MMS Testimony Concerning Proposed Amendments to 105 CMR 700.000

To Implement Changes in the Prescription Monitoring Program (PMP) of the Department of Public Health

The Massachusetts Medical Society (“MMS”) appreciates the opportunity to comment on the latest adaptations to the regulations of the Prescription Monitoring Program (“PMP”). The MMS strongly supports effective efforts to limit prescription drug abuse and diversion and to improve collective efforts by physicians, pharmacists, dentists, physician assistants, nurse practitioners, patient advocates and state agency staff to improve patient care while maintaining access to necessary medication.

The MMS remains concerned that the Department’s proposed regulations do not fully reflect the advice, findings, issues and concerns of the statutorily required broad based policy group  the Department established last year. Recent meetings of the group have made significant progress in identifying issues and solutions on complex issues. Given the complexity of the issues and the need for Massachusetts specific data on the impact of prescribing on opioid addiction and overdose, the MMS feels that the proposed regulations go too far in many areas where a more measured, evidence based  approach is warranted.

This testimony is organized by specific topics reflected in the proposed regulations.

1. The regulations require PMP participants to utilize the PMP prior to issuing a narcotic in schedule II or III or a benzodiazepine for the first time.

Comment: The MMS believes that the PMP is a tool that should be available for use by prescribers and dispensers at their professional discretion. The primary purpose of creating a database and funding a state agency to operate the database is to allow analysis of data on a large scale to identify individual patients, prescribers and dispensers with potential issues, not to enlist all prescribers in screening all patients about to receive opiate and benzodiazepine prescriptions. 

The MMS accepts that in the current climate and given the statutory language passed in 2012 and 2013, the Department is required to craft regulations on first time narcotic prescriptions and on exceptions to those requirements. However, the statutory language does not mandate benzodiazepines and any other drug named by the Department be treated identically. In fact, the language of the statute, allows inclusion by the Department of “benzodiazepines or any other schedule IV or V prescription drug, which is commonly abused and may lead to physical or psychological dependence or which causes patients with a history of substance dependence to experience significant addictive symptoms”.

The MMS suggests that the Department start its mandatory PMP use with opiates, see whether its computers will tolerate the increased demand on access to its database, see the clinical impact of the program on opiate overdoses and addiction and see whether there is a detrimental impact on the treatment of patients first. During this assessment period, the DPH could review Massachusetts specific data to determine whether benzodiazepines are commonly abused in Massachusetts to the extent necessary to require mandatory PMP participation by prescribers.

The legislative language suggests research and a finding before mandating the use of clinical time to review the PMP database. The MMS suggests the process outlined for establishment of an advisory group be utilized before adding benzodiazepines or any drug to the PMP mandatory review process. Additionally we suggest that more specificity is needed in the makeup and role of the advisory group used to determine what drugs must be included. Representatives named by the Massachusetts Medical Society, other organizations representing clinicians and patients must be specified as the majority evidence evaluators and decision makers in this process. If each lookup takes 3 to 7 minutes, mandates should not be expanded lightly or in response to non-clinical factors.

2. The regulations create exemptions for when the PMP does not have to be utilized, as required by statute.

Comment: The MMS strongly supports the expanded exemptions the Department has included over prior drafts of its regulations. For example:

Hospice Patients
The MMS strongly supports the Department’s recognition that hospice patients frequently are prescribed narcotics and do not present the same issues as other patients. The MMS suggests that this category be expanded to include all oncology patients and patients diagnosed with terminal illnesses. Many patients do not enter hospices or do so only for brief periods. In order to make this exception meaningful to many patients and prescribers, the Department should expand the categories in ways that are logically consistent with its intent in exempting hospice patients.

Exemption of small amounts
The MMS supports the exemption of small amounts of drugs prescribed in emergency departments. The PMP remains a valued tool in emergency departments in assessments of patients. The Department should also exempt other physicians who prescribe less than five days’ supply of a particular drug as well. Under the proposed regulations a primary care physician who has known a patient for twenty years would be required to look them up prior to prescribing a one day benzodiazepine prescription for an individual with claustrophobia for whom the physician ordered an MRI. A surgeon prescribing a one day treatment prior to arrival for minor surgery would face similar requirements.  Requiring a look up in such a situation makes no clinical sense and would have no real impact on the volume of prescription drugs dispensed in the Commonwealth. Perhaps the regulations could exempt all physicians prescribing one five day or less course of treatment for an established patient. A second prescription within the year could require the lookup.

Emergency Care
The MMS supports exemption of the use in emergencies but suggests the language be amended to situations where patient harm could result rather than the current requirement that harm would result.

Inpatients
The exemption of inpatients is consistent with the law as argued by the MMS in our testimony last year. The MMS greatly appreciates this change in the proposed regulations.

Immediate Treatment
The MMS supports the exemption of immediate treatment quantities and suggests that it is consistent to exempt the short term prescription for all physicians as requested above as well as exempting the practitioner who actually hands out the drugs.

Impossibility
The MMS supports the exemptions for instances in which it is not possible to utilize the program. The primary role of physicians is the care of patients and physicians who engage in proper clinical care but who cannot do so and utilize the PMP should not be subject to review, discipline or criticism.

Children under 48 Months
The MMS supports an exemption for physicians prescribing for children under 48 months of age. It is not clear why 48 months is appropriate rather than 96 months or some older age. Also addiction issues and side effects are different for children from adults. We suggest review of the clinical data and deference to the American Academy of Pediatrics on this issue. Clearly pediatricians are well aware of the role of parents in drug seeking behavior with injured children and will use their discretion in reviewing both the data on a patient and parent or guardian. The Department should also consider the fact that pediatricians may have strong clinical reasons to look up parents and other individuals who are not their patients. 

Waivers
The MMS supports the provision of waivers for those unable to meet the requirements of the regulations. The last thing the Commonwealth needs is to remove access to care from physicians who for financial or other reasons cannot participate in the program. To remove a physician from prescribing practice who has no history of complaints, substandard care or overprescribing simply because of non-compliance with the proposed regulations is detrimental to the public health and a waste of human resources. The waiver provisions should be available to anyone who formally requests such a waiver during the initial year of the program’s mandate. Thereafter, the Department should include all of the criteria currently listed and an open discretion of the Department. The Department has the ability to have its medical advisory group review the prescribing history of those requesting waivers and determine whether their level of activity warrants a waiver. 

Waiver Appeals
The regulations should specify to whom a waiver appeal may be made and should provide due process given the impact on a prescriber’s professional life if a waiver is denied.

3. The regulations allow account holders to authorize support staff as delegates.

Comment: The MMS strongly supports the use of delegates to make the PMP an efficient clinical tool. We strongly support recent discussions at the best practices group meetings to determine how individual staff at licensed facilities and in physician groups could be designated to do batch look ups or individual look ups for all scheduled appointments in a day or could be assigned to handle emergencies or unscheduled visits. The original requirements in prior editions would have required each prescriber to have dedicated delegates who could only look up their patients. The MMS appreciates the recognition of DPH staff in recent discussion that such a system is unworkable.

We strongly support the designation of as many delegates as needed by practitioners as simply as possible. The section of the regulations on Delegate Sub-Accounts should be rewritten to allow individuals to be delegates for multiple prescribers at the same time and to run one batch look up for a facility’s or practice’s patients regardless of the number of prescribers involved. The regulations create an intimidating and cumbersome process as written to protect against confidentiality breaches which are theoretical and are subject to severe penalties under state and federal law already. For example, requiring notice within one day to the Department of the departure of a delegate from a site seems unnecessarily short as a time frame.

4. The regulations provide for disciplinary suspensions of the right to prescribe by the Department

Comment: New language in the proposed regulations devotes two pages to how the program will work and three pages to grounds for revocation of registrations and disciplinary actions towards physicians, nurse practitioners, dentists, physician assistants, and podiatrists. There is no statutory basis or legal precedent for the Department or the Drug Control Program having any authority or ability to deny a fully licensed prescriber the right to practice under their state license. The Department is clearly overreaching and heavy handed in its listings. The Drug Control Program has no investigative staff, hearing officers, subpoena powers, or governor appointed board with authority to find facts and make determinations of law. The MMS strongly suggests that any violations of its program rules must be referred to an appropriate licensing agency for determination of facts and issuance of sanctions. The outlined hearing process contains no evidentiary standards and requires that if the hearing officer appointed by the Commissioner “finds any single ground for revocation, suspension, or refusal to renew any registration, the Presiding Officer shall render a decision affirming the action initiated by the Department.” Thus the Department dictates even to its own appointees the predetermined outcome of any appeal.

With only these appeals processes, to deny a physician the right to issue prescriptions based on a staff finding that the physician may have “used the online prescription monitoring program system, or prescription data derived therefrom, in a manner inconsistent with the terms and conditions for such use” is beyond draconian. This isn’t limited to a regulatory violation but to staff dictated “terms and conditions”. It is neither necessary nor appropriate for the Department to take these powers on for itself.

This section should be substantially reduced to require referral of significant violations to the appropriate licensing boards.

5. The regulations reference the use of audits

Comment:
We appreciate the decision of the Department to delete the following language contained in its prior proposed regulations: “Usage of the MA Online PMP is recorded and monitored and that your right to use the system may be revoked at any time at the discretion of the Department.” However the proposed regulations still reference system audits as an initiating source of disciplinary actions. The MMS suggests that the Department should utilize its limited staff and resources to working with the Medical Review group to review data in a manner consistent with the primary purpose of the prescription monitoring program. That is, for the Department to monitor prescribing and dispensing activity using clinical expertise to detect potential doctor shoppers, fraudulent prescribing and other sources of drug diversion to provide law enforcement, regulatory agencies, prescribers and dispensers with prescribing information to help inform their professional decisions and actions. The value of the Department’s use of resources to auditing whether prescribers have utilized the system when writing a prescription is certainly something that has never been demonstrated to our knowledge. The MMS urges the Department not to follow this punitive and intimidatory model.

6. The regulations do not completely recognize the automatic registration mandate

Massachusetts General Laws Chapter 94 C Section 7A states: “Upon obtaining or renewing a registration under section 7, a practitioner who prescribes controlled substances shall automatically and without further action be registered as a participant in the prescription monitoring program established in section 24A. The department shall provide each participant with a unique user name and access code for the program. For the purposes of this section, a practitioner shall not include a veterinarian.”

As noted in our testimony on the withdrawn prior regulations, the Department’s proposed regulations directly conflict with specific state law passed at the request of the MMS. 

The Department’s proposed prior regulations both then and now state:

(1) Effective January 1, 2013, every practitioner except a veterinarian who holds a valid Massachusetts Controlled Substance Registration will automatically, in a manner and schedule determined by the Department, be granted authority to utilize the prescription monitoring program, as established pursuant to 105 CMR 700.012(F).

The MMS appreciates that the Department has dropped additional language from the prior proposed regulations mandating that participants in the program “must accept the Terms and Conditions of use for the prescription monitoring program”.

The MMS suggests that the bolded language above be dropped as well. 

We recommend that the Department follow state law and automatically issue registrations and access codes to all practitioners with prescribing and dispensing authority. 

7. Prior Applicability to Physicians, Dentists and Podiatrists only

Comment: The MMS strongly supports the Departments inclusion of all prescribers except veterinarians in the program. 

8. The Problem in Massachusetts

Massachusetts law gives the Department the responsibility and authority to determine, within certain limits, when the PMP should be used and not used. The MMS is very concerned that 688 Massachusetts residents died from opiate overdose in 2012, and more than 200 additional lives have been lost just since November of 2013. More needs to be done to save lives and we applaud the provisions relating to naloxone use in the regulations and in the efforts of the administration. 

More needs to be done with Massachusetts specific data to establish the connection between prescribed drugs and opioid overdoses and addiction. While such a connection is intuitive and supported by anecdotal evidence, more needs to be done to investigate the sources of misused prescription drugs in Massachusetts. In a 2013 study by the Trust for America’s Health, Massachusetts was one of four states that Scored Nine out of 10 for Promising Strategies to Help Curb Prescription Drug Abuse and ranks 32nd in its drug overdose mortality rate. Massachusetts sales of prescription drugs were below the national average and our non-medical use was also below average.  Only two states, New Mexico and Vermont do more than Massachusetts to combat prescription drug abuse. This study is available through the Robert Wood Johnson Foundation. Given these rankings, where is the data to show that the proposed requirements on prescribers are necessary or will be effective?

In recent CDC reports, Massachusetts ranked in the top 10 in prescribing long-lasting painkillers, but ranked low, 41st1 nationally, in overall prescribing of opioids.  Massachusetts has been ranked, prior to the current proposed regulations, in the top ten nationally in the comprehensive measures enacted to oversee prescribing.

It is not clear that the PMP in Massachusetts has the technical capacity to handle inquiries from a hundred or a thousand participants at one time. It is not clear that the database is complete or accurate or how the information in the database should impact clinical decision making. The MMS suggests that the Department continue to work with its advisory group, medical researchers and other potential parties to design a more efficient model prior to seeking to impose mandatory data reviews on all prescribers for opioids, benzodiazepines and any other drug of concern to the Department.

Closing

One of the most difficult tasks for a physician in patient care is balancing the alleviation of pain and the risks of addiction. Distinctions must be made between chronic pain and acute and terminal pain, and we must recognize that patients who experience severe pain still require treatment and should be able to get relief.  A critical need in fighting the opiate abuse problem is getting better data.  We should know the sources of the drugs – how many come from prescriptions, how many from thefts, how many are diverted from home medicine cabinets – to develop appropriate responses. 

More than 20 years ago, the MMS helped to establish the state’s Prescription Monitoring Program (PMP).  It is one of the best available tools to fight prescription drug abuse.  The experiences of New York and Tennessee,2  which saw 75 and 36 percent drops, respectively, in patients seeing multiple prescribers after instituting monitoring, are testimony to the effectiveness of such programs. 

A well-run PMP has four purposes: (1) identifying patients who get schedule II and III prescriptions from multiple doctors; (2) identifying prescribers who inappropriately write many prescriptions or write prescriptions for high dosages; (3) providing a clinical review of those patients and prescribers, to determine what interventions might be necessary; and (4) facilitating research in discovering trends, practices, and problems.

To achieve those advantages, however, all prescribers must participate, and the program must accommodate real-time data. 

We also believe DPH should resurrect its medical review board, created as part of the original PMP but subsequently underutilized.  This board can initiate and approve research as well as determine patterns that may indicate abuse and propose needed interventions and refer such activity to appropriate licensing boards.    

Some caution, however, is warranted. While a monitoring program can be a powerful tool, it should not become a barrier to the practice of good medicine or access to comprehensive care. 


  http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6326a2.htm?s_cid=mm6326a2_w

2  http://www.cdc.gov/vitalsigns/opioid-prescribing/infographic.html#infographic2

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