D.C. Law 21-248. Specialty Drug Copayment Limitation Act of 2016.
To impose a limit on the amount that a person must pay in copayment or coinsurance through a health benefit plan for a prescription for a specialty drug.
BE IT ENACTED BY THE COUNCIL OF THE DISTRICT OF COLUMBIA, That thisact may be cited as the "Specialty Drug Copayment Limitation Act of 2016".
Sec. 2. Definitions.
For the purposes of
(1) "Class of drugs" means a group of medications having similar actions designed to treat a particular disease process.
(2) "Coinsurance" means a cost-sharing amount set as a percentage of the total cost of a drug.
(3) "Copayment" means a cost-sharing amount set as a dollar value.
(4)(A) "Health benefit plan" means a policy, contract, certificate, or agreement offered or issued by a health carrier to provide, deliver, arrange for, pay for, or reimburse any of the costs of health care services.
(B) The term "health benefit plan" does not include:
(i) Coverage only for accident or disability income insurance, or any combination thereof;
(ii) Liability insurance, including general liability insurance and automobile liability insurance;
(iii) Coverage issued as a supplement to liability insurance;
(iv) Workers' compensation or similar insurance;
(v) Automobile medical payment insurance;
(vi) Credit-only insurance;
(vii) Coverage for on-site medical clinics; or
(viii) Other similar insurance coverage specified in federal regulations issued pursuant to the Health Insurance Portability and Accountability Act of 1996, approved August 21, 1996 (110 Stat. 1936; scattered sections of the United States Code) ("HIPAA"), under which benefits for health care services are secondary or incidental to other insurance benefits.
(C) The term "health benefit plan" does not include the following benefits if they are provided under a separate policy, certificate of insurance, or contract of insurance, or are otherwise not an integral part of the plan:
(i) Limited scope dental or vision benefits;
(ii) Benefits for long-term care, nursing-home care, home-health care, community-based care, or any combination thereof; or
(iii) Other similar, limited benefits specified in federal regulations issued pursuant to HIPAA.
(D) The term "health benefit plan" does not include the following benefits if the benefits are provided under a separate policy, certificate of insurance, or contract of insurance, and there is no coordination between the provision of the benefits and any exclusion of benefits under any group health plan maintained by the same health insurer, and the benefits are paid with respect to an event without regard to whether benefits are provided with respect to such an event under any group health plan maintained by the same health insurer:
(i) Coverage only for a specified disease or illness; or
(ii) Hospital indemnity or other fixed indemnity insurance.
(E) The term "health benefit plan" does not include the following if offered as a separate policy, certificate of insurance, or contract of insurance:
(i) A Medicare supplemental policy as defined in section 1882(g)(1) of the Social Security Act, approved June 9, 1980 (94 Stat. 476; 42 U.S.C. § 1395ss(g)(1));
(ii) Coverage supplemental to the coverage provided under An Act To amend titles 10, 14, and 32, United States Code, to codify recent military law, and to improve the Code, approved September 2, 1958 (72 Stat. 1437; 10 U.S.C. § 1071 et seq.); or
(iii) Similar supplemental coverage provided under a group health plan.
(5) "Health insurer" means any person that provides one or more health benefit plans or insurance in the District of Columbia, including an insurer, a hospital and medical services corporation, a fraternal benefit society, a health maintenance organization, a multiple employer welfare arrangement, or any other person providing a plan of health insurance subject to the authority of the Commissioner of the Department of Insurance, Securities and Banking.
(6) "Member" means an individual who is enrolled in a health benefit plan.
(7) "Member representative" means a:
(A) Person acting on behalf of a member with the member's consent;
(B) Person authorized by law to provide substituted consent for a member;
(C) Family member of the member;
(D) Member's treating health care professional when the member is unable to provide consent; or
(E) In the case of a request regarding an emergency or urgent medical condition, a health-care professional with knowledge of the member's medical condition.
(8) "Non-preferred drug" means a specialty drug formulary classification for certain specialty drugs that are subject to limits on eligibility for coverage or to higher cost-sharing amounts than preferred specialty drugs.
(9) "Preferred drug" means a specialty drug formulary classification for certain specialty drugs that are not subject to limits on eligibility for coverage or to higher cost-sharing amounts than a non-preferred drug.
(10) "Specialty drug" means a prescription drug that:
(A) Is prescribed for a person with:
(i) A physical, behavioral, or developmental condition that may have no known cure, is progressive, or can be debilitating or fatal if left untreated or undertreated, such as multiple sclerosis, hepatitis C, or rheumatoid arthritis; or
(ii) A disease or condition that affects fewer than 200,000 persons in the United States or approximately one in 1,500 persons worldwide, such as cystic fibrosis, hemophilia, or multiple myeloma;
(B) Has a total monthly prescription cost of $600 or more; and
(C) Has one or more of the following characteristics:
(i) Is an oral, injectable, or infusible drug product or a drug product that is delivered topically, through inhalation, implantation, or transmucosally;
(ii) Requires unique storage or shipment, such as refrigeration; or
(iii) Requires patient education and support beyond traditional dispensing activities.
(11) "Specialty tier" means a tier of cost sharing designed for select specialty drugs that imposes a cost-sharing obligation that is based on a coinsurance or copayment and exceeds that amount for non-specialty drugs.
(12) "Step therapy" means a protocol established by a health insurer that requires a prescription drug or sequence of prescription drugs to be used by an insured or an enrollee before a prescription drug ordered by a prescriber for the insured or the enrollee is covered.
(13) "Tiered formulary" means a formulary that provides coverage for prescription drugs as part of a health benefit plan for which cost-sharing, deductibles, or coinsurance is determined by category or tier of prescription drugs, and that includes at least 2 different tiers.
Sec. 3. Specialty drug copayment or coinsurance limitation.
(a)(1) A health benefit plan that provides coverage for prescription drugs shall ensure that a required copayment or coinsurance applicable to a drug on a specialty tier does not exceed $150 per month for up to a 30-day supply of the specialty drug or $300 for a 90-day supply.
(2) On July 1 of each year, the limit on a required copayment or coinsurance applicable to a drug on a specialty tier provided in paragraph (1) of this subsection shall increase by a percentage equal to the percentage change from the preceding year in the medical care component of the March Consumer Price Index for All Urban Consumers, Washington-Baltimore metropolitan area, as published by the Bureau of Labor Statistics of the United States Department of Labor.
(b)(1) For a health benefit plan that provides coverage for prescription drugs and utilizes a tiered formulary, a member or member representative shall have the right to request that a non-preferred drug be covered under the cost sharing applicable for preferred drugs if the prescribing physician determines that the preferred drug for treatment of the same condition either would not be as effective for the individual or would have adverse effects for the individual, or both.
(2) The denial of a request made pursuant to paragraph (1) of this subsection shall be considered an adverse event and shall be subject to the health benefit plan's internal review process.
(c) A health benefit plan that provides coverage for prescription drugs shall not place all drugs in a given class of drugs on a specialty tier.
(d) Nothing in this section shall be construed to require a health benefit plan to:
(1) Provide coverage for any additional drugs not otherwise required by law;
(2) Implement specific utilization management techniques, such as prior authorization or step therapy; or
(3) Cease the use of tiered cost-sharing structures, including strategies used to incentivize use of preventive services, disease management, and low-cost treatment options.
(e) Nothing in this section shall be construed to require a pharmacist to substitute a drug without the consent of the prescribing physician.
(f) A health insurer shall not be precluded from requiring specialty drugs to be obtained through a designated pharmacy or other source of specialty drugs.
Sec. 4. Applicability.
Sec. 5. Fiscal impact statement.
The Council adopts the fiscal impact statement in the committee report as the fiscal impact statement required by section 4a of the General Legislative Procedures Act of 1975, approved October 16, 2006 (120 Stat. 2038; D.C. Official Code § 1-301.47a).
Sec. 6. Effective date.
This act shall take effect following approval by the Mayor (or in the event of veto by the Mayor, action by the Council to override the veto), a 30-day period of congressional review as provided in section 602(c)(1) of the District of Columbia Home Rule Act, approved December 24, 1973 (87 Stat. 813; D.C. Official Code § 1-206.02(c)(1)), and publication in the District of Columbia Register.