generics

Logo

July 11, 2024

Senate Passes Key Generic and Biosimilar Drug Competition Measure The Senate unanimously passed a bill that would bar so-called “patent thickets” and similar measures that brand drug makers use to stop the swift entry of generics and biosimilars. Drug makers would be barred from using multiple patents and lawsuits to stop generic and biosimilar approval. As well, the companies could not essentially “re-patent” drugs by making cosmetic changes. The Federal Trade Commission (FTC) would also have power to impose limits on patent litigation on biologics. (Article may require a subscription.) #drugpricing #branddrugmakers #biosimilars #generics https://insidehealthpolicy.com/inside-drug-pricing-daily-news/advocates-applaud-senate-passage-patent-thicket-reform-bill Could Smaller, Innovative PBMs Thrive At Expense of Big 3 Not too many years ago, the Big 3 pharmacy benefits managers (PBMs) dominated the business because their size and scope delivered the most cost-savings.  But the rise of transparency and headlines about how traditional PBMs could be abusing employers and insurers has smaller PBMs, including

Read More »

Federal Court Stays CMS Medicare Broker-Agent Compensation Reform

A stay issued by a federal court was not well publicized as it came out during the July 4 holiday, but the action could have major implications for the 2025 Medicare Advantage (MA) enrollment season. A federal judge suspended the implementation of the Centers for Medicare and Medicaid Services’ (CMS) MA broker and agent compensation reform changes. The move has major implications for the agency’s efforts to reform what I believe is a badly broken system. What problem did CMS identify? For the past number of years, the number of marketing related complaints have increased dramatically. CMS has attempted to force health plans to have better delegated oversight over the independent third-party marketing organizations (TPMOs) that have grown considerably because of the lucrative nature of enrolling MA members. Agents receive compensation each year a person stays with MA and even more for first-year enrollees. I value the role of agents

Read More »
Logo

July 10, 2024

FTC To Sue Big Three PBMs The Wall Street Journal (WSJ) is reporting that the Federal Trade Commission (FTC) will sue the Big 3 pharmacy benefits managers (PBMs) – United’s Optum, Cigna’s Express Scripts, and CVS’ Caremark — over anti-competitive behavior.  The suits could center on the vertical integration with their sister health plans, which means the PBMs favor corporate-owned pharmacy assets at higher costs to the public. The suit may also challenge rebate deals with brand drug makers and concomitant formulary restrictions. The move likely means more pushes on Capitol Hill to reform PBMs. While some of this may be true, I continue to believe that brand drug makers are the biggest problem in terms of high drug prices. Additional article: https://www.fiercehealthcare.com/payers/wsj-ftc-sue-pbms-over-drug-pricing-tactics #pbms #drugpricing #ftc #antitrust https://www.healthcaredive.com/news/ftc-to-sue-pharmacy-benefit-managers-caremark-express-scripts-optumrx-wsj/72102 Brand New Interoperability Rule Published Even though major new interoperability requirements have yet to go into effect, the nation’s healthcare interoperability regulator,

Read More »
Logo

July 9, 2024

New FTC Investigation Report Targets PBMs In its initial report on an antitrust investigation into the role of pharmacy benefits managers (PBMs), the competitiveness watchdog Federal Trade Commission (FTC) says PBMs have vast power that disadvantages consumers and independent pharmacies. It reports the following: The major PBM lobbying group pushed back on the findings vigorously.  While PBMs need reform and more transparent approaches, I feel the FTC has put the entire onus for high prices and anti-competitive behavior on PBMs and not brand drug makers. The FTC has adopted the same whipping boy mentality as Congress. Additional articles: https://www.fiercehealthcare.com/payers/ftc-report-pbms-may-urgently-require-potential-regulation and https://www.modernhealthcare.com/politics-policy/pharmacy-benefit-managers-pbms-higher-prices-ftc-cvs-cigna-unitehealth and https://thehill.com/policy/healthcare/4762024-federal-trade-commission-report-pharmacy-middlemen-price-hikes/ (Some articles may require a subscription.) #pbms #drugpricing https://www.healthcaredive.com/news/ftc-pharmacy-benefit-manager-investigation-interim-report/720814 Physician Burnout Declining The portion of physicians who report at least one symptom of burnout has dropped below 50%, the first-time since the beginning of the COVID-19 pandemic. #covid #providers #physicians https://www.fiercehealthcare.com/providers/physician-burnout-drops-below-50-first-time-2020-ama-poll-finds Sackler Family May Be Sued By

Read More »
Logo

July 8, 2024

New Wall Street Journal Study To Generate Huge Capitol Hill Focus A Wall Street Journal (WSJ) analysis published today finds that Medicare Advantage (MA) plans filed numerous questionable diagnoses in the risk adjustment program to generate about $50 billion between 2018 and 2021. The WSJ found diagnoses for patients that did not have certain conditions or could not possibly have such conditions. It also found that many conditions were diagnosed at a much higher rate in MA than in the traditional fee-for-service (FFS) prorgam. This adds to numerous other private and public studies that will be fodder for reforms coming from Capitol Hill on MA overpayments. As many of you know, I am a defender of MA and feel that some accusations of overpayments are not accurate.  I do not doubt there are some inaccuracies in what the WSJ found as well.  At the same time, I have said there

Read More »

It Is Time For Site-Neutral Payments In Our Healthcare System

Late last year, the House of Representatives passed a small step toward site-neutral payment policies in Medicare. But the Senate did not pass the bill due to opposition from the hospital industry. Since then, healthcare advocate groups have made a full court press to pass something in 2024. The hospital lobby is strong and has resisted these types of reforms for years. But advocates, health plans, and other parties have made the case that the reform is critical to lowering overall costs in the system as well as rising out-of-pocket costs for everyday Americans. Of course they are right. I have it as a key reform within one of my healthcare reform tenets – price reform. What are site-neutral payment policies? Quite simply, it means paying the same amount for the same service regardless of the place of service or location. Traditionally, outpatient hospital settings have gotten paid far more

Read More »
Logo

July 5, 2024

Brand Pharma Spends More On Stock Buybacks And Marketing Than R&D A report from Accountable, a nonpartisan watchdog group, found that brand drug makers spent more on stock buybacks, marketing, and other related spending than on research and development (R&D). Accountable said the companies spent $95.9 billion on R&D expenditures in 2023, but spent 70% more on stock buybacks, dividends, and marketing and administrative costs. It also found that the companies spent nearly $500 million collectively on executive and board compensation, at least $83.2 million on trade association dues, $10.6 million on political contributions and $57.8 million on lobbying. This is consistent with a report from Sen. Bernie Sanders, I-VT, and Democrats on the Senate HELP Committee. Accountable argues that these are areas that spending could be reduced to offset any potential impact on margins and a commensurate reduction in R&D due to Medicare drug price negotiations. As they always

Read More »

What Does The End Of Chevron Deference Mean For Healthcare?

In an expected move, the Supreme Court ruled that the so-called 1984 Chevron deference under the nations’ regulatory system is no more. It has now thrown the Supreme Court precedent out. It is a technically complex ruling that has major implications for policymaking throughout government. Chevron was not a precedent just for healthcare agencies but applied to every executive department and agency out there – defense, environment, health, commerce, consumer protection and more. The decision split along rather pure ideological grounds, with six more conservative justices lining up against three more liberal ones. The Chevron doctrine said that courts must give deference to reasonable interpretations of regulations issued by regulatory agencies that may be in part based on laws that are ambiguous. In essence, regulators had reasonably wide discretion to interpret what these ambiguous parts of a law meant and if so, how a law might be implemented. Proponents think that Chevron

Read More »
Logo

July 3, 2024

CMS Published Recalculated 2024 Medicare Advantage Star Scores The Centers for Medicare and Medicaid Services (CMS) made public its revised Star scores for 2024 for Medicare Advantage (MA) plans today. The agency will have to fund an additional $1.3 billion after being rebuked by two courts on how it ignored regulations when setting guardrails for 2024. Actuarial firm Milliman says seventy-six MA contracts from 44 insurers (with almost 3.5 million members) saw increased Star scores. (Article may require a subscription.) #medicareadvantage #stars #cms https://www.modernhealthcare.com/medicare/medicare-advantage-star-ratings-recalculation-scan-elevance Application Backlogs And Lagging Redeterminations In Medicaid Healthcare policy advocates are reporting that more states might be falling behind in processing Medicaid applications due to all going on with redeterminations.  The Centers for Medicare and Medicaid Services (CMS) recently said nine states and the District of Columbia will go past the June 2024 deadline for processing redeterminations. (Article may require a subscription.) #medicaid #coverage #redeterminations https://insidehealthpolicy.com/daily-news/latest-unwinding-data-show-states-falling-behind-medicaid-application-processing

Read More »
Logo

July 2, 2024

KFF Analysis Says MA Still Has Highest Margins A Kaiser Family Foundation (KFF) analysis says that the highest gross margins were found in Medicare Advantage (MA) in 2023. At the end of 2023, gross margins per enrollee in MA were $1,982 on average compared to $1,048 in the individual market. Medicaid was the lowest at $753. Group plans fell in the middle at $910. Despite some of the troubles health plan are having with MA right now, the data proves MA is still a good place to be, with high revenues per enrollee and the ability to reduce spending to generate good margins. KFF Analysis: https://www.kff.org/medicare/issue-brief/health-insurer-financial-performance/ #medicareadvantage #healthplans https://www.fiercehealthcare.com/payers/kff-insurance-market-had-highest-gross-margins-last-year Five States Extend Medicaid To Incarcerated Individuals Residents in Illinois, Kentucky, Oregon, Utah and Vermont will receive Medicaid or children’s health insurance coverage prior to release to minimize gaps in insurance coverage. #medicaid #chip #managedcare #coverage #healthcare #healthcarereform https://www.fiercehealthcare.com/payers/hhs-approves-incarceration-transition-coverage-five-states Biden And

Read More »

Available Now

$30.00