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Big Pharma Gets Partial Win in Medicare Drug Price Negotiations Case

The brand drug industry got a partial victory in a Medicare drug price negotiation lawsuit when a federal appellate court partially reversed a Texas federal district court’s decision to dismiss the brand drug lobby’s lawsuit. The higher court said the drug lobby and another entity had standing on a Fifth Amendment claim, but not on others. The district court will now have to hold a full summary judgment briefing on the merits of the plaintiffs’ Fifth Amendment due process claim. This is the only one of numerous claims that Big Pharma has won in its quest to overturn Medicare drug price negotiations.

Additional article: https://www.reuters.com/business/healthcare-pharmaceuticals/challenge-us-drug-price-negotiation-program-revived-by-appeals-court-2024-09-20/

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#drugpricing #ira #branddrugmakers

https://insidehealthpolicy.com/daily-news/fifth-circuit-remands-phrma-infusion-provider-case-against-medicare-drug-price

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Bombshell FTC Lawsuit Against PBMs

The Federal Trade Commission (FTC) unveiled a bombshell lawsuit against the Big 3 pharmacy benefits managers (PBMs) – CVS’ Caremark, Cigna’s Express Scripts, and United’s OptumRx – charging that the PBMs have used formulary placement and rebates to rig the system and disadvantage the American public at the point of sale. The FTC says that the PBMs use the formulary and rebate scheme to line their pockets and to attract business, leaving diabetics dependent on insulin with high prices and often an inability to pay. 

Now I have defended PBMs in the past for some of the good they do. I believe the brand drug makers are the real culprits in the drug pricing problem in America. But I also welcome the lawsuit as we need to change the drug price paradigm. Yes, prices are the main culprit and brand drug makers shoulder that blame. But the perverse rebate system also creates high prices, perverse incentives, a lack of transparency, and often means consumers get little or no benefit of discounts at the point of sale. It also materially impacts the adoption of generics and biosimilars in the market. Those rebates are kept by the PBM, health plans, or employer group clients.

In his years at the White House, Donald Trump had proposed eliminating rebates by changing the anti-kickback statute. While there are pros and cons to doing so, I wonder if the time has arrived to go this road. The current construct can no longer be countenanced.

I am a little disturbed by the sole focus on PBMs as the culprits here. Certainly, brand drug makers bear as much blame here. I do not think the so-called manipulation of the market and anti-competitive behavior is limited to the PBMs, although much of it appears to have begun with exclusionary formularies more than a decade ago. The FTC did put brand drug makers on notice they could be next, but should the FTC have waited if they were not ready to file against the brand drug makers?

I would say that the FTC faces an uphill fight to win given the posture of courts of late. But change needs to happen. The suit alone will shine a new light on the PBM transparency movement and usher forward reforms from Capitol Hill.

There is also the question of corporate responsibility. While some companies have done so, why aren’t more companies demanding in their PBM agreements that rebates get passed through at the point of sale?

PBMs and brand drug makers should get ready for the brave new world of antitrust lawsuits and activity. I think a Harris administration will be very active on this front and a Trump administration may be more active than in the past as well.

Additional articles: https://www.fiercehealthcare.com/payers/ftc-formally-sues-pbms-over-insulin-prices-and-warns-manufacturers and https://www.beckershospitalreview.com/legal-regulatory-issues/ftc-sues-nations-3-largest-pbms-10-notes.html and https://www.managedhealthcareexecutive.com/view/ftc-sues-pbms-for-artificially-hiking-insulin-prices

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#pbms #drugpricing #branddrugmakers #ftc #antitrust

https://www.modernhealthcare.com/legal/express-scripts-optum-cvs-caremark-ftc-complaint-insulin

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Paragon Institute Sees Fraud In Enhanced Premium Subsidies

As Democrats are calling for the extension or permanent adoption of enhanced premium subsidies in the Exchange, the conservative Paragon Institute is arguing that the enhanced premium subsidies are creating fraud as enrollees and/or brokers misrepresent income to get better subsidies.

They say this is occurring very much in the 100% to 150% of the federal poverty level (FPL) income group, where free premiums are offered under the enhancement. Paragon says the original subsidies should be put back in place to lessen fraud. In addition, Paragon says small business coverage has eroded since the enhanced subsidies have been in effect.

There is fraud going on in the program, with brokers illegally signing people up or changing their plans. But Paragon is now raising a different issue of fraud – the true misrepresentation of income.

Paragon also raised a possible compromise. While it wants to return to the less-generous law as its preferred option, the Paragon president did suggest that existing enrollees could be grandfathered into the higher subsidies.

I favor some extension of the enhanced premium subsidies. While I do think they have become far too generous at the lower end of the income scale, no one can debate the benefit of the surge in coverage due to the enhancements. Upfront coverage is good. At the same time, no one wants fraud in the program. Perhaps a short-term grandfather may be a good compromise here so that all the issues can be sorted out and we ensure an accountable system.

(Article may require a subscription.)

#aca #obamacare #exchanges

https://insidehealthpolicy.com/daily-news/paragon-alleges-there-fraud-aca-plans-dems-push-aptc-extension

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Near Final Medicaid Redetermination Data In

The Kaiser Family Foundation (KFF) has done a great public service tracking and explaining the fallout over the reintroduction of Medicaid redeterminations. While some states will carry out remaining redeterminations into 2025, we are nearing the end of the journey.

About 25 million people were disenrolled for some period of time since redeterminations began again in April 2023. There is some good news and bad news to the near-end of this redetermination story. The pause in redeterminations during the pandemic allowed rolls to grow in Medicaid and children’s health insurance to 94 million. Even with losses, almost 10 million more people are covered now than before the pandemic. At the same time, 13 million have lost Medicaid coverage since the peak. Many but not all have gained coverage in other ways.

Kaiser Family Foundation press release: https://www.kff.org/medicaid/press-release/as-medicaid-unwinding-concludes-in-most-states-kff-finds-25-million-lost-medicaid-coverage-but-enrollment-is-10-million-higher-than-pre-pandemic-levels/

#medicareadvantage #walmart #humana #primarycare

https://www.beckerspayer.com/leadership/why-centerwell-is-moving-into-walmart.html?utm_medium=email&utm_content=newsletter

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Fireworks At Senate Finance Hearing On Healthcare

Fireworks erupted at the Senate Finance hearing on various healthcare issues. Supporters of the Inflation Reduction Act’s (IRA) Medicare drug price negotiations say it is a good first step and will reduce drug costs in the country. Opponents argue it will impact innovation and Part D changes will increase premiums.

Others attacked GOP VP candidate J.D. Vance’s explanation of what a Trump Obamacare repeal may look like – principally setting up risk pools for those who are sick. On enhanced premiums, many support their extension, but the GOP discussed the huge price tag.

Both parties seemed to favor pharmacy benefit manager reform.

#healthcare #election2024 #healthcarereform

https://www.fiercehealthcare.com/payers/lawmakers-policy-experts-spar-over-inflation-reduction-act

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JD Vance Seemingly Flips on Obamacare And Says Trump Has A Repeal Plan

As a senatorial candidate and even as a senator, GOP VP nominee JD Vance poo-pooed the idea of repealing the popular Affordable Care Act (ACA). He argued the program was helping many working Americans. It was a compassionate argument that many viewed as novel in the GOP.

But on a Sunday news show, Vance said that Trump has a repeal plan and its cornerstone appears to be the old conservative policy of removing sicker populations from most insurance and putting them in high-risk pools. Despite Vance saying people would be protected, it certainly raises the issue of what happens to people with pre-existing conditions – both from a coverage and affordability standpoint.

Such high-risk pools rarely worked as they did not protect patients with pre-existing conditions, were not funded correctly, and had exorbitant premiums. The GOP argues that community rating as introduced in Obamacare hurts healthier people by driving up premiums. But what they forget is that is how employer coverage works.

Healthcare will be a swing-state issue and Vance’s comments now will be used as campaign fodder by the Harris campaign – very appropriately as it is such a terrible policy. I will have a blog next week on the subject.

Additional article: https://thehill.com/homenews/4880616-jd-vance-donald-trump-health-care/

#aca #obamacare #aca #exchanges #trump #vance #election2024 #harris

https://thehill.com/policy/healthcare/4882811-vance-health-insurance-high-risk-pools/

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Medicare Drugs Prices Analyzed

A good article in Health Affairs Forefront analyzes the final prices of the ten drugs subject to Medicare drug price negotiations for 2026. The analysis shows that savings are indeed achieved on a net basis when taking into account Part D rebates. However, the data also show that the new prices are far above net prices in other developed countries.

As I have argued, Medicare drug price negotiations amount to a cautious start. As the authors also note, the best prices CMS can negotiate are for those drugs that have close therapeutic alternatives or substitutes.

The authors also suggest that an ancillary benefit of the negotiation law is the publication of net prices.  This could now drive changes in other lines of business.

(Article may require a subscription.)

#drugpricing #ira #branddrugmakers

https://www.healthaffairs.org/content/forefront/medicare-negotiation-tells-us-drug-pricing-u-s

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Key Republican Dismisses Idea ACA Could Be Repealed

At the recent presidential debate, Donald Trump declared that he was still open to repealing the Affordable Care Act (ACA). Admittedly, he is much more measured in his views on the ACA now. He tries to stress that the ACA would only be repealed if a plan were developed to make coverage better. He as of yet has not unveiled a plan.

But prominent congressional Republicans again are throwing cold water on the prospect of any repeal.  Sen. Bill Cassidy, R-LA and currently ranking member on the Senate HELP Committee, dismissed the idea that the ACA would be repealed by Congress. And Republicans are likely to take control of the Senate. Cassidy would lead the HELP committee. Along with the Finance Committee, HELP is a committee of cognizance over healthcare matters. Cassidy stressed that comprehensive healthcare reform would have to be bipartisan. He noted that repealing the ACA would be a non-starter for Democrats.

(Article may require a subscription.)

#aca #obamacare #exchanges #medicaid #election2024 #trump #healthcarereform

https://www.statnews.com/2024/09/11/bill-cassidy-affordable-care-act-repeal-site-neutral-payment-policy-healthcare/

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Too Many Medicare Pilots

A great article in the Health Affairs Forefront Blog discussing the proliferation of traditional Medicare pilots testing alternative payment schemes. The authors find that there are more than 30 different payment program schemes, including accountable care organizations (ACOs). They also note that the Congressional Budget Office (CBO) finds that, of the $7.9 billion spent to operate pilot health care payment models between 2011 and 2020, only $2.6 billion in savings were realized.

The authors point out the government and system take on huge administrative complexity each time a new pilot is added. They recommend simplifying Part B payment model options and streamlining into a limited set of whole-person, population-based models.

Well said. I have argued the same on these pages.

(Article may require a subscription.)

#acos #medicare #providers #cms

https://www.healthaffairs.org/content/forefront/medicare-part-b-clinician-payment-programs-and-growing-costs-administrative-complexity

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Uninsured Rate Remains Steady

Despite major erosion in Medicaid coverage, the census bureau announced that the uninsured rate remained steady in 2023 at about 8%. Experts say that it appears that most of those disenrolled either regained coverage in Medicaid or enrolled in other coverage. The rate also benefited from a generally good economy and strong private coverage.

At the same time, the Biden administration announced that 50 million have taken advantage of the Affordable Care Act (ACA) since its passage in 2010. I am surprised that the numbers have not increased, but I do expect them to do so in the future.

Further, Democrats are pushing for a vote this year to make permanent the enhanced premium subsidies that are set to expire Dec. 31, 2025. The Congressional Budget Office (CBO) says the cost would be $335 billion over 10 years, plus $48 billion in net interest outlays.

Additional articles: https://insidehealthpolicy.com/daily-news/uninsurance-rate-sticks-record-low-admin-says-50m-have-used-exchanges and https://insidehealthpolicy.com/health-insider/congress-returns-facing-cr-uncertainty-harris-trump-debate-deck and https://www.nytimes.com/2024/09/10/us/politics/affordable-care-act-marketplaces-enrollment.html

(Some articles may require a subscription.)

 #aca #obamacare #exchanges #medicaid

https://kffhealthnews.org/news/article/uninsured-rate-stable-2023-medicaid-unwinding-census/

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