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
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.
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.