Maine Statute | Act | Code |Title 22. Health And Welfare| US Code - US Statute | Chapter 603. Prescription Drug Access (heading. Pl 1999, C. 786, Pt. A, @3 (new))

Title 22 - §2681. Maine Rx Plus Program established

Title 22: HEALTH AND WELFARE
Subtitle 2: HEALTH
Part 5: FOODS AND DRUGS
Chapter 603: PRESCRIPTION DRUG ACCESS (HEADING: PL 1999, c. 786, Pt. A, @3 (new))
Subchapter 1: MAINE RX PLUS PROGRAM (HEADING: PL 1999, c. 786, Pt. A, @3 (new); 2003, c. 494, @1 (rpr))

§2681. Maine Rx Plus Program established

The Maine Rx Plus Program, referred to in this subchapter as the "program," is established to reduce prescription drug prices and to improve the quality of health care for residents of the State. The program is administered by the department and must utilize manufacturer rebates and pharmacy discounts to reduce prescription drug prices. [2003, c. 494, §3 (amd).]

1. Program goals. The Legislature finds that affordability is critical in providing access to prescription drugs for Maine residents. This subchapter is enacted by the Legislature to enable the State to take steps to make prescription drugs more affordable for qualified Maine residents, thereby increasing the overall health of Maine residents, promoting healthy communities and protecting the public health and welfare, and to integrate the program as part of any statewide program for the uninsured. It is not the intention of the State to discourage employers from offering or paying for prescription drug benefits for their employees or to replace employer-sponsored prescription drug benefit plans that provide benefits comparable to those made available to qualified Maine residents under this subchapter. [2003, c. 494, §4 (amd).]

2. Definitions. As used in this subchapter, unless the context otherwise indicates, the following terms have the following meanings.

A. "Average wholesale price" means the wholesale price charged on a specific commodity that is assigned by the drug manufacturer and is listed in a nationally recognized drug pricing file. [1999, c. 786, Pt. A, §3 (new).]

A-1. "Covered drugs" means drugs that are on the MaineCare preferred drug list established and revised from time to time by the department pursuant to its authority to operate the MaineCare program. [2003, c. 494, §4 (new).]

B. "Initial discounted price" for a drug means the amount that participating retail pharmacies may charge qualified residents participating in the program for that drug, as established by the department through rulemaking. [2003, c. 513, Pt. G, §1 (amd).]

C. "Labeler" means an entity or person that receives prescription drugs from a manufacturer or wholesaler and repackages those drugs for later retail sale and that has a labeler code from the federal Food and Drug Administration under 21 Code of Federal Regulations, 207.20 (1999). [1999, c. 786, Pt. A, §3 (new).]

D. "Participating retail pharmacy" or "retail pharmacy" means a retail pharmacy located in this State, or another business licensed to dispense prescription drugs in this State, that participates in the program. [2003, c. 494, §4 (amd).]

E. [2003, c. 494, §4 (rp).]

F. "Qualified resident" means a resident of the State who has a family income equal to or less than 350% of the federal poverty level and who is enrolled in the program. "Qualified resident" also means a resident of the State whose family incurs unreimbursed expenses for prescription drugs that equal 5% or more of family income or whose total unreimbursed medical expenses equal 15% or more of family income. For purposes of this paragraph, the cost of drugs provided under this subchapter is considered an expense incurred by the family for eligibility determination purposes. [2003, c. 494, §4 (amd).]

G. "Secondary discounted price" means the initial discounted price minus any further discounts paid for out of the fund. [2003, c. 494, §4 (amd).]

[2003, c. 513, Pt. G, §1 (amd).]

3. Rebate agreement. A drug manufacturer or labeler that sells prescription drugs in this State through the elderly low-cost drug program under section 254-D or any other publicly supported pharmaceutical assistance program shall enter into a rebate agreement with the department for this program. The rebate agreement must require the manufacturer or labeler to make rebate payments to the State each calendar quarter or according to a schedule established by the department. [2005, c. 401, Pt. C, §3 (amd).]

4. Rebate amount. The commissioner shall negotiate the amount of the rebate required from a manufacturer or labeler in accordance with this subsection.

A. The commissioner shall take into consideration the rebate calculated under the Medicaid Rebate Program pursuant to 42 United States Code, Section 1396r-8, the average wholesale price of prescription drugs and any other information on prescription drug prices and price discounts. [1999, c. 786, Pt. A, §3 (new).]

B. The commissioner shall use the commissioner's best efforts to obtain an initial rebate amount equal to or greater than the rebate calculated under the MaineCare program pursuant to 42 United States Code, Section 1396r-8. [2003, c. 494, §4 (amd).]

C. With respect to the rebate taking effect no later than October 1, 2004, the commissioner shall use the commissioner's best efforts to obtain an amount equal to or greater than the amount of any discount, rebate or price reduction for prescription drugs provided to the Federal Government. [2003, c. 494, §4 (amd).]

[2003, c. 494, §4 (amd).]

5. Discounted prices for qualified residents. Each participating retail pharmacy shall sell covered drugs to qualified residents at the lower of the initial discounted price and the secondary discounted price as such prices are determined by the department pursuant to this subchapter.

A. The department shall establish discounted prices for drugs covered by a rebate agreement and shall promote the use of efficacious and reduced-cost drugs, taking into consideration reduced prices for state and federally capped drug programs, differential dispensing fees, administrative overhead and incentive payments. [1999, c. 786, Pt. A, §3 (new).]

B. Beginning January 1, 2004, a participating retail pharmacy shall offer the initial discounted price. [2003, c. 494, §4 (amd).]

C. No later than October 1, 2004, a participating retail pharmacy shall offer the secondary discounted price if available. [2003, c. 494, §4 (amd).]

D. [2003, c. 494, §4 (rp).]

[2003, c. 494, §4 (amd).]

6. Operation of program. The requirements of this subsection apply to participating retail pharmacies.

A. The Maine Board of Pharmacy shall adopt rules requiring disclosure by participating retail pharmacies to qualified residents of the amount of savings provided as a result of the program. The rules must consider and protect information that is proprietary in nature. Rules adopted pursuant to this paragraph are routine technical rules as defined in Title 5, chapter 375, subchapter 2-A. [2003, c. 494, §4 (amd).]

B. The department may not impose transaction charges under this program on retail pharmacies that submit claims or receive payments under the program. [1999, c. 786, Pt. A, §3 (new).]

C. A participating retail pharmacy shall submit claims to the department to verify the amount charged to qualified residents under subsection 5. [1999, c. 786, Pt. A, §3 (new).]

D. On a weekly or biweekly basis, the department must reimburse a participating retail pharmacy for the difference between the initial discounted price and the secondary discounted price provided to qualified residents under subsection 5. [2003, c. 494, §4 (amd).]

E. [2003, c. 494, §4 (rp).]

F. The department shall conduct ongoing quality assurance activities similar to those used in the MaineCare program. [2003, c. 494, §4 (new).]

[2003, c. 494, §4 (amd).]

7. Action with regard to nonparticipating manufacturers and labelers. [2003, c. 494, §5 (rpr); T. 22, §2681, sub-§7 (rp).]

7-A. Action with regard to nonparticipating manufacturers and labelers. The names of manufacturers and labelers who do and do not enter into rebate agreements pursuant to this subchapter are public information. The department shall release this information to health care providers and the public on a regular basis and shall publicize participation by manufacturers and labelers that is of particular benefit to the public. The department shall impose prior authorization requirements in the MaineCare program, as permitted by law, to the extent the department determines it is appropriate to do so in order to encourage manufacturer and labeler participation in the program and so long as the additional prior authorization requirements remain consistent with the goals of the MaineCare program and the requirements of the federal Social Security Act, Title 19. This subsection takes effect on the date that the department begins offering prescription drug benefits under the program. [2003, c. 494, §6 (new).]

8. Discrepancies in rebate amounts. [2003, c. 494, §7 (rp).]

9. Dedicated fund. The Maine Rx Plus Dedicated Fund, referred to in this section as the "fund," is established to receive revenue from manufacturers and labelers who pay rebates as provided in subsection 4 and any appropriations or allocations designated for the fund. The purposes of the fund are to reimburse retail pharmacies for discounted prices provided to qualified residents pursuant to subsection 5; to reimburse the department for contracted services including pharmacy claims processing fees, administrative and associated computer costs and other reasonable program costs; and to benefit the elderly low-cost drug program under section 254-D. The fund is a nonlapsing dedicated fund. Interest on fund balances accrues to the fund. Surplus funds in the fund must be used for the benefit of the program. Notwithstanding Title 5, section 1585, surplus funds may also be transferred to the elderly low-cost drug program established under section 254-D. [2005, c. 401, Pt. C, §4 (amd).]

10. Annual summary report. The department shall report the enrollment and financial status of the program to the Legislature by the 2nd week in January each year. [1999, c. 786, Pt. A, §3 (new).]

11. Obligations of department. The department shall establish simplified procedures for determining eligibility and issuing Maine Rx enrollment cards to qualified residents and shall undertake outreach efforts to build public awareness of the program and maximize enrollment of qualified residents. The department may adjust the requirements and terms of the program to accommodate any new federally funded prescription drug programs. [1999, c. 786, Pt. A, §3 (new).]

12. Contracting. The department may contract with a 3rd-party or 3rd-parties to administer any or all components of the program, including, but not limited to, outreach, eligibility, claims, administration and rebate recovery and redistribution. [1999, c. 786, Pt. A, §3 (new).]

13. Medical assistance programs. The department shall administer the program and other medical and pharmaceutical assistance programs under this Title in a manner that is advantageous to the programs and to the enrollees in those programs. In implementing this subsection the department may coordinate the other programs and this program and may take actions to enhance efficiency, reduce the cost of prescription drugs and maximize the benefits to the programs and enrollees, including providing the benefits of this program to enrollees in other programs. [1999, c. 786, Pt. A, §3 (new).]

14. Rulemaking. The department may adopt rules to implement the provisions of this section. Rules adopted pursuant to this subsection are routine technical rules as defined in Title 5, chapter 375, subchapter II-A. [1999, c. 786, Pt. A, §3 (new).]

15. Waivers. The department may seek any waivers of federal law, rule or regulation necessary to implement the provisions of this subchapter. [1999, c. 786, Pt. A, §3 (new).]

The Revisor's Office cannot provide legal advice or interpretation of Maine law to the public. If you need legal advice, please consult a qualified attorney.
Office of the Revisor of Statutes
7 State House Station
State House Room 108
Augusta, Maine 04333-0007 This page created on: 2005-10-01
Title 22 - §2682. Display of Maine Rx Plus Program participation information

Title 22: HEALTH AND WELFARE
Subtitle 2: HEALTH
Part 5: FOODS AND DRUGS
Chapter 603: PRESCRIPTION DRUG ACCESS (HEADING: PL 1999, c. 786, Pt. A, @3 (new))
Subchapter 1: MAINE RX PLUS PROGRAM (HEADING: PL 1999, c. 786, Pt. A, @3 (new); 2003, c. 494, @1 (rpr))

§2682. Display of Maine Rx Plus Program participation information

A drug dispensed pursuant to prescription, including a drug dispensed without charge to the consumer, must be accompanied by program participation information in a manner approved by the commissioner and as permitted by law. [2001, c. 471, Pt. E, §5 (amd); §8 (aff).]

1. Exceptions. The requirements of this section do not apply to:

A. A drug dispensed to a consumer who has health coverage that pays part or all of the retail cost of the drug; [2001, c. 379, §1 (new).]

B. A generic drug; or [2001, c. 379, §1 (new).]

C. A drug of a manufacturer or labeler that has entered into an agreement with the department pursuant to section 2681, subsection 3. [2001, c. 379, §1 (new).]

[2001, c. 379, §1 (new).]

2. Rulemaking. The commissioner shall adopt rules to implement this section. Rules adopted pursuant to this section are routine technical rules as defined by Title 5, chapter 375, subchapter II-A. [2001, c. 379, §1 (new).]

3. Program participation information. [2001, c. 471, Pt. E, §6 (rp); §8 (aff).]

3-A. Program participation information. The rules must provide for the disclosure of program participation information, including, but not limited to, the following:

A. Notification that the manufacturer or labeler has not entered into an agreement with the Department of Health and Human Services pursuant to section 2681, subsection 3; and [2001, c. 471, Pt. E, §7 (new); §8 (aff); 2003, c. 689, Pt. B, §6 (rev).]

B. Advice to consult a health care provider or pharmacist about access to drugs at lower prices. [2001, c. 471, Pt. E, §7 (new); §8 (aff).]

[2001, c. 471, Pt. E, §7 (new); §8 (aff); 2003, c. 689, Pt. B, §6 (rev).]

4. Separate writing. The requirements of this section may be met by the distribution of a separate writing that is approved by or produced and distributed by the department. [2001, c. 379, §1 (new).]

5. Waivers. The rules must provide for waivers to the requirements of this section, particularly when the manufacturer or labeler is negotiating with the commissioner pursuant to section 2681, subsection 3. [2001, c. 379, §1 (new).]

The Revisor's Office cannot provide legal advice or interpretation of Maine law to the public. If you need legal advice, please consult a qualified attorney.
Office of the Revisor of Statutes
7 State House Station
State House Room 108
Augusta, Maine 04333-0007 This page created on: 2005-10-01
Title 22 - §2691. Short title; purpose

Title 22: HEALTH AND WELFARE
Subtitle 2: HEALTH
Part 5: FOODS AND DRUGS
Chapter 603: PRESCRIPTION DRUG ACCESS (HEADING: PL 1999, c. 786, Pt. A, @3 (new))
Subchapter 2: PRESCRIPTION DRUG PRICE REDUCTION ACT (HEADING: PL 1999, c. 786, Pt. A, @3 (new))

§2691. Short title; purpose

This subchapter may be known and cited as the "Prescription Drug Price Reduction Act." The Legislature finds that affordability is critical in providing access to prescription drugs for Maine residents. This subchapter is enacted by the Legislature as a positive measure to make prescription drugs more affordable for qualified Maine residents, thereby increasing the overall health of Maine residents, promoting healthy communities and protecting the public health and welfare of Maine residents. [1999, c. 786, Pt. A, §3 (new).]
The Revisor's Office cannot provide legal advice or interpretation of Maine law to the public. If you need legal advice, please consult a qualified attorney.
Office of the Revisor of Statutes
7 State House Station
State House Room 108
Augusta, Maine 04333-0007 This page created on: 2005-10-01
Title 22 - §2692. Prescription Drug Advisory Commission

Title 22: HEALTH AND WELFARE
Subtitle 2: HEALTH
Part 5: FOODS AND DRUGS
Chapter 603: PRESCRIPTION DRUG ACCESS (HEADING: PL 1999, c. 786, Pt. A, @3 (new))
Subchapter 2: PRESCRIPTION DRUG PRICE REDUCTION ACT (HEADING: PL 1999, c. 786, Pt. A, @3 (new))

§2692. Prescription Drug Advisory Commission

The Prescription Drug Advisory Commission, referred to in this subchapter as the "commission," is established to review access to and the pricing of prescription drugs for residents of the State, to advise the commissioner on prescription drug pricing and to provide periodic reports to the commissioner, the Governor and the Legislature. [1999, c. 786, Pt. A, §3 (new).]

1. Membership. The commission consists of the following 12 members:

A. Three members of the public, appointed by the President of the Senate, one of whom must represent the interests of senior citizens. Of the initial appointees, one must be appointed for a 2-year term and 2 for 3-year terms; [1999, c. 786, Pt. A, §3 (new).]

B. Three members of the public, appointed by the Speaker of the House, one of whom must represent the interests of senior citizens. Of the initial appointees, one must be appointed for a 2-year term and 2 for 3-year terms; [1999, c. 786, Pt. A, §3 (new).]

C. Two members of the health care community who are authorized by the laws of this State to prescribe drugs, appointed by the Governor. Of the initial appointees, one must be appointed for a 2-year term and one for a 3-year term; [1999, c. 786, Pt. A, §3 (new).]

D. Two pharmacists, appointed by the Governor. Of the initial appointees, one must be appointed for a 2-year term and one for a 3-year term. To be appointed to and remain on the commission, each pharmacist must:

(1) Be licensed to practice pharmacy and be engaged in the practice of retail pharmacy in this State;

(2) Have at least 5 years of experience in this State as a licensed pharmacist; and

(3) Be a resident of this State; and
[1999, c. 786, Pt. A, §3 (new).]

E. The Director of the Bureau of Medical Services and the Commissioner of Professional and Financial Regulation, or their designees, who shall serve as ex officio, nonvoting members. [1999, c. 786, Pt. A, §3 (new).]

[1999, c. 786, Pt. A, §3 (new).]

2. Terms. With the exception of the initial appointees, all members of the commission serve for terms of 3 years and may be reappointed. With the exception of the pharmacist members, if the profession or qualifications of a commission member change during the term of commission membership, the member may continue to complete the term for which the appointment was made. [1999, c. 786, Pt. A, §3 (new).]

3. Meetings; chair. The commission shall meet at least 4 times per year. The members shall select a chair from among the members. Additional meetings may be called by the chair. [1999, c. 786, Pt. A, §3 (new).]

4. Duties. The duties of the commission include the following:

A. To review access to prescription drugs for residents of the State, including, but not limited to, pricing and affordability information; [1999, c. 786, Pt. A, §3 (new).]

B. To advise the commissioner on access to prescription drugs and prescription drug prices, including, but not limited to, insurance and 3rd-party payments for prescription drugs, the need for maximum retail prices, and, if maximum retail prices are established, the procedures for adoption and periodic review of maximum retail prices, the procedures for establishing maximum retail prices for new prescription drugs and for reviewing maximum retail prices of selected drugs and the procedures for phasing out or terminating maximum retail prices; [1999, c. 786, Pt. A, §3 (new).]

C. To advise the commissioner on the adoption of rules necessary to implement this subchapter; and [1999, c. 786, Pt. A, §3 (new).]

D. To report to the commissioner, the Legislature and the Governor by April 1, 2001, and annually thereafter by the 2nd week in January, including in the report any recommendations for action regarding access to and the pricing of prescription drugs. [1999, c. 786, Pt. A, §3 (new).]

[1999, c. 786, Pt. A, §3 (new).]

5. Staffing. The department shall provide staffing for the commission. [1999, c. 786, Pt. A, §3 (new).]

6. Compensation. Public members not otherwise compensated by their employers or other entities whom they represent are entitled to receive reimbursement of necessary expenses and a per diem equal to the legislative per diem for their attendance at authorized meetings of the commission. [1999, c. 786, Pt. A, §3 (new).]

7. Cooperation. In performing its duties, the commission shall work with the department, the Maine Board of Pharmacy and the Department of Professional and Financial Regulation. [1999, c. 786, Pt. A, §3 (new).]

The Revisor's Office cannot provide legal advice or interpretation of Maine law to the public. If you need legal advice, please consult a qualified attorney.
Office of the Revisor of Statutes
7 State House Station
State House Room 108
Augusta, Maine 04333-0007 This page created on: 2005-10-01
Title 22 - §2693. Emergency drug pricing

Title 22: HEALTH AND WELFARE
Subtitle 2: HEALTH
Part 5: FOODS AND DRUGS
Chapter 603: PRESCRIPTION DRUG ACCESS (HEADING: PL 1999, c. 786, Pt. A, @3 (new))
Subchapter 2: PRESCRIPTION DRUG PRICE REDUCTION ACT (HEADING: PL 1999, c. 786, Pt. A, @3 (new))

§2693. Emergency drug pricing

In order to achieve the public health purposes listed in section 2691, maximum retail prices for prescription drugs sold in Maine may be established pursuant to this section. [1999, c. 786, Pt. A, §3 (new).]

1. Emergency drug pricing procedures. The following provisions apply to determinations regarding maximum retail prices for prescription drugs and to the procedures for establishing those prices.

A. By July 1, 2005, the department shall adopt rules establishing the procedures for adoption and periodic review of maximum retail prices, the procedures for establishing maximum retail prices for new prescription drugs and for reviewing maximum retail prices of selected drugs and the procedures for phasing out or terminating maximum retail prices. Prior to adopting rules pursuant to this paragraph, the commissioner shall consult with and consider the recommendations of the commission regarding the rules. [2003, c. 494, §10 (amd).]

B. By January 5, 2006, the commissioner shall determine whether the cost of prescription drugs provided to qualified residents under the Maine Rx Plus Program pursuant to subchapter 1 is reasonably comparable to the lowest cost paid for the same drugs delivered or dispensed in the State. In making this determination the following provisions apply.

(1) The commissioner shall review prescription drug use in the MaineCare program using data from the most recent 6-month period for which data is available.

(2) Using the data reviewed in subparagraph (1), the commissioner shall determine the 100 drugs for which the most units were provided and the 100 drugs for which the total cost was the highest.

(3) For each prescription drug listed in subparagraph (2), the commissioner shall determine the cost for each drug for qualified residents who are provided those drugs under the Maine Rx Plus Program on a certain date. The average cost for each such drug must be calculated.

(4) For each prescription drug listed in subparagraph (2), the commissioner shall determine the lowest cost for each drug paid by any purchaser on the date that is used for subparagraph (3) delivered or dispensed in the State, taking into consideration the federal supply schedule and prices paid by pharmaceutical benefits managers and by large purchasers and excluding drugs purchased through the Maine Rx Plus Program. The average cost for each such drug must be calculated.

(5) If the average cost for one or more prescription drugs under the Maine Rx Plus Program as determined in subparagraph (3) is not reasonably comparable to the average lowest cost for the same drug or drugs as determined in subparagraph (4), the commissioner shall establish maximum retail prices for any or all prescription drugs sold in the State. Maximum prescription drug prices established under this subparagraph must take effect July 1, 2006.
[2003, c. 494, §10 (amd).]

C. In establishing maximum retail prices under this paragraph, the commissioner shall consider the advice of the commission and shall follow procedures set forth by rules adopted by the department. [1999, c. 786, Pt. A, §3 (new).]

D. Rules adopted pursuant to this subsection are major substantive rules as defined in Title 5, chapter 375, subchapter II-A. [1999, c. 786, Pt. A, §3 (new).]

[2003, c. 494, §10 (amd).]

2. Select prescription drugs. In making a determination under this section the commissioner may rely on pricing information on a selected number of prescription drugs if that list is representative of the prescription drug needs of the residents of the State and is made public as part of the process of establishing maximum retail prices. [1999, c. 786, Pt. A, §3 (new).]

3. Public health or welfare. The commissioner may take actions that the commissioner determines necessary if there is a severe limitation or shortage of or lack of access to prescription drugs in the State that could threaten or endanger the public health or welfare. [1999, c. 786, Pt. A, §3 (new).]

4. Appeals. A retailer of prescription drugs may appeal the maximum retail price of a prescription drug established pursuant to this section in accordance with the Maine Administrative Procedure Act. [1999, c. 786, Pt. A, §3 (new).]

5. Enforcement. A violation of the maximum retail prices established under this section is a violation of the Maine Unfair Trade Practices Act. [1999, c. 786, Pt. A, §3 (new).]

The Revisor's Office cannot provide legal advice or interpretation of Maine law to the public. If you need legal advice, please consult a qualified attorney.
Office of the Revisor of Statutes
7 State House Station
State House Room 108
Augusta, Maine 04333-0007 This page created on: 2005-10-01
Title 22 - §2694. Rulemaking

Title 22: HEALTH AND WELFARE
Subtitle 2: HEALTH
Part 5: FOODS AND DRUGS
Chapter 603: PRESCRIPTION DRUG ACCESS (HEADING: PL 1999, c. 786, Pt. A, @3 (new))
Subchapter 2: PRESCRIPTION DRUG PRICE REDUCTION ACT (HEADING: PL 1999, c. 786, Pt. A, @3 (new))

§2694. Rulemaking

With the exception of rules designated in this subchapter as major substantive rules, rules adopted pursuant to this subchapter are routine technical rules as defined by Title 5, chapter 375, subchapter II-A. [1999, c. 786, Pt. A, §3 (new).]
The Revisor's Office cannot provide legal advice or interpretation of Maine law to the public. If you need legal advice, please consult a qualified attorney.
Office of the Revisor of Statutes
7 State House Station
State House Room 108
Augusta, Maine 04333-0007 This page created on: 2005-10-01
Title 22 - §2697. Profiteering in prescription drugs

Title 22: HEALTH AND WELFARE
Subtitle 2: HEALTH
Part 5: FOODS AND DRUGS
Chapter 603: PRESCRIPTION DRUG ACCESS (HEADING: PL 1999, c. 786, Pt. A, @3 (new))
Subchapter 3: PROFITEERING IN PRESCRIPTION DRUGS (HEADING: PL 1999, c. 786, Pt. A, @3 (new))

§2697. Profiteering in prescription drugs

Prescription drugs are a necessity of life. Profiteering in prescription drugs is unlawful and is subject to the provisions of this section. The provisions of this section apply to manufacturers, distributors and labelers of prescription drugs. [1999, c. 786, Pt. A, §3 (new).]

1. Definitions. As used in this subchapter, unless the context otherwise indicates, the following terms have the following meanings.

A. "Labeler" means an entity or person that receives prescription drugs from a manufacturer or wholesaler and repackages those drugs for later retail sale and that has a labeler code from the federal Food and Drug Administration under 21 Code of Federal Regulations, 207.20 (1999). [1999, c. 786, Pt. A, §3 (new).]

B. "Manufacturer" means a manufacturer of prescription drugs and includes a subsidiary or affiliate of a manufacturer. [1999, c. 786, Pt. A, §3 (new).]

[1999, c. 786, Pt. A, §3 (new).]

2. Profiteering. A manufacturer, distributor or labeler of prescription drugs engages in illegal profiteering if that manufacturer, distributor or labeler:

A. Exacts or demands an unconscionable price; [1999, c. 786, Pt. A, §3 (new).]

B. Exacts or demands prices or terms that lead to any unjust or unreasonable profit; [1999, c. 786, Pt. A, §3 (new).]

C. Discriminates unreasonably against any person in the sale, exchange, distribution or handling of prescription drugs dispensed or delivered in the State; or [1999, c. 786, Pt. A, §3 (new).]

D. Intentionally prevents, limits, lessens or restricts the sale or distribution of prescription drugs in this State in retaliation for the provisions of this chapter. [1999, c. 786, Pt. A, §3 (new).]

[1999, c. 786, Pt. A, §3 (new).]

3. Right of action and damages. The State may bring a civil action in District Court or Superior Court for a direct or indirect injury to any person, group of persons, the State or a political subdivision of the State caused by a violation of this subchapter. There is a right to a jury trial in any action brought in Superior Court under this section. If the State prevails, the defendant shall pay 3 times the amount of damages and the costs of suit, including necessary and reasonable investigative costs, reasonable expert fees and reasonable attorney's fees. For a willful or repeated violation of this section, punitive damages may be awarded. After deduction of the costs of distribution, the damages must be equitably distributed by the State to all injured parties. [1999, c. 786, Pt. A, §3 (new).]

4. Civil violation. Each violation of this section is a civil violation for which the Attorney General may obtain, in addition to other remedies, injunctive relief and a civil penalty in an amount not to exceed $100,000, plus the costs of suit, including necessary and reasonable investigative costs, reasonable expert fees and reasonable attorney's fees. [1999, c. 786, Pt. A, §3 (new).]

5. Unfair trade practice. A violation of this section is also a violation of the Maine Unfair Trade Practices Act. [1999, c. 786, Pt. A, §3 (new).]

The Revisor's Office cannot provide legal advice or interpretation of Maine law to the public. If you need legal advice, please consult a qualified attorney.
Office of the Revisor of Statutes
7 State House Station
State House Room 108
Augusta, Maine 04333-0007 This page created on: 2005-10-01
Title 22 - §2698-A. Marketing costs (REALLOCATED FROM TITLE 22, SECTION 2699)

Title 22: HEALTH AND WELFARE
Subtitle 2: HEALTH
Part 5: FOODS AND DRUGS
Chapter 603: PRESCRIPTION DRUG ACCESS (HEADING: PL 1999, c. 786, Pt. A, @3 (new))
Subchapter 3: PROFITEERING IN PRESCRIPTION DRUGS (HEADING: PL 1999, c. 786, Pt. A, @3 (new))

§2698-A. Marketing costs (REALLOCATED FROM TITLE 22, SECTION 2699)

A manufacturer or labeler of prescription drugs dispensed in this State that employs, directs or utilizes marketing representatives in this State shall report marketing costs for prescription drugs in this State as provided in this section. [RR 2003, c. 1, §17 (ral); §18 (aff).]

1. Purposes. Marketing costs for prescription drugs in this State must be reported to the department for the purposes of assisting this State in its role as a purchaser of prescription drugs and an administrator of prescription drug programs, enabling this State to determine the scope of prescription drug marketing costs and their effect on the cost, utilization and delivery of health care services and furthering the role of this State as guardian of the public interest. [RR 2003, c. 1, §17 (ral); §18 (aff).]

2. Definitions. As used in this section, unless the context otherwise indicates, the following terms have the following meanings.

A. "Labeler" has the same meaning as provided in section 2697, subsection 1. [RR 2003, c. 1, §17 (ral); §18 (aff).]

B. "Manufacturer" has the same meaning as provided in section 2697, subsection 1. [RR 2003, c. 1, §17 (ral); §18 (aff).]

C. "Marketing" means advertising and promotional activities, including, but not limited to, the activities described in subsection 4. [RR 2003, c. 1, §17 (ral); §18 (aff).]

[RR 2003, c. 1, §17 (ral); §18 (aff).]

3. Manner of reporting. Beginning in 2007, by July 1st each year, a manufacturer or labeler of prescription drugs that directly or indirectly distributes prescription drugs for dispensation to residents of this State shall file a report with the department in the form and manner provided by the department. The report must be accompanied by payment of a fee, as set by the department in rule, to support the work of the department under this section. [2005, c. 286, §1 (amd).]

4. Content of annual report by manufacturer or labeler. The annual report filed under subsection 3 must include the following information for each calendar year, beginning with calendar year 2006, as it pertains to marketing activities conducted within this State in a form that provides the value, nature, purpose and recipient of the expense:

A. All expenses associated with advertising, marketing and direct promotion of prescription drugs through radio, television, magazines, newspapers, direct mail and telephone communications as they pertain to residents of this State, except for expenses associated with advertising purchased for a regional or national market that includes advertising within the State; [RR 2003, c. 1, §17 (ral); §18 (aff).]

B. With regard to all persons and entities licensed to provide health care in this State, including health care professionals and persons employed by them in this State, carriers licensed under Title 24 or Title 24-A, health plans and benefits managers, pharmacies, hospitals, nursing facilities, clinics and other entities licensed to provide health care under this Title, the following information:

(1) All expenses associated with educational or informational programs, materials and seminars and remuneration for promoting or participating in educational or informational sessions, regardless of whether the manufacturer or labeler provides the educational or informational sessions or materials;

(2) All expenses associated with food, entertainment, gifts valued at more than $25 and anything provided to a health care professional for less than market value;

(3) All expenses associated with trips and travel; and

(4) All expenses associated with product samples, except for samples that will be distributed free of charge to patients; and
[RR 2003, c. 1, §17 (ral); §18 (aff).]

C. The aggregate cost of all employees or contractors of the manufacturer or labeler who directly or indirectly engage in the advertising or promotional activities listed in paragraphs A and B, including all forms of payment to those employees. The cost reported under this paragraph must reflect only that portion of payment to employees or contractors that pertains to activities within this State or to recipients of the advertising or promotional activities who are residents of or are employed in this State. [RR 2003, c. 1, §17 (ral); §18 (aff).]

[2005, c. 286, §1 (amd).]

5. Exceptions. The following marketing expenses are not subject to the requirements of this section:

A. Expenses of $25 or less; [RR 2003, c. 1, §17 (ral); §18 (aff).]

B. Reasonable compensation and reimbursement for expenses in connection with a bona fide clinical trial of a new vaccine, therapy or treatment; and [RR 2003, c. 1, §17 (ral); §18 (aff).]

C. Scholarships and reimbursement of expenses for attending a significant educational, scientific or policy-making conference or seminar of a national, regional or specialty medical or other professional association if the recipient of the scholarship is chosen by the association sponsoring the conference or seminar. [RR 2003, c. 1, §17 (ral); §18 (aff).]

[RR 2003, c. 1, §17 (ral); §18 (aff).]

6. Department reports. Beginning in 2007, by November 30th each year, the department shall provide an annual report, providing information in aggregate form, on prescription drug marketing expenses to the Legislature and the Attorney General. By January 1, 2008 and every 2 years after that date, the department shall provide a report to the Legislature and the Attorney General, providing information in aggregate form, containing an analysis of the data submitted to the department, including the scope of prescription drug marketing activities and expenses and their effect on the cost, utilization and delivery of health care services and any recommendations with regard to marketing activities of prescription drug manufacturers and labelers. [2005, c. 286, §1 (amd).]

7. Confidentiality; public information. Notwithstanding any provision of law to the contrary, information submitted to the department pursuant to this section is confidential and is not a public record as defined in Title 1, section 402, subsection 3. Disclosure may be made by the department to a contractor providing services to the department under this section; however, that disclosure does not change the confidential status of the information. Data compiled in aggregate form by the department for the purposes of reporting required by this section is a public record as defined in Title 1, section 402, subsection 3, as long as it does not reveal trade information that is protected by state or federal law. [2005, c. 286, §2 (amd).]

8. Penalty. This section may be enforced in a civil action brought by the Attorney General. A manufacturer or labeler that fails to provide a report as required by this section commits a civil violation for which a fine of $1,000 plus costs and attorney's fees may be adjudged. [RR 2003, c. 1, §17 (ral); §18 (aff).]

9. Rulemaking. The department shall adopt rules to implement this section. Rules adopted pursuant to this section are routine technical rules as defined in Title 5, chapter 375, subchapter 2-A. [RR 2003, c. 1, §17 (ral); §18 (aff).]

The Revisor's Office cannot provide legal advice or interpretation of Maine law to the public. If you need legal advice, please consult a qualified attorney.
Office of the Revisor of Statutes
7 State House Station
State House Room 108
Augusta, Maine 04333-0007 This page created on: 2005-10-01
Title 22 - §2698-B. Actual price disclosure and certification

Title 22: HEALTH AND WELFARE
Subtitle 2: HEALTH
Part 5: FOODS AND DRUGS
Chapter 603: PRESCRIPTION DRUG ACCESS (HEADING: PL 1999, c. 786, Pt. A, @3 (new))
Subchapter 3: PROFITEERING IN PRESCRIPTION DRUGS (HEADING: PL 1999, c. 786, Pt. A, @3 (new))

§2698-B. Actual price disclosure and certification

1. Quarterly report. A manufacturer of prescription drugs dispensed in this State under a health program directed or administered by the State shall, on a quarterly basis, report by National Drug Code the following pharmaceutical pricing criteria to the commissioner for each of its drugs:

A. [2005, c. 402, §1 (rp).]

B. [2005, c. 402, §1 (rp).]

C. The average manufacturer price as defined in 42 United States Code, Section 1396r-8(k); and [2003, c. 667, §1 (new); §2 (aff).]

D. The best price as defined in Section 1927 of the Social Security Act, 42 United States Code, Section 1396r-8(c)(1)(C) as in effect on January 1, 2005. [2005, c. 402, §1 (amd).]

The pricing information required under this subsection is for drugs defined under the Medicaid drug rebate program. [2005, c. 402, §1 (amd).]

2. Calculation. [2005, c. 402, §2 (rp).]

3. Description of methodology. When reporting the average manufacturer price and best price, a manufacturer of prescription drugs dispensed in this State shall also include a summary of its methodology. The department may accept the standards of the national drug rebate agreement entered into by the federal Department of Health and Human Services and Section 1927 of the Social Security Act, 42 United States Code, Section 1396r-8(c)(1)(C) for reporting pricing methodology or may adopt its own standards by rule. [2005, c. 402, §3 (amd).]

4. Certification. When a manufacturer of prescription drugs dispensed in this State reports the average manufacturer price or best price, the chief executive officer or chief officer of the manufacturer or an employee of the manufacturer in a position that reports directly to the chief executive officer or chief financial officer who has been delegated authority to sign shall certify to the department, on a form provided by the commissioner, that the reported prices are accurate as of the date they are submitted. [2005, c. 402, §3 (amd).]

5. Confidentiality. Except as provided in this subsection, all information provided to the commissioner by a manufacturer of prescription drugs under this section is confidential and may not be disclosed by any person or by the department to any person without the consent of the manufacturer. Disclosure may be made by the department to an entity providing services to the department under this section and such a disclosure does not change the confidential status of the information. The information may be used by the entity only for the work that is authorized or approved by the department. Disclosure may be ordered by a court for good cause shown or made in a court filing under seal unless or until otherwise ordered by a court. Nothing in this subsection limits the Attorney General's use of civil investigative demand authority under the Maine Unfair Trade Practices Act to investigate violations of this section. [2005, c. 402, §3 (amd).]

6. Violation. A violation of this section is a violation of Title 5, section 207 and must be enforced by the Attorney General pursuant to Title 5, section 209. [2003, c. 667, §1 (new); §2 (aff).]

7. Funding restriction. The department's costs for implementing this section must be met through the use of money that the Attorney General has acquired as a result of consumer protection litigation involving pharmaceutical pricing or practices. General Fund funding may not be used for the purposes of this section. [2003, c. 667, §1 (new); §2 (aff).]

8. Rulemaking. The department may adopt rules to implement this section. Rules adopted pursuant to this subsection are routine technical rules as defined in Title 5, chapter 375, subchapter 2-A. [2005, c. 402, §4 (new).]

The Revisor's Office cannot provide legal advice or interpretation of Maine law to the public. If you need legal advice, please consult a qualified attorney.
Office of the Revisor of Statutes
7 State House Station
State House Room 108
Augusta, Maine 04333-0007 This page created on: 2005-10-01
Title 22 - §2698. Investigation by Attorney General

Title 22: HEALTH AND WELFARE
Subtitle 2: HEALTH
Part 5: FOODS AND DRUGS
Chapter 603: PRESCRIPTION DRUG ACCESS (HEADING: PL 1999, c. 786, Pt. A, @3 (new))
Subchapter 3: PROFITEERING IN PRESCRIPTION DRUGS (HEADING: PL 1999, c. 786, Pt. A, @3 (new))

§2698. Investigation by Attorney General

The Attorney General, upon the Attorney General's own initiative or upon petition of the commissioner or of 50 or more residents of the State, shall investigate suspected violations of this subchapter. [1999, c. 786, Pt. A, §3 (new).] div>
The Attorney General may require, by summons, the attendance and testimony of witnesses and the production of books and papers before the Attorney General related to any such matter under investigation. The summons must be served in the same manner as summonses for witnesses in criminal cases, and all provisions of law related to criminal cases apply to summonses issued under this section so far as they are applicable. All investigations or hearings under this section to which witnesses are summoned or called upon to testify or to produce books, records or correspondence are public or private at the choice of the person summoned and must be held in the county where the act to be investigated is alleged to have been committed, or if the investigation is on petition, it must be held in the county in which the petitioners reside. The expense of the investigation must be paid from the appropriation provided in Title 5, section 203. [1999, c. 786, Pt. A, §3 (new).] div>
A Justice of the Superior Court may by order, upon application of the Attorney General, compel the attendance of witnesses, the production of books and papers, including correspondence, and the giving of testimony before the Attorney General in the same manner and to the same extent as before the Superior Court. Any failure to obey such an order may be punishable by that court as a contempt. [1999, c. 786, Pt. A, §3 (new).]
The Revisor's Office cannot provide legal advice or interpretation of Maine law to the public. If you need legal advice, please consult a qualified attorney.
Office of the Revisor of Statutes
7 State House Station
State House Room 108
Augusta, Maine 04333-0007 This page created on: 2005-10-01
Title 22 - §2699. Prescription drug practices

Title 22: HEALTH AND WELFARE
Subtitle 2: HEALTH
Part 5: FOODS AND DRUGS
Chapter 603: PRESCRIPTION DRUG ACCESS (HEADING: PL 1999, c. 786, Pt. A, @3 (new))
Subchapter 4: PRESCRIPTION DRUG PRACTICES (HEADING: PL 2003, c. 456, @1 (new))

§2699. Prescription drug practices

Pharmacy benefits managers shall and contracts for pharmacy benefits management must comply with the requirements of this section. [2003, c. 456, §1 (new).]

1. Definitions. As used in this chapter, unless the context otherwise indicates, the following terms have the following meanings.

A. "Covered entity" means a nonprofit hospital or medical service organization, insurer, health coverage plan or health maintenance organization licensed pursuant to Title 24 or 24-A; a health program administered by the department or the State in the capacity of provider of health coverage; or an employer, labor union or other group of persons organized in the State that provides health coverage to covered individuals who are employed or reside in the State. "Covered entity" does not include a health plan that provides coverage only for accidental injury, specified disease, hospital indemnity, Medicare supplement, disability income, long-term care or other limited benefit health insurance policies and contracts. [2003, c. 456, §1 (new).]

B. "Covered individual" means a member, participant, enrollee, contract holder or policy holder or beneficiary of a covered entity who is provided health coverage by the covered entity. "Covered individual" includes a dependent or other person provided health coverage through a policy, contract or plan for a covered individual. [2003, c. 456, §1 (new).]

C. "Generic drug" means a chemically equivalent copy of a brand-name drug with an expired patent. [2003, c. 456, §1 (new).]

D. "Labeler" means an entity or person that receives prescription drugs from a manufacturer or wholesaler and repackages those drugs for later retail sale and that has a labeler code from the federal Food and Drug Administration under 21 Code of Federal Regulations, 270.20 (1999). [2003, c. 456, §1 (new).]

E. "Pharmacy benefits management" means the procurement of prescription drugs at a negotiated rate for dispensation within this State to covered individuals, the administration or management of prescription drug benefits provided by a covered entity for the benefit of covered individuals or any of the following services provided with regard to the administration of pharmacy benefits:

(1) Mail service pharmacy;

(2) Claims processing, retail network management and payment of claims to pharmacies for prescription drugs dispensed to covered individuals;

(3) Clinical formulary development and management services;

(4) Rebate contracting and administration;

(5) Certain patient compliance, therapeutic intervention and generic substitution programs; and

(6) Disease management programs.
[2003, c. 456, §1 (new).]

F. "Pharmacy benefits manager" means an entity that performs pharmacy benefits management. "Pharmacy benefits manager" includes a person or entity acting for a pharmacy benefits manager in a contractual or employment relationship in the performance of pharmacy benefits management for a covered entity and includes mail service pharmacy. [2003, c. 456, §1 (new).]

[2003, c. 456, §1 (new).]

2. Required practices. A pharmacy benefits manager owes a fiduciary duty to a covered entity and shall discharge that duty in accordance with the provisions of state and federal law.

A. A pharmacy benefits manager shall perform its duties with care, skill, prudence and diligence and in accordance with the standards of conduct applicable to a fiduciary in an enterprise of a like character and with like aims. [2003, c. 456, §1 (new).]

B. [2003, c. 673, Pt. FFF, §1 (rp).]

C. A pharmacy benefits manager shall notify the covered entity in writing of any activity, policy or practice of the pharmacy benefits manager that directly or indirectly presents any conflict of interest with the duties imposed by this subsection. [2003, c. 456, §1 (new).]

D. A pharmacy benefits manager shall provide to a covered entity all financial and utilization information requested by the covered entity relating to the provision of benefits to covered individuals through that covered entity and all financial and utilization information relating to services to that covered entity. A pharmacy benefits manager providing information under this paragraph may designate that material as confidential. Information designated as confidential by a pharmacy benefits manager and provided to a covered entity under this paragraph may not be disclosed by the covered entity to any person without the consent of the pharmacy benefits manager, except that disclosure may be ordered by a court of this State for good cause shown or made in a court filing under seal unless or until otherwise ordered by a court. Nothing in this paragraph limits the Attorney General's use of civil investigative demand authority under the Maine Unfair Trade Practices Act to investigate violations of this section. [2003, c. 688, Pt. C, §9 (amd); §11 (aff).]

E. With regard to the dispensation of a substitute prescription drug for a prescribed drug to a covered individual the following provisions apply.

(2) If a pharmacy benefits manager makes a substitution in which the substitute drug costs more than the prescribed drug, the pharmacy benefits manager shall disclose to the covered entity the cost of both drugs and any benefit or payment directly or indirectly accruing to the pharmacy benefits manager as a result of the substitution.

(3) The pharmacy benefits manager shall transfer in full to the covered entity any benefit or payment received in any form by the pharmacy benefits manager either as a result of a prescription drug substitution under subparagraph (2) or as a result of the pharmacy benefits manager's substituting a lower-priced generic and therapeutically equivalent drug for a higher-priced prescribed drug.
[2003, c. 673, Pt. FFF, §2 (amd).]

F. A pharmacy benefits manager that derives any payment or benefit for the dispensation of prescription drugs within the State based on volume of sales for certain prescription drugs or classes or brands of drugs within the State shall pass that payment or benefit on in full to the covered entity. [2003, c. 456, §1 (new).]

G. A pharmacy benefits manager shall disclose to the covered entity all financial terms and arrangements for remuneration of any kind that apply between the pharmacy benefits manager and any prescription drug manufacturer or labeler, including, without limitation, formulary management and drug-switch programs, educational support, claims processing and pharmacy network fees that are charged from retail pharmacies and data sales fees. A pharmacy benefits manager providing information under this paragraph may designate that material as confidential. Information designated as confidential by a pharmacy benefits manager and provided to a covered entity under this paragraph may not be disclosed by the covered entity to any person without the consent of the pharmacy benefits manager, except that disclosure may be ordered by a court of this State for good cause shown or made in a court filing under seal unless or until otherwise ordered by a court. Nothing in this paragraph limits the Attorney General's use of civil investigative demand authority under the Maine Unfair Trade Practices Act to investigate violations of this section. [2003, c. 688, Pt. C, §9 (amd); §11 (aff).]

[2003, c. 673, Pt. FFF, §§1, 2 (amd); c. 688, Pt. C, §9 (amd); §11 (aff).]

3. Compliance. Compliance with the requirements of this section is required in all contracts for pharmacy benefits management entered into in this State or by a covered entity in this State. [2003, c. 456, §1 (new).]

4. Enforcement. A violation of this section is a violation of the Maine Unfair Trade Practices Act, for which a fine of not more than $10,000 may be adjudged. [2003, c. 456, §1 (new).]

5. Application. This section applies to contracts executed or renewed on or after September 13, 2003. For the purposes of this subsection, a contract executed pursuant to a memorandum of agreement executed prior to September 13, 2003 is deemed to have been executed prior to September 13, 2003 even if the contract was executed after that date. [2003, c. 688, Pt. C, §10 (new); §11 (aff).] 22 §02699 Marketing costs (REPEALED) (REALLOCATED TO TITLE 22, SECTION 2698-A)

The Revisor's Office cannot provide legal advice or interpretation of Maine law to the public. If you need legal advice, please consult a qualified attorney.
Office of the Revisor of Statutes
7 State House Station
State House Room 108
Augusta, Maine 04333-0007 This page created on: 2005-10-01

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