Randy Vogenberg, PhD

Centers for Medicare & Medicaid Services releases draft guidance for the second cycle of Medicare Drug Price Negotiation Program, aiming to lower drug costs and improve access for Medicare beneficiaries through price negotiations. Read at The Evidence Base® #heor #healtheconomics #marketaccess #pharma #biopharma #hta #healthtechnologyassessment #healthdata #healthequity #healthpolicy #inflationreductionact #drugpricing

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Adding to the #benefits craziness, did you fully understand what just happened in Michigan for GLP-1 coverage? See the post from #epcouncil.org as it illustrates why you have to fully read what is going on along with who may be effected as a plan sponsor or employee member. Focusing on short-term issues without a long-term #strategicplan gets a #fiduciary in trouble.

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MA: The "STAR" of the show. Silly me, given my recent articles on benchmarking and bidding in Medicare Advantage (MA) as well as the recent stargate fiasco that is happening this year, I thought I’d write a brief article that explains the basics around the star ratings. Well, just like those other topics, the details are super complicated and confusing. 2024 Star Ratings represent services provided in 2022, but don’t impact payments until 2025 and the technical notes include words and phrases like “clustering,” “relative distribution” and “Tukey outer fence outlier deletion.” So instead of a superficial overview, I am making the mistake of taking a deep dive into Star Ratings. I apologize in advance for pulling you down this rabbit hole with me. Given the extent of the information, I’m choosing to start off by sharing it in bite sized pieces and will then post the whole thing in its entirety once I’m finished. Let's start off with...Why do we even have Star Ratings? As you know, in Medicare Advantage, private health plans are paid a fixed monthly amount for each of the Medicare beneficiaries that are signed up with their plan. Given the number of options an individual beneficiary may have to choose from, CMS wanted to help them choose the best plan for them and not just incentivize plans to provide high quality care, but to facilitate growth in the best performers. At a high level, the Star Rating system has two impacts: a guide to consumers choosing among MA plans and as a factor in determining MA plan payments. It is important to remember that there is no real quality data for Traditional Medicare, so star ratings only enable comparisons between MA plans and not between MA and Traditional FFS Medicare. #MA #Medicare #Stars #Tukey

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Cigna Group allegedly exaggerated the health conditions of its enrollees to fraudulently obtain hundred of millions in federal funds. Read more: https://direc.to/fhHz Cigna Group significantly impacts healthcare today by expanding its pharmacy and medical customer base, as evidenced by a 25% increase in pharmacy customers and a growth in medical customers. Additionally, Cigna's involvement in healthcare trends and innovations, such as the Better Care Bulletin, showcases its role in improving health outcomes and integrating technology in healthcare. The HHS Office of Inspector General (HSS-OIG) combats healthcare fraud through rigorous oversight, investigations, and audits. It collaborates with the Department of Justice (DOJ) to enforce laws and impose penalties on fraudulent activities, as seen in actions against the Center for Medicare and Medicaid Services (CMS) fraud. #unitedseniorassociation #USA #eldercare #FDA #seniorliving #ADA #AI #NIH #patientcare #compliance #hospitals #OIG #healthcare #HHSOIG #digitalhealth #HSS #CMS #assistedliving #nursinghomes #seniorcare #medicare #seniorcitizen #homehealthcare #caregiver #dementia #inhomecare #seniorhealth #kloekorby #alzheimers #mentalhealth

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Many thoughts as Medicare Advantage continues to come under scrutiny. - MA has features of a value-based program, but most of the current "value" is being delivered through diagnosis capture and complexity payments. Ironically, much like FFS, it pays more to keep people sick (or make them look sick). Don't think that's anyone's definition of value. - To be fair, most doctors (especially specialists) don't do a great job of capturing diagnosis and patient complexity beyond their immediate area of expertise. (We're especially bad at this in MSK). We should have accurate representation of a patient's health in the medical record. Complexity and co-morbidities affect treatments and outcomes. We don't yet have a good way to account for this complexity -- and it's becoming clear the MA system isn't it. - EMRs make all of this worse. It's both too easy and too hard to record, change, or resolve diagnoses. EMRs should facilitate accurate complexity capture and treatment personalization. The goal shouldn't be to increase billing, it should be to increase sophistication and precision. - As MA scrutiny grows, the business model of many alternative care models (especially in primary care) will be challenged (potentially dealing another blow to retail healthcare). - CVS' purchase of Signify health is put into full context by this article. - It boggles the mind that CMS can develop and administer a program that nets billions for inscos (at the expense of taxpayers) while reducing physician reimbursement yearly and rolling out ineffective VBC programs for providers. CMMI should have an open-door policy for anyone delivering care and working on true value-based models. Ears, eyes, and minds should be wide open. h/t Mahek Shah MD, MBA Moby Parsons, MD #medicine #healthcare #vbc #valuebasedcare #health

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Why do UnitedHealth's #MedicareAdvantage patients have a 15x higher rate of diabetic cataract diagnoses versus the general population? Hint: the vast majority of them don't actually have diabetes. Some don't even have cataracts. But each one of these diagnoses adds $2863 to the insurer's bottom line each year. This WSJ article uncovered a similar story for HIV, AFib, and Parkinson's, across many MA plans (not just from United). CMS administrators won't admit this in public, but Medicare Advantage's risk adjustment formula is basically a license to steal. CMS shouldn't be paying for things that it can't effectively police. #ethicalhealthcare #hippocraticcapitalism #healthcarefraud

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Thank you for sharing, Jeanmarie Loria, MBA, PMP, CPC ! Medicare Advantage Challenges: Higher Spending: While some argue MA plans deliver efficient care, studies show they sometimes receive higher payments from Medicare than traditional Medicare spends on a similar beneficiary. This raises concerns about overall program sustainability. Potential for Skimping on Care: There are worries that MA plans might focus on enrolling healthy beneficiaries and avoid sicker ones who require more expensive care. This could lead to an uneven distribution of costs between traditional Medicare and MA. Limited Choice for Beneficiaries: While MA plans offer additional benefits like vision or dental, they may have narrower networks of providers compared to traditional Medicare. This could limit beneficiary choice, especially in rural areas. The Spending Dilemma: Rising Costs: The popularity of MA plans is a double-edged sword. While it offers beneficiaries more choices, it also increases overall Medicare spending. This is because MA plans are paid based on a beneficiary's diagnosis, and some argue they may be upcoding diagnoses to receive higher payments. Long-Term Sustainability: The increasing cost of MA raises concerns about the long-term sustainability of the Medicare program. Potential Solutions: Monitoring Consolidation: Policymakers could scrutinize mergers and acquisitions in the healthcare industry to prevent excessive concentration. Reevaluating MA Payments: There could be reforms to the way MA plans are paid by Medicare, ensuring they receive appropriate funding based on the actual cost of care provided. Promoting Transparency: More transparency is needed regarding how MA plans spend their money and the quality of care they deliver. The issue of consolidation and MA spending is complex, with both benefits and drawbacks. Finding the right balance to ensure a competitive market, quality care, and program sustainability is an issue.

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An overview of the April 22, 2024, #CMS #Medicaid #ManagedCare Final Rule focused on the #financial requirements is now available. Mercer US Government's Nicole Kaufman and Charles Greenberg review the financial topics, including #ILOS, #SDPs, #MLRs and comparative #rate analyses. References to #MCOs include Prepaid #Inpatient Health Plans and Prepaid #Ambulatory Health Plans. Read the review here and download the full PFD: https://lnkd.in/d_RQt754

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#HRSA Punts on the “Patient Definition”—Again The Final #340b #ADR Rule punts on the patient definition, even though #drug makers pressed for clarity. Where manufacturers hoped that HRSA would leverage the Rule to fix the damage done by the Genesis case, the agency categorically refused. Having failed to appeal the Genesis case, HRSA has now missed a ready made opportunity to limit the resulting damage. #Drug Makers Press: As HRSA acknowledged in summarizing the comments, “[m]any manufacturers …objected to the lack of an explicit definition in the proposal for the terms ‘patient’ or ‘diversion’”. In offering that summary, however, OPA carefully avoided any reference to the Genesis case or the court’s decision, which held that Genesis need not have been responsible for the prescription of a drug to claim a discount on it. Without referencing the source of drug maker concerns, HRSA did state that manufacturers specifically asked the agency to “revise and clarify its current [1996 patient definition] guidance”. Drug makers tied the “patient definition” issue to the need “to strengthen administration of the 340B Program, including the 340B ADR process and the parties' ability to work together to resolve disputes in good faith”—all items clearly at the core of the proposed rule Having None of It: Despite the Genesis problem, HRSA slapped the drug maker request for clarification to the side. “Revision of the 1996 patient definition guidance,” HRSA flatly declared, “is outside the scope of this rule.” That answer is incredibly unsatisfying, reflecting an utter failure to use an available regulatory power to address a core threat to the program. What Did HRSA Say?: Not much. Instead of giving guidance on what the material connection must be between a patient, a CE, and a discounted drug, HRSA fell back on a description of its intended procedure: “When a #diversion claim is presented before a 340B ADR Panel, the Panel will follow the 340B statute and all applicable regulations, and consider 340B policies and guidance documents”. Interestingly, that statement doesn’t include any reference to case law, such as the Genesis case. Drug makers hope that omission is telling. But, putting that to the side, HRSA merely offered “[e]xamples of a diversion claim that may be submitted” to ADR. Specifically, HRSA referenced “(1) transferring of covered outpatient drugs to a patient where there was no record of the individual's health care or no provider relationship or (2) transferring covered outpatient drugs to an individual who is an inpatient”. In other words, by offering these “examples”, HRSA stuck to obvious scenarios, steering clear of any of the Genesis issues, whether a CE must be responsible for the prescription or at least for the treatment of the underlying condition. Bottom Line: The Rule could have plugged the gaping hole in the current “patient definition”, but HRSA took a pass, abdicating its regulatory responsibility.

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Remote physiologic monitoring #RPM use increased by more than 1,300 percent from 2019 to 2021 in #Medicaid, and use varied tremendously by state (~50X differences in adoption rates across states). This is the first study of remote monitoring adoption in Medicaid - just published in Health Affairs with my colleagues Nathan Pauly and Puja Nair. Read more here: https://lnkd.in/e_gxbxTZ

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well worth the read if you are in managed healthcare.

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Reason #8 why geographic restrictions are bad policy for #340B contract pharmacies. Complexity of management with geographic areas. Covered Entity patients move frequently, and covered entities often have sites that are hundreds of miles from a covered entity “headquarters”. Geographic restrictions on the location of the pharmacy or the patient are overly complex to administer and not beneficial to covered entities. Many covered entities have migrant farmworker programs that even account for mobile populations. Health Resources and Services Administration (HRSAgov), HHS Centers for Medicare & Medicaid Services National Association of Community Health Centers (NACHC) PhRMA #340B #CoveredEntities Advocates for Community Health

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An Outpatient Clinical Documentation Improvement (CDI) program offers substantial advantages to healthcare organizations by elevating patient care and operational efficiency. By integrating risk stratification with chronic conditions, enhancing quality measures, addressing social determinants of health, and establishing a collaborative team empowered by technology, such strategic initiatives result in improved patient outcomes and streamlined operations.

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***Drug Pricing*** The Centers for Medicare & Medicaid Services (CMS) is rapidly advancing its drug price negotiation program following the release of draft guidance for the next cycle of its price-setting scheme. Established under the Inflation Reduction Act, this plan aims to reduce costs for 10 Medicare Part D drugs by 2026 and an additional 15 drugs by 2027. Key Elements: 📢 Consideration of manufacturer-reported data and alternative treatments in developing initial offers. 📢 Collection of patient-focused information on selected drugs. 📢 Process for offer and counteroffer exchanges between CMS and drug companies. 📢 Data exchange requirements among pharmacies and drug companies via a Medicare Transaction Facilitator (MTF). 📢 Solicitation of public comments on various elements, including the MTF's payment facilitation functionality. The guidance provides new details on implementing the maximum fair price (MFP) for selected drugs and introduces the use of a Medicare transaction facilitator (MTF) to streamline data and payment exchanges among pharmaceutical supply chain entities, ensuring that drug prices are correctly dispensed to eligible individuals. CMS is soliciting public feedback on this guidance until July 2. Early responses highlight the extensive responsibilities placed on drugmakers and pharmacies to ensure compliance with the MFP. The draft guidance outlines requirements and parameters for the second cycle of negotiations for the Medicare Drug Price Negotiation Program and includes information on CMS support for manufacturers to implement MFPs in 2026 and 2027. Comments on the draft guidance for the initial price applicability year 2027 and the implementation of negotiated MFPs for 2026 and 2027 are being accepted for 60 days. Submissions should be sent to IRARebateandNegotiation@cms.hhs.gov with the subject line “Medicare Drug Price Negotiation Program Draft Guidance.” Comments received by 11:59 PM Pacific Time on July 2, 2024, will be considered. CMS will review the feedback and issue final guidance for the 2027 initial price applicability year and the implementation of the MFP in 2026 and 2027. ----- Cardinal Health Merck Novartis Siemens Healthineers American Hospital Association Daiichi Sankyo US Takeda Roche McKesson Cencora Bridge Oncology John Hennessy Blake Madden OncoHealth

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Speak Up! Comments due by July 1st on the draft CMS guidance related to Maximum Fair Price (MFP) and its interaction with 340B. There is a huge flaw... nay, intentional and misguided policy that is clearly the result of powerful lobbying efforts by those that profit from the 340B racket. CMS is requiring that covered entities dispensing drugs subject to the MFP voluntary report 340B claims. This approach is fundamentally inadequate, not only undermining the effectiveness of drug pricing reforms but also inviting exploitation. The voluntary nature of this system allows covered entities, such as hospitals, to potentially manipulate the pricing benefits to their advantage. Since there is no compulsory mechanism to report whether a drug sold at a discount is under the 340B or MFP, these entities can feasibly claim discounts under both programs for the same drug—without sufficient checks. This loophole is not just a gap; it's a wide-open door for financial misuse, allowing covered entities to "double-dip" at the expense of patients, manufacturers and, ultimately, the taxpayers. And you know that I am no apologist for pharma. But in this case, the manufacturers seem to have had the less effective lobby, as they are put in a rather precarious position. Without a reliable way to verify the eligibility of sales under 340B and MFP, they are at a heightened risk of financial losses and increased regulatory complexity. The lack of mandatory reporting leads to a non-transparent system where accountability is all but absent. Transparency and accountability must be non-negotiable elements of our healthcare system; yet they continue to be put on the chopping block and up for bid to the highest political spender or most influential lobby.

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It’s full steam ahead in the US towards an interoperability. We will be speaking to John Halamka, M.D., M.S. Steven Posnack and Paul Wilder at our Health Services Daily Connected Care Summit to find out more about the work they are doing in the US and the outcomes it is delivering. #onc #21stcenturycuresact These new certification criteria, which would improve public health response and advance the delivery of value-based care, focus heavily on standards-based application programming interfaces to improve end-to-end interoperability between data exchange partners (health care providers and public health organizations or payers). The health IT for public health-oriented certification criteria were developed in tandem with the Centers for Disease Control and Prevention (CDC) to support its ongoing Data Modernization Initiative. Similarly, the health IT for payer-oriented certification criteria were developed in coordination with the Centers for Medicare & Medicaid Services (CMS) to support technical requirements included in the CMS Interoperability and Prior Authorization final rule (89 FR 8758).

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