MODEL LEGISLATION

Dispensing of Medications

 In many states the ability of Physician Assistants (PAs) and Nurse Practitioners (NPs) to dispense medications and devices is not allowed even though these “extenders” are supervised and responsible to a physician.  There are any number of situations where an office or clinic is staffed by an “extender” but the physician is not actually on site.  This may be a particularly true in rural areas.

1. PA and NP Extenders:

PRI believes that “physician extenders: such as PAs and NPs should be allowed to dispense medicines and medical devices so long as the physician permits them to do so and remains responsible.  To that end, Maryland, in 2018, enacted a bill permitting PAs to dispense provided that their supervising physician had delegated that task. MedChi, the Maryland State Medical Society, was a leading advocate for that legislation.

A pdf copy of the final text of that enacted bill can be found at   http://mgaleg.maryland.gov/2018RS/chapters_noln/Ch_442_hb0591T.pdf

Drug Abuse

There is a general consensus that drug abuse has reached epic proportions in the United States. In many cases this is because of the consumption of illegal drugs such as heroin; in other cases, it is because of the abuse of the prescribed drugs where, for example, a patient improperly obtains prescriptions from multiple prescribers and either sells or abuses the prescribed medicines. The problems of drug abuse are manifold including overdose deaths. While there is no single solution, there are a number of legislative measures which will assist, including the following (see 2-5 below).

2. 2018 Proposed Legislation in Georgia Requiring Coverage for Non-Opioid and Lesser Opioid Therapy:

View Proposed Legislation

3. Deterrent Opioid Analgesic Drug Products; Coverage (Maryland Senate Bill 606):

The United States Food and Drug and Administration has recognized that the development of opioid medicines which are formulated to deter abuse is a high public health priority. However, many insurance companies either refuse to pay for such medicines or impose unreasonable co-pays and deductibles. One sensible response is to pass legislation requiring insurance companies to recognize and pay for abuse deterrent opioid drug products. In 2015, the Maryland General Assembly passed Senate Bill 606 which was signed into law by the Governor. The provisions of Senate Bill 606 as introduced, amended and finally enacted may be found here.

4. Overdose Response Program (Maryland Senate Bill 516):

One public health emergency which has occurred because of the opioid epidemic is fatal overdoses. Naloxone, sold under the brand-name Narcan among others, is a medication used to block the effects of opioids, especially in overdose. Given the effectiveness of Naloxone, it should be freely available. However, many state pharmacy laws restrict the ability of frontline personnel to administer Naloxone. In 2015, the Maryland General Assembly passed Senate Bill 516 which allowed for many additional individuals to administer Naloxone even though they would not normally be permitted to prescribe or dispense medicine. The provisions of Senate Bill 516 as introduced, amended and finally enacted may be found here.

5. Prescription Drug Monitoring Programs (“Batching”):

In the last 10 years almost all states have enacted laws creating Prescription Drug Monitoring Programs (PDMPs). A PDMP allows law enforcement personnel to observe prescription patterns so as to assist in determining improper behavior. More importantly, however, a PDMP allows a prescribing physician to determine whether a patient is receiving medicines from other sources. As such, the PDMP becomes a tool for physicians to identify patients who are abusing medicines. However, there are a number of problems with most state PDMPs. One problem is that PDMPs are not technically set up to “batch” patients so that a physician’s office could send in a list of patients to be seen on a particular day and receive information back on that grouping.  At least 10 states allow for “batching.”  Most states, however, do not allow “batching.” a problem that can be cured either by amending the state PDMP law or extending the technical ability of the PDMP.

Physician Autonomy

There are any number of insurance company practices which impinge upon a physician’s ability to properly treat his or her patients.  The following model bills would be helpful in insuring that doctors – not insurance companies – decide on the proper therapy for their patients (see 6-8 below).

6. Treatment Guidelines/Formulary Regulation:

As outlined in the White Paper on the PRI Homepage, a number of for-profit companies are actively lobbying state workers’ compensation commissions to adopt” evidence based” treatment guidelines to combine with their drug formulary in order to regulate the treatment and medicine is given to injured workers.  These companies tout the results of their program as delivering significant cost savings.  In fact, however, these guidelines are not “evidence-based” at all but rather “cookbook medicine” designed to restrict physicians’ autonomy in deciding on proper treatment and proper medicine.

The “gold standard” for evidence-based medicine is a certification by the National Guideline Clearinghouse (NGC), an arm by the Federal Agency for Healthcare Research and Quality (AHRQ).  NGC is explained in more detail in the PRI White Paper.

New York requires that “evidence based” guidelines must receive an NGC stamp of approval.  This automatically disqualifies the efforts of a company known as ODG which refuses to submit its guidelines to NGC.  Moreover the other big player, Reed, has received NGC approval for only a few guidelines.

Requiring NGC certification will block most of the” evidence based” guidelines which are not, in fact, up to snuff.  Many medical specialty societies have guidelines that have received NGC certification.  The following is suggested language for legislative or regulatory proposals:

“(1) Treatment Guidelines means protocols suggested or required for the treatment of patients.

(2) Treatment Guidelines may be suggested or required only if they are certified by the National Guideline Clearinghouse created under the auspices of the Federal Agency for Healthcare Research and Quality (AHRQ).”

7. Prohibitions Against Financial Incentives for Utilization Review (California Senate ill 563):

California, like many states, has a law which allows employers to review proposed medical procedures for injured workers. This review process is known as “utilization review”. Senate Bill 563 was passed by the California Senate in 2015 and provides that no employer can you give a financial incentive to a “utilization reviewer” on the basis of the reviewer’s’ delay or denial of proposed therapy or procedure. Such a law helps to insure that a medical review is done on the basis of sound medical principles and not on the basis of avoiding the costs of a needed therapy. The provisions of Senate Bill 563 as introduced may be found here.

8. Regulating Step Therapy Practices of Health Insurers:

“Step Therapy” is a method that health insurers use to discourage their subscriber patients from getting the medicines that their doctor has ordered. In a nutshell, the insurer requires the patient to “fail” a number of steps (generally cheaper medicines) before qualifying for the prescribed medicine. This is particularly harmful where a patient has been well controlled on a particular medicine, changes insurance plans and then is required to “fail” on other medicines before getting back to the medicine which had been effective. Below is model legislation designed to curb and regulate the practice of step therapy.

DRAFT STEP-THERAPY MODEL LANGUAGE:

(A) The legislature finds that health insurance plans are increasingly making use of step therapy protocols under which patients are required to try one or more prescription drugs before coverage is provided for a drug selected by the patient’s health care provider.

(B) The legislature further finds that such step therapy protocols, where they are based on well-developed scientific standards and administered in a flexible manner that takes into account the individual needs of patients, can play an important role in controlling health care costs.

(C) The legislature further finds that, in some cases, requiring a patient to follow a step therapy protocol may have adverse and even dangerous consequences for the patient who may either not realize a benefit from taking a prescription drug or may suffer harm from taking an inappropriate drug.

(D) The legislature further finds that, without uniform policies in the state for step therapy protocols, patients may not receive the best and most appropriate treatment.

(E) The legislature further finds that it is imperative that step therapy protocols in the state preserve the heath care provider’s right to make treatment decisions in the best interest of the patient.

(F) Therefore, the legislature declares it a matter of public interest that it require health insurers to base step therapy protocols on appropriate clinical practice guidelines developed by independent experts with knowledge of the condition or conditions under consideration; that patients be exempt from step therapy protocols when inappropriate or otherwise not in the best interest of the patients; and that patients have access to a fair, transparent and independent process for requesting an exception to a step therapy protocol when appropriate.

(A) “Clinical practice guidelines” means a systematically developed statement to assist health care provider and patient decisions about appropriate healthcare for specific clinical circumstances and conditions.

(B) “Clinical review criteria” means the written screening procedures, decision abstracts, clinical protocols and practice guidelines used by an insurer, health plan, or utilization review organization to determine the medical necessity and appropriateness of healthcare services.

(C) “Step therapy protocol” means a protocol or program that establishes the specific sequence in which prescription drugs for a specified medical condition and medically appropriate for a particular patient are covered by an insurer or health plan.

(D) “Step therapy override determination” means a determination as to whether a step therapy protocol should apply in a particular situation, or whether the step therapy protocol should be overridden in favor of immediate coverage of the health care provider’s selected prescription drug. This determination is based on a review of the patient’s or prescriber’s request for an override, along with supporting rationale and documentation.

(E) “Utilization review organization” means an entity that conducts utilization review, other than an insurer or health plan performing utilization review for its own health benefit plans.

(A) Requirements and Restrictions. Clinical review criteria used to establish a step therapy protocol shall be based on clinical practice guidelines that:

  1. Recommend that the prescription drugs be taken in the specific sequence required by the step therapy protocol.
  2. Are developed and endorsed by an independent, multidisciplinary panel of experts not affiliated with an insurer, health plan or utilization review organization.
  3. Are based on high quality studies, research, and medical practice.
  4. Are created by an explicit and transparent process that:
    1. Minimizes biases and conflicts of interest;
    2. Explains the relationship between treatment options and outcomes;
    3. Rates the quality of the evidence supporting recommendations; and
    4. Considers relevant patient subgroups and preferences.
  5. Are continually updated through a review of new evidence and research.

OPTIONAL SECTIONS – May be added to provide additional oversight.

(B) Certification. An insurer, health plan, or utilization review organization shall certify [annually in rate filing documents submitted to the DOI] that the clinical review criteria used in step therapy programs for pharmaceuticals meet the requirements set forth in this Act.

(C) Review. Proposed clinical review criteria will be submitted to [the state department of insurance for review (where such department is equipped to conduct such review)] and must receive approval or accreditation prior to implementation.

(A) Exceptions Process. When coverage of a prescription drug for the treatment of any medical condition is restricted for use by an insurer, health plan, or utilization review organization through the use of a step therapy protocol, the patient and prescribing practitioner shall have access to a clear and convenient process to request a Step Therapy Exception Determination. An insurer, health plan, or utilization review organization may use its existing medical exceptions process to satisfy this requirement. The process shall be made easily accessible on the insurer’s, health plan’s, or utilization review organization’s website.

(B) Exceptions. A step therapy override determination request shall be expeditiously granted if:

  1. The required prescription drug is contraindicated or will likely cause an adverse reaction by or physical or mental harm to the patient;
  2. The required prescription drug is expected to be ineffective based on the known relevant physical or mental characteristics of the patient and the known characteristics of the prescription drug regimen;
  3. The patient has tried the required prescription drug while under their current or a previous health insurance or health benefit plan, or another prescription drug in the same pharmacologic class or with the same mechanism of action and such prescription drug was discontinued due to lack of efficacy or effectiveness, diminished effect, or an adverse event;
  4. The required prescription drug is not in the best interest of the patient, based on medical appropriateness.
  5. The patient is stable on a prescription drug selected by their health care provider for the medical condition under consideration.

(C) Effect of Exception. Upon the granting of a step therapy override determination, the insurer, health plan, utilization review organization shall authorize coverage for the prescription drug prescribed by the patient’s treating health care provider, provided such prescription drug is a covered prescription drug under such policy or contract. An exception shall remain valid for a period no less than one year from the date of approval. Once an insurer, health plan, or utilization review organization approves the exception, they shall not retroactively deny coverage for the approved prescription drug.

(D) Limitations. This section shall not be construed to prevent:

  1. An insurer, health plan, or utilization review organization from requiring a patient to try an AB-rated generic equivalent prior to providing coverage for the equivalent branded prescription drug;
  2. A health care provider from prescribing a prescription drug that is determined to be medically appropriate.

OPTIONAL SECTION
(E) Review. Each health insurer shall maintain written or electronic records and data sufficient to demonstrate compliance with the requirements of this section and on an annual basis submit to the [Insurance Commissioner], the following information with respect to requests made under paragraphs (B) and (C):

  1. The total number of requests received;
  2. The number of requests approved and denied; and
  3. Any other information the [Insurance Commissioner] may request.
(A) Notwithstanding any other provision of state or federal law, an entity licensed in this state to sell a health insurance or health benefits plan directly to a consumer shall ensure that where step therapy protocols are used to impose clinical prerequisites for coverage of prescription drugs, such drugs shall be available to the consumer at the preferred cost-sharing level for the item once the clinical prerequisites have been satisfied.

(B) This section shall not be construed to prevent insurers from using tiered copayment structures.

Notwithstanding any law to the contrary, the [Division of Insurance] shall promulgate any regulations necessary to enforce this Act.
This Act shall apply only to a health insurance and health benefit plans delivered, issued for delivery, or renewed on or after January 1, 2017.

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