Elite Pharmaceuticals Inc (ELTP)

[Couch]

As I've stated, the Perfect Storm is brewing for this little Pharma company. Here is the current legislation pertaining to abuse deterrent opioids by state that will only help Elite should they pass.

NOTICE: Tennessee passed one of its two bills and Massachusetts has already signed a similar bill into law.

1) Colorado CO [R] HB 1214 - Updated (Hearing 03/02/2015)

The bill prohibits an opioid analgesic drug product that is not abuse-deterrent to be substituted for an abuse-deterrent opioid analgesic drug product if a health care provider prescribes an abuse-deterrent opioid analgesic drug product to a patient and the prescription includes the instructions "dispense as written". A carrier must cover the abuse-deterrent opioid analgesic drug product at the lowest cost-sharing level as an opioid analgesic drug product. A carrier cannot require treatment failure with an opioid analgesic drug product that is not abuse-deterrent prior to providing coverage for the abuse-deterrent opioid analgesic drug product if the prescribing health care provider determines that the covered person would benefit from the abuse-deterrent opioid analgesic drug product.

http://www.cqstatetrack.com/texis/statetrack/insession/insession/+/nodisplay/kwic?bid=54db07212&pid=51252f0a514

2a) Connecticut CT [R] HB 5784 - Updated (Status 02/12/2015)

To prevent pharmacists from making a substitution when an abuse-deterrent opioid is prescribed, unless the pharmacist receives written permission from the prescribing health care provider.

http://www.cqstatetrack.com/texis/statetrack/insession/insession/+/nodisplay/kwic?bid=54bf460b2&pid=51252f0a514

2b) CT [R] SB 21 - Updated (Status 02/11/2015)

To require health insurance policies that provide coverage for prescription drugs to provide coverage for abuse-deterrent opioid analgesics on a basis no less favorable than for covered nonabuse-deterrent opioid analgesics.

http://www.cqstatetrack.com/texis/statetrack/insession/insession/+/nodisplay/kwic?bid=54ad788a1&pid=51252f0a514

3a) Florida Number: FL [R] HB 1021 - Updated (New 02/26/2015)

An act relating to health insurance coverage for abuse-deterrent opioids; providing that a health insurance policy that covers opioid analgesic drug products may impose a prior authorization requirement for an abuse-deterrent opioid analgesic drug product only if the insurer imposes the same requirement for each opioid analgesic drug product without an abuse-deterrence labeling claim; prohibiting such health insurance policy from requiring use of an opioid analgesic drug product without an abuse-deterrence labeling claim before providing coverage for an abuse-deterrent opioid analgesic drug product.

http://www.cqstatetrack.com/texis/statetrack/insession/insession/+/nodisplay/kwic?bid=54eee6bebc9&pid=51252f0a514

3b) FL [R] SB 728 - Updated (Status 02/14/2015)

An act relating to health insurance coverage for opioids; providing that a health insurance policy that covers opioid analgesic drug products may impose a prior authorization requirement for an abuse-deterrent opioid analgesic drug product only if the insurer imposes the same requirement for each opioid analgesic drug product without an abuse-deterrence labeling claim; prohibiting such health insurance policy from requiring use of an opioid analgesic drug product without an abuse-deterrence labeling claim before providing coverage for an abuse-deterrent opioid analgesic drug product; providing an effective date.

http://www.cqstatetrack.com/texis/statetrack/insession/insession/+/nodisplay/kwic?bid=54d481cb1&pid=51252f0a514

4a) Illinois IL [R] HB 2743 - Updated (New 02/21/2015)

Provides that government programs and accident and health insurance policies providing coverage for prescription drugs shall provide coverage for abuse-deterrent opioid analgesic drugs as preferred drugs on their formulary, preferred drug list, or other lists of similar construct. Prohibits cost sharing for abuse-deterrent opioid analgesic drugs that exceeds the lowest cost sharing level applied to prescription drugs. Prohibits insurers from requiring require that a covered individual first use an opioid analgesic drug product without abuse-deterrence labeling claims before providing coverage for an abuse-deterrent opioid analgesic product. Provides that any prior authorization requirements or other utilization review measures for opioid analgesic drug products, and any service denials made under those, shall not require first use of non-abuse-deterrent opioid analgesic drug products in order to access opioid analgesic drug products with abuse-deterrent properties.

4b) IL [R] SB 1802 - Updated (New 02/21/2015)

Provides that government programs and accident and health insurance policies providing coverage for prescription drugs shall provide coverage for abuse-deterrent opioid analgesic drugs as preferred drugs on their formulary, preferred drug list, or other lists of similar construct. Prohibits cost sharing for abuse-deterrent opioid analgesic drugs that exceeds the lowest cost sharing level applied to prescription drugs. Prohibits insurers from requiring require that a covered individual first use an opioid analgesic drug product without abuse-deterrence labeling claims before providing coverage for an abuse-deterrent opioid analgesic product. Provides that any prior authorization requirements or other utilization review measures for opioid analgesic drug products, and any service denials made under those, shall not require first use of non-abuse-deterrent opioid analgesic drug products in order to access opioid analgesic drug products with abuse-deterrent properties.

http://www.cqstatetrack.com/texis/statetrack/insession/insession/+/nodisplay/kwic?bid=54e87a3fc5&pid=51252f0a514

5) Kansas KS [R] SB 102 - Updated (Status 01/29/2015)

An insurance carrier or health plan shall provide coverage for abuse-deterrent opioid analgesic drugs as preferred drugs on their formulary, preferred drug list or other lists of similar construct. Cost sharing for abuse-deterrent opioid analgesic drug products shall not exceed the lowest cost-sharing level applied to prescription drugs. An increase in patient cost sharing or other disincentives for prescribers or dispensers shall not be allowed to achieve compliance with this section.

Further, any prior authorization requirements or other utilization review measures for opioid analgesic drug products, and any service denials made pursuant thereto, shall not require first use of non-abuse-deterrent opioid analgesic drug products in order to access opioid analgesic drug products with abuse-deterrent properties. This subsection shall not be construed to prevent an insurer or health plan from applying prior authorization requirements to abuse-deterrent opioid analgesic drug products, provided that such requirements are applied to non-abuse-deterrent versions of that opioid.

http://www.cqstatetrack.com/texis/statetrack/insession/insession/+/nodisplay/kwic?bid=54c995ad16c&pid=51252f0a514

6) Kentucky KY [R] HB 538 - Updated (New 02/24/2015)

An insurer or health benefit plan shall provide coverage for abuse-deterrent opioid analgesic drug products as preferred drugs on its formulary, preferred drug list, or similar lists of coverage for prescriptions. Cost sharing for abuse-deterrent opioid analgesic drug products shall not exceed the lowest cost-sharing level applied to prescription drugs in the same health benefit plan. An increase in patient cost-sharing or other disincentives for prescribers or dispensers to prescribe or dispense abuse-deterrent opioid analgesic drug products shall not be allowed to achieve compliance with this subsection.

Any prior authorization requirements or other utilization review measures for opioid analgesic drug products on the market, and any service denials made pursuant to these requirements, shall not require first use of non-abuse-deterrent opioid analgesic drug products in order to access abuse-deterrent opioid analgesic drug products with abuse-deterrent properties. This subsection shall not be construed to prevent an insurer or health benefit plan from requiring prior authorization for abuse-deterrent opioid analgesic drug products only if the requirement is applied to non-abuse-deterrent versions of the opioid analgesic drug product for which abuse deterrence is intended.

http://www.cqstatetrack.com/texis/statetrack/insession/insession/+/nodisplay/kwic?bid=54ed4c184&pid=51252f0a514

7a) Maryland MD [R] HB 887 - Updated (Hearing 02/27/2015)

A bill for the purpose of requiring certain insurers, nonprofit health service plans, and health maintenance organizations to provide coverage for abuse–deterrent opioid analgesic drug products; prohibiting the insurers, nonprofit health service plans, and health maintenance organizations from imposing certain limits or cost–sharing requirements on coverage for abuse–deterrent opioid analgesic drug products that are less favorable to an insured or an enrollee than the limits or cost–sharing requirements that apply to coverage for any other opioid analgesic drug product; prohibiting the insurers, nonprofit health service plans, and health maintenance organizations from requiring an insured or an enrollee to first use a certain drug product before providing coverage for an abuse–deterrent opioid analgesic drug product; prohibiting the insurers, nonprofit health service plans, and health maintenance organizations from increasing certain cost–sharing requirements or other out–of–pocket expenses to achieve certain compliance; authorizing the insurers, nonprofit health service plans, and health maintenance organizations to undertake utilization review for an abuse–deterrent opioid analgesic drug product under certain circumstances; defining certain terms; providing for the application of this Act; and generally relating to health insurance coverage for abuse–deterrent opioid analgesic drug products.

http://www.cqstatetrack.com/texis/statetrack/insession/insession/+/nodisplay/kwic?bid=54dde926b3b&pid=51252f0a514

7b) MD [R] SB 606 - Updated (Hearing 02/24/2015)

For the purpose of requiring certain insurers, nonprofit health service plans, and health maintenance organizations to provide coverage for abuse–deterrent opioid analgesic drug products; prohibiting the insurers, nonprofit health service plans, and health maintenance organizations from imposing certain limits or cost–sharing requirements on coverage for abuse–deterrent opioid analgesic drug products that are less favorable to an insured or an enrollee than the limits or cost–sharing requirements that apply to coverage for any other opioid analgesic drug product; prohibiting the insurers, nonprofit health service plans, and health maintenance organizations from requiring an insured or an enrollee to first use a certain drug product before providing coverage for an abuse–deterrent opioid analgesic drug product; prohibiting the insurers, nonprofit health service plans, and health maintenance organizations from increasing certain cost–sharing requirements or other out–of–pocket expenses to achieve certain compliance; authorizing the insurers, nonprofit health service plans, and health maintenance organizations to undertake utilization review for an abuse–deterrent opioid analgesic drug product under certain circumstances; defining certain terms; providing for the application of this Act; and generally relating to health insurance coverage for abuse–deterrent opioid analgesic drug products.

http://www.cqstatetrack.com/texis/statetrack/insession/insession/+/nodisplay/kwic?bid=54d9e71ad981&pid=51252f0a514

8a) Minnesota MN [R] HF 1038 - Updated (Text 02/21/2015)

A health plan that provides prescription drug coverage must provide coverage for abuse-deterrent opioid analgesic drug products as a preferred drug on the health plan company's drug formulary or preferred drug list. Cost-sharing requirements for abuse-deterrent opioid analgesic drug products must not exceed the lowest cost-sharing requirements applied to other covered prescription drugs on the drug formulary or preferred drug list. A health plan company shall not impose as part of a prior authorization or utilization review requirement the use of a non-abuse-deterrent opioid analgesic drug product in order to access an abuse-deterrent opioid analgesic drug product. Nothing in this subdivision prevents a health plan company from applying a prior authorization requirement to an abuse-deterrent opioid analgesic drug product, so long as the same prior authorization requirements are applied to non-abuse-deterrent opioid analgesic drug products.

http://www.cqstatetrack.com/texis/statetrack/insession/insession/+/nodisplay/kwic?bid=54e57e7f1bd&pid=51252f0a514

8b) MN [R] SF 917 - Updated (Text 02/21/2015)

A health plan that provides prescription drug coverage must provide coverage for abuse-deterrent opioid analgesic drug products as a preferred drug on the health plan company's drug formulary or preferred drug list. Cost-sharing requirements for abuse-deterrent opioid analgesic drug products must not exceed the lowest cost-sharing requirements applied to other covered prescription drugs on the drug formulary or preferred drug list. A health plan company shall not impose as part of a prior authorization or utilization review requirement the use of a non-abuse-deterrent opioid analgesic drug product in order to access an abuse-deterrent opioid analgesic drug product. Nothing in this subdivision prevents a health plan company from applying a prior authorization requirement to an abuse-deterrent opioid analgesic drug product, so long as the same prior authorization requirements are applied to non-abuse-deterrent opioid analgesic drug products.

http://www.cqstatetrack.com/texis/statetrack/insession/insession/+/nodisplay/kwic?bid=54e57e80115&pid=51252f0a514

9) Missouri MS [R] HB 422 - Updated (Status 02/04/2015)

An Act to prohibit pharmacists from substituting analgesic drugs for an opioid analgesic drug incorporating a tamper resistance technology without verifying equivalence or obtaining the written, signed consent of the prescribing physician.

http://www.cqstatetrack.com/texis/statetrack/insession/insession/+/nodisplay/kwic?bid=54bd9d5819&pid=51252f0a514

10) Oklahoma OK [R] SB 737 - Updated (Status 02/04/2015)

No pharmacist filling a prescription covered by the Oklahoma Medicaid Program shall interchange or substitute an opioid analgesic drug product, brand or generic equivalent for an opioid analgesic drug product with abuse-deterrent properties if a generic equivalent for opioid analgesic products with drug-deterrent properties has been approved by the United States Food and Drug Administration. The requirements of this subsection shall only be effective following FDA approval of a generic equivalent for an opioid analgesic product with abuse-deterrent properties.

A determination of interchangeability between two abusedeterrent opioid analgesic drug products shall not require that both products incorporate the same methods of abuse-deterrence, but that the opioid analgesic drug products have the same level of FDA approved abuse-deterrence labeling claims.

http://www.cqstatetrack.com/texis/statetrack/insession/insession/+/nodisplay/kwic?bid=54c301661&pid=51252f0a514

11) Oregon OR [R] SB 661 - Updated (Status 02/21/2015)

A health benefit plan that provides coverage of opioid analgesic drug products must provide coverage of abuse-deterrent opioid analgesic drug products. A health benefit plan may not impose cost-sharing requirements on the coverage of abuse-deterrent opioid analgesic drug products that exceed the lowest cost-sharing level for any other prescription drug covered by the plan. Further, a health benefit plan may not impose prior authorization requirements or other utilization control measures to require initial treatment using an opioid analgesic drug product without abuse-deterrent properties before an insured may be prescribed or dispensed an abuse-deterrent opioid analgesic drug product, nor may they mpose on abuse-deterrent opioid analgesic drug products prior authorization requirements or other utilization control measures only if the same requirements or measures are applied to opioid analgesic drug products without abusedeterrent properties. Lastly, an insurer may not increase the lowest cost-sharing level imposed on drugs covered by the plan in order to comply with this section, or create financial disincentives for prescribers and dispensers to prescribe or dispense abuse-deterrent opioid analgesic drug products.

http://www.cqstatetrack.com/texis/statetrack/insession/insession/+/nodisplay/kwic?bid=54e713c41&pid=51252f0a514

12a) Rhode Island RI [R] H 5219 - Updated (Status 02/21/2015)

This act would require policies and plans issued by health insurers to cover abuse-deterrent drug formulations of opioid analgesics in the same manner in which the policies and plans cover non-abuse deterrent drugs formations.

http://www.cqstatetrack.com/texis/statetrack/insession/insession/+/nodisplay/kwic?bid=54cc9b6c85ee&pid=51252f0a514

12b) RI [R] S 167 - Updated (New 02/06/2015)

This act would prevent health insurance policies, plans or contracts that provide coverage for prescription drugs, from requiring a beneficiary to use an opioid drug not indicated by the FDA for the condition being treated prior to the use of a non-opioid drug that is approved by the FDA for the condition being treated, or to use a non-abuse-deterrent formulation prior to using an abuse-deterrent formulation.

http://www.cqstatetrack.com/texis/statetrack/insession/insession/+/nodisplay/kwic?bid=54d48656302&pid=51252f0a514

13a) Tennessee TN [R] HB 746 - Updated (Status 02/20/2015)

As introduced, requires all health insurance coverage to provide coverage for abuse-deterrent opioid analgesic drugs at the same price as other opioid analgesic drugs. Further, a health insurance entity shall not require that a covered individual first use an opioid analgesic drug product without abuse-deterrence labeling claims before providing coverage for an abuse-deterrent opioid analgesic drug product. This section shall not prohibit a health insurance entity from using utilization review, including preauthorization, for abuse-deterrent opioid analgesic drug products; provided, that the same utilization review requirements are applied to all opioid analgesic drug products.

http://www.cqstatetrack.com/texis/statetrack/insession/insession/+/nodisplay/kwic?bid=54dc4b2c41&pid=51252f0a514

13b) TN [R] SB 601 - Updated (New 02/11/2015) PASSED

As introduced, requires all health insurance coverage to provide coverage for abuse-deterrent opioid analgesic drugs at the same price as other opioid analgesic drugs. Further, a health insurance entity shall not require that a covered individual first use an opioid analgesic drug product without abuse-deterrence labeling claims before providing coverage for an abuse-deterrent opioid analgesic drug product. This section shall not prohibit a health insurance entity from using utilization review, including preauthorization, for abuse-deterrent opioid analgesic drug products; provided, that the same utilization review requirements are applied to all opioid analgesic drug products.

http://www.cqstatetrack.com/texis/statetrack/insession/insession/+/nodisplay/kwic?bid=54dafb867&pid=51252f0a514

14) Utah UT [R] SB 265 - Updated (Status 02/28/2015)

A health benefit plan that provides coverage of opioid analgesic drug products shall provide coverage of abuse-deterrent opioid analgesic drug products. A health benefit plan may not impose: 1) cost-sharing requirements on the coverage of abuse-deterrent opioid analgesic drug products that exceed the lowest cost-sharing level for any other prescription drug covered by the plan; or 2) prior authorization requirements or other utilization control measures to require initial treatment using an opioid analgesic drug product without abuse-deterrent properties before an insured may be prescribed or dispensed an abuse-deterrent opioid analgesic drug product. A health benefit plan may impose on an abuse-deterrent opioid analgesic drug product prior authorization requirements or other utilization control measures only if the same requirements or measures are applied to another opioid analgesic drug product without abuse-deterrent properties. An insurer may not increase the lowest cost-sharing level imposed on drugs covered by the plan in order to comply with this section, nor may they create a financial disincentive for a prescriber or dispenser to prescribe or dispense an abuse-deterrent opioid analgesic drug product.

http://www.cqstatetrack.com/texis/statetrack/insession/insession/+/nodisplay/kwic?bid=54f018b92b78&pid=51252f0a514

15) Vermont VT [R] S 59 - Updated (Status 02/05/2015)

A health insurance or other health benefit plan offered by a health insurer or by a pharmacy benefit manager on behalf of a health insurer that provides coverage for prescription drugs shall include abuse-deterrent formulations of pain relieving medications as preferred drugs on its prescription drug formulary.

http://www.cqstatetrack.com/texis/statetrack/insession/insession/+/nodisplay/kwic?bid=54d1d1d71&pid=51252f0a514

16) Washington WA [R] SB 5695 - Updated (New 01/30/2015)

Requires health plans that include coverage for prescription drugs to also provide coverage for abuse-deterrent opioid analgesic drugs as preferred drugs on their formulary, preferred drug list, or other lists of similar construct.

http://www.cqstatetrack.com/texis/statetrack/insession/insession/+/nodisplay/kwic?bid=54cb93692043&pid=51252f0a514

17) West Virginia WV [R] HB 2961 - Updated (Status 02/28/2015)

Any health insurance policy, issued or renewed on or after July 1, 2015, shall provide coverage for abuse-deterrent opioid analgesic drugs as preferred drugs on their formulary, preferred drug list or other lists of similar construct. Cost-sharing for abuse-deterrent opioid analgesic drug products shall not exceed the lowest cost-sharing level applied to prescription drugs. An increase in patient cost sharing or other disincentives for prescribers or dispensers is not allowed to achieve compliance with this section.

Any prior authorization requirements or other utilization review measures for opioid analgesic drug products, and any service denials made pursuant thereto, may not require first use of non abuse-deterrent opioid analgesic drug products in order to access opioid analgesic drug products with abuse-deterrent properties. This section does not be prevent an insurer or health plan from applying prior authorization requirements to abuse-deterrent opioid analgesic drug products: Provided, that the requirements are applied to non abuse-deterrent versions of that opioid.

http://www.cqstatetrack.com/texis/statetrack/insession/insession/+/nodisplay/kwic?bid=54ed81489&pid=51252f0a514