Wisconsin Legislature: AB1,33

450.01 (21s) “Third party Third-party logistics provider" means a person that contracts with a prescription drug manufacturer to provide or coordinate warehousing, distribution, or other services on behalf of the manufacturer but that does not take title to the manufacturer's prescription drug or have general responsibility to direct the prescription drug's sale or disposition.

AB1,26 Section 26 . 450.01 (23) (p) of the statutes is created to read:

450.01 (23) (p) The services of a 3rd-party logistics provider or out-of-state 3rd-party logistics provider.

AB1,27 Section 27 . 450.02 (1) of the statutes is amended to read:

450.02 (1) The department shall keep a record of the proceedings and a register of the names and places of practice or business of pharmacies, manufacturers, wholesale distributors, 3rd-party logistics providers, out-of-state 3rd-party logistics providers, and other persons licensed under this chapter, and the books, registers and records of the department shall be prima facie evidence of the matters recorded.

AB1,28 Section 28 . 450.03 (1) (fm) of the statutes is created to read:

450.03 (1) (fm) A person who is enrolled at an accredited school of pharmacy and whose practice of pharmacy is limited to administering vaccines under the direct supervision of a person licensed as a pharmacist by the board.

AB1,29 Section 29 . 450.035 (2g) of the statutes is amended to read:

450.035 (2g) A person engaged in the practice of pharmacy under s. 450.03 (1) (f), (fm), or (g) may not administer a vaccine unless he or she acts under the direct supervision of a pharmacist and he or she and the supervising pharmacist have successfully completed 12 hours in a course of study and training, approved by the Accreditation Council for Pharmacy Education or the board, in vaccination storage, protocols, administration technique, emergency procedures, and record keeping and the supervising pharmacist has satisfied the requirements specified in sub. (2t). A person engaged in the practice of pharmacy under s. 450.03 (1) (f), (fm), or (g) may not administer a vaccine under this subsection to a person who is under the age of 6.

AB1,30g Section 30g. 450.035 (2i) (a) of the statutes is amended to read:

450.035 (2i) (a) Subject to subs. (2) and (2g), a pharmacist or a person engaged in the practice of pharmacy under s. 450.03 (1) (f), (fm), or (g) may administer without a prescription order any vaccine listed in the current immunization schedules recommended by the federal advisory committee on immunization practices and published by the federal centers for disease control and prevention.

AB1,30r Section 30r. 450.035 (2i) (b) of the statutes is amended to read:

450.035 (2i) (b) Subject to subs. (2) and (2g), a pharmacist or a person engaged in the practice of pharmacy under s. 450.03 (1) (f), (fm), or (g) may initiate and administer any vaccine not listed in the current immunization schedules recommended by the federal advisory committee on immunization practices and published by the federal centers for disease control and prevention if the vaccine is administered pursuant to a prescription order, vaccination protocol, or standing order.

AB1,31 Section 31 . 450.035 (3) of the statutes is amended to read:

450.035 (3) A pharmacist or a person engaged in the practice of pharmacy under s. 450.03 (1) (f), (fm), or (g) who successfully completes a course of study and training specified in sub. (1r), (1t), (2), or (2g) shall maintain proof of completion and, upon request, provide copies of such proof to the department or the board.

AB1,32 Section 32 . 450.035 (4) of the statutes is amended to read:

450.035 (4) A pharmacist or person engaged in the practice of pharmacy under s. 450.03 (1) (f), (fm), or (g) who administers a vaccine to a person under this section shall update, or cause a pharmacy to update, the Wisconsin Immunization Registry established by the department of health services within 7 days of administering the vaccine.

AB1,33 Section 33 . 450.075 of the statutes is created to read:

450.075 Third-party logistics providers; licensure. (1) License allowed. A person acting as a 3rd-party logistics provider or an out-of-state 3rd-party logistics provider of any drug or device may apply to obtain a license from the board under this section. Where operations are conducted at more than one facility, a person acting as a 3rd-party logistics provider or out-of-state 3rd-party logistics provider may apply to obtain a license from the board for each such facility.

(2) Application. An applicant for a license under this section shall submit a form provided by the board showing all of the following and swear or affirm the truthfulness of each item in the application:

(a) The name, business address, and telephone number of the applicant.

(b) All trade or business names used by the applicant.

(c) Names, addresses, and telephone numbers of contact persons for all facilities used by the applicant for the warehousing, distribution, or other services on behalf of the manufacturer of prescription drugs.

(d) The type of ownership or operation for the applicant's business.

(e) If the applicant's 3rd-party logistics provider business is a partnership, the name of each partner and the name of the partnership.

(f) If the applicant's 3rd-party logistics provider business is a corporation, the name of each corporate officer and director, the name of the corporation, and the state of incorporation.

(g) If the applicant's 3rd-party logistics provider business is a sole proprietorship, the name of the sole proprietor and the name of the business entity.

(h) A list of all licenses and permits issued to the applicant by any other state that authorizes the applicant to warehouse or distribute prescription drugs.

(i) The name, address, and telephone number of a designated representative.

(j) For the person identified as the designated representative in par. (i), a personal information statement that contains all of the following:

1. The person's date and place of birth.

2. The person's place of residence for the 7-year period immediately preceding the date of the application.

3. The person's occupations, positions of employment, and offices held during the 7-year period immediately preceding the date of the application.

4. The name and addresses for each business, corporation, or other entity listed in subd. 3.

5. A statement indicating whether the person has been, during the 7-year period immediately preceding the date of the application, the subject of any proceeding for the revocation of any business or professional license and the disposition of the proceeding.

6. A statement indicating whether the person has been, during the 7-year period immediately preceding the date of the application, enjoined by a court, either temporarily or permanently, from possessing, controlling, or distributing any prescription drug, and a description of the circumstances surrounding the injunction.

7. A description of any involvement by the person during the past 7 years with any business, including investments other than the ownership of stock in a publicly traded company or mutual fund, that manufactured, administered, prescribed, distributed, or stored pharmaceutical products or drugs, and a list of any lawsuits in which such a business was named as a party.

8. A description of any misdemeanor or felony criminal offense of which the person was, as an adult, found guilty, whether adjudication of guilt was withheld or the person pleaded guilty or no contest. If the person is appealing a criminal conviction, the application shall include a copy of the notice of appeal, and the person shall submit a copy of the final disposition of the appeal not more than 15 days after a final disposition is reached.

9. A photograph of the person taken within the 12-month period immediately preceding the date of the application.

(k) A statement that each facility used by the applicant for 3rd-party logistics provider services has been inspected in the 3-year period immediately preceding the date of the application by the board, a pharmacy examining board of another state, the National Association of Boards of Pharmacy, or another accrediting body recognized by the board, with the date of each such inspection.

(3) Licensure. The board shall grant a license to an applicant to act as a 3rd-party logistics provider or an out-of-state 3rd-party logistics provider if all of the following apply:

(a) The applicant pays the fee specified in s. 440.05 (1).

(b) The inspections conducted pursuant to sub. (2) (k) satisfy requirements adopted by the board for 3rd-party logistics providers or out-of-state 3rd-party logistics providers.

1. The person is at least 21 years old.

2. The person has been employed full time for at least 3 years in a pharmacy or with a wholesale prescription drug distributor in a capacity related to the dispensing of and distribution of, and record keeping related to, prescription drugs.

3. The person is employed by the applicant full time in a managerial position.

4. The person is physically present at the 3rd-party logistics provider's or out-of-state 3rd-party logistics provider's facility during regular business hours and is involved in and aware of the daily operation of the 3rd-party logistics provider or the out-of-state 3rd-party logistics provider. This subdivision does not preclude the person from taking authorized sick leave and vacation time or from being absent from the facility for other authorized business or personal purposes.

5. The person is actively involved in and aware of the daily operation of the 3rd-party logistics provider or the out-of-state 3rd-party logistics provider.

6. The person is a designated representative for only one applicant at any given time. This subdivision does not apply if more than one 3rd-party logistics provider or out-of-state 3rd-party logistics provider is located at the facility and the 3rd-party logistics providers or out-of-state 3rd-party logistics providers located at the facility are members of an affiliated group.

7. The person has not been convicted of violating any federal, state, or local law relating to distribution of a controlled substance.

8. The person has not been convicted of a felony.

9. The person submits to the department 2 fingerprint cards, each bearing a complete set of the applicant's fingerprints. The department of justice shall provide for the submission of the fingerprint cards to the federal bureau of investigation for purposes of verifying the identity of the person and obtaining the person's criminal arrest and conviction record.

(d) The applicant satisfies any other requirements established by the board by rule.

(4) Rules. The board shall promulgate rules implementing this section. The rules shall ensure compliance with the federal drug supply chain security act, 21 USC 360eee, et seq. The board may not promulgate rules that impose requirements more strict than the federal drug supply chain security act, or any regulations passed under the federal drug supply chain security act. The board may not promulgate rules that require a license under this section.

(5) Access to records. Applications for licensure under this section are not subject to inspection or copying under s. 19.35, and may not be disclosed to any person except as necessary for compliance with and enforcement of the provisions of this chapter.

(6) Inspections. A 3rd-party logistics provider or an out-of-state 3rd-party logistics provider shall allow the board and authorized federal, state, and local law enforcement officials to enter and inspect its facilities and delivery vehicles, to audit its records and written operating procedures, and to confiscate prescription drugs and records to the extent authorized by law, rule, or regulation.

(7) Applicability. This section does not apply if the board determines that the federal food and drug administration has established a licensing program for 3rd-party logistics providers under 21 USC 360eee-3 and that licensing by this state of resident 3rd-party logistics providers is not required for a resident 3rd-party logistics provider to provide 3rd-party logistics provider services in another state.

AB1,34 Section 34 . 450.11 (5) (br) 2. d. of the statutes is amended to read:

450.11 (5) (br) 2. d. A pharmacist may not extend a prescription order under subd. 1. for a particular patient if a prescription order was previously extended under subd. 1. for that patient during the applicable period described in subd. 3.

AB1,35 Section 35 . 450.11 (5) (br) 3. of the statutes is renumbered 450.11 (5) (br) 3. (intro.) and amended to read:

450.11 (5) (br) 3. (intro.) This paragraph applies only during as follows:

a. During the public health emergency declared on March 12, 2020, by executive order 72, and for 30 days after the conclusion of that public health emergency. During that time,

4. While this paragraph applies as specified in subd. 3., it supersedes par. (bm) to the extent of any conflict.

AB1,36 Section 36 . 450.11 (5) (br) 3. b. of the statutes is created to read:

450.11 (5) (br) 3. b. During the period beginning on the effective date of this subd. 3. b. .... [LRB inserts date], and ending on June 30, 2021.

AB1,37 Section 37 . 609.205 (2) (intro.) and (a) of the statutes are amended to read:

609.205 (2) (intro.) All of the following apply to a defined network plan or preferred provider plan during the state of emergency related to public health declared under s. 323.10 on March 12, 2020, by executive order 72, and for the 60 days following the date that the state of emergency terminates until the conclusion of a national emergency declared by the U.S. president under 50 USC 1621 in response to the 2019 novel coronavirus or June 30, 2021, whichever is earlier:

(a) The plan may not require an enrollee to pay, including cost sharing, for a service, treatment, or supply provided by a provider that is not a participating provider in the plan's network of providers more than the enrollee would pay if the service, treatment, or supply is provided by a provider that is a participating provider. This subsection applies to any service, treatment, or supply that is related to diagnosis or treatment for COVID-19 and to any service, treatment, or supply that is provided by a provider that is not a participating provider because a participating provider is unavailable due to the public health emergency.

AB1,38 Section 38 . 609.205 (3) (intro.) of the statutes is amended to read:

609.205 (3) (intro.) During the state of emergency related to public health declared under s. 323.10 on March 12, 2020, by executive order 72, and for the 60 days following the date that the state of emergency terminates Until the conclusion of a national emergency declared by the U.S. president under 50 USC 1621 in response to the 2019 novel coronavirus or June 30, 2021, whichever is earlier, all of the following apply to any health care provider or health care facility that provides a service, treatment, or supply to an enrollee of a defined network plan or preferred provider plan but is not a participating provider of that plan:

AB1,38g Section 38g. 609.205 (3m) of the statutes is created to read:

609.205 (3m) This section does not apply to the reimbursement for administration of the vaccine against the SARS-CoV-2 coronavirus, which results in COVID-19. The reimbursement administration of the SARS-CoV-2 vaccine shall be consistent with Section 3203 of the federal Coronavirus Aid, Relief, and Economic Security Act and 45 CFR 147.130 (a).

AB1,38h Section 38h. 609.205 (3r) of the statutes is created to read:

609.205 (3r) This section does not apply to a service, treatment, or supply that is a dental service, treatment, or supply.

AB1,39 Section 39 . 632.895 (14g) (b) of the statutes is amended to read:

632.895 (14g) (b) Before March 13, 2021 Until the conclusion of a national emergency declared by the U.S. president under 50 USC 1621 in response to the 2019 novel coronavirus or June 30, 2021, whichever is earlier, every disability insurance policy, and every self-insured health plan of the state or of a county, city, town, village, or school district, that generally covers vaccination and testing for infectious diseases shall provide coverage of testing for COVID-19 and vaccination against the SARS-CoV-2 coronavirus without imposing any copayment or coinsurance on the individual covered under the policy or plan.

AB1,40 Section 40 . 632.895 (16v) (a) (intro.) of the statutes is amended to read:

632.895 (16v) (a) (intro.) During the period covered by the state of emergency related to public health declared by the governor on March 12, 2020, by executive order 72 Until June 30, 2021, an insurer offering a disability insurance policy that covers prescription drugs, a self-insured health plan of the state or of a county, city, town, village, or school district that covers prescription drugs, or a pharmacy benefit manager acting on behalf of a policy or plan may not do any of the following in order to maintain coverage of a prescription drug:

AB1,41 Section 41 . 655.0025 of the statutes is created to read:

655.0025 Participation during COVID-19 national emergency. Until the conclusion of a national emergency declared by the U.S. president under 50 USC 1621 in response to the 2019 novel coronavirus or June 30, 2021, whichever is earlier, all of the following apply to a physician or nurse anesthetist for whom this state is not a principal place of practice but who is authorized to practice in this state on a temporary basis:

(1) The physician or nurse anesthetist may fulfill the requirements of s. 655.23 (3) (a) by filing with the commissioner a certificate of insurance for a policy of health care liability insurance issued by an insurer that is authorized in a jurisdiction accredited by the National Association of Insurance Commissioners.

(2) The physician or nurse anesthetist may elect, in the manner designated by the commissioner by rule under s. 655.004, to be subject to this chapter.

AB1,42 Section 42 . 895.476 of the statutes is created to read:

895.476 Civil liability exemption; exposure to the novel coronavirus SARS-CoV-2 or COVID-19. (1) In this section:

(a) “COVID-19” means the infection caused by the novel coronavirus SARS-CoV-2 or by any viral strain originating from SARS-CoV-2, and conditions associated with the infection.

(b) “Entity” means a partnership, corporation, association, governmental entity, tribal government, tribal entity, or other legal entity, including a school, institution of higher education, or nonprofit organization. “Entity” includes an employer or business owner, employee, agent, or independent contractor of the entity, regardless of whether the person is paid or an unpaid volunteer.

(2) Beginning March 1, 2020, an entity is immune from civil liability for the death of or injury to any individual or damages caused by an act or omission resulting in or relating to exposure, directly or indirectly, to the novel coronavirus identified as SARS-CoV-2 or COVID-19 in the course of or through the performance or provision of the entity's functions or services.

(3) Subsection (2) does not apply if the act or omission involves reckless or wanton conduct or intentional misconduct.