US Pharm. 2019;44(3):36-37.
This article is intended to address recent initiatives by the Centers for Medicare & Medicaid Services (CMS) of the U.S. Department of Health and Human Services related to pain-management treatment guidelines and payment policies under Medicare Parts C and D.
CMS has recognized that opioids are effective for treating certain types of pain, but carry significant risks, including increased tolerance, development of an opioid-use disorder, and overdose. In 2018, to counter this public-health emergency, CMS adopted a three-pronged approach focusing on 1) the treatment of new cases of opioid-use disorder; 2) the treatment of patients who are dependent on or addicted to opioids; and 3) the utilization of data across the United States to more effectively target prevention and treatment activities.1
Pain-Management Initiatives
As part of its initiatives related to pain management, CMS published Part I of the 2020 Advance Notice of Methodological Changes for Medicare Advantage Capitation Rates and Part D Payment Policies (the 2020 Advance Notice) on December 20, 2018. CMS then followed with its publication of Part II of the Advance Notice and the Draft 2020 Call Letter on January 30, 2019. CMS accepted comments on Parts I and II of the 2020 Advance Notice and the draft 2020 Call Letter through March 1, 2019, and it is expected to publish the final rate announcement and the final 2020 Call Letter by April 1, 2019.2
CMS began reporting measures related to pain management in the patient-safety reports for 2018. The measures included concurrent use of opioids and benzodiazepines, polypharmacy use of multiple anticholinergic medications in older adults, and polypharmacy use of multiple central nervous system–active medications in older adults. CMS plans to add these measures to its display page for 2021 (using 2019 data) and 2022 (using 2020 data).3
CMS is also implementing new policies in 2019, including Medicare Part D management programs for high-risk opioid users. Under Part D drug-management programs, sponsors may “lock in” at-risk beneficiaries’ coverage of opioids and benzodiazepines to a selected prescriber or prescribers or a network pharmacy or pharmacies, or both. Also, CMS recommends certain safety alerts, including a hard safety edit to limit initial opioid prescription fills for treatment of acute pain to no more than a 7-day supply. CMS also expects Part D plan sponsors to implement real-time opioid care coordination safety edits with prescriber and pharmacy counts. Residents of long-term-care facilities, beneficiaries in hospice care, those receiving palliative or end-of-life care, and those treated for active cancer-related pain should be excluded from the Medicare Part D policies. CMS notes that the policies should not impact beneficiaries’ access to medication-assisted treatment such as buprenorphine, which may be used to treat addiction. Plan sponsors are encouraged to identify other vulnerable patient populations (e.g., those with sickle cell disease) for exclusion from opioid safety edits to avoid impeding critical access to needed medication. CMS is evaluating the policies in 2019 and proposes to continue them in 2020.4
Proposals for New Policies
CMS is proposing a number of new policies for 2020 that are designed to assist Medicare plan sponsors in preventing and limiting opioid overuse. The policies are designed to encourage Medicare Advantage plans in offering supplemental benefits. The benefits would include medically approved nonopioid pain management and complementary treatment, such as peer-support services, to facilitate recovery and to navigate healthcare resources, chiropractic services, acupuncture, and therapeutic massage furnished by a state-licensed massage therapist. The massage must be ordered by a physician or medical professional to be considered primarily health-related and not primarily for the comfort or relaxation of the patient. The nonopioid management item or service must treat or ameliorate the impact of the injury or illness (e.g., pain, stiffness, and loss of range of motion).5
The policies are also intended to encourage Medicare Part D sponsors to offer lower cost-sharing for opioid-reversal agents such as naloxone. CMS strongly encourages Part D sponsors, at a minimum, to place naloxone products on the plans’ generic formulary tiers and to place them on a formulary tier with zero or low cost-sharing for plans using such a formulary model. CMS states that benefit designs that inappropriately restrict naloxone access to products for beneficiaries for whom the drug is clinically appropriate will not be approved.6
CMS also encourages the coprescribing of naloxone with opioid prescriptions to beneficiaries who are at increased risk for opioid overdose. CMS wants plan sponsors to ensure that authorizations are in place for beneficiaries who are more susceptible to opioid-associated harm. CMS is also prompting plan sponsors to provide patient-specific pharmacy messaging to alert pharmacists to provide naloxone to at-risk beneficiaries taking opioids in states that allow for standing naloxone orders.7
CMS implemented the Star Ratings program, in part, to help Medicare enrollees, their families, and their caregivers compare the quality of health and drug plans being offered, and it manages the program to encourage Medicare Advantage plans to improve, on a continuing basis, the quality of care provided to their enrollees. Consistent with these goals, Medicare Advantage organizations are eligible for bonus payments from CMS so long as the organizations meet the quality standards under the Star Ratings program. In connection with pain management, CMS is proposing changes to the Star Ratings program to advance opioid-related measures. CMS currently includes on its display page three measures showing use of opioids at high doses and from multiple providers. CMS proposes additional separate display measures related to the use of opioids at high dosages and from multiple providers, and another measure related to the concurrent use of opioids and benzodiazepines. CMS expects to consider these measures for inclusion in the 2023 Star Ratings based on 2021 data.8
Conclusion
In summary, CMS is balancing the goals of improvement in the quality of care for patients needing pain management with the public-health crisis arising from overuse or misuse of opioids and treatment of new cases of opioid-use disorder. In furtherance of these goals, CMS continues to compel Medicare plans to adopt policies and practices designed to monitor and control opioid use while at the same time making appropriate medication available to vulnerable populations suffering from chronic pain. CMS’s policies in this area are still developing, as shown by the new display measures CMS is implementing in connection with the Star Ratings program. All these actions by CMS are part of a long-term strategy to address the pain-management needs of Medicare enrollees.
The information in this article is general in nature and is not intended to provide legal or other professional advice.
REFERENCES
1. CMS. Part II of advance notice of methodological changes for calendar year (CY) 2020 for Medicare Advantage (MA) capitation rates, Part C and Part D payment policies and 2020 draft call letter 2000, p. 186. www.cms.gov/Medicare/Health-Plans/MedicareAdvtgSpecRateStats/Downloads/Advance2020Part2.pdf. Accessed February 21, 2019. In addition, on December 28, 2018, the U.S. Department of Health and Human Services (HHS) Pain Management Best Practices Inter-Agency Task Force issued a draft report calling for individualized patient-centered pain management; comments are to be received by April 1, 2019. HHS press release: Pain Management Task Force calls for patient-centered approach to improve treatment of pain, December 28, 2018, 83 Fed. Reg. 67729, December 31, 2018.
2. CMS. Fact sheet: 2020 Medicare Advantage and Part D Advance Notice Part II and Draft Call Letter. www.cms.gov/newsroom/fact-sheets/2020-medicare-advantage-and-part-d-advance-notice-part-ii-and-draft-call-letter. Accessed February 14, 2019.
3. CMS. Part II of 2020 Advance Notice, pp. 135-136.
4. CMS. Part II of 2020 Advance Notice, pp. 175, 187. CMS. Fact sheet: 2020 Medicare Advantage and Part D Advance Notice Part II and Draft Call Letter. In addition, the National Council for Prescription Drug Programs (NCPDP) Telecommunication Standard D.0 was adopted by HHS for certain retail pharmacy transactions under the Health Insurance Portability and Accountability Act, as amended (HIPAA). Recently, HHS has proposed to adopt a modification to NCPDP D.0 by requiring the use of the “quantity prescribed” (460-ET) field for retail pharmacy transactions pertaining to Schedule II drugs. The modification is structured so that covered entities can distinguish whether a prescription is a partial fill or a refill in HIPAA retail pharmacy transactions. The modification also is intended to ensure that information is available to help prevent impermissible refills of Schedule II drugs. 84 Fed. Reg. 633, January 31, 2019. www.federalregister.gov/documents/2019/01/31/2019-00554/administrative-simplification-modification-of-the-requirements-for-the-use-of-health-insurance. Accessed February 22, 2019.
5. CMS. Part II of 2020 Advance Notice, p. 159.
6. CMS. Part II of 2020 Advance Notice, p. 174.
7. CMS. Part II of 2020 Advance Notice, p. 175.
8. CMS. Medicare offers improved access to high-quality health coverage choices in 2018. www.cms.gov/newsroom/press-releases/medicare-offers-improved-access-high-quality-health-coverage-choices-2018. Accessed February 21, 2019. CMS. Part II of 2020 Advance Notice, pp. 135-136. Display measures published on CMS.gov are not part of the Star Ratings. The display measures may include measures that are transitioned from inclusion in the Star Ratings, new measures being tested before inclusion in the Star Ratings, or measures displayed solely for informational purposes. CMS, Part II of 2020 Advance Notice, p. 127. In addition, the National Committee for Quality Assurance is exploring the development of new measures assessing the use of nonopioid therapies (both pharmacologic and nonpharmacologic) for pain to manage care of patients with chronic pain. Id. at 140.
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