SENATE  .  .  .  .  .  .  .  .  .  .  .  .  .  .  No. 2520

The Commonwealth of Massachusetts

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In the One Hundred and Ninety-Fourth General Court
(2025-2026)

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by inserting after section 7 the following 6 sections:-

"SECTION 7A. Section 1 of chapter 6D of the General Laws, as most recently amended by sections 11 of chapter 342 of the acts of 2024, is hereby further amended by inserting after the definition of “Disproportionate share hospital” the following definition:-

“Early notice”, advanced notification by a pharmaceutical manufacturing company of a: (i) new drug, device or other product coming to market; or (ii) a price increase, as described in subsection (b) of section 15A.

SECTION 7B. Said section 1 of said chapter 6D, as so amended, is hereby further amended by inserting after the definition of “Physician” the following definition:-

“Pipeline drug”, a prescription drug product containing a new molecular entity for which the sponsor has submitted a new drug application or biologics license application and received an action date from the United States Food and Drug Administration.

SECTION 7C. Said section 1 of said chapter 6D, as so amended, is hereby further amended by adding the following definition:-

“Wholesale acquisition cost”, the cost of a prescription drug as defined in 42 U.S.C. 1395w-3a(c)(6)(B).

SECTION 7D. Said chapter 6D is hereby further amended by striking out section 2A, as appearing in the 2022 Official Edition, and inserting in place thereof the following section:-

Section 2A. The commission shall keep confidential all nonpublic clinical, financial, strategic or operational documents or information provided or reported to the commission in connection with any care delivery, quality improvement process, performance improvement plan or early notice authorized under sections 7, 10, 14, 15, 15A, 24 or 25 of this chapter or under section 2GGGG of chapter 29 and shall not disclose the information or documents to any person without the consent of the entity providing or reporting the information or documents under said sections 7, 10, 14, 15, 15A, 24 or 25 of this chapter or under said section 2GGGG of said chapter 29, except in summary form in evaluative reports of such activities or when the commission believes that such disclosure should be made in the public interest after taking into account any privacy, trade secret or anticompetitive considerations. The confidential information and documents shall not be public records and shall be exempt from disclosure under clause Twenty-sixth of section 7 of chapter 4 or under chapter 66.

SECTION 7E. Said chapter 6D is hereby further amended by inserting after section 15 the following section:-

Section 15A. (a) A pharmaceutical manufacturing company shall provide early notice to the commission in a manner described in this section for a: (i) pipeline drug; (ii) generic drug; or (iii) biosimilar drug. The commission shall provide nonconfidential information received under this section to the office of Medicaid, the division of insurance and the group insurance commission.

Early notice under this subsection shall be submitted to the commission in writing not later than 30 days after receipt of the United States Food and Drug Administration approval date.

For each pipeline drug, early notice shall include a brief description of the: (i) primary disease, health condition or therapeutic area being studied and the indication; (ii) route of administration being studied; (iii) clinical trial comparators; (iv) estimated date of market entry; and (v) any other information the commission deems relevant. To the extent possible, information shall be collected using data fields consistent with those used by the National Institutes of Health for clinical trials.

For each pipeline drug, early notice shall include whether the drug has been designated by the United States Food and Drug Administration: (i) as an orphan drug; (ii) for fast track; (iii) as a breakthrough therapy; (iv) for accelerated approval; (v) for priority review for a new molecular entity; or (vi) for an expedited approval program not listed in this subsection; provided, however, that notwithstanding clause (v), submissions for drugs in development that are designated as new molecular entities by the United States Food and Drug Administration shall be provided as soon as practical upon receipt of the relevant designations. For each generic drug, early notice shall include a copy of the drug label approved by the United States Food and Drug Administration. If said drug label has not been approved by the time early notice would otherwise be required, the label shall be provided within a reasonable time as determined by the commission.

(b) A pharmaceutical manufacturing company shall provide early notice to the commission if it plans to increase the wholesale acquisition cost of a: (i) brand-name drug by more than 15 per cent per wholesale acquisition cost unit during any 12-month period; or (ii) a brand-name drug, generic drug or biosimilar drug with a significant price increase as determined by the commission during any 12-month period; provided, however, that a significant price increase may include, but need not be limited to, a price increase below 15 per cent. The commission shall provide non-confidential information received under this section to the office of Medicaid, the division of insurance and the group insurance commission.

Early notice under this subsection shall be submitted to the commission in writing not less than 60 days before the planned effective date of the increase.

A pharmaceutical manufacturing company required to notify the commission of a price increase under this subsection shall, not less than 30 days before the planned effective date of the increase, report to the commission any information regarding the price increase that the commission deems relevant including, but not limited to: (i) drug identification information; (ii) drug sales volume information; (iii) wholesale price and related information for the drug; (iv) net price and related information for the drug; (v) drug acquisition information, if applicable; (vi) revenue from the sale of the drug; and (vii) manufacturer costs.

(c) If a pharmaceutical manufacturing company fails to timely comply with the requirements under subsection (a) or subsection (b), or otherwise knowingly obstructs the commission’s ability to receive early notice under this section, including, but not limited to, providing false or misleading information, the commission may impose sanctions against the manufacturer, including monetary penalties not more than $500,000, per violation. The commission shall seek to promote compliance with this section and shall only impose a civil penalty on the manufacturer as a last resort. Amounts collected under this section shall be deposited into the Prescription Drug Cost Assistance Trust Fund established in section 2KKKKKK of chapter 29.

(d) The commission may promulgate regulations to implement this section.

SECTION 7F. Said chapter 6D is hereby further amended by adding the following 2 sections:-

Section 24. (a) As used in this section, the following words shall have the following meanings unless the context clearly requires otherwise:

“Eligible drug”, (i) a brand name drug or biologic, not including a biosimilar, that has a launch wholesale acquisition cost of $25,000 or more for a 1-year supply or full course of treatment; (ii) a biosimilar drug that has a launch wholesale acquisition cost that is less than 15 per cent lower than the referenced brand biologic at the time the biosimilar is launched; (iii) a generic drug that has a wholesale acquisition cost of $100 or more for a 30-day supply or full course of treatment, for which the wholesale acquisition cost increased by 200 per cent or more during the preceding 12 months; (iv) a public health essential drug, as defined in subsection (f) of section 13 of chapter 17, with a significant price increase over a defined period of time as determined by the commission by regulation or with a wholesale acquisition cost of $10,000 or more for a 1-year supply or full course of treatment; (v) all drugs selected pursuant to section 17Z of chapter 32A, section 10Z of chapter 118E, section 47CCC of chapter 175, section 8DDD of chapter 176A, section 4DDD of chapter 176B and section 4VV of chapter 176G; (vi) a brand name, generic or biologic drug with a total aggregate annual spend by public and private payors of $25 million or more; or (vii) other prescription drug products which, due to their cost or an increase in their cost: (A) may have a significant negative impact on patient access, such as by significantly contributing to high patient out-of-pocket costs compared to other drugs, increased utilization management compared to other drugs, lack of coverage by payers or similar factors as determined by the commission; or (B) may create significant affordability challenges for the commonwealth’s health care system and patients, such as by contributing significantly to increased premiums, costs to the commonwealth or patient out-of-pocket costs compared to other drugs, by having a substantial impact on state programs involved in the provision of health care, by affecting the ability of the state and other entities that contribute to the health care cost growth benchmark to meet said benchmark or similar factors, as determined by the commission; provided, however, that the commission shall promulgate regulations to establish the type of prescription drug products classified under clause (vii) prior to classification of any such prescription drug product under said clause (vii), and the commission may adjust the dollar amounts in this definition from time to time for good cause including, but not limited to, inflation.

“Manufacturer”, a pharmaceutical manufacturer of an eligible drug.

“Public health essential drug”, shall have the same meaning as defined in subsection (f) of section 13 of chapter 17.

(b)(1) The commission shall review: (i) the negative impact of eligible drug costs on patient access, such as by significantly contributing to high patient out-of-pocket costs compared to other drugs, increased utilization management compared to other drugs, lack of coverage by payers or similar factors as determined by the commission; and (ii) the extent to which eligible drug costs have created or likely will create affordability challenges for the state’s health care system and patients, such as by contributing significantly to increased premiums, costs to the state, or patient out-of-pocket costs compared to other drugs, by having a substantial impact on state programs involved in the provision of health care, by affecting the ability of the state and other entities that contribute to the health care cost growth benchmark to meet said benchmark or similar factors, as determined by the commission; provided, however, that the commission shall review the eligible drugs that the commission determines may have the most significant impact to patients under clause (i) or may create the most significant affordability challenges under clause (ii).

(2) In conducting a review of eligible drugs, the commission shall consider:

(i) available information about the relevant factors contributing to the price paid and amount spent in the state for the drug, including the wholesale acquisition cost, change in price as compared to the launch price, annual price increases over time, discounts, rebates or other price concessions, utilization and utilization trends, aggregate annual spending in the state on the drug and the impact of the drug’s cost on the state budget;

(ii) the average patient co-pay or other cost-sharing for the drug in the commonwealth;

(iii) whether the cost of the drug contributes to inequities in health care access or outcomes;

(iv) the price and availability of therapeutic alternatives in the commonwealth;

(v) input from patients affected by the condition or disease treated by the drug and individuals with medical or scientific expertise related to the condition or disease treated by the drug;

(vi) input from other stakeholders, which may include, but shall not be limited to, patient advocacy organizations, consumer advocacy organizations, providers, provider organizations and payers; and

(vii) any other factors the commission deems relevant.

(3) In conducting a review of eligible drugs, the commission shall notify the manufacturer that the commission is reviewing the manufacturer’s drug, and shall provide the manufacturer with the opportunity to provide relevant information about the drug’s pricing. The commission may request relevant information from the manufacturer of said eligible drug and from pharmacy benefit managers, payers, wholesalers, pharmacies, clinical experts, providers and other persons or entities. The commission, to the extent feasible, shall collaborate with the center to avoid collecting duplicative information and reduce the administrative burden on all parties.

(c)(1) Using the records and information provided under subsection (b), available information from the center, from an outside third party, from another agency or department within the commonwealth or that is otherwise available to the commission or any of its subdivisions, the commission shall identify a proposed value for eligible drugs the commission has reviewed pursuant to subsection (b) and which the commission has determined have or likely will have a significant impact on patient access or which have created or likely will create significant affordability challenges for the state’s health care system or patients, as described in clauses (i) and (ii) of paragraph (1) of subsection (b). In identifying proposed values for eligible drugs, the commission may prioritize drugs based on the commission’s determination of the significance of the drug cost’s negative impact on patient access or the extent to which the drug’s cost has created or likely will create affordability challenges for the state’s health care system or patients, as described in clauses (i) and (ii) of paragraph (1) of subsection (b) of this section.

(2) The commission shall base the proposed value on:

(i) the cost of delivering and administering the drug and other administrative costs related to the production and delivery of the drug that the commission deems relevant;

(ii) the status of the drug on the drug shortage list published by the United States Food and Drug Administration;

(iii) the drug’s status as an orphan drug;

(iv) information the commission collected pursuant to paragraph (2) of subsection (b) that the commission deems relevant, including, but not limited to input from patients and stakeholders; and

(v) other factors the commission deems relevant in determining a drug’s value.

(3) The commission shall not base its determination on the proposed value of the eligible drug solely on the analysis or research of an outside third party and shall not employ a measure or metric that assigns a reduced value to the life extension provided by a treatment based on a pre-existing disability or chronic health condition of the individuals whom the treatment would benefit. If the commission relies upon a third party to provide cost-effectiveness analysis or research related to the proposed value of the eligible drug, such analysis or research shall also include, but not be limited to: (i) a description of the methodologies and models used in the analysis; (ii) any assumptions and potential limitations of research findings in the context of the results; and (iii) outcomes for affected subpopulations that utilize the drug, including, but not limited to, potential impacts on individuals of marginalized racial or ethnic groups and on individuals with specific disabilities or health conditions who regularly utilize the eligible drug.

(d) If, after review of an eligible drug the commission determines that the cost of the eligible drug, as determined by the commission, does not substantially exceed the proposed value of the drug, the commission shall notify the manufacturer, in writing, of its determination and shall evaluate other ways to mitigate the eligible drug’s cost in order to improve patient access to the eligible drug and help address affordability challenges. For the purposes of this subsection, to “substantially exceed” shall mean to exceed by not less than 15 per cent; provided, however, that for good cause, the commission may determine that a drug’s cost does not substantially exceed the proposed value even if the cost exceeds the value by more than 15 per cent; provided further, that the commission shall adopt regulations defining good cause prior to making such a determination. The commission may engage with stakeholders, including, but not limited to, patients, patient advocacy organizations, consumer advocacy organizations, providers, provider organizations and payers, to explore options for mitigating the cost of the eligible drug. Upon the conclusion of a stakeholder engagement process under this subsection, the commission shall issue recommendations on ways to reduce the cost of the eligible drug for the purpose of improving patient access to the eligible drug and helping to address affordability challenges. Recommendations may include but shall not be limited to: (i) an alternative payment plan or methodology; (ii) a bulk purchasing program; (iii) co-payment, deductible, co-insurance or other cost-sharing restrictions; (iv) risk-based solutions; and (v) public reporting of the drugs. The recommendations shall be publicly posted on the commission’s website and provided to the clerks of the house of representatives and senate, the joint committee on health care financing and the house and senate committees on ways and means; provided, however, that the report shall be published on the website of the commission.

(e) If, after review of an eligible drug, the commission determines that the cost of the eligible drug, as determined by the commission, substantially exceeds the proposed value of the drug, the commission shall notify and provide the manufacturer with an opportunity provide further information related to the pricing of the eligible drug, the manufacturer’s reasons for the pricing, and any actions the manufacturer has taken or will imminently take that have a high likelihood of lowering the cost of the drug for units of the drugs that are dispensed or administered to an individual in the state in person, by mail, or by other means. For the purposes of this subsection, to “substantially exceed” shall mean to exceed by at least 15 per cent. However, the commission may determine that a drug’s cost substantially exceeds the proposed value even if the cost exceeds the value by less than 15 per cent, if the commission has good cause for making such a determination; provided however, that the commission shall adopt regulations defining good cause prior to making such a determination.

(f) The commission may revise the proposed value for an eligible drug based on the information provided, if any, pursuant to subsection (e). Not later than 60 days after receiving information from the manufacturer under subsection (b) or subsection (e), if any, the commission shall publicly issue a determination on whether the cost of an eligible drug, as determined by the commission, substantially exceeds the commission’s proposed value of the drug. If the commission determines that the cost of an eligible drug substantially exceeds the commission’s proposed value of the drug, the commission shall confidentially notify the manufacturer, in writing, of its determination and shall set an upper payment limit for the drug pursuant to section 25. For the purposes of this subsection, to “substantially exceed” shall mean to exceed by not less than 15 per cent; provided, however, that, for good cause, the commission may determine that a drug’s cost substantially exceeds the proposed value if the cost exceeds the value by less than 15 per cent; and provided further, that the commission shall adopt regulations defining good cause prior to making such a determination.

(g) Records disclosed by a manufacturer or other person or entity pursuant to this section, if any, shall: (i) be accompanied by an attestation that all information provided is true and correct; (ii) not be public records as defined under clause Twenty-sixth of section 7 of chapter 4 or chapter 66; and (iii) remain confidential; provided, however, that the commission may produce reports summarizing any findings; provided further, that any such report shall not be in a form that identifies specific prices charged for or rebate amounts associated with drugs by a manufacturer or in a manner that is likely to compromise the financial, competitive or proprietary nature of the information.

A request for further information made by the commission under subsection (e) or a determination issued or written notification made by the commission under subsection (f) shall not be public records as defined under said clause Twenty-sixth of said section 7 of said chapter 4 or said chapter 66.

In issuing public determinations under subsection (f), the commission shall not identify specific prices charged for, or rebate amounts associated with, drugs by a manufacturer or in a manner that is likely to compromise the financial, competitive or proprietary nature of the information. Such prices or rebates shall not be public records as defined under said clause Twenty-sixth of said section 7 of said chapter 4 or said chapter 66.

(h) The commission’s proposed value of an eligible drug and the commission’s underlying analysis of the eligible drug shall not be used to determine whether any individual patient meets prior authorization or utilization management criteria for the eligible drug. The proposed value and underlying analysis shall not be the sole factor in determining whether a drug is included in a formulary or whether the drug is subject to step therapy.

(i) The commission may request relevant information to implement this section from the manufacturer of eligible drug and from pharmacy benefit managers, payers, wholesalers, pharmacies, clinical experts, providers and other persons or entities; provided, however, that if a manufacturer, pharmacy benefit manager, wholesaler or payer fails to timely comply with the commission’s request for records pursuant to subsections (b) or (e), or otherwise knowingly obstructs the commission’s ability to issue its determination under subsection (f), by taking actions including, but not limited to, providing false or misleading information, the commission may impose sanctions against the entity, including monetary penalties not to exceed $500,000, per violation. The commission shall promote compliance with this section and shall only impose a civil penalty on the manufacturer as a last resort. Penalties collected under this subsection shall be deposited into the Prescription Drug Cost Assistance Trust Fund established under section 2KKKKKK of chapter 29. The commission, to the extent feasible, shall collaborate with the center to avoid collecting duplicative information and reduce the administrative burden on all parties.

The failure of an entity to provide requested information to the commission or the center pursuant to paragraph (3) of subsection (b), paragraph (3) of subsection (c), subsection (e) or any other provision in this section or sections 23 or 25 shall not impair the commission’s ability to determine which drugs are eligible drugs, to review eligible drugs, to determine proposed values, to set upper payment limits or otherwise exercise the commission’s authority under this section or sections 23 or 25.

(j) The commission shall adopt any written policies, procedures or regulations that it determines necessary to implement this section.

Section 25. (a) Upon providing written notice provided under subsection (f) of section 24, the commission shall set an upper payment limit for an eligible drug. The upper payment limit shall be the maximum amount that may be paid or billed for a prescription drug purchased or reimbursed in any financial transaction under subsection (c).

(b) The upper payment limit shall be the proposed value for the eligible drug; provided, however, that if the commission revised the proposed value pursuant to subsection (f) of section 24, the upper payment limit shall be the drug’s revised proposed value. The commission may set an upper payment limit that is different than the proposed value for good cause; provided, however, that the commission shall adopt regulations defining good cause prior to setting any upper payment limit. The commission may annually raise a drug’s upper payment limit to account for inflation. An upper payment limit shall not include a pharmacy dispensing fee and nothing in this section shall be interpreted to prevent a retail pharmacy from receiving a payment that includes a dispensing fee above the upper payment limit.

(c)(1) The upper payment limit shall apply:

(i) when an individual purchases a prescription drug from a provider located in the commonwealth or a pharmacy licensed by the commonwealth and the drug is dispensed or administered to an individual in the commonwealth in person, by mail or by other means; provided, however, that if the person is insured, the amount the person pays, plus the amount the person’s carrier, the commonwealth or entity acting on behalf of the commonwealth, including, but not limited to the medical assistance program established under chapter 118E, or the participating self-insured plan pays, shall not exceed the upper payment limit plus applicable dispensing fees; and provided further, that a person shall be considered to have purchased a drug if they are not required to pay any cost-sharing amount;

(ii) when a provider located in the commonwealth or a pharmacy licensed by the commonwealth purchases from a wholesaler or other entity a prescription drug that is dispensed or administered to a person in the commonwealth in person, by mail or by other means;

(iii) when a carrier, a pharmacy benefits manager, the commonwealth or entity acting on behalf of the commonwealth, including, but not limited to, the medical assistance program established under chapter 118E, or a participating self-insured plan pays or reimburses a pharmacy, provider or other entity for a prescription drug that is dispensed or administered to a person in the commonwealth in person, by mail or by other means; provided, however, that the amount the person pays for the drug, plus the amount the carrier, the commonwealth or entity acting on behalf of the commonwealth, or the participating self-insured plan pays shall not exceed the upper payment limit plus applicable dispensing fees; and

(iv) to any other transaction within the commonwealth’s jurisdiction to which the commission determines is necessary to apply the upper payment limit to effectuate the purposes of this section.

(2) For the purposes of this subsection, “carrier” shall have the same meaning as in section 1 of chapter 176O.

(d) Upper payment limits shall become effective 6 months after the commission has issued a public determination pursuant to subsection (f) of section 24.

(e) A self-insured plan governed by the Employee Retirement Income Security Act of 1974 may elect to be subject to the upper payment limits.

(f) The commission may suspend an upper payment limit if the commission determines that there is a shortage of the drug in the commonwealth, unless the commission determines that the shortage was caused by a manufacturer or the manufacturer’s agent due to the commission establishing an upper payment limit for the drug.

(g) Any manufacturer or wholesaler that intends to withdraw from sale or distribution within the commonwealth a drug for which the commission has established an upper payment limit shall provide a notice of withdrawal in writing not less than 6 months before the withdrawal to the commission, the commissioner of the division of insurance, the attorney general and any entity in the commonwealth with which the manufacturer or wholesaler has a contract for the sale or distribution of the drug. The commission shall assess a penalty not more than 1 year’s worth of the manufacturer’s revenue attributable to use of the drug in the commonwealth, as determined by the commission, if the commission determines that a manufacturer or wholesaler failed to provide said notice. This subsection shall not apply in instances where the drug is being withdrawn due to a recall or revocation of the drug’s approval by the United States Food and Drug Administration or similar reasons as determined by the commission.

(h) Any savings that a carrier, a participating self-insured plan or the group insurance commission generates due to the implementation of an upper payment limit shall be used to reduce costs to consumers, prioritizing the reduction of premiums or out-of-pocket costs for prescription drugs. Annually, each carrier, participating self-insured plan, the group insurance commission and the division of medical assistance shall submit to the commission a report describing the savings achieved as a result of implementing upper payment limits and how those savings were used to reduce costs to consumers.

(i) The attorney general may enforce this section.

(j) The commission shall promulgate regulations, including, but not limited to, civil penalties, as necessary to implement this section.”; and

By inserting after section 9 the following section:-

“SECTION 9A. Section 13 of said chapter 17 , as so appearing, is hereby amended by adding the following subsection:-

(f) As used in this subsection, “Public health essential drug” shall mean a prescription drug, biologic or biosimilar approved by the United States Food and Drug Administration that: (i) appears on the Model List of Essential Medicines most recently adopted by the World Health Organization; (ii) is selected pursuant to section 17Z of chapter 32A, section 10Z of chapter 118E, section 47CCC of chapter 175, section 8DDD of chapter 176A, section 4DDD of chapter 176B and section 4VV of chapter 176G; or (iii) is deemed an essential medicine by the commission due to its efficacy in treating a life-threatening health condition or a chronic health condition that substantially impairs an individual’s ability to engage in activities of daily living or because limited access to a certain population would pose a public health challenge.

The commission shall identify and publish a list of public health essential drugs. The list shall be updated not less than annually and be made publicly available on the department’s website; provided, however, that the commission may provide an interim listing of a public health essential drug prior to an annual update. The commission shall notify and forward a copy of the list to the health policy commission established under chapter 6D.”; and

By inserting after section 16 the following section:-

“SECTION 16A. Said chapter 29 is hereby further amended by inserting after section 2JJJJJJ the following section:-

2KKKKKK. (a) There shall be a Prescription Drug Cost Assistance Trust Fund. The secretary of health and human services shall administer the fund and shall make expenditures from the fund, without further appropriation, to provide financial assistance to residents of the commonwealth for the cost of prescription drugs through the prescription drug costs assistance program established under section 249 of chapter 111. For the purposes of this section, “prescription drug” shall mean a prescription drug and any drug delivery device needed to administer the drug that is not included as part of the underlying drug prescription.

The fund shall be credited with: (i) revenue from appropriations or other money authorized by the general court and specifically designated to be credited to the fund; and (ii) funds from public or private sources, including, but not limited to, gifts, grants, donations, rebates and settlements received by the commonwealth that are specifically designated to be credited to the fund. Money remaining in the fund at the close of a fiscal year shall not revert to the General Fund and shall be available for expenditure in the following fiscal year. 

(b) Annually, not later than March 1, the secretary shall report on the fund’s activities detailing expenditures from the previous calendar year. The report shall include: (i) the number of individuals who received financial assistance from the fund; (ii) the breakdown of fund recipients by race, gender, age range, geographic region and income level; (iii) a list of all prescription drugs that were covered by money from the fund; and (iv) the total cost savings received by all fund recipients and the cost savings broken down by race, gender, age range and income level. The report shall be submitted to the clerks of the senate and house of representatives, senate and house committees on ways and means and the joint committee on health care financing; provided, however, that annually, not later than March 1, the report shall be published on the website of the executive office of health and human services.

(c) The secretary shall promulgate regulations for the expenditure of the funds under this section.”; and

By inserting after section 30 the following section:-

SECTION 30A. Said chapter 111 is hereby further amended by adding the following section:-

Section 249. (a) The department shall establish and administer a prescription drug cost assistance program, which shall be funded by the Prescription Drug Cost Assistance Trust Fund established in section 2KKKKKK of chapter 29. The program shall provide financial assistance for prescription drugs used to treat: (i) chronic respiratory conditions, including, but not limited to, chronic obstructive pulmonary disease and asthma; (ii) chronic heart conditions, including, but not limited to, those heart conditions that disproportionately impact a particular demographic group; (iii) diabetes; and (iv) any other chronic condition identified by the department that disproportionately impacts a particular demographic group; provided, however, that “prescription drug” shall include the prescription drug and any drug delivery device needed to administer the drug that is not included as part of the underlying drug prescription. Financial assistance shall cover the cost of any copayment, coinsurance and deductible for the prescription drug for an individual who is eligible for the program.

(b) An individual shall be eligible for the program if the individual: (i) is a resident of the commonwealth; (ii) has a current prescription from a health care provider for a drug that is used to treat a chronic condition listed in subsection (a); (iii) has a family income of not more than 500 per cent of the federal poverty level; and (iv) is not enrolled in MassHealth.

(c) The department shall create an application process, which shall be available electronically and in hard copy form, to determine whether an individual meets the program eligibility requirements under subsection (b). The department shall determine an applicant’s eligibility and notify the applicant of the department’s determination within 10 business days of receiving the application. If necessary for its determination, the department may request additional information from the applicant; provided, however, that the department shall notify the applicant within 5 business days of receipt of the original application as to what specific additional information is being requested. If additional information is requested, the department shall, within 3 business days of receipt of the additional information, determine the applicant’s eligibility and notify said applicant of the department’s determination.

If the department determines that an applicant is not eligible for the program, the department shall notify the applicant and shall include in said notification the specific reasons why the applicant is not eligible. The applicant may appeal this determination to the department within 30 days of receiving such notification.

If the department determines that an applicant is eligible for the program, the department shall provide the applicant with a prescription drug cost assistance program identification card, which shall indicate the applicant’s eligibility; provided, however, that the program identification card shall include, but not be limited to, the applicant’s full name and the full name of the prescription drug that the applicant is eligible to receive under the program without having to pay a co-payment, co-insurance or deductible. An applicant’s program identification card shall be valid for 12 months and shall be renewable upon a redetermination of program eligibility.

(d) An individual with a valid program identification card may present such card at any pharmacy in the commonwealth and, upon presentation of such card, the pharmacy shall fill the individual’s prescription and provide the prescribed drug to the individual without requiring the individual to pay a co-payment, co-insurance or deductible; provided, however, that the pharmacy shall be reimbursed by the Prescription Drug Cost Assistance Trust Fund established in section 2KKKKKK of chapter 29 in a manner determined by the department, in an amount equal to what the pharmacy would have received had the individual been required to pay a co-payment, co-insurance or deductible.

(e) The department, in collaboration with the division of insurance, board of registration in pharmacy and stakeholders representing consumers, pharmacists, providers, hospitals and carriers, shall develop and implement a plan to educate consumers, pharmacists, providers, hospitals and carriers regarding eligibility for and enrollment in the program under this section. The plan shall include, but not be limited to, appropriate staff training, notices provided to consumers at pharmacies and a designated website with information for consumers, pharmacists and other health care professionals.

(f) The department shall compile a report detailing information about the program from the previous calendar year. The report shall include: (i) the number of applications received, approved, denied and appealed; (ii) the total number of applicants approved and the number of applicants approved delineated by race, gender, age range and income level; (iii) a list of all prescription drugs that qualify for the program under subsection (b) and a list of prescription drugs for which applicants actually received financial assistance; and (iv) the total cost savings received by all approved applicants and the cost savings delineated by race, gender, age range and income level. The report shall be submitted annually, not later than March 1, to the clerks of the senate and house of representatives, the house and senate committees on ways and means and the joint committee on health care financing; provided, however, that annually, not later than March 1, the report shall be published on the website of the department.

(g) The department shall promulgate regulations for the implementation and enforcement of this section.”; and

By inserting after section 85 the following 3 sections:-

“SECTION 85A. The health policy commission shall consult with relevant stakeholders, including, but not limited to, consumers, consumer advocacy organizations, organizations representing people with disabilities and chronic health conditions, providers, provider organizations, payers, pharmaceutical manufacturers, pharmacy benefit managers and health care economists and other academics, to assist in the development and periodic review of regulations to implement section 24 of chapter 6D of the General Laws, including, but not limited to: (i) establishing the criteria and processes for identifying the proposed value of an eligible drug as defined in said section 24 of said chapter 6D; and (ii) determining the appropriate price increase for a public health essential drug as described within the definition of eligible drug in said section 24 of said chapter 6D.

The commission shall hold its first public outreach pursuant to this section not more than 45 days after the effective date of this act and shall, to the extent possible, ensure fair representation and input from a diverse array of stakeholders.

SECTION 85B. Notwithstanding subsection (b) of section 15A of chapter 6D of the General Laws, for the purposes of providing an initial early notice under said section 15A of said chapter 6D, the health policy commission shall determine a significant price increase for a generic drug to be defined as a generic drug priced at $100 or more per wholesale acquisition cost unit that increases in cost by 100 per cent or more during any 12-month period.

SECTION 85C. Section 85B is hereby repealed.”; and

By inserting after section 89 the following section:-

“SECTION 89A. Section 85C shall take effect on January 1, 2027.".