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Compliance Insights Newsletter – January 2016

Compliance Insights Newsletter – January 2016

IMPORTANT REMINDERS

On December 30, 2015, CMS provided an update to the Standard Operating Procedures (SOP) for theshutterstock_134715920_important-Note.jpg handling of Complaints Tracking Module (CTM) Complaints. It is effective January 1, 2016 and replaces Section 2 of the previous HPMS memorandum released on February 6, 2015. Other portions of that HPMS memorandum remain in force.

Model of Care (MOC) submissions are due by February 17, 2016 for those organizations whose MOC approvals expire December 31, 2016. MMPs required to resubmit MOCs for CY 2017 were notified of this requirement, as well as any state-specific elements to include in their MOC submissions, via an HPMS memorandum in November 2015.

Part D sponsors with an approved Medication Therapy Management (MTM) program are required to submit beneficiary-level MTM program data. The reporting deadline for these data is 2/29/2016. The OMB approved reporting requirements document, and supporting technical specifications, are posted on the CMS website: https://www.cms.gov/Medicare/Prescription-Drug-Coverage/PrescriptionDrugCovContra/RxContracting_ReportingOversight.html

Summary-level and patient-level HEDIS data are due concurrently on June 15, 2016. Please note that files not submitted and successfully validated by the submission deadline, June 15, 2016 midnight EDT, will result in a 1 Star Rating in each of the Star Rating HEDIS measures connected with the patient-level detail file.

COMPLIANCE NEWS

Addendum to the 2015/2016 Program Audit Protocols

Based on feedback from the industry, on January 19, 2016 CMS created an addendum to the Program Audit Protocols that offers clarification on the fields causing confusion, and should be used in conjunction with the CY 2016 audit protocols. It does not change any of the data CMS is requesting, it simply provides clarification to certain fields that continue to cause confusion. The addendum has a table for each protocol, and indicates which page or record layout field is affected, what the initial language was that caused confusion, an explanation of the change, and the updated language sponsors should utilize when preparing for audit. MedHOK has updated any CDAG/ODAG universe reports affected by this addendum.

If there are any questions relating to the program audit protocols, please send those questions to the audit mailbox, part_c_part_d_audit@cms.hhs.gov. The addendum, protocols and other associated audit documents are located in the Downloads section of the CMS Program Audit website, located at: https://www.cms.gov/Medicare/Compliance-and-Audits/Part-C-and-Part-D-Compliance-and-Audits/ProgramAudits.html

Medicare Prescription Drug Benefit Manual – Chapter 6

On January 19, 2016 CMS released a revised Chapter 6 – Part D Drugs and Formulary Requirements of the Medicare Prescription Drug Benefit Manual. The updated chapter reflects updates from pertinent final regulations, Call Letters, and memoranda. Changes were also made in consideration of feedback relating to operationalizing the Part D benefit.

The following sections have significant updates and/or reorganization:
* Section 30.2.2 – Formulary Benefit Management Tools
* Section 30.4 – Transition

Based on comments, CMS also decided to remove instead of revise the following:
* Appendix A – Common Acute Care Home Infusion Drugs

Any suggestions or questions regarding this manual chapter should be directed to PartDPolicy@cms.hhs.gov.

HEDIS 2016 Patient-Level Data Submission Information

Medicare Advantage (MA), Demonstration (Medicare-Medicaid Plans), and §1876 Cost contracts that are required to report HEDIS 2016 summary-level data for the 2015 measurement year (MY) must also provide the patient-level data used to calculate the summary-level scores for each contract. Summary-level and patient-level data are due concurrently on June 15, 2016.

Please note that files not submitted and successfully validated by the submission deadline, June 15, 2016 midnight EDT, will result in a 1 Star Rating in each of the Star Rating HEDIS measures connected with the patient-level detail file. No late submissions or corrections are allowed passed the submission deadline of June 15, 2016. CMS strongly recommends that you participate in the testing period detailed below.

The Centers for Medicare & Medicaid Services (CMS) recently placed updated versions of the following documents at: http://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/MCRAdvPartDEnrolData/index.html under the “downloads” section.

  • 2016 Patient-level file specifications, File 1 of 2 (2015 Measurement Year)
  • 2016 Patient-level file specifications, File 2 of 2 (2015 Measurement Year)
  • 2016 Patient-level data submission instructions (2015 Measurement Year)
  • Crosswalk document showing changes from 2015 to 2016 Patient-level file specifications

Please use all of the 2016 documents for the creation of the MY 2015 patient-level data files. Please access the 2016 versions for use for creating and submitting your patient-level data submission. Be sure to deliver the 2016 versions of these documents to your NCQA-Certified HEDIS Compliance Auditor and any third-party vendor submitting data on your behalf.

For questions about the 2016 HEDIS Patient-level file specifications and submission process, please contact MA_patient_data@edaptivesys.com. For questions about 2016 HEDIS summary-level data submission, please contact your HEDIS account manager at NCQA.

CMS is currently seeking volunteers for testing the 2016 patient-level submission process and would welcome your participation. CMS recommends that all contracts consider testing the 2016 patient-level submission process. Beginning April 9, 2016 through May 4, 2016, contracts or third-party vendors may submit test data files to CMS via Gentran or Connect:Direct or MFT Internet Server. This testing period is being offered to contracts that would like to verify their Gentran or Connect:Direct connection or the MFT Internet Server and to find programmer or logic errors prior to the official submission period. For more information about providing a test submission, please read the “Patient-Level Data Submission Overview” section of the Submission Instructions or contact Ma_patient_data@edaptivesys.com

For questions about this memo, please email HEDISquestions@cms.hhs.gov or see the January 19, 2016 memo.

Reinstatement of Enrollment for Good Cause – Policy Clarifications for CY 2016

On December 30, 2015, CMS released a memo with clarifications related to reinstatement of enrollment for good cause for the contract year 2016.

Effective January 1, 2016, an entity (i.e., the plan) is permitted to act on behalf of CMS to effectuate reinstatements when good cause criteria are met. CMS transferred this responsibility to plans starting January 1, 2016, such that plans will be responsible for the intake and processing of good cause reinstatement requests for individuals disenrolled effective January 1, 2016, and later, due to nonpayment of plan premiums. CMS will continue to process good cause reinstatement requests from individuals disenrolled by CMS for failure to pay Part D-IRMAA.

As a result of the information discussed during the November 18, 2015 Plan User Call, CMS made a few clarifications in the guidance:

  • An individual may make only one request for good cause during the 60-day period following the involuntary disenrollment. Should an individual not be eligible to make a request for good cause due to their indication that he or she did not have an unexpected or uncontrollable circumstance that prevented their ability to make timely payment or is unable to pay the owed amounts within three months following the disenrollment, the individual may not make a second request during that timeframe. He or she will remain disenrolled and will need a valid enrollment period in order to submit a new enrollment request.
  • There may be other situations in addition to the list of circumstances provided in guidance that may result in favorable good cause determinations. Such situations must meet the regulatory standards of being outside of the member’s control or unexpected such that the member could not have reasonably foreseen its occurrence, and this circumstance had to be the cause for the non-payment of plan premiums.
  • Initial requests whether via telephone, mail or fax are considered received by the plan at the time the request first arrives. If the individual meets the eligibility criteria to make a good cause request, the initial receipt by the plan is considered Day zero, and the five business day clock begins.
  • Plans have a total of five business days to review the request and make a determination; no additional time will be provided if the plan does not have sufficient details to make an informed determination. In situations where the plan needs more information to make the determination, it should make a good faith effort to gather the information within that five-day timeframe. If attempts are unsuccessful, the plan must use the information provided with the initial request to make its determination.
  • Plans may add their contact information to the model notices related to good cause and CMS will consider it a model without modification, as long as it is the only addition. CMS has updated the model notice language to include this information.

Clarifying text is incorporated into the MA, PDP and cost plan enrollment guidance materials posted at the links below:

MA and Cost Plan enrollment guidance: http://www.cms.gov/Medicare/Eligibility-and-Enrollment/MedicareMangCareEligEnrol/index.html
PDP enrollment guidance: http://www.cms.gov/Medicare/Eligibility-and-Enrollment/MedicarePresDrugEligEnrol/index.html

It is expected that organizations have developed the internal processes and procedures necessary to assume responsibility for the receipt, review and effectuation of the good cause reinstatement requests for individuals disenrolled for nonpayment of plan premium effective January 1, 2016, and later. However, plans should implement any operational changes to meet the policy clarifications as soon as possible, but not later than 90 days from the date of this memorandum.

Please direct questions regarding the submission and/or review of member materials to your CMS Account Manager. For enrollment policy questions, please submit your inquiry to PDPENROLLMENT@cms.hhs.gov and copy your CMS Account Manager.

CY 2016 Core Reporting Requirements for Medicare-Medicaid Plans

On January 8, 2016 CMS released the Calendar Year 2016 Medicare-Medicaid Capitated Financial Alignment Model Reporting Requirements. Medicare-Medicaid Plans (MMPs) should follow these revised requirements for all reporting periods that commence on or after January 1, 2016.

Please see below for a summary of the substantive changes that were made as compared to the CY 2015 reporting requirements document that was previously released on December 14, 2015.

Should you have any questions, please contact the Medicare-Medicaid Coordination Office at mmcocapsreporting@cms.hhs.gov.

Summary of Changes:

Part C and Part D Reporting Sections

MMP-Specific Reporting Section

Core Measure 2.1

  • In the Data Element Definitions section, clarified that data element A should only include members who were currently enrolled at the end of the reporting period. For data elements B and C, added guidance that the member’s unwillingness to participate or the member’s completed assessment must be clearly documented in order for the member to be counted in the respective data element.
  • In the Edits and Validation Checks section, added additional validation steps that MMPs should complete prior to the submission of data for this measure.
  • Made several revisions to the Notes section, including:
    • Added clarifying language regarding the determination of the 90th day of enrollment.
    • Clarified that data elements B, C, and D should be mutually exclusive, and provided guidance on how to classify members that may meet the criteria for multiple data elements.
    • Added guidance that the assessment tool should meet any state-specific criteria and include the appropriate domains as determined by the state.
    • Added direction that MMPs should refer to their state’s reporting appendix for information on reporting assessments completed by the MMP prior to a member’s effective enrollment date, reporting assessments for members with a break in coverage, and reporting assessments completed previously by the MMP’s affiliated product (note that applicability of this guidance varies by state).
    • Clarified that members who decline care management activities overall or refuse any contact with the MMP may be counted under data element B.

Core Measure 2.3

  • In the Notes section, added guidance that the assessment tool should meet any state-specific criteria and include the appropriate domains as determined by the state.

Core Measure 7.1

  • Added this measure, which provides additional detail about the required annual network submission. For further information, MMPs should refer to the MMP Medicare Network Submission Guidance that will be issued in the summer of 2016.

Marc Ryan

Marc S. Ryan serves as MedHOK’s Chief Strategy and Compliance Officer. During his career, Marc has served a number of health plans in executive-level regulatory, compliance, business development, and operations roles. He has launched and operated plans with Medicare, Medicaid, Commercial and Exchange lines of business. Marc was the Secretary of Policy and Management and State Budget Director of Connecticut, where he oversaw all aspects of state budgeting and management. In this role, Marc created the state’s Medicaid and SCHIP managed care programs and oversaw its state employee and retiree health plans. He also created the state’s long-term care continuum program. Marc was nominated by then HHS Secretary Tommy Thompson to serve on a panel of state program experts to advise CMS on aspects of Medicare Part D implementation. He also was nominated by Florida’s Medicaid Secretary to serve on the state’s Medicaid Reform advisory panel.

Marc graduated cum laude from the Edmund A. Walsh School of Foreign Service at Georgetown University with a Bachelor of Science in Foreign Service. He received a Master of Public Administration, specializing in local government management and managed healthcare, from the University of New Haven. He was inducted into Sigma Beta Delta, a national honor society for business, management, and administration.

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