BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF DELAWARE:

Section 1. Amend Chapter Title 16, of the Delaware Code by ADDING A Chapter to read as follows:

1. Twenty-first century pharmaceuticals offer patients and physicians life saving, cost-effective medicines, vaccines, and other therapies to predict, prevent, diagnose, treat, and cure disease.
2. Because medicines often are a substitute for expensive, outmoded or invasive medical treatments, such as hospitalization and surgery, they offer a cost-effective means of allowing patients to meet medical needs while preserving or recovering an active, productive role in their community and family.
3. Access to medicines is indispensable for any twenty-first century health benefit program, whether the benefit program is designed for private sector or public sector enrollees.
4. Benefit design and care management techniques and procedures, when properly used, can improve health care outcomes and reduce overall costs, but improperly used, they can restrict individuals’ access to medically-necessary care, potentially increasing total health care costs.
5. Public sector programs that use economically-motivated coverage exclusions and improperly designed cost sharing requirements cause low-income patients to inappropriately make choices that interfere with the treatment recommendations of their doctors, which ultimately may increase the costs to the health benefits program by delaying proper treatment, as well as jeopardizing the patient’s health and well-being.
6. Switching of therapies based solely on economic motives:

1. exposes a patient whose care is already well-managed to the possibility of new side effects and adverse interactions with co-existing therapies or disease;
2. creates confusion and administrative burdens for patients and families who must accommodate different dosing schedules, routes of administration, and interactions with food and other medicines; and
3. is an inappropriate interference with provider-patient relationship.

1. Prior authorization and coverage limitations that are designed solely to use administrative hurdles to achieve economic goals:

1. impose medically inappropriate delays in the receipt of medically-necessary care in order for the health benefit program to complete its administrative processes, and by confusing or burdening patients and their families about whether or not the care prescribed by a physician is needed; and
2. result in the de facto denial of medically-necessary care prescribed by the patient’s patient’s physician.

1. A health benefit program for low-income persons or seniors should not impose barriers to access to care or burdens on patients and physicians that would not be tolerated in health benefits programs designed for the private sector.

1. ‘Acute condition’ means a symptom, condition, or disease that is expected to have a duration of two-weeks or less, or where prompt receipt of medication is needed for infection or exposure requiring antibiotics, for pain, for life-threatening symptoms.
2. ‘Covered Beneficiary’ means an individual who is enrolled to receive benefits paid for in whole or in part by the State Medicaid Program, Children’s Health Insurance Program, or a State Pharmacy Assistance Program.
3. ‘Chronic condition’ means a symptom, condition, or disease that is expected to have a duration of more than two-weeks.
4. ‘Emergency’ means a situation in which a physician indicates that delay of care exclusively to fulfill administrative requirements would be medically inappropriate, and shall include any administrative delay that results from a failure to respond to a request for authorization within the time periods required by this Act.
5. ‘Medically accepted indication’ means use of a drug for an indication that is specified in the drug’s labeling, the drug compendia, or peer-reviewed medical literature.
6. ‘Therapeutic chemical class’ means a group of pharmaceutical agents approved by the FDA that are used to treat the same spectrum of disorders with similar patient outcomes, have similar effects on all relevant drug receptors or other biological targets, and have similar tolerability throughout their clinically accepted dosing range across all relevant patient populations.
7. ‘Pharmacy Benefit Program’ means a stand-alone outpatient prescription drug benefit established by this State under Medicaid, the State Children’s Health Insurance Program, or a State Pharmacy Assistance Program that is operated in whole or in part by the State or by a contractor, administrator or fiscal agent pursuant to the State’s beneficiary cost sharing rules, coverage, prior authorization or product selection rules.

1. It is unlawful for a Pharmacy Benefit Program to request or require, directly or indirectly, as a condition of coverage for a prescription for a covered beneficiary, that a physician switch from a medication previously used for a particular indication for the covered beneficiary to another medication based primarily on economic considerations.
2. It is unlawful for a Pharmacy Benefit Program to request or require, directly or indirectly, as a condition of a covered beneficiary receiving favorable cost-sharing or administratively prompt refill or renewal of a prescription that a physician switch from a medication previously used by the patient for a particular indication to another medication based primarily on economic considerations.

1. It is unlawful for a Pharmacy Benefit Program, or its contracted benefit manger, to employ a care management technique for covered beneficiaries (including, but not limited to, implementation of a formulary, preferred drug list, treatment protocol or guideline, step therapy or other use of prior authorization) without assuring that its clinical foundation is consistent with quality patient care.
2. The assurances required for purposes of this Section include evidence of:

1. clinically-based definitions for each ‘therapeutic class’ of drugs;
2. reliance on scientific and clinical data in updating formularies, preferred drug lists, protocols or treatment guidelines; and
3. for any drug subject to prior authorization, a specific set of clinical criteria, available to physicians and patients, specifying when that drug is authorized for coverage.

1. the prior authorization system provides for a real-time receipt of requests, by voice mail, fax, or electronic transmission, on a twenty-four hour basis, seven days a week;
2. the prior authorization systems provides in-persons answers to emergency requests by physician offices or pharmacies with telephone answering queues that do not exceed ten minutes;
3. any request for authorization or approval of a drug that the prescriber indicates is for an acute condition, including infection or exposure requiring treatment with antibiotics, acute pain, or life threatening symptoms, shall be answered in no more than four hours of the time that authorization is requested by the clinician or pharmacy;
4. any request for authorization or approval of a drug that the prescriber indicates is for a chronic or non-acute condition shall be answered in no more than twenty-four hours of the time authorization is requested by clinician or pharmacy;
5. in an emergency or, with respect to an acute condition, a failure (after an initial denial) to authorize a prescribed course of therapy within the same business day in which the requests commenced, the patient shall coverage of an initial course of therapy for an acute condition, or seven days supply for a chronic condition; and
6. no prior authorization requirement shall apply to renewals or refills of a prescription authorized by the same prescriber.

1. Any formulary or preferred list of drugs that will be covered only with prior authorization shall be implemented only if established by a pharmaceutical and therapeutics committee whose membership includes a majority of practicing physicians, including specialty physicians, pharmacists, and others independent of the payer, payer’s agents, contractors, and fiscal intermediaries and who have expertise in the care of the beneficiary population served by the payer, payer’s agents, contractors, and fiscal intermediaries. The decisions of the Committee regarding any limitations to be imposed on any drug or its use for a specific indication shall be based on sound clinical evidence found in labeling, drug compendia, and peer-reviewed clinical literature pertaining to use of the drug in the relevant population. The clinical basis for decisions regarding the formulary or list of preferred drugs shall be made transparent through a written report that is publicly available. If the decision of the Committee is contrary to the clinical evidence found in labeling, drug compendia, and/or peer-reviewed literature, such decisions shall be justified in writing.
2. Notwithstanding the generic drugs that may be available in each class, a formulary is a per se unlawful denial of medically necessary patient care if it fails to provide for coverage of drugs from every therapeutic chemical class in which the FDA has approved at least one drug. When FDA has approved more than one drug in a therapeutic chemical class, a formulary or preferred drug list shall offer multiple choices of pharmaceutical or biological entities within that class. Further, the formulary shall not prefer any one therapeutic chemical class over another for treatment of a specific condition or disorder, nor shall it prefer one drug over another within a therapeutic chemical class or among different therapeutic chemical classes. This Section does not apply to those drugs or drug classes that may be restricted or excluded according to 42 U. S. C § 1396r-8.

1. A Pharmacy Benefit Program shall complete its review of a request for review of coverage within four-weeks of the date it is submitted by a patient, or provider or other person on behalf of a patient, whether orally or in writing.
2. A patient, or provider or other person on behalf of a patient, may use the hearing mechanism provided for in the State Medicaid Plan to appeal from a Pharmacy Benefit Program’s adverse decision where:

1. the time is not excluded from the benefit package available to beneficiaries under the patient’s plan, and the prescriber maintains that the coverage restriction imposed for the specific individual is a denial of medically necessary care; or
2. the Pharmacy Benefit Program or contractor, administrator or fiscal agent, fails to issue to the patient within seven days, a written confirmation of its decision regarding review of a coverage denial of an item that is not excluded from the benefit package available to beneficiaries under that patient’s plan.

1. The Pharmacy Benefit Program shall pay for a drug lawfully prescribed by a physician for a medically accepted indication throughout the pendency of an appeal of the denial of coverage for such a drug under this Section.

§ 4910A. Prohibiting Financial Incentives and Bonuses Based on Administrator’s Restricting Access to Care.

A State agency contracting for a pharmaceutical benefit management services to administer, develop, manage or implement any aspect of the Medicaid prescribed drug benefit offered under its State plan to develop a formulary or preferred drug list for such benefit shall establish the fee paid to any program contractor based on the reasonable cost of services provided. A State agency may not offer or pay directly or indirectly any material inducement, bonus or other financial incentive to a program contractor based on the denial or administrate delay of medically appropriate prescription drug therapy, or on the decreased usage of a particular drug or class of drugs, or a reduction in the proportion of beneficiaries who receive prescription drug therapy under the Medicaid program. Bonuses cannot be based on percentage cost savings of program.".