S2086-2013 Actions

• Jan 10, 2013: REFERRED TO INSURANCE

S2086-2013 Memo

BILL NUMBER:S2086

TITLE OF BILL:  An act to amend the insurance law, in relation to the
prohibition on first fail policies

PURPOSE: This bill would amend the insurance law by adding Article 33
which would prohibit fail first accident/or health insurance policies
that require a patient to exhaust the least expensive drug options
before insurers will cover more expensive treatment options. The bill
would also prohibit switching patients to a different prescription
drug without the full knowledge and consent of the prescribing
physician and the patient, would require simple, common-sense steps to
protect patients from the risks of ill-considered changes in their
prescribed medicines. The bill would provide consumers with
safeguards, transparency, and medical oversight that is necessary to
ensure their health and safety.

SUMMARY OF PROVISIONS: This bill would amend the insurance law by
adding a new article 33 which would prohibit fail first accident/or
health insurance policies and unauthorized therapeutic substitution.

Section 3301 defines key terms.

Section 3302 prohibits health benefit plans that provide prescription
coverage from reducing, limiting, or denying coverage when the insured
was taking the medication or was currently covered by a policy that
covered the drug. Section 3303 also prohibits switching patients to a
different prescription drug without the full knowledge and consent of
the prescribing physician and the patient, and would require simple,
common-sense steps to protect patients from the risks of
ill-considered changes in their prescribed medicines. The legislation
specifies that an insurer is allowed to make uniform changes in its
benefit design that apply to all covered drugs or increase
cost-sharing obligations' only due to an increase in the underlying
drug prices.

Section 3303 ensures the "consumers' right to know" and requires that
any time a change to a patient's medication is recommended, that all
"switch communications" clearly inform the insured of the originally
prescribed medication, advise the insured of their rights and any
cost-sharing changes they will assume.

Section 3304 establishes penalties in the event that an unauthorized
therapeutic substitution or a "switch communication" is non-compliant
or contains a false statement. These penalties include fines that
shall not exceed $25,000.

Section 3305 authorizes the prescribing physician to override
restrictions placed on a patient's medication by a PBM or insurer
through fail first protocol in situations including when the treatment
has been or is expected to be ineffective in treating the patient's
disease or medical condition or is likely to cause an adverse reaction
or other harm. Additionally, for medications with no generic
equivalent and for which the prescribing physician feels there is no
appropriate therapeutic alternative, the insurer or PMB is required to


provide access to medications labeled by the United States Food and
Drug Administration without restriction.

JUSTIFICATION:  Fail first, is an approach to prescribing drugs used
by health insurers to control costs. Fail first, also called step
therapy, insists that the least expensive drug in any class be
proscribed to a patient first. If the treatment is ineffective,
insurers will cover more expensive treatment options. This practice
has serious negative consequences for consumers and the public health
system. By limiting the array of medication options, both physicians
and consumers are forced to compromise their treatment decisions in a
way that is dangerous, time consuming and more expensive from a direct
and indirect out-of-pocket cost perspective.

Under fail first, a consumer will often have to fail on one or more
medications before they are allowed access to the medication that his
or her physician would have tried as an initial treatment. It is poor
clinical care to delay the start of effective treatment and expose a
person to unnecessary risk. In this way, fail first denies patients
the drugs they need when they need them, and effectively allows
insurers to practice medicine without a license. There axe significant
administrative costs associated with these types of policies and most
importantly, consumers can relapse and require more expensive medical
interventions such as hospitalization.

Of equal importance is the prohibition of unauthorized switching of
patients to a different prescription drug without the full knowledge
and consent of the prescribing physician and the patient. This bill
would require simple, common-sense steps to protect patients from the
risks of ill-considered changes in their prescribed medicines.

Because therapeutic substitution switches a patient to a different
drug, it should only be done with the full knowledge and consent of
the prescribing physician and the patient, and as a result of a
discussion between them. "Therapeutic" substitutes may differ from
each other in important ways; for example, therapeutic substitutes may
not be equally effective in treating a patient's disease, and they may
have different safety profiles or side effects.  Consequently, many
medical societies have spoken out against allowing therapeutic
substitution without the prescribing physician's consent.

When physicians prescribe a particular medication, they evaluate which
drug is likely to work best for the individual patient -- based on
their knowledge of the patient's illness and treatment history, other
medical conditions, drug-to-drug interactions, and drug-disease
interactions. Only the prescribing physician has enough clinical
information to make these decisions.

Requiring that the prescribing physician authorize any change to a
different medication is therefore a critical safeguard to protect
patients' health. Likewise, patients must not feel pressured to agree
to a proposed switch -- they must understand, for example, that they
can talk to their physician about a proposed switch, and have the
right to say no -- and the prescribing physician and the.patient both
must have full information on the substitute drug proposed for a
patient. These simple safeguards can make a critical difference in
many cases; they are especially important, for example, when a patient


is being successfully treated with the originally prescribed
medication and could suffer a setback from a switch that fails to
account for the patient's medical conditions and history, or when a
switch is recommended for an elderly patient who has multiple chronic
conditions and is taking many medications.

The bill prohibits insurers that provide prescription coverage under a
health benefit plan from reducing, limiting, or denying coverage when
the insured was taking the medication or was currently covered by a
policy that covered the drug. The legislation provides transparency by
requiring that all "switch communications" clearly inform the insured
of the originally prescribed medication. Further, "switch
communications" must advise the insured of their rights and any
cost-sharing changes they will incur.

Most significantly, this bill allows the prescribing physician to
override any step therapy, fail first protocol and manage medication
therapy as appropriate. This medical veto and therapy management
authority is essential to ensure patient safety when the suggested
change in medication has been ineffective in treating the patient's
disease or medical condition, is expected to be ineffective, or is
likely to cause an adverse reaction or other harm.

LEGISLATIVE HISTORY: 2011,2012: S.5110/A.8609 Referred to Insurance

FISCAL IMPLICATIONS: This bill is budget neutral. The bill does not
apply to any health care services paid for by any state, department or
agency. This bill should save patients and health care providers a
considerable amount in administrative costs and unnecessary medical
treatment.

EFFECTIVE DATE: This bill would become effective 120 days after it
shall have become law.

S2086-2013 Text

                      S T A T E   O F   N E W   Y O R K
  ________________________________________________________________________

                                    2086

                         2013-2014 Regular Sessions

                              I N  SENATE

                              January 10, 2013
                                 ___________

  Introduced  by  Sens.  YOUNG, ADDABBO -- read twice and ordered printed,
    and when printed to be committed to the Committee on Insurance

  AN ACT to amend the insurance law, in relation  to  the  prohibition  on
    first fail policies

    THE  PEOPLE OF THE STATE OF NEW YORK, REPRESENTED IN SENATE AND ASSEM-
  BLY, DO ENACT AS FOLLOWS:


    Section 1. The insurance law is amended by adding a new article 33  to
  read as follows:

                                  ARTICLE 33
                   PROHIBITION ON FIRST FAIL POLICIES AND
                    UNAUTHORIZED THERAPEUTIC SUBSTITUTION
  SECTION 3301. DEFINITIONS.
          3302. PRESCRIPTION DRUG DENIALS.
          3303. SWITCH COMMUNICATIONS/CONSUMER RIGHT TO KNOW.
          3304. PENALTIES.
          3305. PRESCRIPTION DRUG RESTRICTION OVERRIDES.
    S 3301. DEFINITIONS. AS USED IN THIS ARTICLE:

    (A)  "INSURER"  SHALL MEAN ANY PERSON OR ENTITY WHO OFFERS A POLICY OF
  ACCIDENT AND/OR HEALTH INSURANCE PURSUANT TO SECTION THREE THOUSAND  TWO
  HUNDRED SIXTEEN, THREE THOUSAND TWO HUNDRED TWENTY-ONE, OR FOUR THOUSAND
  THREE  HUNDRED THREE OF THIS CHAPTER OR ARTICLE FORTY-FOUR OF THE PUBLIC
  HEALTH LAW; EXCEPT WHEN SUCH HEALTH CARE SERVICES ARE  PROVIDED,  DELIV-
  ERED,  ARRANGED FOR, PAID FOR, OR REIMBURSED BY ANY STATE, DEPARTMENT OR
  AGENCY;
    (B) "PHARMACY BENEFITS MANAGER" OR "PBM", MEANS  A  PERSON  OR  ENTITY
  OTHER  THAN  A  PHARMACY  OR  PHARMACIST  ACTING  AS AN ADMINISTRATOR IN
  CONNECTION WITH PHARMACY BENEFITS;
    (C) "SWITCH COMMUNICATION", MEANS A  WRITTEN  COMMUNICATION  FROM  ANY
  INSURER OR PBM TO A PATIENT OR THE PATIENT'S PHYSICIAN THAT RECOMMENDS A
  PATIENT'S MEDICATION BE SWITCHED BY THE ORIGINAL PRESCRIBING HEALTH CARE

   EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                        [ ] is old law to be omitted.
                                                             LBD04369-01-3

 S. 2086                             2

  PROFESSIONAL  TO  A  DIFFERENT MEDICATION THAN THE MEDICATION ORIGINALLY
  PRESCRIBED BY THE PRESCRIBING HEALTH CARE PROFESSIONAL.
    (D)  "GENERIC  EQUIVALENT"  MEANS  A  DRUG  THAT  IS THE SAME CHEMICAL
  COMPOUND AS ANOTHER DRUG AND IS THE SAME DOSAGE FORM, STRENGTH, ROUTE OF
  ADMINISTRATION, AND INTENDED USE, AND IS LISTED AS EQUIVALENT  IN  FDA'S
  APPROVED  DRUG PRODUCTS WITH THERAPEUTIC EQUIVALENCE EVALUATIONS (ORANGE
  BOOK).
    (E) "THERAPEUTIC SUBSTITUTION" MEANS THE DISPENSING  OF  A  CHEMICALLY
  DIFFERENT  DRUG  IN  THE  PLACE OF THE DRUG ORIGINALLY PRESCRIBED BY THE
  PATIENT'S PHYSICIAN  OR  OTHER  PRESCRIBING  HEALTH  CARE  PROFESSIONAL,
  INCLUDING  BIOLOGICS  AND  PLASMA-DERIVED THERAPIES. THERAPEUTIC SUBSTI-
  TUTION DOES NOT INCLUDE SUBSTITUTION OF A GENERIC EQUIVALENT.
    S 3302. PRESCRIPTION DRUG DENIALS. (A) A  POLICY  OF  ACCIDENT  AND/OR
  HEALTH INSURANCE THAT COVERS PRESCRIPTION DRUGS SHALL NOT LIMIT, REDUCE,
  OR DENY COVERAGE FOR ANY DRUG IF, PRIOR TO THE LIMITATION, REDUCTION, OR
  DENIAL OF COVERAGE:

    (1) ANY INSURED WAS USING THE DRUG;
    (2) SUCH INSURED OR INSUREDS WERE COVERED UNDER THE POLICY; AND
    (3)  THE DRUG WAS COVERED UNDER THE POLICY FOR SUCH INSURED INDIVIDUAL
  OR INDIVIDUALS.
    (B) A LIMITATION, REDUCTION, OR DENIAL OF COVERAGE INCLUDES REMOVING A
  DRUG FROM THE FORMULARY OR OTHER DRUG LIST, IMPOSING NEW PRIOR  AUTHORI-
  ZATION  OR  OTHER UTILIZATION MANAGEMENT TOOLS, OR PLACING THE DRUG ON A
  FORMULARY TIER THAT INCREASES THE PATIENT'S COST-SHARING OBLIGATIONS  OR
  OTHERWISE INCREASES THE PATIENT'S COST-SHARING OBLIGATIONS.
    (C)  NOTHING  IN  THIS  SECTION  SHALL PROHIBIT AN INSURER FROM MAKING
  UNIFORM CHANGES IN ITS BENEFIT DESIGN THAT APPLY TO ALL  COVERED  DRUGS,
  UNIFORMLY  REMOVING  A DRUG FROM THE FORMULARY LIST FOR ALL INSUREDS, OR
  INCREASING COST-SHARING OBLIGATIONS MERELY DUE TO A  PERCENTAGE  COINSU-
  RANCE  PAYMENT THAT NECESSARILY INCREASES WITH AN INCREASE IN THE UNDER-
  LYING DRUG PRICES.
    (D) NO THERAPEUTIC SUBSTITUTION OF A MEDICATION BY  ANYONE  AUTHORIZED
  TO  DISPENSE  MEDICATIONS  FOR SELF OR HOME ADMINISTRATION BY A CONSUMER
  SHALL BE ALLOWED WITHOUT  THE  EXPRESS  AUTHORIZATION  OF  THE  ORIGINAL
  PRESCRIBING  PHYSICIAN  OR  HEALTH  CARE  PROFESSIONAL AND NOTICE TO THE
  PATIENT AND THE POLICY SPONSOR AS PROVIDED FOR IN SECTION THREE THOUSAND
  THREE HUNDRED THREE OF THIS  ARTICLE.  PRIOR  TO  MAKING  A  THERAPEUTIC
  SUBSTITUTION  IN  A  PATIENT'S PRESCRIPTION INCLUDING BUT NOT LIMITED TO
  CHANGES IN PRODUCT SELECTION AND CHANGES IN DOSAGE, THE DISPENSING PHAR-
  MACIST SHALL:

    (1) VERBALLY  REQUEST  THE  PATIENT  TO  AGREE  TO  A  CHANGE  TO  THE
  PRESCRIPTION, AND EXPLAIN THAT THE CHANGE CANNOT BE MADE UNLESS BOTH THE
  PATIENT  AND THE PRESCRIBING PHYSICIAN (OR OTHER PRESCRIBING HEALTH CARE
  PROFESSIONAL) EXPRESSLY AGREE TO THE CHANGE;
    (2) VERBALLY DESCRIBE THE PROPOSED CHANGE THAT WOULD BE  MADE  TO  THE
  PRESCRIPTION,  INCLUDING  CLEARLY  IDENTIFYING THE ORIGINALLY PRESCRIBED
  MEDICATION  AND  THE  MEDICATION  THAT  WOULD  BE  SUBSTITUTED  FOR  THE
  ORIGINALLY PRESCRIBED MEDICATION; AND
    (3)  VERBALLY  INFORM  THE  PATIENT  OF  THE  IMPACT,  IF  ANY, ON THE
  PATIENT'S OUT-OF-POCKET COST.
    S 3303. SWITCH COMMUNICATIONS/CONSUMER RIGHT TO KNOW.  (A) ANY TIME  A
  PATIENT'S PRESCRIBED MEDICATION IS RECOMMENDED TO BE SWITCHED TO A MEDI-
  CATION  OTHER THAN THAT ORIGINALLY PRESCRIBED BY THE PRESCRIBING PRACTI-
  TIONER, A SWITCH COMMUNICATION SHALL BE SENT TO:


 S. 2086                             3

    (1) THE PATIENT AND SHALL PROVIDE INFORMATION ABOUT WHY THE SWITCH  IS
  PROPOSED AND THE PATIENT'S RIGHTS FOR REFUSING THE RECOMMENDED CHANGE IN
  TREATMENT; AND
    (2) THE POLICY SPONSOR AND SHALL INFORM SUCH SPONSOR OF THE PHARMACEU-
  TICAL  WHOLESALE ACQUISITION COST, SHOWN IN CURRENCY FORM, OF THE RECOM-
  MENDED MEDICATION AND THE WHOLESALE ACQUISITION COST, SHOWN IN  CURRENCY
  FORM, OF THE ORIGINALLY PRESCRIBED MEDICATION.
    (B) SUCH SWITCH COMMUNICATION SHALL:

    (1)  CLEARLY  IDENTIFY  THE  ORIGINALLY  PRESCRIBED MEDICATION AND THE
  MEDICATION TO WHICH IT HAS BEEN PROPOSED  THAT  THE  PATIENT  SHOULD  BE
  SWITCHED;
    (2)  PROVIDE INFORMATION WHICH IS TRUTHFUL, ACCURATE, AND NOT MISLEAD-
  ING, WITH APPROPRIATE FAIR BALANCE, CONSISTENT WITH  THE  UNITED  STATES
  FOOD AND DRUG ADMINISTRATION FOR MEDICATIONS;
    (3)  INCLUDE  CURRENT  APPROVED PRODUCT LABELING AND INFORMATION ABOUT
  RISKS ASSOCIATED WITH THE RECOMMENDED MEDICATION;
    (4) CLEARLY ACKNOWLEDGE THAT  NO  THERAPEUTIC  SUBSTITUTION  SHALL  BE
  ALLOWED  WITHOUT  THE  EXPRESS AUTHORIZATION OF THE ORIGINAL PRESCRIBING
  PHYSICIAN OR OTHER ORIGINAL PRESCRIBING HEALTH CARE PROFESSIONAL;
    (5) ADVISE THE PATIENT OF HIS OR HER RIGHTS TO  DISCUSS  THE  PROPOSED
  CHANGE  IN  TREATMENT  BEFORE  SUCH  A  SWITCH  TAKES PLACE, INCLUDING A
  DISCUSSION WITH THE PATIENT'S PRESCRIBING PRACTITIONER, THE FILING OF  A
  GRIEVANCE  WITH  THE  INSURER  TO PREVENT THE SWITCH IF SUCH A SWITCH IS
  BASED ON A FINANCIAL INCENTIVE AND THE FILING OF A  GRIEVANCE  WITH  THE
  DEPARTMENT; AND
    (6)  EXPLAIN ANY COST-SHARING CHANGES FOR WHICH THE PATIENT IS RESPON-
  SIBLE.
    (C) A COPY OF ANY SWITCH COMMUNICATION SENT TO A PATIENT SHALL ALSO BE
  SENT TO THE PRESCRIBING PRACTITIONER.
    (D) HEALTH  INSURANCE  PAYERS,  INCLUDING  EMPLOYERS  RESPONSIBLE  FOR
  PAYING THE HEALTH CARE PREMIUM OR PORTIONS THEREOF, SHALL BE NOTIFIED OF
  THERAPEUTIC SUBSTITUTIONS AMONG POLICY PARTICIPANTS AND OF ANY THERAPEU-
  TIC  SUBSTITUTION  PROGRAMS ADOPTED BY HEALTH PLANS AND PHARMACY BENEFIT
  MANAGERS IN ANY PLAN OFFERED BY SUCH PREMIUM PAYER OR EMPLOYER.
    (E) THE DEPARTMENT SHALL CREATE ONE FORM  FOR  INSURERS  AND  PHARMACY
  BENEFIT  MANAGERS TO USE IN SWITCH COMMUNICATIONS TO PATIENTS, PRESCRIB-
  ING PRACTITIONERS, AND HEALTH INSURANCE PAYERS INCLUDING EMPLOYERS.
    (F) THE DEPARTMENT SHALL PROMULGATE RULES  GOVERNING  SWITCH  COMMUNI-
  CATIONS. SUCH RULES SHALL INCLUDE, BUT NOT BE LIMITED TO THE FOLLOWING:

    (1) PROCEDURES FOR VERIFYING THE ACCURACY OF ANY SWITCH COMMUNICATIONS
  FROM  POLICIES  OF ACCIDENT AND/OR HEALTH INSURANCE AND PHARMACY BENEFIT
  MANAGERS TO ENSURE THAT SUCH SWITCH COMMUNICATIONS ARE  TRUTHFUL,  ACCU-
  RATE,  AND  NOT MISLEADING BASED ON COST TO THE PATIENT AND POLICY SPON-
  SOR, THE PRODUCT PACKAGE LABELING, MEDICAL COMPENDIA RECOGNIZED  BY  THE
  DRUG  UTILIZATION  REVIEW  BOARD,  AND PEER-REVIEWED MEDICAL LITERATURE,
  WITH APPROPRIATE REFERENCES PROVIDED;
    (2) EXCEPT FOR A SUBSTITUTION  DUE  TO  THE  FOOD  AND  DRUG  ADMINIS-
  TRATION'S  WITHDRAWAL OF A DRUG FOR PRESCRIPTION, A REQUIREMENT THAT ALL
  SWITCH COMMUNICATIONS BEAR A PROMINENT LEGEND ON  THE  FIRST  PAGE  THAT
  STATES:    "THIS  IS  NOT A PRODUCT SAFETY NOTICE. THIS IS A PROMOTIONAL
  ANNOUNCEMENT FROM YOUR HEALTH CARE INSURER OR PHARMACY BENEFITS  MANAGER
  ABOUT ONE OF YOUR CURRENT PRESCRIBED MEDICATIONS.";
    (3)  A  REQUIREMENT  THAT,  THE NOTIFICATION OF REQUEST FOR MEDICATION
  CHANGE (I) EXPRESSLY STATES  THAT  THE  CHANGE  INVOLVES  A  THERAPEUTIC
  SUBSTITUTION,  NOT  A  GENERIC SUBSTITUTION; (II) EXPLAIN THE DIFFERENCE
  BETWEEN THERAPEUTIC SUBSTITUTION AND  GENERIC  SUBSTITUTION;  AND  (III)

 S. 2086                             4

  PROVIDE  A TRUTHFUL, FAIR, AND BALANCED EXPLANATION REGARDING THE POTEN-
  TIAL, RAMIFICATIONS OF THE THERAPEUTIC SUBSTITUTION, INCLUDING  BUT  NOT
  LIMITED  TO,  THAT MEDICATIONS IN THE SAME THERAPEUTIC CLASS ARE ASSOCI-
  ATED  WITH  DIFFERENT  RISKS  AND  BENEFITS  AND MAY WORK DIFFERENTLY IN
  DIFFERENT PATIENTS.
    S 3304. PENALTIES. (A) ISSUING OR DELIVERING OR CAUSING TO  BE  ISSUED
  OR  DELIVERED  A  SWITCH COMMUNICATION THAT HAS NOT BEEN APPROVED AND IS
  NOT IN COMPLIANCE WITH THE REQUIREMENTS OF SECTION THREE THOUSAND  THREE
  HUNDRED  THREE  OF  THIS  ARTICLE  IS PUNISHABLE BY A FINE NOT TO EXCEED
  TWENTY-FIVE THOUSAND DOLLARS.
    (B) PROVIDING A MISREPRESENTATION  OR  FALSE  STATEMENT  IN  A  SWITCH
  COMMUNICATION  UNDER  SECTION THREE THOUSAND THREE HUNDRED THREE OF THIS
  ARTICLE IS PUNISHABLE BY A  FINE  NOT  TO  EXCEED  TWENTY-FIVE  THOUSAND
  DOLLARS.
    (C)  ANY  OTHER  MATERIAL  VIOLATION  OF  SECTION THREE THOUSAND THREE
  HUNDRED THREE OF THIS ARTICLE IS PUNISHABLE BY  A  FINE  NOT  TO  EXCEED
  TWENTY-FIVE THOUSAND DOLLARS.
    S  3305. PRESCRIPTION DRUG RESTRICTION OVERRIDES. (A) WHEN MEDICATIONS
  FOR THE TREATMENT OF ANY MEDICAL CONDITION ARE RESTRICTED FOR USE BY  AN
  INSURER  OR  PBM  BY A STEP THERAPY OR FAIL FIRST PROTOCOL, A PRESCRIBER
  SHALL HAVE ACCESS TO A CLEAR AND CONVENIENT  PROCESS  TO  OVERRIDE  SUCH
  RESTRICTIONS  FROM  THE  INSURER  AND  MAY  EXPEDITIOUSLY  OVERRIDE SUCH
  RESTRICTION IF:

    (1) THE PREFERRED TREATMENT BY THE INSURER OR THE PBM HAS  BEEN  INEF-
  FECTIVE  IN  THE  TREATMENT  OF  THE COVERED PERSON'S DISEASE OR MEDICAL
  CONDITION; OR
    (2) BASED ON  SOUND  CLINICAL  EVIDENCE  AND  MEDICAL  AND  SCIENTIFIC
  EVIDENCE:

    (A) THE PREFERRED TREATMENT IS EXPECTED TO BE INEFFECTIVE BASED ON THE
  KNOWN  RELEVANT PHYSICAL OR MENTAL CHARACTERISTICS OF THE COVERED PERSON
  AND KNOWN CHARACTERISTICS OF THE DRUG REGIMEN, AND IS LIKELY TO BE INEF-
  FECTIVE OR ADVERSELY AFFECT THE DRUG'S EFFECTIVENESS OR PATIENT  COMPLI-
  ANCE; OR
    (B)  THE  PREFERRED  TREATMENT  HAS  CAUSED  OR  IS LIKELY TO CAUSE AN
  ADVERSE REACTION OR OTHER HARM TO THE COVERED PERSON.
    (B) THE DURATION OF ANY STEP THERAPY OR FAIL FIRST PROTOCOL SHALL  NOT
  BE  LONGER THAN THE PERIOD DEEMED NECESSARY BY THE PRESCRIBING PHYSICIAN
  OR HEALTH CARE PROFESSIONAL TO DETERMINE THE TREATMENT'S CLINICAL EFFEC-
  TIVENESS OR A PERIOD OF FOURTEEN DAYS.
    (C) FOR MEDICATIONS WITH NO  GENERIC  EQUIVALENT  AND  FOR  WHICH  THE
  PRESCRIBING PHYSICIAN IN THEIR CLINICAL JUDGMENT FEELS THAT NO APPROPRI-
  ATE THERAPEUTIC ALTERNATIVE IS AVAILABLE AN INSURER OR PBM SHALL PROVIDE
  ACCESS TO UNITED STATES FOOD AND DRUG ADMINISTRATION (FDA) LABELED MEDI-
  CATIONS  WITHOUT  RESTRICTION TO TREAT SUCH MEDICAL CONDITIONS FOR WHICH
  AN FDA LABELED MEDICATION IS AVAILABLE.
    (D) NOTHING IN THIS SECTION SHALL REQUIRE COVERAGE FOR  AN  ADDITIONAL
  CONDITION  NOT  ALREADY  COVERED BY THE POLICY OR WHICH IS NOT OTHERWISE
  COVERED BY LAW.
    S 2. This act shall take effect on the one hundred twentieth day after
  it shall have become a law.