11/15 FOR A TALK ON OUR SUSTAINABLE FUTURE: As the sustainability movement heats up, so have calls for a national standard for clean fuel. Join POLITICO on Nov. 15 in Washington D.C. as we convene leading officials from the administration, key congressional committees, states and other stakeholders to explore the role of EVs, biofuels, hydrogen and other options in the clean fuel sector and how evolving consumer behaviors are influencing sustainable energy practices. REGISTER HERE. | | | | | | | | | ‘CRISIS’ LOOMS ON GENE THERAPY COSTS — The FDA’s top biologics regulator said Monday that gene therapies are at an inflection point — and that portion of the pharma industry needs manufacturing advances, regulatory certainty and some global alignment on approval standards to ensure patients can access treatments at affordable prices. The business model for gene therapies “has to change” to bring costs down, Dr. Peter Marks, head of the agency’s Center for Biologics Evaluation and Research, said at the Milken Institute’s annual health conference in Washington. The curative potential of the treatments means companies force many customers to pay for the treatments upfront before demand trails off. That — plus the labor-intensive work that goes into manufacturing the therapies — contributes to their million-plus-dollar price tags. “If we don’t get this right in the next 10 years, I think we’re going to have a real problem of crisis proportion of having the technology to address a lot of these diseases but not being able to deliver them because health care payers have decided that it’s more important that people can get their annual flu vaccine,” Marks said. FDA’s role: Marks said the FDA tries to support companies developing automated manufacturing capabilities, hoping to cut production costs, which could translate to lower prices for patients. The agency is also working to eliminate regulatory uncertainty for gene therapy companies, he said, by leveraging accelerated approvals as much as possible for rare disease treatments.
| | | | A message from Arnold Ventures:   | | | | | BIDEN’S CANCER MOONSHOT NEEDS THE FDA — Mitch Zeller, the former FDA head of the FDA’s Center for Tobacco Products, thinks that without a focus on the FDA, President Joe Biden’s goal of dramatically reducing cancer deaths by 2047 could remain out of reach. “It starts with tobacco,” Zeller said in an interview with POLITICO. Tobacco use is responsible for about 30 percent of all cancer deaths, making it the leading cause of preventable cancers and cancer deaths — and yet smoking-cessation tools are outdated and don’t work for many of the millions of smokers who want to quit. “What the White House and the FDA commissioner need to do is figure out — in the context of both the [cancer] moonshot and an HHS framework that has not yet been finalized — how to account for the need for improvements in the toolkit for smokers who want to quit,” Zeller said. Read the full interview on the Politico Pro website.
| | Biogen has appointed Monish Patolawala to its board of directors, effective Jan. 1. He is president and chief financial officer at 3M. Susan Lane Stone is CEO and executive director of the National Headache Foundation after serving as interim leader.
| | | | A NEW POLITICO PODCAST: POLITICO Tech is an authoritative insider briefing on the politics and policy of technology. From crypto and the metaverse to cybersecurity and AI, we explore the who, what and how of policy shaping future industries. We’re kicking off with a series exploring darknet marketplaces, the virtual platforms that enable actors from all corners of the online world to traffic illicit goods. As malware and cybercrime attacks become increasingly frequent, regulators and law enforcement agencies work different angles to shut these platforms down, but new, often more unassailable marketplaces pop up. SUBSCRIBE AND START LISTENING TODAY. | | | | | | | | | An analysis from the Institute for Clinical and Economic Review found that large insurers’ health formularies improve access to some treatments but might still block patients from others, Ed Silverman reports for STAT. BioNTech has acquired a biotech startup devoted to the lipid nanoparticles that deliver mRNA therapeutics, Ryan Cross writes for Endpoints News.
| | The FDA issued two guidance documents offering recommendations for companies submitting complex datasets in product applications. The FDA warned consumers about a glucose support supplement found to contain trace amounts of metformin and glyburide, the active ingredients in some prescription drugs for type II diabetes.
| | | | A message from Arnold Ventures: In the next five years, national spending on prescription drugs is expected to reach over half a trillion, and yet, tens of millions of Americans still lack access to life-saving treatments.
One reason? Many drug manufacturers abuse the patent system to extend their monopolies and keep their drug prices – and their profits – high. These companies are exploiting loopholes to extend patent protection far beyond the typical 20 years.
These anticompetitive behaviors, combined with high launch prices and unjustified price increases, created a market where nearly one in every four Americans struggles to afford the drugs they are prescribed.
Through enacting evidence-based solutions, the United States can remain at the forefront of pharmaceutical research and innovation while also ensuring that life-saving treatments are affordable and accessible to all. Learn how anticompetitive behaviors are blocking competition and keeping prescription drug prices high: https://www.arnoldventures.org/work/drug-prices | | | | | | | Follow us on Twitter | | | | Follow us | | | | |  |
