The Health Policy War Room

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...

 Last week, the FDA's Center for Drug Evaluation and Research released it 2021 report of New Drug Therapy Approvals. The approvals are notable for the potential to provide a positive impact on patient care. The following infographic shows some of the more notable statistics from this year's report. According to the FDA, CDER approved 50 new drugs in 2021. The applications represented both new molecular entities under New Drug Applications or new therapeutic biologics under Biologics License Applications. In each case, the active ingredient or ingredients have never been approved in the U.S.  New drugs advance treatment options in heart, blood, kidney and endocrine disease; autoimmune, inflammatory and lung diseases; infectious disease; neurological and psychiatric disorders; cancer; and other orphan conditions. 98 percent of the approvals were granted within the Prescription Drug User Fee Act timeframes and nearly 90 percent were approved on the first cycle. The FDA credits th...

 On July 9, 2021, President Biden issued an Executive Order affirming his administration’s commitment to encouraging competition in the prescription drug market as well as reducing the prices of prescription drugs in the United States. The order required the Secretary of Health and Human Services to report on the challenges addressing innovation and costs within the prescription drug market and to recommend legislative and administrative actions. The HHS report focused on three “guiding principles”: affordability, competition and innovation. By following these three principles, the report intends to illustrate a pathway to protecting patient access to prescription drugs while simultaneously improving quality of care. Controlling drug pricing has been a focal point for many years. Many proposals have been made but few have taken root. In fact, according to AARP’s report “ TRENDS IN RETAIL PRICES OF BRAND NAME PRESCRIPTION DRUGS USED BY OLDER AMERICANS, 2006 TO 2020 ” the c...

On December 10, 2021, President Joe Biden signed into law the "Protecting Medicare and American Farmers from Sequester Cuts Act" (S.610). In addition to establishing procedures to be used to increase the nation's debt limit, the Act makes a number of changes to the Medicare program that stakeholders have called for. Stakeholders have argued that without these changes, Medicare fee-for-service payments could have fallen by $14.1 billion in 2022 alone. The infographic below shows the five key Medicare takeaways from this Act.  The full text of the act is online .

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...