Posted in: Government Outreach
August 29, 2025
Dr. Mehmet Oz
Centers for Medicare & Medicaid Services
Department of Health and Human Services
Attention: CMS-1828-P
P.O. Box 8013
Baltimore, MD 21244-8013
RE: CMS-1828-P
Submitted via: https://www.regulations.gov
Dear Dr. Oz,
The Accreditation Association for Ambulatory Health Care, Inc. (AAAHC) appreciates the opportunity to submit comment to the Centers for Medicare & Medicaid Services (CMS) regarding the recently proposed rule entitled Medicare and Medicaid Programs; Calendar Year 2026 Home Health Prospective Payment System (HH PPS) Rate Update; Requirements for the HH Quality Reporting Program and the HH Value-Based Purchasing Expanded Model; Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Competitive Bidding Program Updates; DMEPOS Accreditation Requirements; Provider Enrollment; and Other Medicare and Medicaid Policies.
AAAHC is a private and independent 501(c)(3) non-profit accrediting organization formed in 1979. Since its inception, AAAHC has promoted a voluntary, peer-based, and educational survey process to advance patient care. These values hold true today, as embodied in our mission statement: Improving health care quality through accreditation. With more than 6,700 accredited organizations in a variety of ambulatory health care settings, AAAHC is a leader in developing Standards to advance and promote patient safety, quality care, and value for ambulatory health care through its accreditation programs, education, research, and other resources. Currently, more than 1,000 ASCs are committed to excellence through AAAHC accreditation under the deemed status program, making AAAHC the leading Medicare-deemed ambulatory surgical center accrediting organization in the country.
AAAHC also provides accreditation services to the United States Coast Guard (USCG) ambulatory health centers, Federally Qualified Health Centers (FQHCs) that receive funds from the United States Health Resources and Services Administration (HRSA), and Indian Health Services (IHS) funded health centers. Other AAAHC-accredited organizations include Community Health Centers, Student Health Centers, Medical Group Practices, and office-based surgery procedure centers.
As one of four AOs granted deeming authority for ambulatory surgical centers (ASCs), AAAHC has a significant interest in providing thoughtful and meaningful commentary to the agency in support of a continuing effective relationship. While AAAHC does not currently accredit DMEPOS suppliers, as a partner to CMS with the shared goal of improving the quality of health care, and in support of federal government initiatives to reduce burden and provide for consistency across similar programs, the following includes AAAHC comments to the DMEPOS Accreditation Requirements and Provider Enrollment sections of the proposal. The AAAHC comments generally reiterate those AAAHC submitted on April 15, 2024 in response to the February 2024 proposal entitled Medicare Program; Strengthening Oversight of Accrediting Organizations (AOs) and Preventing AO Conflict of Interest, and Related Provisions (RIN 0938-AU88, CMS-3367-P)(“AO Oversight Proposal”).
Note: For ease of reading, this comment lists the specific sections to which AAAHC is responding. Any sections for which AAAHC does not provide comment should not be interpreted to mean that AAAHC supports or opposes the proposal.
VI. Provider Enrollment, Certain Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Accreditation Policies, and DMEPOS Prior Authorization Provider Enrollment
2. DMEPOS Accreditation Proposed Provisions
a. Definitions (New § 424.58(b))
CMS proposes to define “unannounced survey” as meaning: 1) A survey conducted without any prior notice of any type (through any means of communication or forum) to the supplier to be surveyed, such that the supplier does not expect the survey until the surveyors arrive; and 2) The AO schedules its surveys so that suppliers cannot predict when they will be performed. As noted in our comment to the AO Oversight Proposal, AAAHC also disagrees with the definition of “Unannounced Survey” as proposed at 424.58.
While AAAHC accredits ambulatory health care organizations that provide direct patient care, distinct from DMEPOS suppliers, there are operational similarities between the two, such as re-accreditation cycles and defined hours of operation that could contribute to a supplier predicting their survey date (as we discussed in our April comment letter). If CMS adopts the proposed definition of unannounced survey in 424.58 and 488.1, AOs are still at risk of engaging in activity that CMS could find unacceptable.
Since AAAHC understands that it is impossible to account for all scenarios that might result in survey date prediction, AAAHC respectfully requests that CMS address the existing ambiguity by updating the proposed definition of unannounced survey in 424.58 and 488.1 to simply state: AOs may not 1) communicate survey dates or possible timeframes to the supplier/provider, and may not 2) allow surveyors to communicate with the supplier/provider prior to the first day of the survey until they enter the facility. This revision would preserve the integrity of unannounced surveys while acknowledging the operational realities of both AOs and suppliers.
b. Initial Application for Approval of AO’s Accreditation Program (New § 424.58(c))
(4) Conflicts of Interest, Consulting Services, and Number of Surveyors (New § 424.58(c)(1)(vii)(D) and (E))
In its proposed rule, CMS seeks to strengthen oversight of AOs by including definitions and addressing potential and actual conflicts of interest. Among proposed provisions, CMS would require AOs to submit to CMS their policies for handling potential or actual conflicts of interest that could arise from situations in which a DMEPOS AO owner, surveyor, or employee has an interest in, or relationship with, a DMEPOS supplier to which the AO provides accreditation services. In the proposal, CMS lists such interests or relationships as a variety of conflict-of-interest scenarios and would require AOs to address conflicts related to “immediate family members” who may be involved in such scenarios.
In our response to the AO Oversight Proposal, AAAHC expressed concern with the expansive definition of “immediate family member” as it relates to conflict of interest. AAAHC acknowledges the public policy interest that the proposed definition serves in reference to the professional courtesy exception for physician and health care entity referral prohibitions, Securities and Exchange Commission restrictions on transactions with related persons, and other laws related to campaign contributions. We also acknowledge the CMS concerns described in criminal cases, specifically related to a DMEPOS supplier. However, should CMS move forward with adopting the proposed definition of “immediate family member,” as described in this proposed rule and in the AO Oversight Rule, to drive consistency across programs, AAAHC respectfully recommends that CMS provide AOs with standardized conflict of interest disclosure forms or questionnaires. These tools should clearly outline the types of scenarios and relationships that CMS considers problematic, thereby helping AOs ensure compliance while maintaining operational efficiency.
(13) CAPs (§ 424.58(c)(1)(xx))
In this section, CMS notes that it has received information that, depending on the AO, Corrective Action Plans (CAP) are sometimes applied in instances of non-compliance, even for significant violations of the quality standards as opposed to denying or terminating accreditation. CMS proposes that AOs outline the policies and procedures for which it will apply a CAP to the supplier.
While AAAHC is not a DMEPOS AO, as a partner in quality improvement to CMS, AAAHC appreciates the opportunity to explain its process for Corrective Action Plans under the ambulatory surgical center deemed status program. AAAHC requires Corrective Action Plans for all facilities, regardless of the severity identified. This requirement reflects our 1095 Strong, Quality Every Day philosophy, which emphasizes continuous compliance and improvement throughout the accreditation term. The Corrective Action Plan encourages organizations to review and understand identified deficiencies, implement corrections to address those deficiencies, and demonstrate a commitment to ongoing compliance, even when the outcome may result in non-accreditation. Importantly, the CAP also provides organizations with an opportunity to contest findings and submit additional evidence to support compliance at the time of the survey. AAAHC’s Accreditation Committee reviews the survey findings and CAP but bases its decision solely on compliance at the time of the survey, not on post-survey corrections submitted through the CAP. This approach ensures that the CAP serves as both a quality improvement tool and a mechanism for transparency and fairness, while maintaining the integrity of the accreditation decision-making process.
(14) Describing and Defining DMEPOS Supplier Deficiencies (New § 424.58(c)(1)(xxi))
CMS expresses concern that the meaning of “deficiency” and any AO-identified levels thereof may differ among DMEPOS AOs, resulting in inconsistent determinations.
As previously stated, AAAHC supports consistency across accreditation programs and recommends for DMEPOS that CMS adopt the same language and process it utilizes for the ambulatory surgical center deemed status program to provide consistency across regulations. AAAHC utilizes the language in 42 CFR 488.26 to consider the “manner” and “degree” of compliance or non-compliance with the requirement, and the State Operations Manual provides process guidance for assessing deficiencies. While we understand there are immediate concerns regarding the integrity of some DMEPOS accreditation programs, AAAHC surveyors are trained to use their professional judgement and review the entire picture of the organization’s operations, and to further investigate potential deficiencies to ensure accuracy in compliance determinations. There may be certain circumstances where compliance may seem deficient (or not deficient) at first look, but only after further review and investigation can the surveyor make a compliance determination.
Another way to resolve concerns related to inconsistent deficiency ratings is for CMS to require binary (yes or no) compliance ratings and to include specific, objective review elements that roll up to that determination. To do that, CMS would need to drive the development of objective guidelines for review through regulation that AOs can adapt into Standards. AAAHC recommends that CMS further mitigate ambiguity by adopting a standardized evaluation process, potentially mirroring the SOM’s principles of documentation and citation structure to promote consistency and fairness.
It is also important to recognize that AOs provide organizations with the opportunity to dispute deficiency findings throughout the accreditation process. These processes mitigate any issues of inconsistency in deficiency determinations. If an organization disputes a deficiency rating, due process, built into the system through the Plan of Correction process, allows organizations to demonstrate that, at the time of the survey, the organization was in compliance with the Conditions for Coverage. If the organization cannot demonstrate compliance at the time of the survey and continues to dispute the result, it may escalate to CMS. If the deficiency results in a non-accreditation decision, AAAHC has a reconsideration and appeal process. These mechanisms help ensure that deficiency determinations are not only consistent but also subject to due process.
Finally, if CMS is concerned that inconsistent determinations may result in deficiencies improperly cited as compliant, AAAHC notes that validation surveys serve as an additional safeguard. (See AAAHC’s comment on validation surveys in section 5. Continuing Federal Oversight of AOs below).
(15) Potentially Fraudulent Activity (New § 424.58(c)(1)(xxii))
In the proposed § 424.58(c)(1)(xxii), CMS would require AOs to describe their process for: (1) detecting and addressing potential fraud, waste, and abuse by suppliers (including identifying the AO’s definitions of the terms “fraud”, “waste”, and “abuse”); and (2) reporting this conduct to CMS, and, as applicable, law enforcement.
AAAHC agrees with CMS that while an AO’s principal function is to perform the accreditation activities described in the applicable law, the AO must not disregard possible fraud, waste, or abuse by suppliers. For example, if an AO is performing a survey and identifies falsified records, it should have procedures in place to escalate the issue appropriately. AAAHC upholds a commitment to maintaining the integrity of its program through its survey procedures and Standards. For example,
AAAHC Standard GOV.160.50 states:
The governing body ensures fulfillment of all applicable obligations under prevailing laws and regulations, such as those addressing disabilities, medical privacy, grievances, fraud and abuse, self-referral, anti-trust, reporting to the National Practitioner Data Bank, etc.
If an organization cannot provide evidence of policies and compliance with those policies to address the issues listed in the above Standard, this would lead to further investigation of the actual practices within the organization. If an organization cannot provide evidence of compliance with the elements of this Standard during the survey, the issue is escalated to our headquarters for additional review. CMS receives all accreditation survey reports and has the opportunity to review all compliance ratings.
In addition, the AAAHC complaint procedure serves to address fraud, waste, and abuse concerns of patients, staff, and other third parties outside of the survey. Complaints are triaged for review, and if AAAHC determines requirements for additional review of onsite documentation, AAAHC follows its survey procedures and will conduct an unannounced onsite review.
AAAHC recommends that CMS provide standardized definitions of “fraud,” “waste,” and “abuse” for use across all AOs to ensure consistency. Additionally, CMS could support AOs by offering explicit requirements that define the types of conduct that AOs should cite and incorporate into survey reports. This approach would help ensure alignment across all AOs while reducing ambiguity and administrative burden.
5. Continuing Federal Oversight of AOs (New § 424.58(f))
b. Validation Survey of Suppliers (New § 424.58(f)(2))
In the proposed rule, CMS references the use of validation surveys (typically referred to as “lookback” surveys both under the new DMEPOS provisions and as required in 42 CFR § 488.9) as a mechanism for assessing AO performance. AAAHC respectfully requests that CMS reconsider the utility of this model. AAAHC maintains that lookback surveys are not a reliable or meaningful method of validation. The fundamental issue is that conditions within a facility are expected to change following an accreditation survey. Facilities are required to implement corrective actions in response to deficiencies. As a result, a validation survey conducted weeks or months later may reflect a significantly different operational environment, making it difficult to draw accurate conclusions about the original survey findings. Moreover, many aspects of care and compliance are inherently variable and time sensitive. For example, if a validation surveyor observes a hand hygiene lapse, it would be inappropriate to assume that the original AO surveyor failed to identify a similar issue, especially if observed during the initial survey. The ability to determine whether a disparity was “reasonably likely to have existed” during a previous survey is a subjective analysis that could allow CMS to penalize its AO partners based upon an assumption.
AAAHC supports accountability in the accreditation process and believes that the lookback validation surveys create unnecessary ambiguity and risk. Instead, we recommend that CMS continue to explore the direct observation validation survey (DOVS) process with structured feedback loops between CMS and AOs to address real-time discrepancies with objective and actionable oversight mechanisms.
Thank you again for the opportunity to comment on these significant proposals. For any questions regarding this comment, please contact Ann Carrera, Senior Counsel, Legal & Corporate Affairs, at 847-853-6060 or acarrera@aaahc.org.
Sincerely,
Noel M. Adachi, MBA
President & CEO
