March 26, 2001 Michael McMullan Acting Deputy Administrator Health Care Financing Administration Department of Health and Human Services P.O. Box 8013 Baltimore, Md. 21244-8013 Attention: HCFA-4024-P RE: Medicare Program; Improvements to the Medicare+Choice Appeals and Grievance Procedures. Proposed Rule. Dear Ms. McMullan: On behalf of the American Health Quality Association (AHQA), the membership organization of state-based quality improvement/peer review organizations (PROs), thank you for the opportunity to comment on the Medicare+Choice (M+C) Appeals and Grievance Procedures Proposed Rule. AHQA supports the Health Care Financing Administration's (HCFA's) efforts to improve the appeals and grievance procedures for M+C plan enrollees. By providing a fast-track independent review to an enrollee when discharged from a Skilled Nursing Facility (SNF), Home Health Agency (HHA), or a Comprehensive Outpatient Rehabilitation Facility (CORFs), HCFA recognizes the importance of a timely appeal decision to the health and well being of a beneficiary. AHQA believes that Medicare beneficiaries in any setting should be able to seek independent review of the medical appropriateness of the timing of their discharge. However, we are puzzled and very concerned that this regulation does not recognize that HCFA already contracts with entities upon which beneficiaries depend to perform these fast track appeals. Instead of building on this infrastructure and designating that the PROs should extend their work in hospitals to other settings, the regulation is silent on what type of entity should be qualified to become an Independent Review Entity (IRE). PROs already interact on a daily basis with families who question whether the timing of a provider discharge affecting a loved one is appropriate. Relying on an entity other than the PROs will be confusing to beneficiaries and providers, requires the development of an unnecessarily duplicative HCFA contracting process, and deprives beneficiaries of protections established in the carefully crafted federal PRO statute. Congress established the PRO program in 1982 to review the medical necessity and quality of care delivered to Medicare beneficiaries, and has periodically directed the PROs to apply their independent medical expertise to new situations in which quality of care concerns threatened beneficiaries. In 1986, responding to concerns about the effect the new hospital prospective payment system might have on lengths of stay, Congress directed the PROs to review the appropriate timing of discharges from hospitals, when requested by beneficiaries. PROs conduct these reviews within 72 hours (usually 24 hours) utilizing physicians who must meet stringent federal requirements. Concerns about similar M+C incentives drove the Grijalva lawsuit. The point in time when a beneficiary is going to be discharged from a setting of care is a vulnerable and confusing one for themselves and their families. When they have concerns about the appropriateness of the discharge they should be able to request a review of that decision from a well-established organization experienced in conducting precisely this kind of expedited review. Specific Recommendations Designation of an independent review entity (IRE). - Section 422.626 describes the fast track appeal of service termination process. It establishes IREs as the entities to which the beneficiaries would come for a review of the appropriateness of the timing of the termination of service or discharge from the setting. While the regulation includes few requirements for the IREs, the description of the time frames and coverage implications is nearly identical to the current Hospital Issued Notice of Non-Coverage (HINN) and Notice of Discharge Medicare Appeals Rights (NODMAR) appeal process that PROs currently perform. Ironically, what is absent from the regulation are the characteristics of the PRO program that make the hospital discharge appeals process speedy, fair and efficient for beneficiaries, providers and plans alike. Several safeguards and standards are missing in this regulation which are necessary to ensure a thorough, fair, efficient process including: Statutory authority and qualifications to determine medical necessity- In Section 422.626 (d), if an enrollee files a fast-track appeal with an IRE, the M+C plan is required to demonstrate that the discharge is based on their own definition of medical necessity or on Medicare coverage policies. However, the proposed rule provides no authority for the IRE to independently evaluate the medical necessity of discharging the beneficiary. In addition, the rule provides no assurance that the IRE will be competent to judge medical necessity, or will reflect medical professional standards of care. With neither the authority nor the qualifications to make an independent de novo determination of medical necessity, the IRE will be unduly dependent on the health plan's interpretation of the case and not have the independence necessary to represent mainstream medical standards, and ensure the needs of beneficiaries are met. While the reasons for discharge provided by the plan should be considered in an appeal, they should not carry undue weight in determining an appropriate discharge. The PRO has the statutory authority to perform an independent medical necessity review and this is the manner in which this review is conducted currently for the M+C NODMAR appeals in hospitals. Beneficiaries deserve the same de novo review in SNFs, HHAs, and CORFs. Locally based organizations-In Section 422.626 (a)(1) an enrollee who desires a fast-track appeal is directed to submit a request for an appeal to the IRE under contract with HCFA. This language implies that HCFA will only contract with one IRE. AHQA supports a locally based process in which beneficiaries and providers know their local entity and where the local entity understands the unique needs of local beneficiaries and the availability and utilization of services. In addition, the local PRO is required to conduct outreach to beneficiaries, describing its appeals role in discharges. This regulation does not require this type of outreach for IREs. Therefore, the PRO may be getting requests for these other types of reviews. It will be difficult for beneficiaries to distinguish between these two organizations. Statutory authority access to medical records.- In Section 422.626 (d)(3), the proposed rule specifies a M+C plan or IRE may require the enrollee to authorize release of their medical records to the plan or IRE. However, absent such request and authorization the IRE does not have the authority to obtain the records. If the IRE does receive authorization no requirements are placed on them to maintain these records in a confidential manner. The PROs already have the authority to obtain such records and strict disclosure and confidentiality standards to protect them. The ability to quickly access information and maintain in a confidential manner is critical to ensure a timely and objective process. Clinician and beneficiary input into process - The regulation does not contain any requirements to ensure that the IREs include clinician or beneficiary participation in the governance of their organizations or that the reviewers consist of actively practicing physicians from the specialty or subspecialty relevant to the case. These characteristics of a PRO created by Congress, have helped ensure the independence and trustworthiness of their decisions. Organizations lacking these attributes will lack credibility and support for their decisions. AHQA Recommendation: Eliminate section 422.626 and change all other references in the regulation from IRE to PRO. Absent such a designation the regulation must be even more significantly revised to include standards that ensure beneficiaries continue to have access to reviews from organizations as well-qualified as the PROs. In addition, HCFA will be forced to develop and maintain a costly and unnecessary contractual and regulatory structure that duplicates the PRO program. Designating the PROs also avoids beneficiary and provider confusion about why the setting of care should determine which organizations may respond to their appeal. Beneficiary notice of discharge rights. - Section 489.27 requires hospitals to notify all beneficiaries about their appeal rights at the time of discharge. As noted previously, AHQA supports this policy. However, we have two recommendations to improve the implementation of this policy. After the enactment of the requirements for issuing the Notice of Discharge Medicare Appeals Rights (NODMARs), PROs received many phone calls from confused beneficiaries not understanding the notices. AHQA Recommendation: HCFA should increase its educational and outreach efforts to ensure beneficiaries understand the notices they receive. Hospitals should not be relied on to provide all the education necessary for a beneficiary to understand their Medicare rights. Currently, the PROs receive copies from hospitals of all HINN notices given to the beneficiaries. The PRO then determines the appropriateness of the notice. Because hospitals must give NODMARs to all M+C patients they are not required to give copies of the notices to those patients. If the policy is now changing to require hospitals to give HINNs to all beneficiaries at discharge, it is an unnecessary burden for the hospital to report every HINN to the PRO. AHQA Recommendation: Eliminate the requirement that PROs receive notices of every notice given to a beneficiary regarding their right to appeal a provider discharge. Definition of a "Quality of care" grievance. In Section 422.564 (c), the regulation discusses the process for quality of care grievances. Comments are requested on whether the regulation should include a definition of quality of care. AHQA Recommendation: Do not include a definition of quality of care within the regulation. Such determinations should be made by medical personnel familiar with the particular case and not through a general regulatory definition. Specifying a definition may limit the types of cases upon which beneficiaries perceive they can complain. The PRO statute and regulations address this problem through reference to professional standards of care, another reason to build this new appeals responsibility on the firm foundation of the PRO program. In sum, AHQA supports extending this appeal right to M+C beneficiaries in SNFs, HHAs, and CORFs. We strongly recommend that HCFA streamline the public and private bureaucracy necessary for this function by allowing the Peer Review Organizations created and structured by Congress to perform this type of work to implement these important new appeals. Sincerely, David Schulke Executive Vice President Cc: Jeff Kang Steve Jencks Bill Rollow Patricia MacTaggart