On February 13, 2015, CMS announced new audit protocols and process updates for the 2015 Program Audit Cycle for Medicare Advantage (MA) organizations and Part D sponsors.   According to the memorandum, 2015 begins a new audit cycle.  As such, sponsors audited in the previous audit cycle (2010-2014) will be subject to audit in the new cycle. 

For the 2015 Program Audit Cycle, CMS explained that it “will continue to utilize a risk-based approach to selecting sponsors for audit (both high and low risk), while also taking into account other key factors like: the sponsor has never previously been audited; the sponsor is new to the program (i.e., is in its first 2 years of operation and has no previous affiliation with the Medicare program); or the sponsor represents a large percentage of MA or Part D enrollment.”  

Program Areas/Elements Discontinued for 2015

• Formulary & Benefit Administration: The review of the Pharmacy and Therapeutics (P&T) Committee was removed.  CMS indicated that it will continue to evaluate alternate methods to review the use of the P&T Committee and the implementation of the committee’s recommendations.

Program Areas/Elements Modified for 2015

• Modifications to the Universe Timeliness Tests and Submission of Universes for:
  • Organization Determinations, Appeals and Grievances (ODAG)/Universe Timeliness Tests and Submission of Universes; and
  • Coverage Determinations, Appeals and Grievances (CDAG)/Universe Timeliness Tests and Submission of Universes.

Compliance Program Effectiveness: The Compliance Protocol has been redesigned to be more outcomes-focused and less burdensome.  For example, the content review, which required the sponsor to submit a large number of documents (32 pre-audit), has been eliminated.  Instead, the seven elements will be tested by conducting 5 “tracer” samples, which means that an issue will be selected and the team will “trace” the issue as it moves through the organization’s compliance program.  CMS will continue to conduct interviews, but the interview guides have been streamlined.

New Program Areas/Elements Added for 2015

• Medication Therapy Management (PILOT): All Medicare Part D sponsors are required to have an established Medication Therapy Management (MTM) program in place to ensure optimum therapeutic outcomes for targeted beneficiaries through improved medication use.  The objectives of this program audit area will be to:
  • Assess a Medicare Part D sponsor’s performance with their CMS-approved MTM  Program in accordance with 42 C.F.R. § 423.153(d) and other related CMS guidance;
  • Educate sponsors and correct area(s) of deficiencies; and
  • Initiate enforcement actions and/or identify possible performance measures for sponsors to implement.
• Provider Network Adequacy (PILOT): Sponsors are required to maintain an adequate provider network and ensure access to specialty and sub-specialty providers.  The objectives of this program audit area will be to:
  • Examine the adequacy of a sponsor’s provider network; and
  • Examine the standards for accessibility and ensure that the providers in networks are open to treat enrollees.

According to CMS, the pilot programs will not start until mid-2015.  In addition, CMS has modified certain program audit processes, including timelines for providing notice of the audit and universe submission accuracy requirements.

To view the CMS memorandum, click here.

Reporter, Stephanie F. Johnson, Atlanta, +1 404 572 4629, sfjohnson@kslaw.com.