DEPARTMENT OF HEALTH AND SOCIAL SERVICES
\nDivision of Medicaid and Medical Assistance
\nFINAL
\nORDER
\nObesity Drugs
\nNATURE OF THE PROCEEDINGS:
\n\tDelaware Health and Social Services (“Department”) / Division of Medicaid and Medical Assistance initiated proceedings to amend Title XIX Medicaid State Plan regarding Prescribed Drugs, specifically, to clarify policy related to drugs indicated for the treatment of obesity. The Department’s proceedings to amend its regulations were initiated pursuant to 29 Delaware Code Section 10114 and its authority as prescribed by 31 Delaware Code Section 512.
\n\tThe Department published its notice of proposed regulation changes pursuant to 29 Delaware Code Section 10115 in the September 2019 Delaware Register of Regulations, requiring written materials and suggestions from the public concerning the proposed regulations to be produced by October 1, 2019 at which time the Department would receive information, factual evidence and public comment to the said proposed changes to the regulations.
\nSUMMARY OF PROPOSAL
\n\tEffective for services provided on and after October 1, 2019 Delaware Health and Social Services/Division of Medicaid and Medical Assistance (DHSS/DMMA) proposes to amend Attachment 3.1-A Page 5 of Title XIX Medicaid State Plan regarding Prescribed Drugs, specifically, to clarify policy related to drugs indicated for the treatment of obesity.
\nBackground
\n\tDelaware is a founding member of My Healthy Weight, an initiative committed to working with providers and beneficiaries to increase utilization of standardized benefits and to encourage the collection of obesity metrics. The initiative will provide millions of individuals nationally with consistent coverage to support healthy weight change.
\n\tAs a result of that initiative, DMMA has begun a review of policies related to obesity covered services.
\nStatutory Authority
\n\t42 CFR §440.120
\nPurpose
\n\tThe purpose of this proposed regulation is to clarify policy related to drugs indicated for the treatment of obesity.
\nPublic Notice
\n\tIn accordance with the federal public notice requirements established at Section 1902(a)(13)(A) of the Social Security Act and 42 CFR 447.205 and the state public notice requirements of Title 29, Chapter 101 of the Delaware Code, Delaware Health and Social Services (DHSS)/Division of Medicaid and Medical Assistance (DMMA) gives public notice and provides an open comment period for thirty (30) days to allow all stakeholders an opportunity to provide input on the proposed regulation. Comments were to have been received by 4:30 p.m. on October 1, 2019.
\nCenters for Medicare and Medicaid Services Review and Approval
\n\tThe provisions of this state plan amendment (SPA) are subject to approval by the Centers for Medicare and Medicaid Services (CMS). The draft SPA page(s) may undergo further revisions before and after submittal to CMS based upon public comment and/or CMS feedback. The final version may be subject to significant change.
\nProvider Manuals and Communications Update
\n\tAlso, there may be additional provider manuals that may require updates as a result of these changes. The applicable Delaware Medical Assistance Program (DMAP) Provider Policy Specific Manuals and/or Delaware Medical Assistance Portal will be updated. Manual updates, revised pages or additions to the provider manual are issued, as required, for new policy, policy clarification, and/or revisions to the DMAP program. Provider billing guidelines or instructions to incorporate any new requirement may also be issued. A newsletter system is utilized to distribute new or revised manual material and to provide any other pertinent information regarding DMAP updates. DMAP updates are available on the Delaware Medical Assistance Portal website: https://medicaid.dhss.delaware.gov/provider
\nFiscal Impact Statement
\nThere is no anticipated fiscal impact.
\nSummary of Comments Received with Agency Response and Explanation of Changes
\n\tThe following summarized comments were received:
\n\tComment: Two commenters endorsed the proposed changes to the Medicaid State Plan to clarify policy related to drugs indicated for the treatment of obesity.
\n\tAgency Response: DMMA appreciates the endorsement.
\n\tComment: The commenter suggested the amendment overlooks the issue of mental health. Specifically, the commenter asked the agency to consider removing drugs used for anorexia from the list of Medicaid’s excluded drugs.
\n\tAgency Response: The agency appreciates the feedback on the exclusion of anorexia drugs. The state continues to address mental health care and improve treatment option aligned clinical guidelines. The referenced class will be added to future drug utilization board meeting agendas for review.
\n\tDMMA is pleased to provide the opportunity to receive public comments and greatly appreciates the thoughtful input given by:
\nFINDINGS OF FACT:
\n\tThe Department finds that the proposed changes as set forth in the September 2019 Register of Regulations should be adopted.
\n\tTHEREFORE, IT IS ORDERED, that the proposed regulation to amend Title XIX Medicaid State Plan regarding Prescribed Drugs, specifically, to clarify policy related to drugs indicated for the treatment of obesity, is adopted and shall be final effective December 11, 2019.
\n10/29/19
\nDate of Signature
\n\t\t\t\t\t\t\t\t\t\t\t\t\tKara Odom Walker, MD, MPH, MSHS, Secretary,
\n\t\t\t\t\t\t\t\t\t\t\t\t\tDHSS
\nRevision: HCFA-PM-85-3 (BERC) Attachment 3.1-A
\nMay 1985 Page 5
\nOMB No. 0938-0193
\nSTATE PLAN UNDER TITLE XIX OF THE SOCIAL SECURITY ACT
\nSTATE/TERRITORY: DELAWARE
\nLIMITATIONS ON AMOUNT, DURATION AND SCOPE OF MEDICAL AND REMEDIAL CARE AND SERVICES PROVIDED TO THE CATEGORICALLY NEEDY
\n12.a.\t\tPrescribed Drugs:
\nDrug Coverage
\n1)\tDrug products are covered when prescribed or ordered by a physician, or other licensed practitioner
\n\twithin the scope of their practice and when obtained from a licensed pharmacy. Covered drugs, as
\n\tdefined in Section 1927(k)(2) of the Act, are those which are prescribed for a medically accepted
\n\tindication, medically necessary, and produced by any pharmaceutical manufacturer, which has
\n\tentered into and complies with a drug rebate agreement under Section 1927(a) of the Act.
\n2)\tThe State will cover agents when used for cosmetic purposes or hair growth only when the state has
\n\tdetermined that use to be medically necessary.
\n3)\tThe State will cover drugs indicated for the treatment of obesity to address weight loss with co-
\n\tmorbid conditions with prior authorization.
\n4)\tDrugs excluded from coverage by Delaware Medicaid as provided by Section 1927(d)(2) of the Act, include:
\na.\t\t\tDrugs designated less than effective by the FDA (DESI drugs) or which are identical, similar, or related to such drugs;
\nb.\t\t\tDrugs when used to promote fertility;
\nc.\t\t\tDrugs that have an investigational or experimental or unproven efficacy or safety status;
\nd.\t\t\tDrugs when used for anorexia, weight loss or weight gain, or weight loss for the sole purpose of cosmetic reasons. Drugs indicated for the treatment of obesity to address weight loss with co-morbid conditions are covered by the DMAP with prior authorization.
\n5)\tNon-covered services also include: drugs used to correct sexual dysfunction and compound drugs
\n\t(compound prescriptions must include at least one medication that on its own would be a covered
\n\tentity).
\nQuantity and Duration
\n1.\t\t\tDosage limits: Medications are limited to a maximum dose recommended by the FDA and
\n\t\t\tappropriate medical compendia described in section 1927(k) of the Social Security Act, that indicate
\n\t\t\tthat doses that exceed FDA guidelines are both safe and effective or doses that are specified in
\n\t\t\tregional or national guidelines published by established expert groups such as the American Academy
\n\t\t\tof Pediatrics, or guidelines recommended by the Delaware Medicaid Drug Utilization Review (DUR)
\n\t\t\tBoard and accepted by the DHSS Secretary.