Proposed changes to the Medicare beneficiary election period; dispensing requirements in long-term care facilities; improvements to medication therapy management (MTM) programs; and reviews of medical necessity decisions by a physician or other health care professional are among the issues that the Academy of Managed Care Pharmacy (AMCP) addressed in a January 10, 2011, comment letter to the Centers for Medicare & Medicaid Services (CMS).

AMCP's comments are in response to CMS's proposed changes to the Medicare Advantage (Part C) and the Medicare prescription drug benefit programs (Part D) for contract year 2012 and other proposed changes. CMS's proposed changes serve to implement provisions in the Patient Protection and Affordable Care Act (ACA) and the Health Care and Education Reconciliation Act of 2010. CMS also is proposing other changes to the regulations governing Part C and D programs.

The following comments are included in AMCP's letter:

Beneficiary election: The Academy supports CMS's plan to hold the "election period" when beneficiaries can select a plan under Medicare Part C and D to the timeframe from Oct. 15 to Dec. 7. Under the current system, beneficiaries can enroll in Medicare Part D plans up until 11:59 p.m. on Dec. 31. The change would be implemented for elections effective Jan. 1, 2012.

Late December enrollments have been an implementation challenge for Medicare Advantage (MA) plans and prescription drug plans (PDPs). CMS's proposed change addresses this administrative challenge for benefit year 2012. It will be essential that CMS undertake a strong effort to educate beneficiaries about this change.

Dispensing requirements in long-term care (LTC) facilities: CMS has proposed a requirement that all pharmacies dispense brand-name medications to beneficiaries in long-term care facilities in no greater than 7-day increments at a time.

The Academy is concerned about the operational aspects of implementing this provision of the ACA with less than one-year to prepare after publication of the final rule. The provision will require pharmacies to alter their dispensing system and delivery patterns, which may cause changes in staffing. Part D plans must develop system changes to handle new requirements for copayments and dispensing fees for multiple dispensing events per month.

CMS has also proposed requiring Part D plans to submit only one prescription drug event (PDE) data submission each month. The Academy asks CMS to publish more specific guidance providing direction to Part D plans on how this change to the current PDE submission requirements should be addressed. Because this requirement presents yet another operational challenge to plans, CMS must publish guidance in a timely manner to allow Part D plans to make necessary changes.

In addition, CMS has proposed that all Part D sponsors require any unused Part D drugs originally dispensed to enrollee-residents of LTC facilities to be returned to the pharmacy and reported to the Part D plan sponsor. Where allowed, these returned drugs can be credited, restocked and reused. The proposed effective date for these requirements is Jan. 1, 2012.

In order to implement return/credit of unused medications, a new transmission standard will need to be developed by the National Council for Prescription Drug Programs (NCPDP), a standard development organization. NCPDP has started work on this standard and has set an effective date of March 2013. Given that this date is more than a year later than CMS's proposed effective date, the Academy suggests that implementation of this requirement be postponed until such time as NCPDP has completed implementation of this new standard. This provision is not required by ACA and could be postponed. The Academy recommends that CMS work with NCPDP to determine a feasible timeframe for implementation and that implementation be delayed until January 1, 2014.

Uniform Exceptions and Appeals: Effective Jan. 1, 2012, each Part D sponsor of a prescription drug plan must use a single, uniform exceptions and appeals process with respect to the determination of prescription drug coverage for an enrollee under the plan, and, if determined to be feasible, a single uniform model form for use under such a process. The ACA also requires that Part D plans provide instant access to such processes by enrollees through a toll-free telephone number and an Internet Web site.

The Academy strongly encourages CMS to create a process for significant stakeholder input in creating the uniform exceptions and appeals process. Such a process must have input from the Part D plans that will be required to execute these processes once they have been created.

Improvements to Medication Therapy Management Programs: The Medicare Modernization Act (MMA) requires Part D sponsors to establish medication therapy management (MTM) programs to be designed to ensure that covered Part D drugs are appropriately used to optimize therapeutic outcomes through improved medication use and to reduce the risk of adverse events.

The ACA and the proposed regulations amend current regulations related to MTM programs to require a standardized format for an action plan summary resulting from a review of a beneficiary's medications, and require Part D plans to provide a beneficiary with a written or printed copy. CMS indicates that it will be working with an outside contractor to develop the format for an MTM action plan/summary.

The Academy strongly recommends that input from stakeholders such as health plans, PBMs, pharmacy professional organizations and MTM providers be included. In addition, the ACA and the proposed regulations amend the current MTM provisions to explicitly permit use of telehealth technology. The Academy strongly supports this explicit permission. Part D plans and MTM providers have been successfully providing MTM to Medicare beneficiaries using telehealth technology.

Furthermore, CMS has proposed requiring Part D plans to contract with LTC facilities to provide appropriate MTM services to residents in coordination with monthly medication reviews performed by LTC consultant pharmacists. The Academy opposes such a provision. Part D plans have developed comprehensive MTM programs and contract with MTM providers to provide services that align with the Part D plans' MTM goals. Part D plans should consider LTC consultant pharmacists as important resources for providing MTM services; however, the ultimate decision on who is providing those services is a contract decision that should be made by the plan.

Medicare Advantage Benchmark, Quality Bonus Payments, and Rebate: The ACA required that CMS develop a process to increase Medicare Advantage benchmarks for those plans that attain a high quality score using CMS's five-star quality rating system. CMS has proposed a process for implementing the ACA provisions to determine quality bonus payments (QBP). For plan years 2012- 2014, CMS has indicated that it will use its demonstration authority to modify the QBP provisions set forth in the ACA. Under the demonstration, Medicare Advantage plans with a star rating of 3 to 5 stars will qualify for QBPs.

AMCP notes that provisions in the original version of the Patient Protection and Affordable Care Act (PPACA) - adopted prior to modification by the Health Care and Education Reconciliation Act of 2010 - included bonus payments to Medicare Advantage drug plans that developed MTM programs that exceeded requirements established by CMS for Part D. AMCP and other national pharmacy organizations supported bonus payments for MA plans that implemented enhanced MTM programs, and the Academy encourages CMS to consider quality rating measures that recognize enhanced high quality MTM programs.

Review of Medical Necessity Decisions by a Physician or Other Health Care Professional and the Employment of a Medical Director: CMS proposes requiring "Part D coverage determinations to be reviewed by a physician or other appropriate health care professional with sufficient medical and other expertise, including knowledge of the Medicare program, and require the physician or other health care professional to have a current and unrestricted license to practice within the scope of his or her profession ..." CMS also proposes requiring each Part D plan sponsor to employ a medical director who is responsible for ensuring the clinical accuracy of all coverage determinations and redeterminations that involve medical necessity issues.

The Academy questions the appropriateness and necessity of these new proposed requirements for PDPs. While the Academy does not oppose the employment of a medical director or a decision by a PDP to have a physician review a coverage determination, the reasons put forth by CMS in the draft regulations do not seem to justify such a requirement. In the draft regulations, CMS indicates that the requirement for employment of a medical director is necessary due to:

- Protected class issues
- Inappropriate PA/step therapy
- Issuing denials when indication was specified in compendia
- Transition supply issues

None of these issues are ones that require the training of a physician to properly manage. A pharmacist's training more than adequately equips a pharmacist to make these types of decisions. The Academy strongly recommends that CMS not dictate personnel decisions, which should be made by individual Part D plans. AMCP also believes that a pharmacist does meet the definition of the "appropriate health care professional with sufficient medical and other expertise" and would recommend that CMS clearly state that the provision refers to a physician or pharmacist.

To read the full comment letter visit here and click on the Public Policy & Advocacy tab followed by Analysis, Statements & Letters, or click here.

Source:
Academy of Managed Care Pharmacy