Benefit Category Determinations

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 whether any new item or service meets the definition of a benefit category as well as how the fee schedule amounts for the items and services are established.

In an effort to increase transparency and structure around the process it uses to make benefit category and payment determinations, CMS elected to establish a regulatory process that mirrors the one that has been used since 2001 for obtaining public consultation on BCDs and payment determinations for new DME and since 2005 for requests for HCPCS codes for items and services other than DME.

This infographic helps show this process.

For more information about this process, and to discuss how it could impact the way that developers commercialize new products, contact us by visiting http://www.policypros.net.

Comments

Selecting Therapeutic Alternatives: A Critical Perspective for Drug Manufacturers

The Inflation Reduction Act (IRA) of 2022 instructed the Centers for Medicare and Medicaid Services (CMS) to initiate drug price negotiations with manufacturers for the first time. A key component of these negotiations involves considering factors like the drug's benefits and costs to establish a "lowest maximum fair price." (MFP) For drug manufacturers, CMS’s process for making comparisons of therapeutic alternative(s) to determine the MFP raises a number of crucial questions. The IRA's guidance suggests that CMS will initially compare drugs within the same class as the negotiated drug to determine a starting point for pricing. For drug manufacturers, this approach raises concerns regarding price competition within drug classes. As new drugs are often priced in line with preexisting brand-name drugs in the same class, the negotiation process may result in downward pressure on prices for all drugs in the class. This could significantly affect the revenue and profitabi...

TCET Pathway Could Accelerate Access to Innovating Technologies

The Centers for Medicare & Medicaid Services (CMS) proposed the Transitional Coverage for Emerging Technologies (TCET) pathway to enable quicker coverage decisions for breakthrough devices needing accelerated regulatory review. As described in JAMA Health Forum, TCET allows tailored oversight based on an innovation’s specific benefits and risks. TCET focuses on FDA Breakthrough-designated devices for serious conditions supported by limited clinical data for market authorization. By facilitating transitional coverage, TCET aims to help make cutting-edge technologies accessible to patients while additional real-world evidence is gathered to meet CMS’ “reasonable and necessary” standard. For developers to optimize TCET’s streamlined approach they should be sure to: - Pursue FDA Breakthrough designation when criteria are met. This opens the TCET pathway. - Engage CMS early on study designs and evidence needs. Incorporate draft guidance on endpoints and real-world data....

Bridging the Gap: The Long Road from FDA Approval to Medicare Coverage

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 ...

The Health Policy War Room

Search This Blog