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From Health Law Daily, November 17, 2017

Proposed CY 2019 Part C and D changes address opioid misuse and numerous other policy concerns

By Harold Bishop, J.D.

Calendar year 2019 changes to the Medicare Advantage (MA) (Part C) and the Prescription Drug Benefit Program (Part D) programs have been issued by CMS in an Advance Release of a Proposed rule. The proposed changes are based on CMS’ continued experience with these programs and would (1) implement certain provisions of the Comprehensive Addiction and Recovery Act (CARA) (P.L. 114-198) and the 21st Century Cures Act (P.L. 114-255); (2) update the Part D electronic prescribing standards; (3) change the timing and method of disclosure requirements; (4) rescind the provider and supplier Medicare enrollment requirements for participation in MA and Part D; and (5) make numerous other important changes.

Implementation of CARA. Enacted on July 22, 2016, CARA provided new authority for Part D drug management programs, effective on or after January 1, 2019. Through this authority, CMS proposes a framework under which Part D plan sponsors may establish a drug management program for beneficiaries at risk for prescription drug abuse or misuse, or "at-risk beneficiaries." Under such programs, sponsors may limit at-risk beneficiaries’ access to coverage of controlled substances that CMS determines are "frequently abused drugs" to a selected prescriber(s) and/or network pharmacy(ies). CMS also proposes to limit the use of the special enrollment period (SEP) for dually- or other low income subsidy (LIS)-eligible beneficiaries who are identified as at-risk or potentially at-risk for prescription drug abuse. Finally, CMS proposes to codify the current Part D Opioid Drug Utilization Review (DUR) Policy and Overutilization Monitoring System (OMS) by integrating this current policy with its proposals for implementing the CARA drug management program provisions.

Updating the Part D electronic prescribing standards. CMS proposes an update to the electronic standards to be used by Medicare Part D plans. This includes the proposed adoption of the National Council for Prescription Drug Programs (NDPDP) SCRIPT Standard Version 2017071, and retirement of the current NCPDP SCRIPT Version 10.6, as the official electronic prescribing standard for transmitting prescriptions and prescription-related information using electronic media for covered Part D drugs. These changes would become effective January 1, 2019. The NCPDP SCRIPT standards are used to exchange information between prescribers, dispensers, intermediaries and Medicare prescription drug plans. The proposed updated NCPDP SCRIPT standards have been requested by the industry and could provide a number of efficiencies which the industry and CMS supports.

Timing and method of disclosure requirements. CMS is proposing to allow the electronic delivery of certain information normally provided in hard copy documents such as the Evidence of Coverage (EOC). It also is proposing to change the timeframe for delivery of the EOC to the first day of the Annual Election Period (AEP) rather than 15 days prior to that date. Changing the date by which plans must provide the EOC to members would allow plans more time to finalize the formatting and ensure the accuracy of the information, as well as further distance it from the Annual Notice of Change (ANOC), which will still be delivered 5 days prior to the AEP. In aggregate, CMS estimates a savings to plans (for not producing and mailing hard-copy EOCs) of approximately $51 million.

Preclusion List (Part D). The Proposed rule would rescind the current provisions that require physicians and eligible professionals to enroll in or validly opt-out of Medicare in order for a Part D drug prescribed by the physician or eligible professional to be covered. Instead, CMS proposes that a Part D plan sponsor must reject, or must require its pharmacy benefit manager to reject, a pharmacy claim for a Part D drug if the individual who prescribed the drug is included on the "preclusion list," which would consist of certain prescribers who are currently revoked from the Medicare program and are under an active reenrollment bar. However, to minimize interruptions to Part D beneficiaries’ access to needed medications, CMS proposes to prohibit plan sponsors from rejecting claims or denying beneficiary requests for reimbursement for a drug on the basis of the prescriber’s inclusion on the preclusion list, unless the sponsor has first covered a 90-day provisional supply of the drug and has provided individualized written notice to the beneficiary that the drug is being covered on a provisional basis.

Preclusion List (Part C). The Proposed rule would also rescind the current provisions stating that providers or suppliers that are types of individuals or entities that can enroll in Medicare must be enrolled in Medicare in order to provide health care items or services to a Medicare enrollee who receives his or her Medicare benefit through an MA organization. Instead, CMS proposes that an MA organization must not make payment for an item or service furnished by an individual or entity that is on the "preclusion list." The preclusion list, would consist of certain individuals and entities that are currently revoked from the Medicare program and are under an active reenrollment bar, or have engaged in behavior for which CMS could have revoked the individual or entity to the extent applicable if he or she had been enrolled in Medicare, and CMS determines that the underlying conduct that led, or would have led, to the revocation is detrimental to the best interests of the Medicare program.

Other policy changes. Additional proposed changes to the MA and Part D prescription drug benefit programs would include the following:

  • Ensuring additional transparency for star ratings by codifying key aspects of the Part C and D star ratings methodology, including the principles for adding, updating, and retiring measures, and the methodology for calculating and weighting measures.
  • Eliminating the requirement that MA plans offered by the same organization in the same county comply with artificial limits.
  • Changes to CMS’ interpretation of requirements around the uniformity of Part C benefits offered to MA enrollees.
  • Lessening the burden of marketing submissions and review by focusing the definition of marketing materials on those that are most likely to lead to an enrollment decision.
  • Changing and implementing additional levels of maximum out-of-pocket (MOOP) limits, providing flexibility to encourage plan offerings with lower MOOP limits, and updating guidance regarding discriminatory cost-sharing.
  • Codifying the current optional enrollment mechanism that allows MA organizations to provide seamless continuation of coverage by way of enrollment in an MA plan for newly MA-eligible individuals who are currently enrolled in other health plans offered by the MA organization at the time of the individuals’ initial eligibility for Medicare.
  • Passive enrollment for full-benefit dually eligible beneficiaries from a non-renewing integrated dual eligible special needs plan (D-SNP) to another comparable plan.
  • Revision of existing policy related to formulary tiering exceptions, including the permissible limitations Part D plan sponsors may apply to tiering exception requests.
  • Changing the SEP for dual-eligible and LIS beneficiaries from an open-ended monthly SEP to one that may be used only (1) within a certain period of time after a CMS or state-initiated enrollment; or (2) as a onetime annual opportunity that can be used at any time of the year.
  • Clarifying Part D rules regarding statutorily required "Any Willing Pharmacy" provisions, adding a clarifying definition of mail-order pharmacy, and revising the definition of retail pharmacy.
  • Permitting Part D sponsors to immediately substitute newly released equivalent generics for brand name drugs at the same or lower cost-sharing.
  • Encouraging the use of lower-cost alternatives by classifying follow-on biological products as generics for the purposes of cost-sharing for Part D enrollees who do not receive the LIS and are in the catastrophic portion of the benefit, and for LIS Part D enrollees throughout all phases of the benefit.
  • Replacing the current MA disenrollment period that currently takes place from January 1st through February 14th of every year and replacing it with a new MA open enrollment period (OEP) that will take place from January 1st through March 31st. The new OEP would allow individuals enrolled in an MA plan to make a one-time election to go to another MA plan or Original Medicare. Individuals using the OEP to make a change may make a coordinating change to add or drop Part D coverage.
  • Significantly reducing the amount of medical loss ratio (MLR) data that MA organizations and Part D sponsors submit to CMS on an annual basis and revising the MLR calculation to include in the MLR numerator expenditures related to fraud reduction activities and Medication Therapy Management (MTM) programs.

Request for information. The Proposed rule includes a Request for Information (RFI) on potential policy approaches for applying some manufacturer rebates and all pharmacy price concessions to the price of a drug at the point of sale. CMS plans to use ideas and comments provided in response to the RFI to evaluate and consider proposals for rulemaking.

The Proposed rule will officially publish in the Federal Register on November 28, 2017. Comments are due by January 16, 2018.

MainStory: TopStory NewsStory AgencyNews CMSNews CoPNews ControlledNews CopayNews DrugBiologicNews EHRNews GenericDrugNews HITNews PartANews PartBNews PartCNews PartDNews PrescriptionDrugNews

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