On April 4, 2011, the Center for Medicare Advocacy (the Center) filed comments on a proposal by the Centers for Medicare & Medicaid Services (CMS) to establish a new condition of Medicare participation (CoP) for certain Medicare service providers. These providers would be required to give Medicare beneficiaries notice of the right to seek review of quality of care concerns by a Quality Improvement Organization (QIO), and contact information regarding review by state survey agencies. The proposed CoP would also require the health care providers to document in the beneficiary's medical record that the required notice has been given.
CMS hopes that the proposed CoP will increase the number of beneficiaries who use available QIO and state survey review mechanisms, thereby increasing access to quality Medicare-covered services. The Center has long stressed the importance of using these review mechanisms to address concerns about the quality of care received from Medicare-participating healthcare providers. In particular, the Center argued that:
- Beneficiaries are entitled to and must be provided timely notice of the scope of Medicare-covered services available in the particular care setting for which the beneficiary is eligible;
- Beneficiaries are entitled to and must be provided information about how to file an appeal or grievance when services are denied, reduced, terminated; and
- Beneficiaries are entitled to and must be provided information about how to obtain appropriate review of quality of care matters.
Notice should be provided in readable formats and in a language that is understood by the beneficiary.
Entities Subject to the Proposed Requirement Regarding QIO Review
The proposed CoP requirement to provide notice of QIO review option would apply to ten care settings:
- Ambulatory Surgical Centers (Amending 42 C.F.R. §416.50);
- Hospices (Amending 42 C.F.R. §418.52);
- Hospitals (Amending 42 C.F.R. §482.13);
- Long Term Care Facilities (Amending 42 C.F.R. §483.13);
- Home Health Agencies (Amending 42 C.F.R. §484.10);
- Comprehensive outpatient Rehabilitation Facilities (CORFs) (Amending 42 C.F.R. §485.56);
- Critical Access Hospitals (Amending 485.627);
- Clinics and Rehabilitation Agencies (Amending 42 C.F.R. §485.709);
- Portable X-ray Services (Amending 42 C.F.R. §486.106); and
- Rural Health Clinics and Federally Qualified Health Centers (Amending 42 C.F.R. §491.9).
Entities Subject to the Proposed Requirement Regarding State Surveys
The requirement to provide contact information for state survey agencies would only apply to seven settings:
- Comprehensive Outpatient Rehabilitation Facilities (CORFs);
- Critical Access Hospitals;
- Clinics and Rehabilitation agencies;
- Portable X-ray Services and Rural Health Clinics; and
- Federally Qualified Health Centers.
As noted by CMS, the three excluded agencies – Home Health Agencies (HHAs), Amubulatory Surgical Centers (ASCs) and Long Term care Facilities (LTCs) – are already required to provide contact information for state survey agencies.
Concerns About the CMS Proposal
- The CMS proposal does not provide a specific form of notice to be provided in the above care settings. The lack of specificity may lead to confusion among providers and cause variation in the quality of notices provided. We note that until CMS required specific model notice language to be used by Medicare Advantage and Part D prescription drug plans, there were myriad problems with the form and quality of notice provided. Standard notice remains the best way to achieve CMS' goals and to protect beneficiary rights.
- The CMS proposal excludes ASCs, LTCs, and HHAs from the requirement to provide contact information about state survey agencies. This exclusion may be confusing. This is a concern even though this notice requirement, or some variation of it, may be found in other regulations for the excluded entities. The final regulation should, at a minimum, reference the other regulatory sections that establish such a notice requirement.
- The CMS proposal excludes End Stage Renal Disease (ESRD) services from the CoP. CMS states that this is due to the fact that this care setting already has a similar review mechanism. Some beneficiaries, for various reasons, may nonetheless find one or the other review processes superior and should have the option of either process. This would serve to reinforce the importance of notice rights and would alert providers and beneficiaries that the right of notice may spring from multiple sources.
- The CMS proposal queries whether the notice and information requirement CoP should be required only when services are initiated. It would be helpful to require the provision of notice when services begin and when they end. In many instances, beneficiaries may well have lost various notices and other papers provided at the beginning of services. When beneficiaries enter a new care setting or service, they are often provided a lot of important information at a time when they are experiencing stress caused by their health condition. Providing the notice at both points reinforces the importance of notice as an educational tool. In addition, it will remind beneficiaries of their rights and alert them to review possibilities at a time when quality-of-care concerns are foremost in their thinking.
- The CMS proposal queries whether the notice and information requirement CoP should be triggered by the expression of an adverse event to a provider. Such an approach could be problematic because many beneficiaries are afraid to express concerns over the quality of care they are receiving for fear of retaliation or termination of care. Rather, beneficiaries should be provided with the necessary information about notice and appeal rights, including the review of quality of care concerns, at the beginning and the conclusion of service. This should reduce the fear of reprisal stemming from having to express dissatisfaction directly to a service provider in order to obtain notice of QIO review and information about how to contact state survey agencies.
- The CMS proposed CoP does not address the need for additional resources to meet increased workloads likely to result from more beneficiaries exercising the right to QIO review or pursuing review by state survey agencies. Following the release of the 2006 Institute of Medicine (IoM) study, referenced in the proposed rule, the Center received a grant from the Commonwealth Fund to explore where the QIO beneficiary complaint review function might be located if, as the IoM recommended, that function was moved to a different entity. A resource paper commissioned by the Center for the conference looked at this relocation and capacity issue from a legal prospective. See https://www.medicareadvocacy.org/Projects/QIOConference/Background/BackgroundPaper.LegalPerspective.pdf. A consistent theme of the findings of the paper was the lack of resources to take on additional quality of review responsibilities. Moreover, the entities surveyed for the paper noted the lack of systems capacity to share information with other QIOs, state survey agencies, and medical boards (not all of which review individual complaints). A further concern was the need to develop uniform standards for the review of quality of care across the several review entities.
Limitations of the QIO Statute
There remain serious problems with the Peer Review Improvement Act of 1982 (the QIO statute), Pub. L. No. 97-248, §§141-150, 96 Stat. 382 (codified as amended at 42 U.S.C. §§ 1320c-120c12) as a tool for resolving beneficiary complaints. Chiefly, absent consent of the physician who is the subject of the beneficiary's complaint, the QIO statute precludes providing the beneficiary complainant with detailed information about its findings and actions that relate to the conduct or inaction of the physician who is the subject of the quality of care complaint. See 42 C.F.R. §1320c-9(a)(2000). Rather, the beneficiary is provided only a summary statement of the disposition of the final complaint. See also 42 U.S.C. §1320c-3(a)(14(2000).
The Center is supportive of the CMS quality of care review proposal, and gratified that the notice requirement is being proposed as a Medicare Condition of Participation. Information about how to contact state survey agencies will also be useful in making beneficiaries aware of the entities that address the quality of care beneficiaries receive and of the right to raise quality of care questions. We caution, however, that unless CMS addresses issues of resources, capacity building, and the nature and scope of review, the proposed new Condition of Participation may sound good, but prove hollow in practice.
 See [CMS-3225-P], RIN 0938-AP94, "Medicare and Medicaid Programs; Patient Notification of Right To Access State Survey Agencies and Medicare Beneficiary Notification of the Right To Access Quality Improvement Organizations." 76 Federal Register 5755 (February 2, 2011).
 Hospices, HHAs, SNFs, and CORFs are already required to provide advance notice of discharge and appeal rights pursuant to 42 C.F. R. §405.1200 et seq.
 Hospitals, as a condition of payment under prospective payment systems, are required to have agreements with QIOs to review medical necessity, reasonableness and appropriateness of hospital discharges, including the completeness, adequacy, and quality of services furnished in the hospital. See 42 C.F.R. §412.44.
 Comprising skilled nursing facilities (SNFs) and nursing facilities (NFs). See §1819(a) of the Social Security Act (SNFs) and §1919(a) of the Social Security Act (NFs).
 See 42 C.F.R §416.50(a)(1) (ASCs); 42 C.F.R. §483.10(b)((7)(iii) (LTCs); and 42 C.F.R. §484.10 (HHAs).