DHS 107.10(3)(h)8.
8. Non-legend drugs not within one of the categories described under subds.
1. to
7. that previously had legend drug status and that the department has determined to be cost effective in treating the condition for which the drugs are prescribed.
DHS 107.10(3)(i)
(i) Any innovator multiple–source drug is a covered service only if the prescribing provider under sub.
(1) certifies by writing the phrase “brand medically necessary" on the prescription to the pharmacist that the innovator brand drug, rather than a generic drug, is medically necessary. The prescribing provider shall document in the patient's record the reason why the innovator brand drug is medically necessary. The innovators of multiple source drug are identified in the Wisconsin medicaid drug index.
DHS 107.10(3)(j)
(j) A drug produced by a manufacturer who does not meet the requirements of
42 USC 1396r-8 may be a covered service if the department determines that the drug is medically necessary and cost-effective in treating the condition for which it is prescribed.
DHS 107.10(3)(k)
(k) The department may determine whether or not a drug judged by the U.S. food and drug administration to be “less than effective"shall be reimbursed under the program based on the medical appropriateness and cost-effectiveness of the drug.
DHS 107.10(3)(L)
(L) Services, including drugs, directly related to non-surgical abortions shall comply with s.
20.927, Stats., may only be prescribed by a physician, and shall comply with MA policy and procedures as described in MA provider handbooks and bulletins.
DHS 107.10(4)
(4) Non-covered services. The department may create a list of drugs or drug categories to be excluded from coverage, known as the medicaid negative drug list. These non-covered drugs may include drugs determined “less than effective" by the U.S. food and drug administration, drugs not covered by
42 USC 1396r-8, drugs restricted under
42 USC 1396r-8 (d) (2) and experimental or other drugs which have no medically accepted indications. In addition, the following are not covered services:
DHS 107.10(4)(a)
(a) Claims of a pharmacy provider for reimbursement for drugs and medical supplies included in the daily rate for nursing home recipients;
DHS 107.10(4)(e)
(e) Cosmetics such as non-therapeutic skin lotions and sun screens;
DHS 107.10(4)(f)
(f) Common medicine chest items such as antiseptics and band-aids;
DHS 107.10(4)(g)
(g) Personal hygiene items such as tooth paste and cotton balls;
DHS 107.10(4)(h)
(h) “Patent" medicines such as drugs or other medical preparations that can be bought without a prescription;
DHS 107.10(4)(k)
(k) Drugs not listed in the medicaid index, including over-the-counter drugs not included in sub.
(3) (h) and legend drugs;
DHS 107.10(4)(L)
(L) Drugs included in the medicaid negative drug formulary maintained by the department; and
DHS 107.10(4)(n)
(n) Drugs provided for the treatment of males or females for infertility or to enhance the prospects of fertility;
DHS 107.10(4)(p)
(p) Drugs, including hormone therapy, associated with transsexual surgery or medically unnecessary alteration of sexual anatomy or characteristics;
DHS 107.10 Note
Note: In
Flack v. Wisconsin Dep't of Health Servs,
395 F. Supp. 3d 1001 (W.D. Wis. 2019), the United States District Court for the Western District of Wisconsin held that ss.
DHS 107.03 (23) and
(24) and
107.10 (4) (p) violated the Equal Protection Clause of the Fourteenth Amendment, s. 1557 of the Affordable Care Act, and the federal Medicaid Act. The court in
Flack permanently enjoined the department from enforcing those provisions.
DHS 107.10(4)(s)
(s) Infant formula, except when the product and recipient's health condition meet the criteria established by the department under sub.
(2) (c) to verify medical need; and
DHS 107.10(4)(t)
(t) Enteral nutritional products that do not meet the criteria established by the department under sub.
(2) (c) to verify medical need, when an alternative nutrition source is available, or that are solely for the convenience of the caregiver or the recipient.
DHS 107.10(5)
(5) Drug review, counseling and recordkeeping. In addition to complying with ch.
Phar 7, a pharmacist shall fulfill the requirements of
42 USC 1396r-8 (g) (2) (A) as follows:
DHS 107.10(5)(a)
(a) The pharmacist shall review the drug therapy before each prescription is filled or delivered to an MA recipient. The review shall include screening for potential drug therapy problems including therapeutic duplication, drug–disease contraindications, drug–drug interactions, including serious interactions with non-legend drugs, incorrect drug dosage or duration of drug treatment, drug–allergy interactions and clinical abuse or misuse.
DHS 107.10(5)(b)
(b) The pharmacist shall offer to discuss with each MA recipient, the recipient's legal representative or the recipient's caregiver who presents the prescription, matters which, in the exercise of the pharmacist's professional judgment and consistent with state statutes and rules governing provisions of this information, the pharmacist deems significant, including the following:
DHS 107.10(5)(b)2.
2. The route, dosage form, dosage, route of administration, and duration of drug therapy;
DHS 107.10(5)(b)3.
3. Specific directions and precautions for preparation, administration and use by the patient;
DHS 107.10(5)(b)4.
4. Common severe side effects or adverse effects or interactions and therapeutic contraindications that may be encountered, including how to avoid them, and the action required if they occur;
DHS 107.10(5)(c)
(c) The pharmacist shall make a reasonable effort to obtain, record and maintain at least the following information regarding each MA recipient for whom the pharmacist dispenses drugs under the MA program:
DHS 107.10(5)(c)1.
1. The individual's name, address, telephone number, date of birth or age and gender;
DHS 107.10(5)(c)2.
2. The individual's history where significant, including any disease state or states, known allergies and drug reactions, and a comprehensive list of medications and relevant devices; and
DHS 107.10(5)(c)3.
3. The pharmacist's comments relevant to the individual's drug therapy.
DHS 107.10(5)(d)
(d) Nothing in this subsection shall be construed as requiring a pharmacist to provide consultation when an MA recipient, the recipient's legal representative or the recipient's caregiver refuses the consultation.
DHS 107.10 History
History: Cr.
Register, February, 1986, No. 362, eff. 3-1-86; am. (3) (h),
Register, February, 1988, No. 386, eff. 3-1-88; emerg. am. (2) (e) and (f), (4) (k), cr. (2) (g), (3) (j) and (k), (4) (L), eff. 4-27-91; r. and recr.
Register, December, 1991, No. 432, eff. 1-1-92, r. and recr. (2) (c), am. (2) (d) and (e), cr. (2) (f) and (g), (3) (L) and (4) (n) to (t),
Register, January, 1997, No. 493, eff. 2-1-97;
CR 03-033: am. (1), (2) (d), (3) (b) to (d), (h) (intro.), (i), (4) (L) and (5) (a), r. (2) (a), cr. (3) (h) 8.
Register December 2003 No. 576, eff. 1-1-04; correction in (1) made under s.
13.92 (4) (b)7., Stats.,
Register February 2014 No. 698;
2021 Wis. Act 125: am. (2) (c)
Register February 2022 No. 794, eff. 2-6-22.
DHS 107.11(1)(b)
(b) “Home health aide services" means medically oriented tasks, assistance with activities of daily living and incidental household tasks required to facilitate treatment of a recipient's medical condition or to maintain the recipient's health.
DHS 107.11(1)(c)
(c) “Home health visit" or “visit" means a period of time of any duration during which home health services are provided through personal contact by agency personnel of less than 8 hours a day in the recipient's place of residence for the purpose of providing a covered home health service. The services are provided by a home health provider employed by a home health agency, by a home health provider under contract to a home health agency according to the requirements of s.
DHS 133.19 or by arrangement with a home health agency. A visit begins when the home health provider starts to provide a covered service and ends when the service is complete.
DHS 107.11(1)(d)
(d) “Home health provider" means a person who is an RN, LPN, home health aide, physical or occupational therapist, speech pathologist, certified physical therapy assistant or certified occupational therapy assistant.
DHS 107.11(1)(e)
(e) “Initial visit" means the first home health visit of any duration in a calendar day provided by a registered nurse, licensed practical nurse, home health aide, physical or occupational therapist or speech and language pathologist for the purpose of delivering a covered home health service to a recipient.
DHS 107.11(1)(f)
(f) “Subsequent visit" means each additional visit of any duration following the initial visit in a calendar day provided by an RN, LPN or home health aide for the purpose of delivering a covered home health service to a recipient.
DHS 107.11(1)(g)
(g) “Unlicensed caregiver" means a home health aide or personal care worker.
DHS 107.11(2)
(2) C
overed home health services. Services provided by an agency certified under s.
DHS 105.16 which are covered by MA are those reasonable and medically necessary services required to treat the recipient's condition. Covered services must meet all of the following criteria:
DHS 107.11(2)(b)
(b) The services are provided in a place other than a hospital or nursing home.
DHS 107.11(2)(c)1.
1. Skilled nursing services provided under a plan of care which requires less than 8 hours of skilled nursing care per day and specifies which level of care the nurse is qualified to provide. Skilled nursing services are any of the following:
DHS 107.11(2)(c)1.a.
a. Nursing services performed by a registered nurse, or by a licensed practical nurse under the supervision of a registered nurse, according to the written plan of care and accepted standards of medical and nursing practice, in accordance with ch.
N 6.
DHS 107.11(2)(c)1.b.
b. Services which, due to the recipient's medical condition, may be only safely and effectively provided by an RN or LPN.
DHS 107.11(2)(c)1.d.
d. Teaching and training of the recipient, the recipient's family or other caregivers requiring the skills on an RN or LPN.
DHS 107.11(2)(c)2.
2. Home health aide services and medical supplies, equipment, and appliances. Home health services are any of the following:
DHS 107.11(2)(c)2.a.
a. Medically oriented tasks which cannot be safely delegated by an RN as determined and documented by the RN to a personal care worker who has not received special training in performing tasks for the specific individual, and which may include, but are not limited to, medically oriented activities directly supportive of skilled nursing services provided to the recipient. These may include assistance with and administration of oral, rectal and topical medications ordinarily self-administered and supervised by an RN according to
42 CFR 483.36 (d), ch.
DHS 133, and ch.
N 6, and assistance with activities directly supportive of current and active skilled therapy and speech pathology services and further described in the Wisconsin medical assistance home health agency provider handbook.
DHS 107.11(2)(c)2.b.
b. Assistance with the recipient's activities of daily living only when provided on conjunction with a medically oriented task that cannot be safely delegated to a personal care worker as determined and documented by the delegating RN. Assistance with the recipient's activities of daily living consists of medically oriented tasks when a reasonable probability exists that the recipient's medical condition will worsen during the period when assistance is provided, as documented by the delegating RN. A recipient whose medical condition has exacerbated during care activities sometime in the past 6 months is considered to have a condition which may worsen when assistance is provided. Activities of daily living include, but are not limited to, bathing, dressing, grooming and personal hygiene activities, skin, foot and ear care, eating, elimination, ambulation, and changing bed positions.
DHS 107.11(2)(c)3.
3. Therapy and speech pathology services which the agency is certified to provide.
DHS 107.11(2)(e)
(e) The services are provided with supervision from, and coordination of all nursing care by, a registered nurse.
DHS 107.11(2m)
(2m)
Additional requirements for covered home health services. DHS 107.11(2m)(a)(a) Covered services provided under sub.
(2) must only be safely and effectively performed by a skilled therapist or speech pathologist or by a certified therapy assistant who receives supervision by the certified therapist according to
42 CFR 484.32.
DHS 107.11(2m)(b)
(b) Based on the assessment by the recipient's physician of the recipient's rehabilitation potential, services provided under sub.
(2) are expected to materially improve the recipient's condition within a reasonable, predictable time period, or are necessary to establish a safe and effective maintenance program for the recipient.
DHS 107.11(2m)(c)
(c) In conjunction with the written plan of care, a therapy evaluation shall be conducted prior to the provision of services under sub.
(2) by the therapist or speech pathologist who will provide the services to the recipient.
DHS 107.11(2m)(d)
(d) The therapist or speech pathologist shall provide a summary of activities, including goals and outcomes, to the physician at least every 62 days, and upon conclusion of therapy services
DHS 107.11(3)
(3) Prior authorization. Prior authorization is required to review utilization of services and assess the medical necessity of continuing services for:
DHS 107.11(3)(a)
(a) All home health visits when the total of any combination of skilled nursing, home health aide, physical and occupational therapist and speech pathologist visits by all providers exceeds 30 visits in a calendar year, including situations when the recipient's care is shared among several certified providers;
DHS 107.11(3)(b)
(b) All home health aide visits when the services are provided in conjunction with private duty nursing under s.
DHS 107.12 or the provision of respiratory care services under s.
DHS 107.113;
DHS 107.11(3)(d)
(d) All home health aide visits when 4 or more hours of continuous care is medically necessary; and
DHS 107.11(4)(a)
(a) The written plan of care shall be developed and reviewed concurrently with and in support of other health sustaining efforts for the recipient in the home.
DHS 107.11(4)(c)
(c) Services provided to a recipient who is a resident of a community-based residential facility shall be rendered according to the requirements of ch.
DHS 83 and shall not duplicate services that the facility has agreed to provide.
DHS 107.11(4)(d)1.1. Except as provided in subd.
2., home health skilled nursing services provided by one or more providers are limited to less than 8 hours per day per recipient as required by the recipient's medical condition.
