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Biden Administration Announces First 10 Negotiated Medicare Drug Prices

In a coup for the Biden administration, all manufacturers of the ten drugs subject to negotiation for 2026 either agreed to prices or decided to stay in the Medicare prorgam when a price was imposed. The administration and the Centers for Medicare and Medicaid Services (CMS) say that, if the new prices had been in effect last year, Medicare would have saved an estimated $6 billion, or approximately 22 percent, across the ten selected drugs. The negotiated prices range from 38 to 79 percent discounts from list prices.

About nine million people with Medicare use at least one of the ten drugs. In addition to government savings, Medicare beneficiaries with prescription drug coverage will see savings of $1.5 billion in their personal out-of-pocket costs in 2026.

The drugs accounted for $56.2 billion in Medicare spending, or about 20 percent of total Part D gross spending in 2023.

The Congressional Budget Office (CBO) estimated $100 billion in savings over 10 years from drug negotiations, and a $3.7 billion savings in the first year. So the first-year negotiations could save more.

The journey for Medicare drug price negotiations (passed as part of the Inflation Reduction Act) continues with CMS selecting up to fifteen more drugs covered under Part D for negotiation for 2027 by February 1, 2025. This will continue with up to fifteen more drugs covered by Part B or Part D for 2028, and up to 20 more Part B or Part D drugs for each year after that.

The real issue is while savings from the list prices are between 38 and 79 percent, what will the net savings be? Because prices are now set, brand drug makers will no longer give rebates to the pharmacy benefits managers (PBMs) at the level they did before if at all. But based on estimates of rebates, the final pricing is still a substantial savings. Before the announcement, analysts at JPMorgan suggested the negotiated prices could be on average 40% lower, which is greater than the 22 percent announced by CMS. Still, PBMs often keep portions of rebates, consumers don’t see the rebate relief at the point of sales, and this provides for a much more transparent model more along the lines of generic drugs.

Other concerns revolve around whether pharmacy benefits managers could restrict access to the drugs in favor of others with rebates. CMS says it will use a comprehensive formulary review process to prevent this abuse that would undermine patient access.

CMS announcement materials: https://www.cms.gov/newsroom/press-releases/negotiating-lower-drug-prices-works-saves-billions and https://www.cms.gov/newsroom/fact-sheets/medicare-drug-price-negotiation-program-negotiated-prices-initial-price-applicability-year-2026 and https://www.cms.gov/files/document/fact-sheet-negotiated-prices-initial-price-applicability-year-2026.pdf

Additional articles: https://www.modernhealthcare.com/politics-policy/biden-medicare-drug-price-negotiations-pharmaceutical-costs-abbvie-merck-amgen and https://www.healthcaredive.com/news/medicare-drug-price-negotiations-results/724320/ and https://www.beckershospitalreview.com/pharmacy/cms-negotiated-drug-prices-12-notes.html and https://thehill.com/homenews/4829155-medicare-drug-price-negotiations/ and https://thehill.com/policy/healthcare/4828633-medicare-negotiations-6-billion-savings/ and https://www.managedhealthcareexecutive.com/view/questions-remain-about-whether-negotiated-drug-prices-will-save-money and https://www.managedhealthcareexecutive.com/view/hhs-releases-prices-for-medicare-negotiated-drugs and https://insidehealthpolicy.com/daily-news/cms-drug-negotiations-beat-cbo-expectations-price-cuts-38-79-percent

(Some articles may require a subscription.)

#ira #drugpricing #branddrugmakers #medicareadvantage #partd #pdp #cms

https://www.fiercehealthcare.com/regulatory/cms-negotiated-drug-prices-would-have-saved-medicare-6b-last-year

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Politico Raises Issue Of CMS Premium Stabilization Demonstration For Medicare Part D PDPs

The mainstream media is finally covering the potential October Surprise for Democrats. There are possible huge increases in standalone Medicare Part D (PDP) premiums due to the transfer of costs to plans from the government and member out-of-pocket cost reductions in the Inflation Reduction Act (IRA). The Politico article lays it out well.

The Centers for Medicare and Medicaid Servies (CMS) created a last-minute demonstration to blunt the impacts and the GOP is accusing Democrats of using the U.S. Treasury for political purposes. I continue to doubt that CMS has the authority to do this.  It usurps Congress’ control. I raised this issue in two blogs several weeks ago (July 24 and July 25) here: https://www.healthcarelabyrinth.com/will-democrats-be-victim-of-an-october-surprise-of-their-own-making/ and https://www.healthcarelabyrinth.com/part-d-premium-woes-due-to-the-inflation-reduction-act/ .

In addition to the PDP premium hikes, Medicare Advantage (MA) plans are expected to have benefit cuts for a number of reasons, including the IRA changes and rate reductions.

Additional article: https://www.beckerspayer.com/payer/the-perfect-storm-facing-medicare-recipients-during-enrollment-season.html

#election2024 #medicareadvantage #partd #pdp #ira

https://www.politico.com/news/2024/08/13/biden-adiminstration-medicare-drug-premiums-spike-00173308

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AHIP To Go On Offensive On Medicare Advantage

With Medicare Advantage (MA) facing huge financial difficulties due to lower rates and crippling government regulatory changes, AHIP, the health plan lobby, is underwriting a seven-figure lobbying and advertising campaign to call attention to the challenges, obtain higher rates, and explain the major benefits for Medicare enrollees.

Additional article: https://subscriber.politicopro.com/article/2024/08/top-health-insurance-group-outlines-plans-to-protect-medicare-advantage-00173713

(Some articles may require a subscription.)

#medicareadvantage

https://www.beckerspayer.com/payer/payers-plan-medicare-advantage-lobbying-blitz.html

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PhRMA Attacks FDA Licensing Affordability Proposal

PhRMA, the brand drug manufacturer lobby, is attacking the National Institutes of Health’s (NIH) proposal to tie its licensing process to drug affordability in the United States once products hit the market. The proposal would tie U.S. prices to those in other developed countries.

PhRMA argues that it would discourage collaboration by the private sector with NIH. “History demonstrates that placing unreasonable terms on licensing agreements diminishes willingness to engage in public-private partnership,” PhRMA said.

But there is nothing wrong with the government tying affordability to any collaboration with the government. So much of what the drug industry eventually markets is tied to government innovation and funding.  The proposal is not unlike march-in rights on patents, which is something to consider as well. It also ties to Medicare drug price negotiations.

Let’s remember: the drug market is not a free market and needs reform.

(Article may require a subscription.)

#drugpricing #nih #fda #branddrugmakers

https://insidehealthpolicy.com/inside-drug-pricing-daily-news/phrma-nih-s-plan-limit-price-licensing-will-chill-collaboration

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What Do Q2 Insurer Investor Calls Tell Us?

Q2 2024 investor calls are coming to a close and we see mixed results on the part of insurers. Some insurers, such as Cigna (commercial-dominate, Alignment Healthcare (Medicare Advantage (MA)- dominant), Clover Health (MA-dominant), and Oscar Health (Exchange-dominant), have bucked negative trends.

On the other hand, CVS Health, Humana and Centene have been hurt by Medicare and Medicaid rates and cost pressures.

United remains dominate, but also reported cost pressures and costs from the Change Healthcare cyberattacks.

Elevance Health appears to be performing among the best, growing its services line and mitigating government program pressures with strong commercial performance.

#healthplans #insurers #healthcare #earnings

https://www.fiercehealthcare.com/payers/medicaid-ma-headwinds-pressure-payers-q2-heres-look-how-major-companies-fared

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GOP On Attack On Questionable CMS Part D Demonstration

The GOP is on the attack over the Centers for Medicare and Medicaid Services’ (CMS) announcement of a demonstration project to stabilize 2025 Part D premiums. CMS hurriedly put together the demo after it saw huge increases in Part D premiums come in during the 2025 bid cycle. This was due to the Inflation Reduction Act’s (IRA) shifting of huge costs from the government to health plans and out-of-pocket cost reductions. CVS, the biggest standalone Part D plan, apparently recommended that CMS create the program, although one already exists in law covering just a piece of the benefit.

The conservative Paragon Health Institute says the program could cost $10 billion over three years to limit premiums by bailing out insurers. The IRA approach on Part D was flawed and the public will be hurt by high premiums, but I continue to feel the demo is extra-regulatory and extra-legal.

(Article may require a subscription.)

#partd #pdp #medicareadvantage #premiums #medicare #drugpricing

https://insidehealthpolicy.com/daily-news/conservative-pressure-against-cms-medicare-part-d-demo-mounts

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CVS Struggles Financially; Undertakes $2 Billion In Cost-Cutting

CVS slashed its full-year guidance in its Q2 investor call and has begun a multi-year initiative to generate as much as $2 billion in savings. CVS has been hit by very high utilization in its Medicare Advantage (MA) line and plans to shed about 10% of its Medicare lives in 2025. Its overall medical loss ratio (MLR) is about 90% through 1H 2024.

Its Aetna line is performing so poorly that it terminated its recently-hired Aetna president and CVS Health CEO Karen Lynch will take over day-to-day control. She formerly was president of the unit and knows it well. CVS missed its revenue target but exceeded its margin expectations with $1.8 billion in Q2. CVS’ MA line has negative margins now, but the benefit reductions and contraction it plans in 2025 will return it to 4% to 5% MA margins over time. Lynch also committed to vigorous education and defense of its pharmacy benefits manager.

Additional articles: https://www.fiercehealthcare.com/payers/cvs-ceo-karen-lynch-take-helm-aetna-amid-ongoing-utilization-spike and https://www.modernhealthcare.com/finance/cvs-health-earnings-aetna-president-brian-kane-ceo-karen-lynch and https://www.healthcaredive.com/news/aetna-president-out-cvs-medicare-advantage-woes/723513/ and https://www.beckerspayer.com/payer/cvs-second-half-of-2024-could-be-even-worse-for-medicare-advantage.html and https://www.beckerspayer.com/executive-moves/aetna-president-out-after-disappointing-financial-results.html and https://www.beckerspayer.com/payer/payers-pledge-defense-of-their-pbms.html

(Some articles may require a subscription.)

#medicareadvantage #partd #aetna #cvshealth

https://www.fiercehealthcare.com/payers/cvs-kicks-multiyear-2b-cost-cutting-effort

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Republicans Ask GAO If CMS’ Proposed Part D Premium Stabilization Program Is Legal

A group of House and Senate Republicans are asking the congressional Government Accountability Office (GAO) if the Centers for Medicare and Medicaid Services’ (CMS) proposed additional premium stabilization program for standalone Part D (PDP) plans is legal. CMS announced the creation of the program after it received bids that showed premiums would skyrocket despite some protections in the Inflation Reduction Act (IRA).

The Part D changes in the IRA were much touted as protecting consumers by lowering out-of-pocket (OOP) costs. It also shifted huge costs to plans. These changes were not adequately funded by the government and thus plans had to reduce benefits in other areas and increase premiums. CMS was caught flat-footed and quickly created the program recently to avoid an October Surprise during open enrollment. I have issues with whether CMS has the statutory authority to do this despite broad waiver authority. It will further deplete sparse Medicare funds.

The GOP lawmakers asked the GAO whether the new demo is consistent with the law, to investigate what budgetary analysis CMS did when developing the program, to determine the projected costs, and whether it meets budget neutrality requirements.

See my earlier blogs on this subject: https://www.healthcarelabyrinth.com/part-d-premium-woes-due-to-the-inflation-reduction-act/ and https://www.healthcarelabyrinth.com/will-democrats-be-victim-of-an-october-surprise-of-their-own-making/ .

(Article may require a subscription.)

#medicareadvantage #pdp #partd #cms #ira

https://insidehealthpolicy.com/daily-news/gop-asks-gao-whether-cms-part-d-premium-stabilization-demo-legal

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Another Devastating Piece From The Wall Street Journal On Medicare Advantage

Yet another piece from The Wall Street Journal (WSJ) is bound to generate huge attention on Capitol Hill and among regulators. In its latest expose on Medicare Advantage (MA) finances, WSJ finds that MA home visits’ diagnoses for risk adjustment generated $15 billion in extra pay from 2019 to 2021. WSJ says nurses are pushed to make diagnoses the patient does not have and such diagnoses are never treated by hospitals or physicians. A July article found that $50 billion in overpayments occurred from 2019 to 2021 tied to risk adjustment submissions not treated by healthcare providers.

I am a supporter of MA, but I have made the case that a small number of bad actors are generating a huge amount of overpayments and giving all plans a bad name. I have told plans to expect that the Centers for Medicare and Medicaid Services (CMS) will eventually bar health risk assessment visits as well as manual chart review submissions for encounter data. I think this is fair and reasonable. See my blog on the subject here: https://www.healthcarelabyrinth.com/will-cms-rein-in-risk-adjustment-submissions/.  And my related podcast here: https://www.healthcarelabyrinth.com/25-ma-plans-should-ready-for-changes-to-risk-adjustment-submissions/ .

WSJ article (needs subscription): https://www.wsj.com/health/healthcare/medicare-extra-payments-home-visits-diagnosis-057dca8b

Additional article: https://www.beckershospitalreview.com/care-coordination/insurers-push-diagnoses-during-at-home-visits-bringing-in-billions-wsj.html

(Some articles may require a subscription.)

#medicareadvantage #riskadjustment #radv #overpayments

https://www.beckerspayer.com/payer/medicare-advantage-plans-collect-billions-through-home-visits-wsj.html

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State Affordability Boards Taking On Drug Makers Where The Feds Have Failed

Frustrated by high drug prices and inadequate policy changes at the federal level (save for slow-moving Medicare drug price negotiations), states are setting up drug affordability boards that can have vast powers to reduce drug costs. This includes setting an upper limit for sales in their state for certain coverage and the uninsured. This is similar to the Medicare drug price negotiations.

Due to federal pre-emption, these boards only apply to commercial plans. Medicaid has a federal rebate law that allows for federal and state rebates. Medicare is not covered as private plans negotiate prices with drug makers through pharmacy benefits managers or directly. Under the self-insured employer ERISA law, employer groups appear to be able to opt in and thus this has been built into some state laws.

 So far, eleven states have approved establishing drug affordability boards, and about a dozen more are considering doing so. Drug makers are suing, claiming the boards are unconstitutional and override several federal laws and due process.

#drugpricing #ira #branddrugmakers #employercoverage #erisa

https://www.managedhealthcareexecutive.com/view/states-are-setting-up-affordability-boards-to-rein-in-drug-costs

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