First-time applicants for URAC accreditation often encounter the challenge of finding or creating a Quality Management Committee (“QMC”) within their organizations. This sometimes is “finding” because a committee by another name may already exist and need only a bit of tweaking to comply with URAC’s requirements for such a committee. In fact, an organization may have two or three committees that are likely candidates for such a designation, and therefore must either elevate one of the committees to that position or create a “super-QMC” to pull together the activities of the other committees. Other organizations will find it advantageous to create a new QMC out of whole cloth.

This is particularly true in the world of pharmacy benefit managers (“PBMs”). Most PBMs of which we at Integral Healthcare Solutions are aware will have to do a bit of fiddling with their committee structures to meet the various URAC standards that address the structure, role, and responsibilities of the QMC. It is timely then, as URAC reviewers criss-cross the nation conducting the onsite reviews of the 10 PBMs participating in URAC’s “beta” program for its nascent PBM standards, to summarize what a PBM QMC should look like and do. I use “must” where we found, in either standards or interpretive information accompanying the standards, specific reference to the QMC. I use “should” where we have concluded, based upon our years of experience with URAC-accredited companies’ QMCs, the QMC should be involved to be fully consistent with URAC’s view of QMCs.

Composition

The QMC must have as members:

• a member of senior management with the authority and responsibility for the overall operation of the quality management program (Core 32(e))
• at least one participating provider or a mechanism to receive input from participating providers (Core 33(e)).

Charter

The QMC must be “granted authority for quality management by the organization’s governing body” (i.e., the Board of Directors) (Core 33(a)).

Meetings

The QMC must meet at least quarterly (Core 33 (c)) and maintain minutes at all its meetings (Core 33 (d)).

Reports the QMC must receive

The QMC must receive, periodically:

• reports on progress in meeting quality improvement goals (Core 33(h))
• analyses of consumer complaints and appeals (Core 29)
• reports on ongoing compliance with URAC standards (Core 34(a))
• reports on objectives and approaches utilized in the monitoring and evaluation of QM activities (Core 34(b))
• tracking and trending reports of key indicators relevant to the scope of the entire organization and related to consumer and health care services (Core 34(c))
• reports on the implementation of action plans to improve or correct identified problems (Core 34 (d))

Reports the QMC should receive

The QMC should receive periodic reports on:

• the results of consumer satisfaction surveys (Core 25)
• the organization’s performance with respect to its standards to assure that consumers or clients have access to services (Core 26)
• ongoing compliance with operating requirements for the call center for in-bound telephone calls (CSCD 7)

Reports the QMC must make

The QMC must provide “on-going reporting to the organization’s governing body.” (Core 32(b))

Specific decisions it must make and actions it must take

The QMC must:

• approve the quality improvement projects to undertake (Core 33(g))
• annually evaluate the effectiveness of the QM program (Core 33(i))
• annually review and update the written description of the organization’s QM program (Core 32 (c))

Specific decisions it should make and actions it should take

The QMC should:

• approve the organization’s mechanism to respond on an urgent basis to situations that pose an immediate threat to the health and safety of consumers (Core 23)
• review and approve the organization’s systems:
  • for identifying and communicating drug-drug interactions at point-of-service (DrUM 5(a)); and
  • of drug utilization management tools, such as prospective and concurrent DrUM that identifies situations which may compromise the safety of the consumer (DrUM 5(b))

Ongoing activities of the QMC

The QMC must:

• provide guidance to staff on quality management priorities and projects (Core 33(f));
• monitor progress in meeting quality improvement goals (Core 33(h))

Today, URAC held a conference call to explain to persons and organizations interested in the new PBM accreditation program and the beta testing process currently underway. Here is a summary of my notes (some of which were from the call, some of which are from the materials URAC provided call participants).

Implementation Timeframe Overview: Standards Development Process

• Committee develops draft standards Q3 2006 - Q2 2007
• Public input into Commercial Standards Q4 2006
• Forums (e.g. AMCP, NPC)
• Comment period
• Organization beta testing Q1-Q2 2007
• Final revisions to standards Q2 2007
• Approval by URAC’s Board Q3 2007
• Launch Q3 2007

Beta testing objectives:

• “Is the intent of standard clear to the applicant?
• “Can an organization demonstrate mechanisms to meet the standard?”
• “What are the various (multiple) methods companies can demonstrate compliance with the standard?”
• “Is the standard consistent with industry practice

Review team:

• Christine Leyden
• Annette Watson
• Janice Anderson

NEXT STEPS

• Confirm Onsite Operational Location for Beta Testing via the Application Form by March 5, 2007
• Confirm Beta Onsite Date with Janice Anderson, R.Ph. by March 5, 2007
• Execute URAC Business Associate Agreement prior to commencement of beta onsite activities
• Complete Beta Document List with the Organization’s Comments and Examples of Potential Compliance Methods by the date of the Beta Onsite for all standards
• Evidence of Compliance with Mandatory Standards available at the Beta Onsite

BETA PREPARATION

• Onsite Agenda Review is estimated 1.5 days onsite by a team
• Overview Presentation of the PBM’s Scope of Services with Organization Charts for areas within the scope of the PBM Accreditation
• Document List with Organization’s Feedback pertaining to the proposed standard
• Relevant Documentation Available for Mandatory Standard
• Interview Key Personnel (phone or in-person)

KEY PERSONNEL

• Appropriate Senior Staff and 1 to 2 Operations Staff for each module
• Corporate Quality Oversight
• Information Management System
• Regulatory/Legal Compliance
• Staff Training and Credentialing
• Claims Processing
• Marketing
• Member Communications

What’s Not Addressed in the Standards?

• E-Prescribing (address in next revision)
• Specialty Pharmacy
• Mail Service (See the NABP VIPPS Accreditation)

Other issues

• URAC Revises its Accreditation Programs every 2 years.
• Onsite Review for Beta will be 1.5 days, ending around noon on the second day.

Questions addressed

1. Q: What's the relationship between the document list and the agenda? A: The document list has a column that cross-references to the appropriate standards. In addition, the agenda specifically addresses the standards under review during each time frame in the Beta Onsite agenda.
2. Q: Regarding the beta onsite review, you're placing emphasis on "mandatory standards." Are those the standards rated "5"? A: Yes, we'll be looking for complete documentation on all standards weighted 5, but also will be looking at documentation for the other standards.
3. Q: Can you provide clarity around which standards apply to PBMs and which apply to plans? A: There may be some blurred lines, but we hope to find out during the beta testing process which standards don't apply to PBMs.
4. Q: To whom does "delegation" apply? A: Any organization to which the PBM off-loads any function that is the subject of any of the PBM standards.
5. Q: What happened to Module 7 as it relates to benefits? A: The standards that were eliminated between the "public comment" version and the "beta" version were deemed by the Standards Committee to be inapplicable to PBMs generally. The remainder were folded into the other module.
6. Q: Are there additional fees when you apply for accreditation. A: Generally, no. The only way you would be charged an additional fee would be if URAC needs to visit more sites than originally contemplated.

Not surprisingly, these standards track closely the URAC Health Utilization Management (HUM) standards. Of particular note is the fact that 14 of the module’s 27 standards (52 percent) are mandatory, an unusually high percentage when compared to the other modules. This reflects the committee’s awareness that weaknesses in these processes are more likely to have a dangerous impact on the health and safety of consumers. The mandatory standards are:

• DrUM 1 – DrUM Program Components, which requires the PBM to develop and implement P&Ps that address criteria for optimal drug use and evaluating the available drug submission data.
• DrUM 2 - Coverage Decisions Based on Clinical Information, requiring that such decisions be based upon such considerations as peer-reviewed literature, practice guidelines, and other markers of appropriateness.
• DrUM 4 – Prospective, Concurrent and Retrospective DrUM, requiring that the PBM ensure DUM mechanisms that address such thirteen issues, such as therapeutic appropriateness, over- and under-utilization, proper generic use, and drug-disease contraindications.
• DrUM 5 - Consumer Safety, requiring that the PBM have distinct processes for identifying and rectifying consumer safety issues.
• DrUM 8 - Prospective Reviewer Qualifications, imposing minimum qualifications for prospective reviewers.
• DrUM 9 – Automated Review, which requires PBMs with automated review process to “define the algorighmic protocol being use and validate the initial automated algorithm.” This automated process will need to be reviewed regularly to assure that it’s working properly, that it is up-to-date with current evidence-based knowledge, and examines the rate of appeals.
• DrUM 10 - Review of Automated Review Non-Certifications, requiring that PBMs "have policies and procedures in place to provide oversight of the automated review process and its linkage to the appeals process."
• DrUM 19 - Appeals, requiring that the PBM "provide access to a formal appeal process if a request for a noncovered drug is denied."
• DrUM 20 - Appeals Process Consumer Rights, which requires that PBMs "provide information to the consumer on how to request an exception or appeal."
• DrUM 21 – Non-Certification Appeals Process, specifying that the PBM’s have both a standard appellate process for non-urgent cases and an expedited appellate process for urgent situations. The PBM will need to make the written P&Ps describing these appellate processes available to consumers upon request.
• DrUM 22 - Appeals Process, which fleshes out the essential components of a PBM appeals process.
• DrUM 23 – Appeal Peer Review Qualifications, establishing very specific requirements for the PBM’s appellate reviewers, most notably that they be active, board-certified (where applicable) MDs, DOs, pharmacists, or clinical peers who weren’t involved and don’t work under anybody who was involved in the earlier decision.
• DrUM 24– Expedited Appeals Process Timeframe, requiring notice of the decision in the expedited appeal within 72 hours of the request for review and a written confirmation within 3 days.
• DrUM 25 - Standard Appeals Process Timeframe, requiring that the PBM's standard appeals process be "completed, and written notification of the appeal decision issued,within 30 calendar days of the receipt of the request for appeal."

Resemblance to URAC's Plan and Network Standards

Not surprisingly, the 13 standards in this module look a lot like the Network Management (NM) standards from URAC’s Health Plan and Health Network accreditation programs. Indeed, there is an almost standard-to-standard relationship, e.g., PHARM-DC 1 with P-NM 1, PHARM-DC 2 with P-NM 2, and so on.
Thus, these standards cover what URAC has long thought to be the nuts-and-bolts of network management

• Defining the scope of services and provider selection criteria
• Working to achieve for access and availability
• Implementing policies for out-of-network services
• Provider relations program requirements
• Minimum components of provider agreements and subcontracts
• Provider dispute resolution

Of some interest to those of us who have closely followed the drama around URAC’s provider dispute resolution standards is that their correlates in the PBM standards avoid all the complications of their Plan and Network counterparts. Don’t look for much controversy here.

PBM-Specific Standards

The last two standards of this module, PHARM-DC 12 and 13, break from the Network Management pattern set by the first 11 standards. PHARM-DC 12 requires that the PBM’s claims processing comply with NCPDP transaction standards, while PHARM-DC 13 requires the PBM to disclose to consumers “the exceptions to refilling prescriptions (which would otherwise be limited by benefit design) in order to ensure access to the types of drug therapy needed.” This last standard doesn’t seem to fit in this module, and it wouldn’t surprise me in the least if PHARM-DC 13 were moved in the final draft to hang out with its closer cousins in consumer education in Module 2.

This 12-standard module in the URAC PBM program focuses on required disclosures by the PBM to both the consumer and the client.

"Vanilla" Consumer Education Standards

CSCD 1 lists seven requirements for post-enrollment consumer information, reminiscent of P- MR 3 in the Health Plan standards. CSCD 2-4, 6, 8-11 are rather predictable (and familiar) transparency, accuracy, access, and readability standards for consumer communications of the sort one sees throughout URAC’s and/or Medicare’s standards for organizations that deal with consumers.

Records Verification

A particularly interesting standard, in no small way because it is a mandatory standard, is CSCD 5: “The organization has a mechanism to allow its clients to verify the organization’s records to ensure that the disclosures in CSCD 4 (c) are comprehensive and accurate, per the terms of the client contract.” The on-request disclosures to which this standard refers are “Pricing structure for pharmacy benefit management services, such as: (i) Rebate structure; and (ii) Administration fees.”

Specific Call Center Requirements

I was also interested in the rather specific call center requirements of CSCD 7 (“(a) Incoming calls must have an average speed of answer within 30 seconds, and (b) Average abandonment rate of all incoming calls cannot exceed 5 percent”). URAC has seldom been this specific in this domain of responsiveness to consumers, and may augur similar standards in future versions of other clinical programs.

Generic and Mail Order Programs

Besides CSCD 5, the only other mandatory standard in this module is CSCD 12: “Mandatory generic and mail order programs must offer educational information for the consumer.”

All in all, this module should present few challenges for PBMs with robust consumer communications programs.

As I noted in the February 7 blog, the new URAC Pharmacy Benefit Management (“PBM”) accreditation standards are going through a beta process with a handful of brave applicants. Since that posting, however, we’ve got our hands on the official “Draft for Beta Testing” version. This version has a few significant changes from the “Draft for Public Comment” version released last year.
In this and the next few blogs, I’ll do a high-level analysis of the Beta Testing version, with brief commentary on changes from the Public Comment version.

Definitions

The PBM standards have a lot of concepts not included in the other accreditation standards. As a result, the “Definitions” section is substantially different than you’ll find in other Program Guides. Terms like “Automated review”, “Drug therapy management”, and “Generic substitution” are new. In addition, some terms that have appeared in other Program Guides take on new meanings in these standards, such as “Certification” and “Non-certification” have new, PBM-specific meanings. A close review of this section is, therefore, a must for anyone seeking to safely navigate these standards.

Module 1: Core

Naturally, as this is a clinical accreditation program, all applicants will be required to achieve a “passing score” on the Core module. Of course, as I’ve noted in a number of earlier blogs, this Core module (v.2.0) is changed from v. 1.0 and has some more rigorous standards than before (especially around patient safety).
Of particular interest to URAC during the beta testing period will be applicants’ compliance level with a couple of the Core standards:

• Core 3: The organization: (a) Maintains and complies with written policies and procedures that govern core business processes of its operations related to the scope of the accreditation; (b) Maintains a master list of all such policies and procedures; (c) Reviews clinical policies and procedures no less than annually and non-clinical at least once every three years, and revises as necessary; and (d) Includes the following on all policies and procedures: (i) Effective dates, review dates, including the date of the most recent revision; and (ii) Identification of approval authority.
• Core 10(c): “The organization designates at least one senior clinical staff person who has . . .Post-graduate experience in patient care.”

Draft, public comment, redraft, beta reviews, redraft, and approve.

That's the basic sequence for developing a new set of accreditation standards at URAC. While sometimes it seems as though this is a long, slow process (and sometimes it is), there are passages that seem like the Indy 500. In the history of the development of the URAC Pharmacy Benefit Management ("PBM") accreditation standards, now is one such time.

The public comments are in, and the second draft is being worked on. Yet, within a matter of weeks, URAC accreditation reviewers will be showing up on the doorsteps of the companies participating in the "beta" process to conduct their onsite reviews.

So, if you're a PBM that is participating as a beta applicant, some time in the next few days you'll get a copy of the revised standards and need to start gathering documents like crazy to be ready for the knock on your front door that could be as early as mid-March.

Now, of course, the beta process at URAC is different from the normal application process. The normal approach is to submit an application, receive an evaluation of that application from the reviewer(s), respond to that evaluation (called the "Desktop Review Summary") with additional documentation, then submit your organization to an onsite review. In the beta process, you gather your documents together, engage in a more dialogic back-and-forth with the reviews (and sometimes observers) during the onsite review, and then pull your formal application together after the reviewers have left.

Despite this difference faced by beta applicants, there is a big demand for fast action at this phase of the game. Staff training, gap analysis, document assessment and review, revision of P&Ps, mock onsite reviews, and much more, all within the next 30 business days. One of our clients is in this select crew, and we launch our effort tomorrow.

Ladies and gentlemen, start your engines.

After a several-year dormancy, the idea of a URAC Accreditation Program for Pharmacy Benefit Managers (PBMs) has reawakened. URAC announced today that it has formed a committee to develop standards for PBMs. This comes years after the PBM industry first started discussions with all the major managed care accreditation bodies to see who would be interested in developing such standards.

None of the accreditation organizations were ready for the idea in the early part of this decade, when the idea was first floated. I'm guessing that URAC is better prepared to step into this arena since the advent more recently of the Core Standards, which provide a baseline of sound management practices across all types of organizations. This narrows the range of issues to be hammered out, since the "management 101" principles are handled in the Core module.

What will be interesting to see is how the committee handles the fact that non-M.D. pharmacists typically make the UM-like decisions in the drug use management component of PBM operations. I surmise that once that issue has been resolved (if it has not already been resolved), the rest of the issues will go pretty smoothly.