WASHINGTON — The National Association of Chain Drug Stores and the National Community Pharmacists Association have submitted comments to the Centers for Medicare & Medicaid Services (CMS) as it mulls Medicare Part D prescription drug program changes for the 2019 contract year.

NACDS said Wednesday that in its comments to CMS the association expressed support for and provided added input on the agency’s proposed rule, which involves issues including direct and indirect remuneration (DIR) fees; advancing e-prescribing and medication therapy management (MTM); further addressing opioid issues in a pro-patient and pro-pharmacy manner; and fostering pharmacy access.

“NACDS’ comments reflect extensive member engagement, collaboration and consensus on highly complex issues, which directly affect pharmacy operations and pharmacy patient care,” NACDS president and chief executive officer Steve Anderson said in a statement. “We appreciate CMS’ clear recognition of many of the topics that NACDS has raised on a consistent basis, and we appreciate this opportunity to share additional input from our pro-patient and pro-pharmacy perspective.”

Regarding DIR fees, NACDS said it acknowledged CMS’ understanding of pharmacies’ concerns, such that “retail pharmacies must conduct business in an environment where they are unsure if a reimbursement they received is the final reimbursement or if a fee will be applied to them at some future point.” To address this situation, NACDS proposed solutions to improve the use of fees in Part D to reduce costs for beneficiaries and CMS while promoting a more quality-driven health care system.

NACDS’ recommendations include specific input on the factors involved in determining beneficiary payment and pharmacy reimbursement at the point of sale; the implementation of a meaningful and consistent pharmacy-specific, pharmacy-based quality incentive program; a cap on performance-based fees; and more guidance from CMS to raise transparency and consistency in the use of fees and incentives.

Meanwhile, NCPA said Wednesday that it has endorsed CMS’ plan to consider assessing pharmacy DIR fees at the point of sale. In recent days, NCPA has drawn strong support for its call to end retroactive DIR fees. The association said Tuesday that a bipartisan group of 80 U.S. Representatives has endorsed a proposal to bring DIR fees to the point of sale. And on Friday, NCPA announced that more than 115 health care organizations have signed a letter the shift of DIR fees to the point of sale.

“We commend CMS for addressing in this proposed rule troublesome practices in the Part D program and encourage the agency to implement these provisions to produce greater convenience and savings for Medicare beneficiaries and greater transparency and fairness for pharmacies,” NCPA CEO B. Douglas Hoey commented.

In other comments to CMS on Medicare Part D for 2019, NACDS recommended the following

• Pharmacy “lock-in” programs related to opioid abuse prevention – In implementing provisions of the Comprehensive Addiction and Recovery Act of 2016, CMS proposed a definition of the term “locked-in pharmacy” that’s strongly supported by NACDS. This term refers to a plan sponsor’s “lock-in” ability to require beneficiaries who are at-risk for prescription drug abuse or misuse to obtain frequently abused drugs from selected prescribers and/or network pharmacies. CMS’ proposed definition of “locked-in pharmacy” acknowledges that pharmacies with multiple locations that share real-time electronic data should be treated as one pharmacy, thereby maintaining the spirit of the law while making appropriate allowances for patients’ convenience.

• National Council for Prescription Drug Programs (NCPDP) SCRIPT Standard for electronic prescribing – NACDS noted benefits for patients and health care providers expected to result from CMS’ proposal to adopt the NCPDP SCRIPT Standard Version 2017071 as the official e-prescribing standard for transmitting prescriptions and prescription-related information in Part D. NACDS’ comments urge a transition period to mitigate difficulties with the currently proposed effective date of Jan. 1, 2019.

• MTM and the Medical Loss Ratio – NACDS reiterated its support for a CMS proposal that could further incentivize plans to use medication therapy management (MTM) programs. Under current requirements, Part D plan sponsors and Medicare Advantage plans must meet a medical loss ratio of 85%, meaning the plan cannot spend more than 15% on administrative functions. NACDS said the goal is to force plans to spend more on patient care and items such as quality improving activities (QIA), but there has been confusion about whether the services provided in the Part D MTM program are considered an administrative function or a QIA. CMS is proposing to clarify that Part D MTM programs will fall under the QIA side of the formula.

• Pharmacy networks – NACDS said it expressed appreciation for CMS’ clarification that Part D plan sponsors may not exclude pharmacies with unique or innovative business or care delivery models from participating in their contracted pharmacy network based on not fitting into the correct pharmacy type classification. Part D plan sponsors must not exclude pharmacies from their retail pharmacy networks solely on the basis that they, for example, maintain a traditional retail business while also specializing in certain drugs or diseases or providing home delivery service by mail to surrounding areas, NACDS noted.

“NACDS looks forward to working with CMS on the implementation of these important policy changes and to bringing the perspective of pharmacies and pharmacists serving on the front lines of health care delivery every day,” Anderson added.

In its comments on the proposed 2019 Medicare Part D rule association, NCPA gave its take on the following points, besides DIR fees at the point of sale:

• Support of the revised definition of mail order pharmacy and retail pharmacy, which allows patients to continue getting their prescription drugs from the same pharmacy.

• Endorsement of CMS’ proposal that PBMs may not require onerous pharmacy accreditation and credentialing requirements that go beyond state laws.

• Support of CMS’ proposal to mandate the timeline for when Part D standard terms and conditions are given to pharmacies.

• Concern that revisions to communications materials and activities could create loopholes where incomplete or misleading information is provided to patients.

NCPA said that about 1,000 independent pharmacy owners each submitted their own comments to CMS before the Jan. 16 deadline.

“NCPA and its allies urge CMS to stand firm against pushback from PBMs, who oppose having pharmacy price concessions rolled into the initial adjudication process for prescription drugs, even though doing so is in the interest of patients who need the Part D benefit the most,” Hoey added.