The proposal would revise Medicare Advantage (Part C) and Prescription Drug Benefit (Part D) program regulations to enhance and implement provisions of the Comprehensive Addiction and Recovery Act (CARA) and the 21st Century Cures Act.
The Jan. 16 letter, signed by AAFP Board Chair John Meigs, M.D., of Centreville, Ala., said the AAFP's goal was to "improve further these programs' quality, accessibility, and affordability."
Portions of the AAFP's comments are highlighted below.
CMS proposed implementing a number of new CARA requirements, including one that requires the agency to establish a framework to allow Part D plans to implement a drug management program beginning in 2019 to limit "at-risk" beneficiaries' access to controlled substances deemed by CMS to be "frequently abused drugs."
The AAFP noted its support for some of the proposal's provisions, including "proposed guidelines used to confirm 'at-risk' individuals based on daily use of 90 morphine milligram equivalents or higher of opioids and multiple opioid prescribers and pharmacies," as well as case management and prescriber verification before establishing limits on prescription medication coverage.
"This is a crucial step to verify the accuracy of the information and to inform clinicians of beneficiaries who are receiving opioid prescriptions from multiple prescribers," said the AAFP in its letter, pointing to deficiencies in interoperability among state prescription drug monitoring programs and calling for remediation of such shortfalls.
The AAFP further cited its opposition to actions that "unnecessarily limit patients' access to pharmaceuticals prescribed by a physician using appropriate clinical training and knowledge."
The Academy also stated its concern about proposals related to notices sent to beneficiaries informing them about limits on access to coverage for opioids. Plans should be required to notify patients, the AAFP agreed, but information should be written at appropriate health literacy levels, and beneficiaries should be given the chance to talk with a clinician about receiving substance use disorder treatment.
"There is concern that a written letter may not provide the best vehicle for some beneficiaries to obtain the services they need," said the AAFP. The letter also urged CMS to require plans to support use of evidence-based treatments for substance abuse, including medication-assisted treatment.
Under the proposed rule, CMS would passively enroll full-benefit dually eligible beneficiaries currently enrolled in an integrated Dual Eligible Special Needs Plan into another such plan if these individuals do not actively choose alternative coverage.
The proposal noted that Medicare Advantage plans would be required to have similar provider and facility networks and a minimum "three-star rating." CMS would consider low enrollment contracts or new plans without star ratings as eligible to receive passive enrollments if plans met all other proposed requirements.
The AAFP said it could support CMS' proposal on passive enrollment only if the patient's primary care physician was participating in the plan network. The AAFP urged CMS to protect these all-important physician-patient relationships, proven to achieve better health outcomes, by using recent claims data to identify each patient's key physician and assign the patient to a plan that included his or her primary physician in its network.
Also of concern was passive enrollment of patients into low enrollment contracts or plans without Medicare Advantage star ratings. The letter pointed to data from the Henry J. Kaiser Family Foundation showing that in 2017, 66 percent of Medicare Advantage enrollees chose plans with four or more stars.
"Therefore, the AAFP believes that patients should be passively enrolled in plans with the same number of stars as their previous plan or more," said the letter.
Currently, patients enrolled in a Part D plan with a tiered formulary may request an exception to the plan sponsor's tiered cost-sharing structure; however, products on the specialty tier are not eligible for such an exception.
Because of increased complexity in tiering structures, Part D plans often consider any tier labeled "generic" to be exempt from tiering exceptions if the tier also contains brand name drugs, CMS noted.
In its proposed rule, the agency would require plans to approve tiering exceptions for non-preferred generic drugs when the plan determines the patient cannot take the preferred generic alternatives.
Pointing to its Value-based Insurance Design (VBID) policy, the AAFP said that such a strategy would minimize or eliminate out-of-pocket costs for high-value services in defined patient populations. Value-based insurance design "should encourage beneficiaries with chronic conditions to seek out and receive the care they need before ending up in the emergency room or hospital," said the letter.
The AAFP agreed with CMS' proposals, saying they would "assist patients with lower cost-sharing for needed medications while also advancing VBID," but it also urged CMS to review its current specialty tier policies.
Specifically, the Academy suggested creating a mechanism "that would allow patients to file an exception for specialty drugs."
Furthermore, although not included in the proposed rule, the AAFP urged CMS to increase the $670 specialty tier threshold because it doesn't consider the effects of inflation on drug prices or the increase in high-cost specialty drugs.
"Keeping the specialty tier threshold low means that more drugs fit into this tier, which raises costs for Part D plan enrollees and makes it harder for them to afford needed medications," said the AAFP.
CMS proposed eliminating a current regulation that requires prescribers to enroll in or opt out of Medicare for a pharmacy claim for a Part D drug to be covered; CMS would replace this system with a "preclusion list."
The list would be updated monthly based on internal CMS data and would include individuals and entities currently revoked from Medicare and barred from re-enrollment or who have engaged in behavior for which CMS could have revoked Medicare privileges.
The preclusion list would be made available to Part D prescription plans and Medicare Advantage plans that would then be required to deny claims from or written by prescribers or providers on the list.
The AAFP noted that its opposition to the current policy was "based on the belief that the Medicare covenant is between the beneficiary and the program and that Medicare benefits belong to the beneficiary," and it thanked the agency for taking an approach other than requiring Medicare enrollment.
However, the Academy pointed out that a physician's prescribing authority is already tied to his or her DEA number rather than to the National Provider Identifier.
"Since physicians must already establish a relationship with the federal government through the DEA to prescribe, the AAFP continues to encourage CMS to explore implementation of these policies through closer coordination with the DEA."
The AAFP asked for the same DEA coordination in conjunction with proposed changes to the Part C/Medicare Advantage Cost Plan and PACE (Program of All-inclusive Care for the Elderly) preclusion list.
Other comments the AAFP relayed to CMS covered topics such as
Also in the proposed rule, CMS solicited feedback on ways to reduce the burden physicians and institutions bear from Medicare Advantage organization requests for medical record documentation.
The AAFP urged CMS and Medicare Advantage plans to "focus more on outcomes related to quality and cost and less on procedural safeguards."
"Such an approach would be more consistent with the guiding principle of choice and competition in the market based on quality, costs, and outcomes than the current approach of subjecting beneficiaries and physicians to increasingly stringent forms, coverage criteria, and documentation requirements."
The AAFP shared with CMS its recently adopted principles on administrative simplification, which cover
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AAFP Seeks to Improve Medicare Advantage, Part D Programs