Amendment SSA1-AB68

AB68-SSA1,1370,16 3. Except as provided in subd. 5., if the manufacturer determines under subd. 1. or 2. that the individual is eligible for the patient assistance program, the manufacturer shall provide the individual with a statement of eligibility. The statement of eligibility shall be valid for 12 months and may be renewed upon a determination by the manufacturer that the individual continues to meet the eligibility requirements of par. (b).

AB68-SSA1,1371,2 4. If the manufacturer determines under subd. 1. or 2. that the individual is not eligible for the patient assistance program, the manufacturer shall provide the reason for the determination in the notification under subd. 1. or 2. The individual may appeal the determination by filing an appeal with the commissioner that shall include all of the information provided to the manufacturer under subds. 1. and 2. The commissioner shall establish procedures for deciding appeals under this subdivision. The commissioner shall issue a decision no later than 10 days after the appeal is filed, and the commissioner's decision shall be final. If the commissioner determines that the individual meets the eligibility requirements under par. (b), the manufacturer shall provide the individual with the statement of eligibility described in subd. 3.

AB68-SSA1,1371,11 5. In the case of an individual who has prescription drug coverage through an individual or group health plan, if the manufacturer determines under subd. 1. or 2. that the individual is eligible for the patient assistance program but also determines that the individual's insulin needs are better addressed through the use of the manufacturer's copayment assistance program rather than the patient assistance program, the manufacturer shall inform the individual of the determination and provide the individual with the necessary coupons to submit to a pharmacy. The individual may not be required to pay more than the copayment amount specified in par. (d) 2.

AB68-SSA1,1371,18 (d) Provision of insulin under a patient assistance program. 1. Upon receipt from an individual of the eligibility statement described in par. (c) 3. and a valid insulin prescription, a pharmacy shall submit an order containing the name of the insulin and daily dosage amount to the manufacturer. The pharmacy shall include with the order the pharmacy's name, shipping address, office telephone number, fax number, electronic mail address, and contact name, as well as any days or times when deliveries are not accepted by the pharmacy.

AB68-SSA1,1372,2 2. Upon receipt of an order meeting the requirements under subd. 1., the manufacturer shall send the pharmacy a 90-day supply of insulin, or lesser amount if requested in the order, at no charge to the individual or pharmacy. The pharmacy shall dispense the insulin to the individual associated with the order. The insulin shall be dispensed at no charge to the individual, except that the pharmacy may collect a copayment from the individual to cover the pharmacy's costs for processing and dispensing in an amount not to exceed $50 for each 90-day supply of insulin. The pharmacy may not seek reimbursement from the manufacturer or a 3rd-party payer.

AB68-SSA1,1372,5 3. The pharmacy may submit a reorder to the manufacturer if the individual's eligibility statement described in par. (c) 3. has not expired. The reorder shall be treated as an order for purposes of subd. 2.

AB68-SSA1,1372,8 4. Notwithstanding subds. 2. and 3., a manufacturer may send the insulin directly to the individual if the manufacturer provides a mail-order service option, in which case the pharmacy may not collect a copayment from the individual.

AB68-SSA1,1372,11 (4) Exceptions. (a) This section does not apply to a manufacturer who shows to the commissioner's satisfaction that the manufacturer's annual gross revenue from insulin sales in this state does not exceed $2,000,000.

AB68-SSA1,1372,16 (b) A manufacturer may not be required to make an insulin product available under sub. (2) or (3) if the wholesale acquisition cost of the insulin product does not exceed $8, as adjusted annually based on the U.S. consumer price index for all urban consumers, U.S. city average, per milliliter or the applicable national council for prescription drug programs' plan billing unit.

AB68-SSA1,1372,19 (5) Confidentiality. All medical information solicited or obtained by any person under this section shall be subject to the applicable provisions of state law relating to confidentiality of medical information, including s. 610.70.

AB68-SSA1,1372,25 (6) Reimbursement prohibition. No person, including a manufacturer, pharmacy, pharmacist, or 3rd-party administrator, as part of participating in an urgent need safety net program or patient assistance program may request or seek, or cause another person to request or seek, any reimbursement or other compensation for which payment may be made in whole or in part under a federal health care program, as defined in 42 USC 1320a-7b (f).

AB68-SSA1,1373,3 (7) Reports. (a) Annually, no later than March 1, each manufacturer shall report to the commissioner all of the following information for the previous calendar year:

AB68-SSA1,1373,5 1. The number of individuals who received insulin under the manufacturer's urgent need safety net program.

AB68-SSA1,1373,8 2. The number of individuals who sought assistance under the manufacturer's patient assistance program and the number of individuals who were determined to be ineligible under sub. (3) (c) 4.

AB68-SSA1,1373,10 3. The wholesale acquisition cost of the insulin provided by the manufacturer through the urgent need safety net program and patient assistance program.

AB68-SSA1,1373,14 (b) Annually, no later than April 1, the commissioner shall submit to the governor and the chief clerk of each house of the legislature, for distribution to the legislature under s. 13.172 (2), a report on the urgent need safety net programs and patient assistance programs that includes all of the following:

AB68-SSA1,1373,15 1. The information provided to the commissioner under par. (a).

AB68-SSA1,1373,17 2. The penalties assessed under sub. (9) during the previous calendar year, including the name of the manufacturer and amount of the penalty.

AB68-SSA1,1373,22 (8) Additional responsibilities of commissioner. (a) Application form. The commissioner shall make the application form described in sub. (2) (c) 1. a. available on the office's Internet site and shall make the form available to pharmacies and health care providers who prescribe or dispense insulin, hospital emergency departments, urgent care clinics, and community health clinics.

AB68-SSA1,1373,25 (b) Public outreach. 1. The commissioner shall conduct public outreach to create awareness of the urgent need safety net programs and patient assistance programs.

AB68-SSA1,1374,2 2. The commissioner shall develop and make available on the office's Internet site an information sheet that contains all of the following information:

AB68-SSA1,1374,4 a. A description of how to access insulin through an urgent need safety net program.

AB68-SSA1,1374,5 b. A description of how to access insulin through a patient assistance program.

AB68-SSA1,1374,7 c. Information on how to contact a navigator for assistance in accessing insulin through an urgent need safety net program or patient assistance program.

AB68-SSA1,1374,9 d. Information on how to contact the commissioner if a manufacturer determines that an individual is not eligible for a patient assistance program.

AB68-SSA1,1374,11 e. A notification that an individual may contact the commissioner for more information or assistance in accessing ongoing affordable insulin options.

AB68-SSA1,1374,18 (c) Navigators. The commissioner shall develop a training program to provide navigators with information and the resources necessary to assist individuals in accessing appropriate long-term insulin options. The commissioner shall compile a list of navigators who have completed the training program and are available to assist individuals in accessing affordable insulin coverage options. The list shall be made available on the office's Internet site and to pharmacies and health care practitioners who dispense and prescribe insulin.

AB68-SSA1,1374,24 (d) Satisfaction surveys. 1. The commissioner shall develop and conduct a satisfaction survey of individuals who have accessed insulin through urgent need safety net programs and patient assistance programs. The survey shall ask whether the individual is still in need of a long-term solution for affordable insulin and shall include questions about the individual's satisfaction with all of the following, if applicable:

AB68-SSA1,1374,25 a. Accessibility to urgent-need insulin.

AB68-SSA1,1375,2 b. Adequacy of the information sheet and list of navigators received from the pharmacy.

AB68-SSA1,1375,3 c. Helpfulness of a navigator.

AB68-SSA1,1375,5 d. Ease of access in applying for a patient assistance program and receiving insulin from the pharmacy under the program.

AB68-SSA1,1375,9 2. The commissioner shall develop and conduct a satisfaction survey of pharmacies that have dispensed insulin through urgent need safety net programs and patient assistance programs. The survey shall include questions about the pharmacy's satisfaction with all of the following, if applicable:

AB68-SSA1,1375,11 a. Timeliness of reimbursement from manufacturers for insulin dispensed by the pharmacy under urgent need safety net programs.

AB68-SSA1,1375,12 b. Ease in submitting insulin orders to manufacturers.

AB68-SSA1,1375,13 c. Timeliness of receiving insulin orders from manufacturers.

AB68-SSA1,1375,15 3. The commissioner may contract with a nonprofit entity to develop and conduct the surveys under subds. 1. and 2. and to evaluate the survey results.

AB68-SSA1,1375,18 4. No later than July 1, 2024, the commissioner shall submit to the governor and the chief clerk of each house of the legislature, for distribution to the legislature under s. 13.172 (2), a report on the results of the surveys under subds. 1. and 2.

AB68-SSA1,1375,23 (9) Penalty. A manufacturer that fails to comply with this section may be assessed a penalty of up to $200,000 per month of noncompliance, with the maximum penalty increasing to $400,000 per month if the manufacturer continues to be in noncompliance after 6 months and increasing to $600,000 per month if the manufacturer continues to be in noncompliance after one year.

AB68-SSA1,3002 Section 3002 . 632.869 of the statutes is created to read:

AB68-SSA1,1376,2 632.869 Reimbursement to federal drug pricing program participants. (1) In this section:

AB68-SSA1,1376,6 (a) “Covered entity” means an entity described in 42 USC 256b (a) (4) (A), (D), (E), (J), or (N) that participates in the federal drug pricing program under 42 USC 256b, a pharmacy of the entity, or a pharmacy contracted with the entity to dispense drugs purchased through the federal drug pricing program under 42 USC 256b.

AB68-SSA1,1376,7 (b) “Pharmacy benefit manager” has the meaning given in s. 632.865 (1) (c).

AB68-SSA1,1376,9 (2) Any person, including a pharmacy benefit manager and 3rd-party payer, may not do any of the following:

AB68-SSA1,1376,12 (a) Reimburse a covered entity for a drug that is subject to an agreement under 42 USC 256b at a rate lower than that paid for the same drug to pharmacies that are not covered entities and are similar in prescription volume to the covered entity.

AB68-SSA1,1376,15 (b) Assess a covered entity any fee, charge back, or other adjustment on the basis of the covered entity's participation in the federal drug pricing program under 42 USC 256b.

AB68-SSA1,3003 Section 3003 . 632.87 (4) of the statutes is amended to read:

AB68-SSA1,1376,21 632.87 (4) No policy, plan or contract may exclude coverage for diagnosis and treatment of a condition or complaint by a licensed dentist or dental therapist within the scope of the dentist's or dental therapist's license, if the policy, plan or contract covers diagnosis and treatment of the condition or complaint by another health care provider, as defined in s. 146.81 (1) (a) to (p).

AB68-SSA1,3004 Section 3004. 632.871 of the statutes is created to read:

AB68-SSA1,1376,23 632.871 Telehealth services. (1) Definitions. In this section:

AB68-SSA1,1376,24 (a) “Disability insurance policy” has the meaning given in s. 632.895 (1) (a).

AB68-SSA1,1376,25 (b) “Self-insured health plan” has the meaning given in s. 632.85 (1) (c).

AB68-SSA1,1377,6 (c) “Telehealth" means a practice of health care delivery, diagnosis, consultation, treatment, or transfer of medically relevant data by means of audio, video, or data communications that are used either during a patient visit or a consultation or are used to transfer medically relevant data about a patient. “Telehealth" does not include communications delivered solely by audio-only telephone, facsimile machine, or e-mail unless specified otherwise by rule.

AB68-SSA1,1377,13 (2) Coverage denial prohibited. No disability insurance policy or self-insured health plan may deny coverage for a treatment or service provided through telehealth on the basis that the treatment or service is provided through telehealth if that treatment or service is covered by the policy or plan when provided in person. A disability insurance policy or self-insured health plan may limit coverage of treatments or services provided through telehealth to those treatments or services that are medically necessary.

AB68-SSA1,1377,17 (3) Certain limitations on telehealth prohibited. A disability insurance policy or self-insured health plan may not subject a treatment or service provided through telehealth for which coverage is required under sub. (2) to any of the following:

AB68-SSA1,1377,19 (a) Any greater deductible, copayment, or coinsurance amount than would be applicable if the treatment or service is provided in person.

AB68-SSA1,1377,22 (b) Any policy or calendar year or lifetime benefit limit or other maximum limitation that is not imposed on other treatments or services covered by the plan that are not provided through telehealth.

AB68-SSA1,1377,24 (c) Prior authorization requirements that are not required for the same treatment or service when provided in person.

AB68-SSA1,1377,25 (d) Unique location requirements.

AB68-SSA1,1378,5 (4) Disclosure of coverage of certain telehealth services. A disability insurance policy or self-insured health plan that covers a telehealth treatment or service that has no equivalent in-person treatment or service, such as remote patient monitoring, shall specify in policy or plan materials the coverage of that telehealth treatment or service.

AB68-SSA1,3005 Section 3005. 632.895 (6) (title) of the statutes is amended to read:

AB68-SSA1,1378,7 632.895 (6) (title) Equipment and supplies for treatment of diabetes; insulin.

AB68-SSA1,3006 Section 3006 . 632.895 (6) of the statutes is renumbered 632.895 (6) (a) and amended to read:

AB68-SSA1,1378,20 632.895 (6) (a) Every disability insurance policy which that provides coverage of expenses incurred for treatment of diabetes shall provide coverage for expenses incurred by the installation and use of an insulin infusion pump, coverage for all other equipment and supplies, including insulin or any other prescription medication, used in the treatment of diabetes, and coverage of diabetic self-management education programs. Coverage Except as provided in par. (b), coverage required under this subsection shall be subject to the same exclusions, limitations, deductibles, and coinsurance provisions of the policy as other covered expenses, except that insulin infusion pump coverage may be limited to the purchase of one pump per year and the insurer may require the insured to use a pump for 30 days before purchase.

AB68-SSA1,3007 Section 3007 . 632.895 (6) (b) of the statutes is created to read:

AB68-SSA1,1378,22 632.895 (6) (b) 1. In this paragraph:

AB68-SSA1,1378,24 a. “Cost sharing” means the total of any deductible, copayment, or coinsurance amounts imposed on a person covered under a policy or plan.

AB68-SSA1,1378,25 b. “Self-insured health plan” has the meaning given in s. 632.85 (1) (c).

AB68-SSA1,1379,3 2. Every disability insurance policy and self-insured health plan that covers insulin and imposes cost sharing on prescription drugs may not impose cost sharing on insulin in an amount that exceeds $50 for a one-month supply of insulin.

AB68-SSA1,1379,8 3. Nothing in this paragraph prohibits a disability insurance policy or self-insured health plan from imposing cost sharing on insulin in an amount less than the amount specified under subd. 2. Nothing in this paragraph requires a disability insurance policy or self-insured health plan to impose any cost sharing on insulin.

AB68-SSA1,3008 Section 3008. 632.895 (8) (d) of the statutes is amended to read:

AB68-SSA1,1379,16 632.895 (8) (d) Coverage is required under this subsection despite whether the woman shows any symptoms of breast cancer. Except as provided in pars. (b), (c), and (e), coverage under this subsection may only be subject to exclusions and limitations, including deductibles, copayments and restrictions on excessive charges, that are applied to other radiological examinations covered under the disability insurance policy. Coverage under this subsection may not be subject to any deductibles, copayments, or coinsurance.

AB68-SSA1,3009 Section 3009. 632.895 (13m) of the statutes is created to read:

AB68-SSA1,1379,19 632.895 (13m) Preventive services. (a) In this section, “self-insured health plan” has the meaning given in s. 632.85 (1) (c).

AB68-SSA1,1379,22 (b) Every disability insurance policy, except any disability insurance policy that is described in s. 632.745 (11) (b) 1. to 12., and every self-insured health plan shall provide coverage for all of the following preventive services:

AB68-SSA1,1379,23 1. Mammography in accordance with sub. (8).

AB68-SSA1,1379,25 2. Genetic breast cancer screening and counseling and preventive medication for adult women at high risk for breast cancer.

AB68-SSA1,1380,2 3. Papanicolaou test for cancer screening for women 21 years of age or older with an intact cervix.

AB68-SSA1,1380,4 4. Human papillomavirus testing for women who have attained the age of 30 years but have not attained the age of 66 years.

AB68-SSA1,1380,5 5. Colorectal cancer screening in accordance with sub. (16m).

AB68-SSA1,1380,8 6. Annual tomography for lung cancer screening for adults who have attained the age of 55 years but have not attained the age of 80 years and who have health histories demonstrating a risk for lung cancer.

AB68-SSA1,1380,10 7. Skin cancer screening for individuals who have attained the age of 10 years but have not attained the age of 22 years.

AB68-SSA1,1380,12 8. Counseling for skin cancer prevention for adults who have attained the age of 18 years but have not attained the age of 25 years.

AB68-SSA1,1380,14 9. Abdominal aortic aneurysm screening for men who have attained the age of 65 years but have not attained the age of 75 years and who have ever smoked.

AB68-SSA1,1380,17 10. Hypertension screening for adults and blood pressure testing for adults, for children under the age of 3 years who are at high risk for hypertension, and for children 3 years of age or older.

AB68-SSA1,1380,19 11. Lipid disorder screening for minors 2 years of age or older, adults 20 years of age or older at high risk for lipid disorders, and all men 35 years of age or older.

AB68-SSA1,1380,22 12. Aspirin therapy for cardiovascular health for adults who have attained the age of 55 years but have not attained the age of 80 years and for men who have attained the age of 45 years but have not attained the age of 55 years.

AB68-SSA1,1380,24 13. Behavioral counseling for cardiovascular health for adults who are overweight or obese and who have risk factors for cardiovascular disease.

AB68-SSA1,1380,25 14. Type II diabetes screening for adults with elevated blood pressure.