Commonwealth of Massachusetts Executive Office of Health and Human Services Office of Medicaid 600 Washington Street Boston, MA 02111 www.mass.gov/masshealth MASSHEALTH TRANSMITTAL LETTER POD-56 May 2007 TO: Podiatrists Participating in MassHealth FROM: Tom Dehner, Acting Medicaid Director RE: Podiatrist Manual (Revisions to Regulations about Medicare Part D) This letter transmits revisions to the podiatrist regulations about Medicare Part D, as provided in the Massachusetts state budget for fiscal year 2007. The provision extends and expands the state pharmacy assistance available to MassHealth members who have Medicare. The fiscal year 2007 budget extended the availability of one-time 30-day supplies of prescribed medications for members with Medicare for dates of pharmacy service from July 1, 2006, until December 31, 2006. After this supply, MassHealth paid for a one-time 72-hour supply of the prescribed medication, without a copayment. Effective July 1, 2006, payment for these one-time supplies will be available when a pharmacist is unable to bill a Medicare Part D plan or the point-of-sale facilitator (currently WellPoint/Anthem). Effective January 1, 2007, the one-time 30-day supplies will no longer be available, but MassHealth will still pay for a one-time 72-hour supply of prescribed medications. Effective July 1, 2006, for cost-sharing assistance for MassHealth members who are enrolled in a Medicare Part D prescription drug plan, if the Medicare Part D copayment or deductible is in excess of the member’s applicable MassHealth copayment, the MassHealth member will pay the applicable MassHealth copayment and MassHealth will pay the difference between the applicable MassHealth copayment and the amount charged by the Medicare Part D prescription drug plan. These regulations are being issued as emergency regulations and are effective July 1, 2006. If you have any questions about the information in this transmittal letter please contact MassHealth Customer Service at 1-800-841-2900, e-mail your inquiry to providersupport@mahealth.net, or fax your inquiry to 617-988-8974. NEW MATERIAL (The pages listed here contain new or revised language.) Podiatrist Manual Pages iv and 4-13 through 4-16 OBSOLETE MATERIAL (The pages listed here are no longer in effect.) Podiatrist Manual Page iv — transmitted by Transmittal Letter POD-53 Pages 4-13 and 4-14 — transmitted by Transmittal Letter POD-52 Pages 4-15 and 4-16 — transmitted by Transmittal Letter POD-49 Commonwealth of Massachusetts MassHealth Provider Manual Series Subchapter Number and Title Table of Contents Page iv Podiatrist Manual Transmittal Letter POD-56 Date 07/01/06 4. Program Regulations 424.401: Introduction 4-1 424.402: Definitions 4-1 424.403: Eligible Members 4-3 424.404: Provider Eligibility 4-3 424.405: Service Limitations and Noncovered Services 4-4 424.406: Maximum Allowable Fees 4-5 424.407: Individual Consideration 4-5 424.408: Referral 4-5 424.409: Recordkeeping (Medical Records) Requirements 4-6 424.410: Report Requirements 4-6 424.411: Office Visits 4-7 424.412: Out-of-Office Visits 4-7 424.413: Surgical Services and Utilization Management Program Requirements 4-8 424.414: Surgical Assistants 4-9 424.415: Radiology Services 4-9 424.416: Clinical Laboratory Services 4-10 424.417: Pharmacy Services: Prescription Requirements 4-10 424.418: Pharmacy Services: Covered Drugs 4-12 424.419: Pharmacy Services: Limitations on Coverage of Drugs 4-12 424.420: Pharmacy Services: Insurance Coverage 4-13 424.421: Pharmacy Services: Prior Authorization 4-15 424.422: Pharmacy Services: Member Copayments 4-15 424.423: Pharmacy Services: Drugs Dispensed in Provider’s Office 4-15 424.424: Shoes and Corrective Devices 4-16 Commonwealth of Massachusetts MassHealth Provider Manual Series Subchapter Number and Title 4. Program Regulations (130 CMR 424.000) Page 4-13 Podiatrist Manual Transmittal Letter POD-56 Date 07/01/06 (7) Drugs for Sexual Dysfunction. The MassHealth agency does not pay for drugs when used for the treatment of male or female sexual dysfunction. (C) Service Limitations. (1) MassHealth covers drugs that are not explicitly excluded under 130 CMR 424.419(B). The limitations and exclusions in 130 CMR 424.419(B)(1) through (5) do not apply to medically necessary drug therapy for MassHealth Standard enrollees under age 21. The MassHealth Drug List specifies the drugs that are payable under MassHealth. Any drug that does not appear on the MassHealth Drug List requires prior authorization, as set forth in 130 CMR 424.000. The MassHealth Drug List can be viewed online at www.mass.gov/druglist, and copies may be obtained upon request. The MassHealth agency will evaluate the prior- authorization status of drugs on an ongoing basis, and update the MassHealth Drug List accordingly. See 130 CMR 450.303. (2) The MassHealth agency does not pay for the following types of drugs or drug therapy without prior authorization: (a) immunizing biologicals and tubercular (TB) drugs that are available free of charge through local boards of public health or through the Massachusetts Department of Public Health (DPH); (b) nongeneric multiple-source drugs; and (c) drugs related to sex-reassignment surgery, specifically including but not limited to, presurgery and postsurgery hormone therapy. The MassHealth agency, however, will continue to pay for post sex-reassignment surgery hormone therapy for which it had been paying immediately prior to May 15, 1993. (3) The MassHealth agency does not pay any additional fees for dispensing drugs in a unit-dose distribution system. (4) The MassHealth agency does not pay for any drug prescribed for other than the FDA-approved indications as listed in the package insert, except as the MassHealth agency determines to be consistent with current medical evidence. (5) The MassHealth agency does not pay for any drugs that are provided as a component of a more comprehensive service for which a single rate of pay is established in accordance with 130 CMR 450.307. 424.420: Pharmacy Services: Insurance Coverage (A) Managed Care Organizations. The MassHealth agency does not pay pharmacy claims for services to MassHealth members enrolled in a MassHealth managed care organization (MCO) that provides pharmacy coverage through a pharmacy network or otherwise, except for family planning pharmacy services provided by a non- network provider to a MassHealth Standard MCO enrollee (where such provider otherwise meets all prerequisites for payment for such services). A pharmacy that does not participate in the MassHealth member’s MCO must instruct the MassHealth member to take his or her prescription to a pharmacy that does participate in such MCO. To determine whether the MassHealth member belongs to an MCO, pharmacies must verify member eligibility and scope of services through POPS before providing service in accordance with 130 CMR 450.107 and 450.117. (B) Other Health Insurance. When the member’s primary carrier has a preferred drug list, the prescriber must follow the rules of the primary carrier first. The provider may bill the MassHealth Commonwealth of Massachusetts MassHealth Provider Manual Series Subchapter Number and Title 4. Program Regulations (130 CMR 424.000) Page 4-14 Podiatrist Manual Transmittal Letter POD-56 Date 07/01/06 agency for the primary insurer’s member copayment for the primary carrier’s preferred drug without regard to whether the MassHealth agency generally requires prior authorization, except in cases where the drug is subject to a pharmacy service limitation pursuant to 130 CMR 424.419(C)(2)(a) and (c). In such cases, the prescriber must obtain prior authorization from the MassHealth agency in order for the pharmacy to bill the MassHealth agency for the primary insurer’s member copayment. For additional information about third party liability, see 130 CMR 450.101 et seq. (C) Medicare Part D. (1) Overview. Except as otherwise required in 130 CMR 406.414(C)(2) and (3), for MassHealth members who have Medicare, the MassHealth agency does not pay for any Medicare Part D drugs, or for any cost-sharing obligations (including premiums, copayments, and deductibles) for Medicare Part D drugs, whether or not the member has actually enrolled in a Medicare Part D drug plan. Medications excluded from the Medicare Part D drug program continue to be covered for MassHealth members eligible for Medicare, if they are MassHealth-covered medications. (2) Medicare Part D One-Time Supplies. The MassHealth agency pays for one-time supplies of prescribed medications, as described in 130 CMR 406.414(C)(2)(a) and (b), if the medication is a MassHealth-covered medication and the MassHealth member would otherwise be entitled to MassHealth pharmacy benefits but for being eligible for Medicare prescription drug coverage. MassHealth prior authorization does not apply to such one-time supplies. Between January 1 and June 30, 2006, the MassHealth agency pays for the one-time supplies only if the MassHealth member’s Medicare Part D prescription drug plan will not cover the prescribed medication at the time the prescription is presented. Effective July 1, 2006, the MassHealth agency pays for the one-time supplies in all instances in which the pharmacist cannot bill a Medicare Part D prescription drug plan at the time the prescription is presented. (a) Between January 1 and December 31, 2006, the MassHealth agency pays for a one-time 30-day supply of prescribed medications. Any copayment that would have been charged to the member under MassHealth will apply to a one-time 30-day supply. After this supply of the prescribed medication, the MassHealth agency pays for a one-time 72-hour supply of the same prescribed medication. (b) Effective January 1, 2007, the MassHealth agency pays for a one-time 72- hour supply of prescribed medications. (3) Cost-Sharing Assistance for MassHealth Members Enrolled in a Medicare Part D Prescription Drug Plan. For the purpose of 130 CMR 424.420(C)(3)(a) and (b), the “applicable MassHealth copayment” is the copayment the MassHealth member would pay for prescription drugs if the drugs were covered by MassHealth and not covered by Medicare Part D. (a) Between January 1 and June 30, 2006, for MassHealth members who are enrolled in a Medicare Part D prescription drug plan and are charged a copayment in excess of the member’s applicable MassHealth copayment for a drug that MassHealth would otherwise cover, the member pays the applicable MassHealth copayment and the MassHealth agency pays the difference to the pharmacy, up to the amount that the Medicare Part D prescription drug plan is permitted to charge an eligible enrollee who has both MassHealth and Medicare. Commonwealth of Massachusetts MassHealth Provider Manual Series Subchapter Number and Title 4. Program Regulations (130 CMR 424.000) Page 4-15 Podiatrist Manual Transmittal Letter POD-56 Date 07/01/06 (b) Effective July 1, 2006, for MassHealth members who are enrolled in a Medicare Part D prescription drug plan and are charged a copayment or deductible in excess of the member’s applicable MassHealth copayment for a drug that MassHealth would otherwise cover, the member pays the applicable MassHealth copayment and the MassHealth agency pays the difference between the applicable MassHealth copayment and the amount charged by the Medicare Part D prescription drug plan. 424.421: Pharmacy Services: Prior Authorization (A) Prescribers must obtain prior authorization from the MassHealth agency for drugs identified by the MassHealth agency in accordance with 130 CMR 450.303. If the limitations on covered drugs specified in 130 CMR 424.418 and 424.419(A) and (C) would result in inadequate treatment for a diagnosed medical condition, the prescriber may submit a written request, including written documentation of medical necessity, to the MassHealth agency for prior authorization for an otherwise noncovered drug. (B) All prior-authorization requests must be submitted in accordance with the instructions for requesting prior authorization in Subchapter 5 of the Podiatrist Manual. If the MassHealth agency approves the request, it will notify both the podiatrist and the member. (C) The MassHealth agency will authorize at least a 72-hour emergency supply of a prescription drug to the extent required by federal law. (See 42 U.S.C. 1396r-8(d)(5).) The MassHealth agency acts on requests for prior authorization for a prescribed drug within a time period consistent with federal regulations. (D) Prior authorization does not waive any other prerequisites to payment such as, but not limited to, member eligibility or requirements of other health insurers. (E) The MassHealth Drug List specifies the drugs that are payable under MassHealth. Any drug that does not appear on the MassHealth Drug List requires prior authorization, as set forth in 130 CMR 424.417 through 424.421. The MassHealth agency will evaluate the prior-authorization status of drugs on an ongoing basis, and update the MassHealth Drug List. 424.422: Pharmacy Services: Member Copayments The MassHealth agency requires under certain conditions that members make a copayment to the dispensing pharmacy for each original prescription and for each refill for all drugs (whether legend or nonlegend) covered by MassHealth. The copayment requirements are detailed in 130 CMR 450.130. 424.423: Drugs Dispensed in Provider’s Office Drugs dispensed in the office are payable at the podiatrist’s actual acquisition cost if this cost is more than $1.00. Claims for dispensing drugs must include the name of the drug or biological, the strength, and the dosage. A copy of the invoice showing the actual acquisition cost must be attached to the claim form, and must include the National Drug Code (NDC). Claims without this information will be denied. Commonwealth of Massachusetts MassHealth Provider Manual Series Subchapter Number and Title 4. Program Regulations (130 CMR 424.000) Page 4-16 Podiatrist Manual Transmittal Letter POD-56 Date 07/01/06 424.424: Shoes and Corrective Devices (A) The MassHealth agency pays for only those shoes listed in Subchapter 6 of the Podiatrist Manual. (B) For shoes, providers must submit with their claim a copy of the completed MassHealth Shoe Medical Necessity Form and a copy of the Life and Safety Certification from the primary care physician. (See 130 CMR 424.405.) (C) The MassHealth agency does not pay for casting materials used in the molding of orthotic shoes or corrective devices. The cost of these materials is included in the fee for prescribing and providing the shoe or corrective device. REGULATORY AUTHORITY 130 CMR 424.000: M.G.L. c. 118E, §§7 and 12.