The Health Policy War Room

A new study published in JAMA Health Forum reveals that the road to Medicare coverage for novel medical technologies is a long and winding one. Researchers found that only 44% of innovative devices and diagnostics approved by the FDA from 2016-2019 had even “nominal” Medicare coverage by 2022. This data highlights major hurdles in the system that delay patient access to beneficial emerging technologies. About the Research The study examined 281 novel products cleared through the FDA from 2016-2019 via the high-risk premarket approval, de novo, and breakthrough 510(k) pathways. These included things like groundbreaking diagnostic tests, implantable devices, and other innovative treatment technologies. The goal was to measure how long it took to establish national or regional Medicare coverage policies for these newly approved products. This is important because Medicare coverage is required before hospitals, physicians and patients can reliably access new technologies. Key Findings The ...

Access to affordable health care is a persistent challenge for many Americans. However, a recent bill, the Protecting Health Care for All Patients Act (HR 485) , is making its way through the House of Representatives, which could hinder efforts to improve affordability of prescription drugs and other health care services. The bill seeks to block the use of quality-adjusted life-years (QALYs) and similar measures in government health care programs such as Medicare and Medicaid. QALYs are a widely accepted outcome measure used in health economic studies to assess the benefit of a therapy compared to standard care. They combine two critical health outcomes—length of life and health-related quality of life—into a single measure. QALYs are calculated by assigning weights to different health states, ranging from perfect health to death. By using QALYs, policymakers can estimate the average benefits of a treatment for a specific population. The debate over the use and impact of QALY is beyond...

In the ever-evolving landscape of healthcare, the rising costs of prescription drugs continue to be a major concern for patients, providers, and payers alike. Drug spending is a complex issue with many different dynamics at play. While the Medicare program has recently been given authorities to control drug spending, some have expressed concern that these efforts will only shift drug cost pressures to different parts of the healthcare system. The escalating cost of prescription drugs is a significant burden on both patients and payers. As the prices of pharmaceuticals continue to soar, it is crucial to understand the myriad factors behind this trend. Pharmaceutical companies cite research and development costs, regulatory requirements, and the need for profit as justifications for the high prices. The ballooning drug costs have prompted federal interventions aimed at curbing the financial strain on the healthcare system. CMS now has the authority to negotiate the price of some prescri...

The Centers for Medicare & Medicaid Services (CMS) has recently announced a comprehensive plan aimed at ensuring the availability of new Alzheimer's drugs for beneficiaries granted full approval by the FDA. This significant development comes in response to the anticipated full FDA-approval of the first new drug for Alzheimer's disease in nearly two decades, signaling a critical milestone in the fight against this debilitating condition. CMS recognizes the urgent need to make these treatments accessible to patients, and their plan outlines several key measures to support coverage and access. Under the plan, CMS intends to provide Medicare coverage for the newly approved Alzheimer's drugs under the national coverage determination for Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease.  The plan acknowledges the ongoing debate surrounding the efficacy of these drugs, and CMS emphasizes the importance of allowing patients to make informe...

In an ongoing effort to address the healthcare needs of Americans, Senator Bernie Sanders has introduced the Medicare for All 2023 Bill. This proposed legislation aims to transform the United States healthcare system by providing comprehensive healthcare coverage to all residents, regardless of their age, income, or employment status. Versions of Medicare for All have been introduced in some version since at least 2019 and the concept of single payer health reform has been around for decades. This version of the single payer proposal has 15 sponsors including Mr. Sanders, Ms. Warren (no relation), Mr. Booker and others and reportedly has upwards of 112 co-sponsors. While this level of support does not guarantee that the bill survives, it does demonstrate that Congress is taking health reform seriously and is willing to float various ideas designed to reform and improve the healthcare system. Image created by AI via http://www.gencraft.com Let's delve into the key provisions and obj...

Recently, much has been written about the escalating costs of drug prices in the US. Increasing drug prices are present challenges to those who struggle with affordability and access to their medications. The Inflation Reduction Act brought changes to the way the Medicare program reimburses for prescription drugs. Last year, President Biden challenged the Center for Medicare and Medicaid Innovation (CMMI) to develop and test new payment models that can support value-based payments and promote high-quality healthcare. CMMI has recently proposed three models intended to improve affordability and access to drugs as well as measuring the feasibility of implementation.       1. The Medicare High-Value Drug List Model Under this model, Part D plans would be encouraged to offer a low, fixed co-payment across all cost-sharing phases of the Part D drug benefit for a standardized Medicare list of generic drugs that treat chronic conditions. Patients picking plans that particip...

Medicare is an important aspect of the healthcare system in the United States and plays a crucial role in providing medical coverage to millions of seniors. In recent years, Medicare spending and financing has been a topic of great concern and debate, with many questioning the sustainability of the program. In this article the Kaiser Family Foundation takes a look at some trends in Medicare spending and financing and what policy solutions might address these concerns. In 2020, Medicare spending accounted for 3.7% of the Gross Domestic Product (GDP), and this number is expected to grow in the future. KFF projects that Medicare spending will reach 5.8% of GDP by 2040. The main drivers of this spending growth are the increasing number of beneficiaries, rising healthcare costs, and the increasing costs of new medical technologies. This trend highlights the need for finding solutions to reduce the growth of healthcare costs and improve the efficiency of the healthcare delivery system. With...

 Earlier this week, HHS issued a press release announcing key dates for the first year of the Medicare drug price negotiation process. The Inflation Reduction Act provided Medicare with the authority to negotiate prices for a select number of prescription drugs. These negotiated prices will go into effect in 2026. HHS and the Centers for Medicare and Medicaid Services have committed to providing the opportunity for stakeholders to be engaged in the negotiation process by providing the opportunity for public feedback collection. According to CMS, they will be actively soliciting feedback on areas including: Terms and conditions contained in the manufacturer agreement, including the manufacturer’s and Secretary’s responsibilities. Approach for considering  the manufacturer-reported data elements and  evidence about alternative treatments.  Process for the offer and counteroffer exchange between the Secretary and manufacturers.  Content of an explanation for the m...

On December 21, 2021 CMS released an early Christmas present for stakeholders who have clamored for many years for a formalized process for making benefit category determinations (BCD). A BCD is a national decision by CMS whether an item or service meets the statutory definition of a benefit category. Benefit categories include: durable medical equipment, prosthetics, orthotics, supplies and others. When an item meets the definition of a benefit category, it may be covered by Medicare -- as long as the item is not otherwise excluded from coverage by law and is reasonable and necessary for an individual's medical condition. Since the implementation of Section 531(b) of the Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000 (BIPA), CMS has hosted annual public meetings to discuss preliminary coding and payment determinations for new items and services.  Since 2005, this process of making preliminary payment determinations has included the determination of w...

On August 2, 2021, CMS placed on display at the Federal Register the final fiscal year 2022 Inpatient Prospective Payment System Final rule. Amongst the over 2,000 pages are CMS's final decisions on New Technology Add-on Payments (NTAP) for FY 2022. The NTAP program was designed to identify new technologies and to ensure that payment under the IPPS would be adequate so that early adopters of  new technologies would not be financially disadvantaged. Under the traditional NTAP pathway, a technology must be considered "new",  the charges of cases involving the technology must be more than 75 percent of the unadjusted rate for the MS-DRG to which the technology is assigned, and the technology must represent a substantial clinical improvement over existing technologies.  Beginning in 2021, CMS implemented an alternative NTAP pathway for technologies granted "break-through" approval by the FDA and for certain antimicrobial products. For this alternative pathway, techn...

  Since January 1, 2020, CMS has made separate payment for the treatment of opioid use disorder when furnished by qualified opioid treatment practitioners (OTP). This new Medicare benefit, established by the SUPPORT Act, allows CMS to make bundled payments for weekly episodes of care. Medicare will pay for episodes of care that include drugs, for non-drug episodes of care, for intake and periodic assessments, take-home dosages of methadone and buprenorphine, as well as for additional counseling. Pricing The episodic payment rate includes reimbursement for the drug- and non-drug-components of the encounter. Pricing for the drug component of the bundle is set using the most appropriate pricing mechanism currently in place and varies depending on the drug. Annual updates to the drug component of the bundle are made using the most recently available data from the applicable pricing mechanism. The non-drug portion of the bundle is updated based on the Medicare Economic Index. To reflect...

In the CY 2022 Physician Fee Schedule Proposed Rule, released yesterday (https://public-inspection.federalregister.gov/2021-14973.pdf) CMS is proposing two changes to its long-standing policies on drug pricing.  First, CMS is proposing to require manufacturers of drugs covered under Part B to report ASP data even if the manufacturer does not have a Medicaid rebate agreement. Noting that many manufacturers without a Medicaid rebate agreement currently report ASP data to CMS, CMS believes its proposed will cause little upset to manufacturers and would in fact preserve the status quo.  In a 2017 report (http://medpac.gov/docs/default-source/reports/jun17_ch2.pdf), MEDPAC presented findings many repackagers do not report ASP data to CMS and that this failure to report could be skewing Medicare payment rates. In this year’s proposal, CMS presents its own findings that exempting repackagers from reporting ASP data could increase errors in ASP calculations and delay CMS’s ability to ...