(d) Notwithstanding any inconsistent provision of law, if a manufacturer (as defined under section 1927 of the federal social security act) has entered into a rebate agreement with the department or with the federal secretary of health and human services on behalf of the department under section 1927 of the federal social security act, the department shall reimburse for covered outpatient drugs which are dispensed under the medical assistance program to all persons in receipt of medical assistance benefits as a result of their eligibility having been established under subparagraph one or nine of paragraph (a) of subdivision one of section three hundred sixty-six of this title, and which are dispensed to all persons eligible for health care services as a result of their eligibility having been established under subdivision two of section three hundred sixty-nine-ee of this article, only pursuant to the terms of the rebate agreement between the department and such manufacturer; provided, however, that any agreement between the department and a manufacturer entered into before August first, nineteen hundred ninety-one, shall be deemed to have been entered into on April first, nineteen hundred ninety-one; and provided further, that if a manufacturer has not entered into an agreement with the department before August first, nineteen hundred ninety-one, such agreement shall not be effective until April first, nineteen hundred ninety-two, unless such agreement provides that rebates will be retroactively calculated as if the agreement had been in effect on April first, nineteen hundred ninety-one. The rebate agreement between such manufacturer and the department shall utilize for single source drugs and innovator multiple source drugs the identical formula used to determine the basic rebate for federal financial participation single source drugs and innovator multiple source drugs, pursuant to paragraph one of subdivision (c) of section 1927 of the federal social security act, to determine the amount of the rebate pursuant to this paragraph. The rebate agreement between such manufacturer and the department shall utilize for non-innovator multiple source drugs the identical formula used to determine the basic rebate for federal financial participation non-innovator multiple source drugs, pursuant to paragraphs three and four of subdivision (c) of section 1927 of the federal social security act, to determine the amount of the rebate pursuant to this paragraph. The terms and conditions of such rebate agreement with respect to periodic payment of the rebate, provision of information by the department, audits, manufacturer provision of information verification of surveys, penalties, confidentiality of information, and length of the agreement shall apply to drugs of the manufacturer dispensed under the medical assistance program to all persons in receipt of medical assistance benefits as a result of their eligibility having been established under subparagraph one or nine of paragraph (a) of subdivision one of section three hundred sixty-six of this title, and which are dispensed to all persons eligible for health care services as a result of their eligibility having been established under subdivision two of section three hundred sixty-nine-ee of this article. The department in providing utilization data to a manufacturer (as provided for under section 1927.4(b)(1)(A) of the federal social security act) shall provide such data by zip code, if requested, for drugs covered under a rebate agreement. * (e) During the period from April first, two thousand fifteen through March thirty-first, two thousand twenty, the commissioner may, in lieu of a managed care provider, negotiate directly and enter into an agreement with a pharmaceutical manufacturer for the provision of supplemental rebates relating to pharmaceutical utilization by enrollees of managed care providers pursuant to section three hundred sixty-four-j of this title and may also negotiate directly and enter into such an agreement relating to pharmaceutical utilization by medical assistance recipients not so enrolled. Such rebates shall be limited to drug utilization in the following classes: antiretrovirals approved by the FDA for the treatment of HIV/AIDS and hepatitis C agents for which the pharmaceutical manufacturer has in effect a rebate agreement with the federal secretary of health and human services pursuant to 42 U.S.C. § 1396r-8, and for which the state has established standard clinical criteria. No agreement entered into pursuant to this paragraph shall have an initial term or be extended beyond the expiration or repeal of this paragraph.
- (i) The manufacturer shall not pay supplemental rebates to a managed care provider, or any of a managed care provider's agents, including but not limited to any pharmacy benefit manager on the two classes of drugs subject to this paragraph when the state is collecting supplemental rebates and standard clinical criteria are imposed on the managed care provider.
- (ii) The commissioner shall establish adequate rates of reimbursement which shall take into account both the impact of the commissioner negotiating such rebates and any limitations imposed on the managed care provider's ability to establish clinical criteria relating to the utilization of such drugs. In developing the managed care provider's reimbursement rate, the commissioner shall identify the amount of reimbursement for such drugs as a separate and distinct component from the reimbursement otherwise made for prescription drugs as prescribed by this section.
- (iii) The commissioner shall submit a report to the temporary president of the senate and the speaker of the assembly annually by December thirty-first. The report shall analyze the adequacy of rates to managed care providers for drug expenditures related to the classes under this paragraph.
- (iv) Nothing in this paragraph shall be construed to require a pharmaceutical manufacturer to enter into a supplemental rebate agreement with the commissioner relating to pharmaceutical utilization by enrollees of managed care providers pursuant to section three hundred sixty-four-j of this title or relating to pharmaceutical utilization by medical assistance recipients not so enrolled.
- (v) All clinical criteria, including requirements for prior approval, and all utilization review determinations established by the state as described in this paragraph for either of the drug classes subject to this paragraph shall be developed using evidence-based and peer-reviewed clinical review criteria in accordance with article two-A of the public health law, as applicable.
- (vi) All prior authorization and utilization review determinations related to the coverage of any drug subject to this paragraph shall be subject to article forty-nine of the public health law, section three hundred sixty-four-j of this title, and article forty-nine of the insurance law, as applicable. Nothing in this paragraph shall diminish any rights relating to access, prior authorization, or appeal relating to any drug class or drug afforded to a recipient under any other provision of law. * NB Repealed March 31, 2023 * (f) (1) The department may require manufacturers of drugs other than single source drugs and innovator multiple source drugs, as such terms are defined in 42 U.S.C. § 1396r-8(k), to provide rebates to the department for any drug that has increased more than three hundred percent of its state maximum acquisition cost (SMAC) during the period April 1, 2016 through March thirty-first, two thousand seventeen, or that has increased more than seventy-five percent of its SMAC on or after April first, two thousand seventeen, in comparison to its SMAC at any time during the course of the preceding twelve months. The required rebate shall be limited to the amount by which the current SMAC for the drug exceeds the applicable percentage of the SMAC for the same drug at any time during the course of the preceding twelve months. Such rebates shall be in addition to any rebates payable to the department pursuant to any other provision of federal or state law. Nothing herein shall affect the department's obligation to reimburse for covered outpatient drugs pursuant to paragraph (d) of this subdivision.
- (2) Except as provided in subparagraph three of this paragraph, the commissioner shall not determine any further rebates to be payable pursuant to this paragraph once the Centers for Medicare and Medicaid Services has adopted a final methodology for determining the amount of additional rebates under the federal generic drug price increase rebate program pursuant to 42 U.S.C. § 1396r-8 (c)(3), as amended by section 602 of the Bipartisan Budget Act of 2015.
- (3) During state fiscal year 2016-2017, if the Centers for Medicare and Medicaid Services has adopted a final methodology for determining the amount of additional rebates under the federal generic drug price increase rebate program pursuant to 42 U.S.C. § 1396r-8 (c)(3), as amended by section 602 of the Bipartisan Budget Act of 2015, the department may collect for a given drug the portion of the rebate determined under this paragraph that is in excess of the rebate required by such federal rebate program.
- (4) The additional rebates authorized pursuant to this paragraph shall apply to generic prescription drugs dispensed to enrollees of managed care providers pursuant to section three hundred sixty-four-j of this title and to generic prescription drugs dispensed to Medicaid recipients who are not enrollees of such providers.
- (5) Beginning in two thousand seventeen, the department shall provide an annual report to the legislature no later than February first setting forth:
- (i) The number of drugs that exceeded the ceiling price established in this paragraph during the preceding year in comparison to the number of drugs that experienced at least a three hundred percent price increase during two thousand fourteen and two thousand fifteen, or at least a seventy-five percent price increase during two thousand fifteen and two thousand sixteen;
- (ii) The average percent amount above the ceiling price of drugs that exceeded the ceiling price in the preceding year in comparison to the number of drugs that experienced a price increase more than three hundred percent during two thousand fourteen and two thousand fifteen, or at least a seventy-five percent price increase during two thousand fifteen and two thousand sixteen;
- (iii) The number of generic drugs available to enrollees in Medicaid fee for service or Medicaid managed care, by fiscal quarter, in the preceding year in comparison to the drugs available, by fiscal quarter, during two thousand fourteen, two thousand fifteen, and two thousand sixteen; and
- (iv) The total drug spend on generic drugs for the preceding year in comparison to the total drug spend on generic drugs during two thousand fourteen, two thousand fifteen, and two thousand sixteen. * NB Repealed March 31, 2020 * 8. No government agency shall purchase, pay for, or make reimbursement or grants-in-aid for any service in a residential treatment facility for children and youth or a comprehensive psychiatric emergency program unless at the time such service was provided, the residential treatment facility for children and youth or comprehensive psychiatric emergency program possessed a valid operating certificate authorizing such service. Notwithstanding any inconsistent provision of law, no government agency shall make payments pursuant to this title or title nineteen of the federal social security act to a residential treatment facility for children and youth for service to a person whose need for care and treatment in such a facility was not certified pursuant to section 9.51 of the mental hygiene law. * NB Effective until July 1, 2020 * 8. No government agency shall purchase, pay for, or make reimbursement or grants-in-aid for any service in a residential treatment facility for children and youth unless at the time such service was provided, the residential treatment facility for children and youth possessed a valid operating certificate authorizing such service. Notwithstanding any inconsistent provision of law, no government agency shall make payments pursuant to this title or title nineteen of the federal social security act to a residential treatment facility for children and youth for service to a person whose need for care and treatment in such a facility was not certified pursuant to section 9.51 of the mental hygiene law. * NB Effective July 1, 2020 * 9. Notwithstanding any inconsistent provision of law or regulation to the contrary, for those drugs which may not be dispensed without a prescription as required by section sixty-eight hundred ten of the education law and for which payment is authorized pursuant to paragraph (g) of subdivision two of section three hundred sixty-five-a of this title, and for those drugs that are available without a prescription as required by section sixty-eight hundred ten of the education law but are reimbursed as items of medical assistance pursuant to paragraph (a) of subdivision four of section three hundred sixty-five-a of this title, payments under this title shall be made at the following amounts:
- (a) for drugs provided by medical practitioners and claimed separately by the practitioners, the actual cost of the drugs to the practitioners; and
(b) for drugs dispensed by pharmacies:
(i)
- (A) if the drug dispensed is a generic prescription drug, the lower of: (1) an amount equal to the national average drug acquisition cost set by the federal centers for medicare and medicaid services for the drug, if any, or if such amount if not available, the wholesale acquisition cost of the drug based on the package size dispensed from, as reported by the prescription drug pricing service used by the department, less seventeen and one-half percent thereof; (2) the federal upper limit, if any, established by the federal centers for medicare and medicaid services; (3) the state maximum acquisition cost, if any, established pursuant to paragraph (e) of this subdivision; or (4) the dispensing pharmacy's usual and customary price charged to the general public; (B) if the drug dispensed is available without a prescription as required by section sixty-eight hundred ten of the education law but is reimbursed as an item of medical assistance pursuant to paragraph (a) of subdivision four of section three hundred sixty-five-a of this title, the lower of (1) an amount equal to the national average drug acquisition cost set by the federal centers for medicare and medicaid services for the drug, if any, or if such amount is not available, the wholesale acquisition cost of the drug based on the package size dispensed from, as reported by the prescription drug pricing service used by the department, (2) the federal upper limit, if any, established by the federal centers for medicare and medicaid services; (3) the state maximum acquisition cost if any, established pursuant to paragraph (e) of this subdivision; or (4) the dispensing pharmacy's usual and customary price charged to the general public;
(ii) if the drug dispensed is a brand-name prescription drug, the lower of:
- (A) an amount equal to the national average drug acquisition cost set by the federal centers for medicare and medicaid services for the drug, if any, or if such amount is not available, the wholesale acquisition cost of the drug based on the package size dispensed from, as reported by the prescription drug pricing service used by the department, less three and three-tenths percent thereof; or (B) the dispensing pharmacy's usual and customary price charged to the general public; and
- (iii) notwithstanding subparagraphs (i) and (ii) of this paragraph and paragraphs (d) and (e) of this subdivision, if the drug dispensed is a drug that has been purchased from a manufacturer by a covered entity pursuant to section 340B of the federal public health service act (42 USCA § 256b), the actual amount paid by such covered entity pursuant to such section, plus the reasonable administrative costs, as determined by the commissioner, incurred by the covered entity or by an authorized contract pharmacy in connection with the purchase and dispensing of such drug and the tracking of such transactions. For purposes of this subparagraph, a "covered entity" is an entity that meets the requirements of paragraph four of subsection (a) of such section, that elects to participate in the program established by such section, and that causes claims for payment for drugs covered by this subparagraph to be submitted to the medical assistance program, either directly or through an authorized contract pharmacy. No medical assistance payments may be made to a covered entity or to an authorized contract pharmacy of a covered entity for drugs that are eligible for purchase under the section 340B program and are dispensed on an outpatient basis to patients of the covered entity, other than under the provisions of this subparagraph. Pharmacies submitting claims for reimbursement of drugs purchased pursuant to section 340B of the public health service act shall notify the department that the claim is eligible for purchase under the 340B program, consistent with claiming instructions issued by the department to identify such claims.
- (c) Notwithstanding subparagraph (i) of paragraph (b) of this subdivision, if a qualified prescriber certifies "brand medically necessary" or "brand necessary" in his or her own handwriting directly on the face of a prescription for a multiple source drug for which a specific upper limit of reimbursement has been established by the federal agency, in addition to writing "d a w" in the box provided for such purpose on the prescription form, payment under this title for such drug must be made under the provisions of subparagraph (ii) of such paragraph.
- (d) In addition to the amounts paid pursuant to paragraph (b) of this subdivision, the department shall pay a professional pharmacy dispensing fee for each such drug dispensed in the amount of ten dollars and eight cents per prescription or written order of a practitioner; provided, however that this professional dispensing fee will not apply to drugs that are available without a prescription as required by section sixty-eight hundred ten of the education law but do not meet the definition of a covered outpatient drug pursuant to Section 1927K of the Social Security Act.
- (e) For a multiple source generic drug for which no specific upper payment limit has been established by the federal centers for medicare and medicaid services, the commissioner of health may establish a maximum acquisition cost for such drug which shall be effective until such time as a specific federal upper payment limit has been established for such drug. The department shall use a similar methodology in establishing such an interim price as that utilized by the centers for medicare and Medicaid services in establishing the federal upper payment limit. For this purpose, the department is authorized to enter into a contract with an entity to provide technical and administrative support to the commissioner of health.
- (g) Notwithstanding any other provision of this subdivision to the contrary, the department is authorized to implement a specialty pharmacy program for the purpose of procuring certain specialty drugs at reduced cost. The department is authorized to enter into contracts with one or more contractors in order to obtain certain specialty drugs from a limited number of sources at reduced prices. For purposes of this paragraph, specialty drugs include, but are not limited to, chemotherapy agents, hydration therapy agents, pain therapy agents, intravenous administration of antibiotics or other drugs, and total parenteral nutrition. All contracts entered into by the department to effectuate the provisions of this section shall require the contractors to take steps to assure that drugs provided pursuant to such contracts will be readily accessible to consumers in a fashion that is no more restrictive than that which was in effect prior to the implementation of the specialty pharmacy program. This paragraph shall be effective only to the extent that federal financial participation is available in the cost of drugs obtained pursuant to this paragraph. The commissioner of health is authorized to submit amendments to the state plan for medical assistance and to submit applications for waivers under the social security act to obtain the federal approvals necessary to implement this paragraph. However, any pharmacy owned and operated by a not-for-profit organization solely for the purpose of providing drugs to individuals diagnosed with cystic fibrosis as part of a comprehensive clinical care program approved by the national organization that accredits cystic fibrosis care centers and maintains a national registry of cystic fibrosis clinical data shall be exempt from the specialty pharmacy program.
- (h) The commissioner of health is authorized to establish a medication therapy management pilot program in one or more counties or regions of the state for the purpose of improving compliance with drug therapies and improving clinical outcomes. Payments under such program may be made to retail pharmacies for the provision of one-on-one medication regimen counseling services for persons determined by the commissioner to be eligible to receive such services. The commissioner is authorized to establish fees for such counseling services, subject to the approval of the director of the division of the budget. The provisions of this paragraph shall not take effect unless all necessary approvals under federal law and regulation have been obtained to receive federal financial participation in the costs of services provided under this paragraph. * NB Effective until March 31, 2020 * 9. Notwithstanding any inconsistent provision of law or regulation to the contrary, for those drugs which may not be dispensed without a prescription as required by section sixty-eight hundred ten of the education law and for which payment is authorized pursuant to paragraph (g) of subdivision two of section three hundred sixty-five-a of this title, payments under this title shall be made at the following amounts:
- (a) for drugs provided by medical practitioners and claimed separately by the practitioners, the actual cost of the drugs to the practitioners; and
(b) for drugs dispensed by pharmacies:
- (i) if the drug dispensed is a multiple source prescription drug for which an upper limit has been set by the federal health care financing administration, an amount equal to the specific upper limit set by such federal agency for the multiple source prescription drug, and
- (ii) if the drug dispensed is a multiple source prescription drug or a brand-name prescription drug for which no specific upper limit has been set by such federal agency, the lower of the estimated acquisition cost of such drug to pharmacies, or the dispensing pharmacy's usual and customary price charged to the general public. Estimated acquisition cost means the average wholesale price of a prescription drug based upon the package size dispensed from, as reported by the prescription drug pricing service used by the department, less ten percent thereof, and updated monthly by the department.
- (c) Notwithstanding subparagraph (i) of paragraph (b) of this subdivision, if a qualified prescriber certifies "brand medically necessary" or "brand necessary" in his or her own handwriting directly on the face of a prescription for a multiple source drug for which a specific upper limit of reimbursement has been established by the federal agency, in addition to writing "d a w" in the box provided for such purpose on the prescription form, payment under this title for such drug must be made under the provisions of subparagraph (ii) of such paragraph.
(d) In addition to the amounts paid pursuant to paragraph (b) of this subdivision to pharmacies for those drugs which may not be dispensed without a prescription, as required by section sixty-eight hundred ten of the education law and for which payment is authorized pursuant to paragraph (g) of subdivision two of section three hundred sixty-five-a of this title, the department shall pay a pharmacy dispensing fee for each such prescription drug dispensed, which dispensing fee shall not be less than the following amounts:
- (i) for prescription drugs categorized as generic by the prescription drug pricing service used by the department, five dollars and fifty cents per prescription; and
- (ii) for prescription drugs categorized as brand-name prescription drug by the prescription drug pricing service used by the department, four dollars and fifty cents per prescription. * NB Effective March 31, 2020
10. Any provider except for those providers certified under article twenty-eight of the public health law, of ordered services or supplies under the medical assistance program may be required to provide financial security to assure that funds are available to repay any overpayments made to the provider under this title and to assure the financial security of the medical assistance program. For the purposes of this subdivision, "ordered services or supplies" shall mean those services or supplies described in paragraphs (g), (i) and (j) of subdivision two of section three hundred sixty-five-a of this title.
- (a) Any financial security required by this subdivision must meet the requirements of this paragraph. Financial security may be provided through a bond with a corporate surety, from a company authorized to do business in this state, or an irrevocable letter of credit or certificate of deposit from a New York state or federally chartered bank, trust company, savings bank or savings and loan association qualified to do business in New York state and insured by the federal deposit insurance corporation.
- (b) The bond, letter of credit or certificate of deposit shall be payable in favor of the people of the state of New York for the purpose of indemnifying the medical assistance program against any overpayments made to the provider.
- (c) The bond, letter of credit or certificate of deposit filed and maintained pursuant to this section shall not be cancelled, revoked or terminated except after notice to, and with the consent of, the department at least forty-five days in advance of such cancellation, revocation or termination.
- (d) The department may bring and maintain an action against the provider and the surety or bank, trust company, savings bank or savings and loan association for any claimed overpayments made to the provider.
- (e) Financial security shall not be required for providers which do not submit claims for payment under the medical assistance program exceeding five hundred thousand dollars per annum or forty-two thousand dollars per month.
- (f) Financial security shall be in an amount equal to the provider's estimated claims for payment for a one year period and may be adjusted bi-annually in accordance with the dollar amount of claims actually submitted. If the commissioner is satisfied from an investigation of the financial condition of a provider that the provider is solvent and possessed of sufficient assets to provide reasonable assurance of recovery of any overpayments, the commissioner may modify the amount of financial security to be provided by such provider.
- (g) Financial security must be submitted by a provider upon initial application for enrollment as a provider of medical assistance and with each subsequent enrollment. A change in ownership of a provider shall not release, cancel or terminate liability under this section under any bond, letter of credit or certificate of deposit filed for a provider while such bond, letter of credit or certificate of deposit is in effect unless the transferee, purchaser, successor or assignee of such provider obtains a bond, letter of credit or certificate of deposit under this section for the benefit of such new owner. All providers enrolled in the medical assistance program on the effective date of this subdivision will be required to submit financial security within ninety days of notice of such requirements by the department.
- (h) The department may make the submission of the financial security required by this subdivision a condition of participation in the medical assistance program.
11.
- (a) Any inconsistent provisions of this title or other law notwithstanding, no health insurer, self-insured plan, managed care organization, pharmacy benefit manager, or other party that is, by statute, contract, or agreement, legally responsible for payment of a claim for a health care item or service, employer or organization who has a plan, including an employee retirement income security act or service benefit plan, providing care and other medical benefits for persons, whether by insurance or otherwise, shall exclude a person from eligibility, coverage or entitlement to medical benefits by reason of the eligibility of such person for medical assistance under this title, or by reason of the fact that such person would, except for such plan, be eligible for benefits under this title.
- (b) Any inconsistent provisions of this title or other law notwithstanding, no insurer may impose requirements on the department or a social services district which has been assigned the rights of an individual who is eligible for medical assistance under this title and who is covered for health benefits from the insurer, that are different from requirements applicable to an agent or assignee of any other individual so covered.
- (c) Any inconsistent provisions of this title or other law notwithstanding, the department may, to the extent necessary to reimburse the department and the social services districts for expenditures under this title, certify to the commissioner of taxation and finance pursuant to section one hundred seventy-one-f of the tax law amounts to be withheld from tax refunds otherwise due to any individual who is required by court order to provide medical support in the form of health insurance benefits for a child who is eligible for medical assistance under this title and who has received payment from a third-party for the cost of such services for such child but has not used such payments to reimburse either the other parent or guardian of such child or the provider of such services or the appropriate social services district; provided however, that any claims for current or past-due child support shall take priority over any such claims for the costs of such services and care. Such amounts shall be withheld pursuant to section one hundred seventy-one-f of the tax law, and shall be credited to unreimbursed medical assistance incurred on behalf of such child. The department shall by regulation establish procedures consistent with paragraphs (a) and (b) of subdivision four of section one hundred seventy-one-c of the tax law by which any individual who is the subject of a certification may contest such certification.
- 12. Prior to receiving medical assistance under subparagraphs five and six of paragraph (c) of subdivision one of section three hundred sixty-six of this title, a person whose net available income is at least one hundred fifty percent of the applicable federal income official poverty line, as defined and updated by the United States department of health and human services, must pay a monthly premium, in accordance with a procedure to be established by the commissioner. The amount of such premium shall be twenty-five dollars for an individual who is otherwise eligible for medical assistance under such subparagraphs, and fifty dollars for a couple, both of whom are otherwise eligible for medical assistance under such subparagraphs. No premium shall be required from a person whose net available income is less than one hundred fifty percent of the applicable federal income official poverty line, as defined and updated by the United States department of health and human services.