New Jersey Administrative Code
Title 11 - INSURANCE
Chapter 22 - HEALTH BENEFIT PLANS
Subchapter 5 - MINIMUM STANDARDS FOR HEALTH BENEFIT PLANS, PRESCRIPTION DRUG PLANS AND DENTAL PLANS
Section 11:22-5.9 - Prescription drug benefits
Universal Citation: NJ Admin Code 11:22-5.9
Current through Register Vol. 56, No. 24, December 18, 2024
(a) Health benefit plans and stand-alone prescription drug plans that provide benefits for prescription drugs listed on a formulary may provide higher benefits for formulary drugs than for nonformulary drugs, provided:
1. The benefit for all tiers of formulary and
nonformulary drug coverage shall result in a cost to the covered person of no
more than 50 percent of the plan's contracted cost of the drug, after
application of any deductibles, for prescription drugs provided by network
providers. For prescription drugs provided by out-of-network providers,
coinsurance shall not exceed 50 percent.
2. If a health benefit plan has a separate
deductible for prescription drugs, or a stand-alone prescription drug plan has
a deductible, such deductible shall not exceed $ 250.00 per calendar year for
all tiers of formulary drugs and $ 250.00 per year for all tiers of
nonformulary drugs; and
3. If a
health benefit plan or a stand-alone prescription drug plan has a benefit
maximum for prescription drugs, the maximum shall be the same for formulary and
nonformulary drugs.
(b) Health benefit plans and stand-alone prescription drug plans that provide prescription drug benefits through use of a formulary, shall meet the following criteria:
1. The formulary shall be developed
by a pharmacy and therapeutics committee composed of health care professionals
with recognized knowledge and expertise in clinically appropriate prescribing,
dispensing and monitoring of outpatient drugs or drug use review, evaluation
and intervention. The membership of the committee shall consist of at least
two-thirds licensed and actively practicing physicians and pharmacists, and
shall consist of at least one pharmacist. If the carrier contracts with a third
party to develop the formulary, the carrier shall be responsible for
guaranteeing that the third party complies with all requirements relating to
formularies as set forth in this subsection.
2. All drugs in a formulary shall be approved
under the Federal Food, Drug and Cosmetic Act,
21
U.S.C. §§
301 et seq.
3. The most preferred tier of a formulary,
that is, the tier with the lowest cost sharing, shall include more than one
drug used to treat each covered disease state where more than one drug is
available.
4. A drug may be
excluded from the most preferred tier of a formulary only if, based on the
compendia listed in (c)6 below, it does not have a significant, clinically
meaningful therapeutic advantage in terms of safety, effectiveness or clinical
outcome of treatment for the specific condition for which the drug is intended
over other drugs included in the formulary, and there is a written explanation
of the basis for the exclusion that is available to providers and covered
persons upon request.
5. Each
health benefit plan utilizing selective contracting arrangements that provides
benefits for formulary drugs shall also provide benefits for nonformulary
drugs. There shall be no difference in benefit level between formulary and
nonformulary drugs obtained from out-of-network providers.
6. The carrier shall establish an approval
process to enable health care providers and covered persons to obtain coverage
of nonformulary drugs at the same level as formulary drugs where the
prescribing health care provider certifies the medical necessity of the drug.
i. A nonformulary drug shall be considered
medically necessary if:
(1) It is approved
under the Federal Food, Drug and Cosmetic Act,
21
U.S.C. §§
301 et seq.; or its use
is recognized as being medically appropriate for the specific treatment for
which the drug has been prescribed in one of the following established
reference compendia: The American Hospital Formulary Service Drug Information
or the United States Pharmacopoeia - Drug Information, or it is recommended by
a clinical study or review article in a major peer-reviewed professional
journal; and
(2) The prescribing
health care provider states that all formulary drugs used to treat each disease
state have been ineffective in the treatment of the covered person's disease or
condition, or all such drugs have caused or are reasonably expected to cause
adverse or harmful reactions in the covered person.
ii. The approval process for nonformulary
drugs shall provide that the carrier respond to the prescribing health care
provider by telephone or other telecommunication device within one business day
of a request for prior authorization. Failure to respond within one business
day shall be deemed an approval of the request. Initial denials shall also be
provided to the prescribing health care provider and covered person in writing
within five business days of receipt of the request for approval of a
nonformulary drug, and shall include the clinical reason for the denial. Such
denials are appealable to the Independent Health Care Appeals Program in the
Department of Health and Senior Services pursuant to
P.L.
1997, c. 192,
§11.
7. The carrier shall publish and
distribute, at least quarterly, either its current formulary or a list of
nonformularies to network providers. Such list shall clearly indicate whether
the drugs included are formulary or nonformulary. Alternatively, the carrier
may annually distribute new formularies or a list of nonformularies, and
quarterly updates, to network providers. The current formulary or list of
nonformulary drugs shall be provided by the carrier to covered persons upon
request.
8. The contract and
evidence of coverage form shall disclose the existence of the drug formulary,
describe the approval process to obtain coverage of nonformulary drugs as
formulary drugs and describe the process to appeal a denial of a request for
approval of a nonformulary drug, including the right to appeal to the
Independent Health Care Appeals Program in the Department of Health and Senior
Services pursuant to
P.L.
1997, c. 192,
§11. The contract and
evidence of coverage form shall state that a copy of the formulary will be
provided by the carrier to a covered person upon request.
(c) Health benefit plans and stand-alone prescription drug plans may provide higher benefits for generic drugs than for brand name drugs provided:
1. The benefit for
both generic and brand name drugs must result in a cost to the covered person
of no more than 50 percent of the plan's contracted cost of the medication for
prescription drugs obtained from network providers. A deductible, as described
in 2. below, does not need to be considered in calculating the covered person's
cost. For prescription drugs provided by out-of-network providers, coinsurance
shall not exceed 50 percent.
2. If
a health benefit plan has a separate deductible for prescription drugs or a
stand-alone prescription drug plan has a deductible, such deductible shall not
exceed $ 250.00 per calendar year for generic drugs and $ 250.00 per calendar
year for non-generic drugs.
3. If a
health benefit plan or a stand-alone prescription drug plan has a benefit
maximum for prescription drugs, the maximum shall be the same for generic and
brand name drugs.
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