The 2019 Supreme Court decision Azar v. Allina Health Services, 139 S. Ct. 1804 (2019) has resulted in an increase in formal rulemaking and comment opportunities regarding Medicare. This is because the Centers for Medicare & Medicaid Services (CMS) changed its approach to issuing sub-regulatory guidance. An internal memo issued from Health & Human Services (HHS) states that the holding of the decision is that, under the Medicare Act, “any Medicare issuance that establishes or changes a ‘substantive legal standard’ governing the scope of benefits, or eligibility of individuals, entities, or organizations to furnish services, must go through notice-and-comment rulemaking.” The memo declared that if CMS “intends for a particular guidance document to be used in enforcement actions, then the guidance must comply with Allina.” Given this increase in rulemaking, the Center for Medicare Advocacy is sharing some tips and suggestions for drafting and submitting effective comments on proposed rules.
Where to start:
- Regulations.gov has Commenter’s Checklist- :
- Comment periods close at 11:59 eastern time on the date comments are due (though we have seen some 5 PM deadlines in the past, it is important to double check the first page of proposed rule)
- Identify credentials and experience that may distinguish your comments from others. If you are commenting in an area in which you have relevant personal or professional experience say so.
- Comments on the economic effects of rules that include quantitative and qualitative data are especially helpful.
- “Form Letters Organizations often encourage their members to submit form letters designed to address issues common to their membership. . . . Many in the public mistakenly believe that their submitted form letter constitutes a “vote” regarding the issues concerning them. Although public support or opposition may help guide important public policies, agencies make determinations for a proposed action based on sound reasoning and scientific evidence rather than a majority of votes. A single, well-supported comment may carry more weight than a thousand form letters.”
Structure of Comments:
- Include opening paragraph with background on the individual or organization. Example: “The Center for Medicare Advocacy (the Center) is a national, non-profit law organization that works to ensure access to Medicare, health equity, and quality healthcare. The organization provides education, legal assistance, research and analysis on behalf of older people and people with disabilities, particularly those with long-term conditions. The Center’s policy positions are based on its experience assisting thousands of individuals and their families with Medicare coverage and appeal issues.”
- It is helpful to structure comments based on the order of the rule and cite the section under which your comment belongs, with headings.
- Appropriate to clearly state your support or opposition:
- Example: “In particular, we want to commend CMS for the proposal to allow Medicare payment in more circumstances where dental services are important to the outcome of primary, covered medical treatments. As discussed in our comments below, we strongly support CMS’ proposal to clarify the exception to Medicare’s statutory dental exclusion whereby payment may be made for certain dental services that are ‘inextricably linked to, and substantially related and integral to, the clinical success of other covered medical services.’” (2022 CMA Physician Fee Schedule Comments)
- Example: “We urge HHS to reject this proposal because of the harms it would cause to Tennesseans who rely on Medicaid to access health care and long-term services and supports, including older adults and people with disabilities who are dually eligible for Medicare and Medicaid. The proposed amendment would jeopardize coverage for vulnerable Tennesseans and set a harmful precedent for other states and the Medicaid program as a whole. The Center strongly opposes capped funding of any sort as it would fundamentally alter the Medicaid program, threatening TennCare and the integrity of the Medicaid program nationwide.” (CMA 2019 Tennessee Block Grant proposal comments)
- Example: “The Center is opposed to this proposal. As discussed below, should CMS choose to proceed though, it must, at a minimum, include basic consumer protections and oversight included in the VBID demo. We note that none of these protections or oversight requirements are addressed, contemplated or hinted at in the proposed rule.” (CMA 2018 Comments to MA and Part D)
- Note on your comments that they are “Submitted Electronically via www.regulations.gov”
- Unless very brief to fit in the comment box, it is best to include your comments as an attachment
- Include the proposed rule you are responding to on first page of comments. Example: “Re: Docket No. CMS-2023-0010-0002; Advance Notice of Methodological Changes for Calendar Year (CY) 2024 for Medicare Advantage (MA) Capitation Rates and Part C and Part D Payment Policies”
- The conclusion can be a simple conclusion of just a couple sentences, including thanking the agency for the opportunity to submit comments and provide your contact information.
Use of Template comments:
- When original comments are not possible (though those are best) template comments can be very helpful in framing the issue
- Even if you use template comments, make sure to include stories and experiences through your work
- It is often not helpful to simply copy and paste the template and include the exact same comments by several different organizations. Instead of copying and pasting the template comments, we suggest asking the organization if it is possible for you to join as a sign-on letter or include another organization’s comments by reference:
- Example: “We incorporate here by reference the reasons the Tennessee proposal is not approvable under federal law submitted in our joint comments with Justice in Aging, Medicare Rights Center and National Academy of Elder Law Attorneys.” (CMA comments to 2019 Tennessee Block Grant proposal)
- It is possible to submit comments only on a specific question, issue or proposal- you do not need to submit comments on all of the proposals in a rule
- Provide as much information as possible about how proposals would impact beneficiaries, personal stories and unintended consequences
- Include reports, studies and other supporting references
- Opportunity to ask agency for clarification on a proposal
- Comments are generally public and can be found on website Regulations.gov
- Review the final rule to see the agency’s response to specific concerns (they don’t post all, don’t identify and say “a commenter suggested,” and sometimes group several similar suggestions together)
Commenting on proposals is your opportunity to make your voice heard. Whenever your expertise or experience allows, we urge you to take the opportunity and submit comments.
October 12, 2023 – K. Kertesz