February 13, 2023

APMA submitted two comment letters on February 13. The first was to the Nonprescription Drugs Advisory Committee and Anesthetic and Analgesic Drug Products Advisory Committee, at the Center for Drug Evaluation and Research at the FDA, advocating that the FDA reduce the burden in acquiring naloxone. The second comment letter was to CMS, largely supporting CMS’ proposals related to addressing Medicare Advantage Organizations’ (MAO) abuse of utilization management (UM) tools.

FDA—Reducing Burdens for Obtaining Naloxone

APMA supports making naloxone easier to obtain by reclassifying intranasal naloxone from prescription to over-the-counter, as long as the data support such a change. We want our patients to find themselves in a situation where naloxone is readily available to them, should they need it. APMA also noted its concern that if insurance will no longer cover or subsidize the cost of the drug, then it might become unaffordable for the underinsured or uninsured who are paying out-of-pocket. We asked that steps are taken to make sure that naloxone’s price remains reasonable so as to remain accessible.

CMS—Proposed Changes to Utilization Management Tools for MAOs

APMA expressed strong support for CMS’ proposed updated rules surrounding utilization management—particularly around prior authorization—in its comments. Among other things, APMA supports the following proposals:

1. basic benefit coverage for MA enrollees can be no more restrictive than traditional Medicare;
2. prior authorization policies for coordinated care plans may only be used to confirm the presence of diagnoses or other medical criteria and/or ensure that an item or service is medically necessary based on standards specified in this rule;
3. an approval granted through prior authorization processes must be valid for the duration MA plans must comply with national coverage determinations (NCD), local coverage determinations (LCD), and general coverage and benefit conditions included in Traditional Medicare statutes and regulations as interpreted by CMS; and
4. MA plans cannot deny coverage of a Medicare covered item or service based on internal, proprietary, or external clinical criteria not found in Traditional Medicare coverage policies.

APMA also strongly recommended a change in CMS regulation that requires Medicare Advantage plans that choose to pay contracted providers based on Medicare fee-for-service rates (this would include any agreements in which the payment rate is stated as percentage of Medicare fee-for-service rate) to comply with the coding and payment guidance of LCDs and NCDs and the Medicare National Correct Coding Initiative so that claims for basic benefits would be adjudicated in the same manner as under Medicare fee-for-service. This transparency would help both providers and patients.

To read both of these letters in full, visit www.apma.org/CommentLetters. If you have questions or concerns, contact the APMA Health Policy and Practice department at healthpolicy.hpp@apma.org.