On April 6, 2012, the Centers for Medicare & Medicaid Services (CMS) issued Transmittal 17, which revises and creates new procedures for the review of quality of care concerns by Quality Improvement Organizations (QIOs). Effective May 7, 2012, the new procedures apply to QIO review of the quality of services "among different cases and settings (including post-acute-care settings, ambulatory settings, and health maintenance organizations)." In addition, CMS recently issued a Notice of Proposed Rule Making (NPRM) which discusses and, for the most part, incorporates the content of Transmittal 17. This Alert focuses on the procedures created by Transmittal 17.
The procedures discussed below are complicated, but it is hoped that they will become more streamlined going forward. It is expected, for instance, that there will be refinements made as a result of the above mentioned NRPM. However, despite the complexity of the procedures, it is good that a structure for providing beneficiaries with more information about the resolution of quality of care complaints has been created.
New Quality of Care Review Procedures
Transmittal 17 lays out new procedures for Quality of Care Reviews. It differentiates between Concurrent Reviews (reviews conducted while a beneficiary remains in care or continues to receive services), and Retrospective Reviews (reviews that take place after the beneficiary has left care or is no longer receiving services). Designed to resolve quality concerns quickly, Concurrent Reviews have an accelerated timeline.
Transmittal 17 also differentiates between "Beneficiary Complaint Reviews," which stem from complaints made directly by beneficiaries, and "General Quality of Care Reviews," which are problems that are brought to the attention of the QIO through other means. While beneficiary reviews must come from a beneficiary complaint, the QIO Manual identifies three sources of information for general reviews: 1) concerns identified during other, non-QIO, review activities; 2) referrals from other agencies; and 3) tracking and trending data.
There are only a few differences in the processes for the several types of reviews. First, Beneficiary Complaint Reviews have additional rules on how information from the complainant is initially collected and processed. Second, since beneficiaries are involved directly in Beneficiary Complaint Reviews, the Department of Health and Human Services (HHS) is required to communicate the outcome of the case to the involved beneficiaries. This is a statutory requirement, but has not been part of official HHS procedure until now. Third, the two new alternative dispute resolution procedures created by Transmittal 17, Immediate and Direct Advocacy, are only available for Beneficiary Complaint Reviews.
The New Beneficiary Complaint Structure
The new complaint structure begins with the written complaint or separately identified issue being assigned to an intake specialist (IS), who collects the relevant medical information. If a provider does not provide medical information within a reasonable amount of time, the QIO is authorized to deny the provider's claim for Medicare coverage until the provider submits the requested records. Once the records are submitted, the QIO will complete the review. Throughout the process, the beneficiary must be kept informedof review developments.
Once the medical information has been collected, the IS turns the complaint over to a Review Analyst (RA) who provides an analysis of the situation(s) – not a decision – and then passes the complaint and analysis on to an Initial Determination Peer Reviewer (IDPR). The IDPR reviews the RA's analysis and comes to an Interim Initial Determination (IID). The IDPR then returns the complaint and IID to the RA for his or her review. If it is determined that the standard of care was not met, the RA contacts the provider/practitioner for discussion of the concerns identified. The provider/practitioner can respond and argue against the findings but cannot introduce new medical information. The IDPR and the RA consider the provider/practitioner's argument and issue a Final Initial Determination Letter.
Upon receipt of the Final Initial Determination Letter, the provider/practitioner may request a Re-Review procedure, during which additional evidence may be submitted. Re-Reviews are conducted by a Re-Review Peer Reviewer and are procedurally the same as the Initial Determination Review. After that review, a Final Decision Letter is sent to the beneficiary informing him or her of the QIO's final decision.
Beneficiary Involvement in the Review Procedure
A final decision letter for the beneficiary has been part of QIO procedure for many years, but until Transmission 17, the letter did not have to include information about what the QIO had discovered during the review procedure. While the Peer Review Improvement Act required QIOs to ''inform the individual…of the organization's final disposition of the complaint,'' HHS manuals specified that if physicians or providers refused to consent to the release of information, then the letter could only specify that the QIO had conducted "a thorough review." This limitation should have been removed in 2003, following the decision in Public Citizen, Inc. v. HHS.
In 2002, Public Citizen, a citizens' rights advocacy group, brought a case against HHS, challenging the QIO Manual rules that require provider and practitioner consent. The District Court granted summary judgment for the plaintiff and ordered HHS to inform QIOs that they "are required to disclose the results of [QIO] investigations to beneficiary complainants." In upholding the ruling, the DC Circuit clarified that the QIO statute only requires that the QIO communicate the "final judgment" to the beneficiary and does not specifically require the QIO to tell beneficiaries what action was taken.
Transmittal 17 finally institutes the notification required by the Public Citizen decision. It requires that when the QIO conducts a Beneficiary Complaint Review it must send a letter to the beneficiary detailing: 1) a definitive statement that the quality of care in each instance did or did not meet the standard of care, 2) a statement of the proper standard of care in each instance, and 3) a statement that this is the final decision and that no further rights are available. It also requires the letter to include "a specific statement conveying facts describing how the practitioner and/or provider did or did not meet specific criteria within the standard [of care]."
While not as thorough as it could be, this letter follows Public Citizen and provides some details to beneficiaries about the results of their complaints. However, it should be noted that these letters are not sent to all beneficiaries who submit complaints. These letters are not required in General Quality of Care Review, even if a beneficiary complaint is the cause of such a review. The NPRM also specifies that if a beneficiary contacts the QIO about a potential complaint, but does not follow up with a written complaint, the beneficiary will "not receive any results of the QIO's review."
New QIO Procedural Tools Included in Transmittal 17
Immediate Advocacy is intended as an initial attempt to address the beneficiary's complaint without going through the full complaint procedure. Immediate Advocacy can only be used in limited circumstances. First, the complaint must be made orally for issues that do not rise to the levels of "gross and flagrant," "substantial," or "serious or urgent." "[G]ross and flagrant" issues result in "imminent danger" to the health, safety, or well-being of a beneficiary or unnecessarily place the beneficiary in high-risk situations. "[S]erious or urgent" issues occur when a "beneficiary has been exposed to serious harm" or a "beneficiary may potentially be exposed to imminent future harm."
In addition, both the beneficiary and the provider must consent to the use of Immediate Advocacy and consent can be withdrawn at any time.  If the provider does not consent or if the beneficiary withdraws consent, the QIO must contact the beneficiary immediately and provide an opportunity to file a written complaint.
Immediate Advocacy is conducted in one of two ways. The first possibility is a three-way call between the beneficiary, provider, and the QIO; the second is for the QIO to call the provider on behalf of the beneficiary. If the call cannot be scheduled within 10 days of the initial complaint, Immediate Advocacy cannot be used. If additional information about the complaint arises that raises the level of the complaint to "gross and flagrant," "substantial," or "serious or urgent," the Immediate Advocacy is discontinued. If the QIO "becomes aware of additional information that would render the complaint ineligible for Immediate Advocacy," the QIO must discontinue Immediate Advocacy and may (but does not have to) suggest that the beneficiary submit a written complaint. Early reviews of the Immediate Advocacy procedure, as reported in the NPRM, have been positive.
Direct Advocacy is the second new procedural tool. It may occur following a full complaint review where no significant quality of care concern has been identified, yet the beneficiary has a continuing concern about the quality of care received. In order to use "Direct Advocacy," there can be no issues that are of a "gross and flagrant," "substantial," "serious or urgent" or even "significant" nature. Both the beneficiary and provider/practitioner must consent to Direct Advocacy. Moreover, the beneficiary can revoke consent at any time. As with Immediate Advocacy, the QIO can either conduct a three-way call or can speak directly to the provider or practitioner without the beneficiary's presence.
The new instructions for QIO review provide complex but important information for beneficiaries. It is hoped that the complaint resolution process will be faster and more reliable, and provide more thorough information to beneficiaries.
 For purposes of Transmittal 17, quality of care concerns relate to a range of matters from how one is or was treated by provider staff, whether one is receiving or received the treatment or services requested or expected, and/or whether the services in question are or were provided in a way that meets accepted standards of care, See 42 U.S.C §1320c-3. Matters of premature discharge from a Medicare-covered care settings may often start with a QIO complaint. Even so, with respect to matters of premature discharge or where there has been a denial of a continuing stay in a Medicare-participating hospital, skilled nursing facility, home health agency, or hospice, advocates should use the standard or expedited appeals process. See 42 USC §1395ff, 42 C.F.R. §405.900 et seq. (Traditional Medicare), and §422.560 et seq. (Medicare Advantage).
 CMS, Transmittal 17: QIO Manual Chapter 5 – “Quality of Care Review,” (April 6, 2012), available at http://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/Downloads/R17QIO.pdf .
 See §1154(a)(4)(A) of the Social Security Act, 42 U.S.C. 1320c–3(a)(4)(A); Transmittal 17, §5020. QIOs are entities comprising health care professionals – physicians, nurses, and other allied health care professionals – who contract with the Medicare agency to review quality of care concerns, including beneficiary-generated complaints.
 See 77 Fed. Reg. 45061, 45196ff (July 30, 2012), http://www.gpo.gov/fdsys/pkg/FR-2012-07-30/pdf/2012-16813.pdf. On September 4, 2012, the Center, along with the Medicare Rights Center and California Health Advocates, filed comments on several aspects of this large NPRM.
 See 77 Fed. Reg. 45061, 45196ff.
 Transmittal 17, Id. at §5300 et seq. and §5600 et seq.
 Id. at §5200 et seq. (Retrospective Beneficiary Complaint Review) and §5540 et seq. (Retrospective General Quality of Care Review).
 For example, compare §5220.2 – Retrospective Beneficiary Complaint: Requesting Medical Information – (the QIO expects “the requested information within ten (10) calendar days) with §5320.2 – Concurrent Beneficiary Complaint: Requesting Medical Information – (the QIO expects “the requested information by the close of business the next business day”); §5220.4 – Retrospective Beneficiary Complaint: Review and Preparation of Medical Information – (five days) with §5320.4 – Concurrent Beneficiary Complaint: Review and Preparation of Medical Information – (one day) ; §5230.2 – Retrospective Beneficiary Complaint: Preparation of Quality Review Decision (QRD) Form – (three days) with §5330.2 – Concurrent Beneficiary Complaint: Preparation of Quality Review Decision (QRD) Form – (one day).
 Id. at §5030 (Definitions Related to Quality of Care Reviews).
 Id. at §5500 (General Quality of Care Reviews).
 Id. at §§5110-5110.4.
 Id. at §§5250.3, 5350.3.
 Id. at §5120 (Immediate Advocacy), §5400 (Direct Advocacy).
 Id. at §§5220, 5320, 5550, 5610.
 Id. at §§5220.2, 5320.2, 5550.2, 5610.2.
 Id. at §§5220.3, 5320.3, 5550.3, 5610.3.
 Id. at §§5230.2, 5330.2.
 Id. at §§5230.3, 5330.3.
 Id. at §§5240.1, 5340.1.
 Id. at §§5240.1, 5340.1.
 Id. at §§5240.3, 5340.3.
Id. at §§ 5240.6, 5340.6 (The letter must contain the language that the QIO will include in its letter to the beneficiary about the outcome of the review. For practitioners, the letter must also request the consent of the practitioner to disclose the specific findings of the review to the beneficiary.).
 Id. at §5250.
 See Public Citizen, Inc. v. Dep’t of Health & Human Servs., 332 F.3d 654 (D.C. Cir. 2003), aff’d, 151 F. Supp.2d 64 (D.D.C. 20001). The manual language for QIOs from the 1990s was: “We have carefully examined your concern(s) and conducted a thorough review of the medical records pertaining to the services that (you or name of beneficiary) received. Federal regulations prohibit us from releasing information that identifies the involved practitioner without his or her consent. Because the involved practitioner did not give (his or her) consent, we are unable to release information that would explicitly or implicitly identify him/her. This does not necessarily mean that we found a problem with the services (you or name of beneficiary) received. However, we will take appropriate action if warranted by our review findings.”
 42 U.S.C. § 1320c–3(a)(14)
 See Public Citizen, Inc. v. Dep’t of Health & Human Servs., 332 F.3d 654 (D.C. Cir. 2003), aff’d, 151 F. Supp.2d 64 (D.D.C. 20001). The Public Citizen case sought to provide beneficiaries with more direct and specific information about the resolution of quality of care complaints. For a detailed discussion of the need for reforming the QIO review process, including the need to provide better information to beneficiaries, see Diane E. Hoffmann and Virginia Rowthorn, Achieving Quality and Responding to Consumers, The Medicare Beneficiary Complaint Process: Who Should Respond? 5 Indiana Health Law Review 9 (2008). See also the proceedings of the Center for Medicare Advocacy’s conference, “Beyond QIO: Modeling a Medicare Beneficiary Complaint Process for Quality of Care” (January 19, 2007), available at https://www.medicareadvocacy.org/2007/04/26/center-for-medicare-advocacy-conference-develops-medicare-beneficiary-complaint-process/.
 Id., Public Citizen.
 Transmittal 17 at §5250.3
 NPRM at 45199.
 Immediate Advocacy is discussed in the new manual at §5120 et seq. and in the NPRM at pp.45197-45198.
 Transmittal 17 at §5120.2.
 Transmittal 17 at §5030.
 Id. at §5120.
 Id. at §5120.3.
 Id. at §5120.4 (The manual and the NPRM are not clear about who selects the procedure used).
 Id. at §5120.5.
 Transmittal 17 at §5400 – 5400.5.
 Id. at §5400.
 Id. at §5400.2.
 Id. at §5400.3.
 Id. at §5400.5.
 Id. at §5400.4.