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Eliminating Restriction and Barriers to Health Care Access and Maintaining Independent Oversight

Arce (PR) Introduced Nov. 19 Annual Meeting (Ratified)

Short Title: Patient Protections

WHEREAS, the National Hispanic Caucus Of States Legislators (NHCSL) was founded in 1989 as nonpartisan with the mission of serve as a catalyst for joint action on issues of common concern, such as housing, immigration, education and healthcare, to all segments of the Hispanics communities; and

WHEREAS, the National Hispanic Caucus Of States Legislators has the vision to promote effective, equal and culturally appropriate access to healthcare for all, including American people and all other minorities; and

WHEREAS, limitations to treatment, restrictions and barriers to the access and disruption of continuity of health care can result in detrimental life threatening consequences to the individuals who are the most vulnerable and can result in more medical complications and higher health care costs; and

WHEREAS, scientific research shows there are gender, racial and ethnic differences in responses to treatments and limiting access further widens already existing health disparities; and

\WHEREAS, access to health care includes meaningful access to all medications in order to maintain consistent disease management and continuity of care, regardless of provider; and

WHEREAS, many states, in an effort to cut short-term health care costs, have considered or instigated programs allowing the development and management of a Medicaid formulary or preferred drug list without independent oversight; and

WHEREAS, the Medicaid system, which disproportionally serves people of color, should not establish additional obstacles which might limit access to vital life-saving medications, resulting in disruption of continuity of care and increasing the long-term costs of Medicaid by increasing the number of unnecessary hospitalizations and emergency room visits; and

WHEREAS, basing decisions for inclusion on a formulary or preferred drug list based on cost rather than clinical considerations, ignores important variations that can exist among patients in terms of safety, efficacy and tolerability in drug classes; and

WHEREAS, the National Hispanic Caucus of State Legislators (NHCSL) is made up of 300 Hispanics States Legislators from all states, commonwealths and territories of the United States and is organized to provide a forum for discussion, education and increased communication.

WHEREAS, the NHCSL identifies and proposes legislation and administrative actions to eliminate barriers to achievement of a better quality of life for Hispanics; and
WHEREAS, establishing administrative restrictions and barriers, such as prior authorization requirements can discourage health professionals from prescribing the most appropriate medication for their patients, thus delaying access to care, exacerbating existing heath disparities and increasing costs.

NOW, THEREFORE BE IT RESOLVED THAT, the National Hispanic Caucus of State Legislators asks that states choosing to rely upon a formulary or preferred drug list establish an independent, accountable, committee made up of independent individuals with appropriate clinical experience to develop and manage the program in a manner that institutionalizes basic patient protections and ensures that prescribers maintain necessary discretion with regard to which medications are best for their patients; and

BE IT FURTHER RESOLVED, that to accomplish this goal effectively, the National Hispanic Caucus of State Legislators recommends the following provisions be added at the appropriate place in each state’s Medicaid statute:

Rebates Negotiated by Managed Care Organizations. A managed care organization may not negotiate or obtain a rebate with respect to a product for which the state (or applicable state agency) has negotiated or obtained a supplemental rebate;
Formulary Requirements. Formularies shall comply with the following requirements:
A plan’s drug formulary shall provide coverage for all products where a Medicaid rebate is provided.
A plan’s drug formulary shall include coverage that is no more restrictive than the state’s Medicaid preferred drug list in terms of access to covered drugs. A plan’s drug formulary shall provide coverage in categories and classes for all medical conditions and shall provide a broad range of therapeutic options for all therapeutic categories.
Pharmacy and Therapeutics Committee. Standards shall be developed to assure that a Medicaid managed care plan’s formulary is developed and reviewed by an independent pharmacy and therapeutics committee (P&T) that meets the following requirements:
Formulary development shall be conducted pursuant to a transparent process, such as state open meeting rules.
Not less than 30 days prior to a meeting, the P&T Committee shall post to the appropriate state website: (i) the meeting agenda, (ii) a list of the drug classes to be considered at the meeting; and (iii) background materials and supporting documentation provided to committee members with respect to drugs and drug classes that are before the committee for review.
The P&T Committee shall provide appropriate opportunity for public testimony at each regularly scheduled committee meeting. Prior to deliberating on any recommendations regarding a drug or a class of drugs, the committee shall accept testimony, in writing or in person, that is offered by a manufacturer of those drugs or another interested party.
The P&T Committee shall post its recommendations to an appropriate state website not later than 30 days after the Committee approves the recommendations.
A majority of P&T Committee members shall be state licensed practicing physicians, practicing pharmacists, or both.
The P&T Committee members shall represent various clinical specialties and specialists with expertise in a specific therapeutic area shall participate in formulary decisions regarding each therapeutic area.
The P&T Committee shall meet no less frequently than on a quarterly basis.
The P&T Committee shall base its clinical decisions on the strength of scientific evidence, standards of practice, and nationally accepted treatment guidelines.
The P&T committee shall review formulary management tools, such as prior authorization, step therapy, quantity limitations, generic substitutions, and other drug utilization and management tools for clinical appropriateness (and consistency with industry standards as well as appropriate guidelines from expert patient and provider organizations).
Criteria related to Prior Authorization/Step-Therapy/Fail-First.
A managed care plan shall provide a response within 24 hours of receipt of all necessary information for a request for prior authorization.
If a medicine requires prior authorization, the pharmacist or physician shall be reimbursed for dispensing a 72-hour supply to a Medicaid beneficiary.
A uniform form shall be established, electronic as soon as practicable, for plans to provide physicians seeking authorization for a covered drug, including a uniform, streamlined, convenient process to expeditiously request an override from the insurer of any restriction.
An override of a restriction shall be expeditiously granted by the insurer if: (i) the prescribing practitioner can demonstrate, based on sound clinical evidence, that the preferred treatment required under step therapy or fail first has been ineffective in the treatment of the insured’s disease or medical condition; or (ii) based on sound clinical evidence or medical and scientific evidence the prescribing physician can demonstrate that the preferred treatment required under the step therapy or fail first protocol is expected or likely to be ineffective based on the known relevant physical or mental characteristics of the insured and known characteristics of the drug regimen; or (iii) the prescribing practitioner can demonstrate that the preferred treatment required under the step therapy or fail-first protocol will cause or will likely cause an adverse reaction or other physical harm to the insured.
The prescriber’s recommendation shall ultimately prevail if the prescriber certifies the drug is medically necessary.
Coverage Determination Decisions:
Coverage for any newly approved FDA product shall be made within 180 days of the product’s market entry.
Product selection:
Where the prescriber has indicated on the face of the prescription “dispense as written” [or other notation set forth by state law], or other appropriate form for electronic prescriptions.
The pharmacy shall not substitute another drug without explicit written permission of the prescriber, and
Notwithstanding any other provision of law, the pharmacy shall receive payment for a drug dispensed pursuant to a “dispense as written” order without seeking prior authorization of the state or any benefit administrator, and without telephone or other confirmation that the physician does not wish to substitute another medication; and;
The Department of Health shall be required to prepare a report on Medicaid Managed Care that must be submitted to the Governor and Legislature, that will:
Provide an analysis on Medicaid Patient access to prescription drugs.
Provide an evaluation of any barriers to prescription drugs.
Provide details of the impact of the managed care expansion on utilization of prescription drugs.
Provide details of prior authorization and other utilization tools.
BE IT FURTHER RESOLVED, that states must consider and account for the impact on patient access to health care by evaluating restrictions and barriers to services, the impact on utilization of services, and the use of prior authorization and other management tools, to ensure that existing health disparities are not exacerbated by any efforts to control short term costs by the use of a prescription drug formulary.


Sponsored By: Senator Luz Z. Arce Ferrer (PR)
Co-sponsored By: Senator Iris Y. Martinez (IL)
Hon. Felix W. Ortiz (NY)