The MMS strongly supports the availability of an efficient and accurate prescription monitoring database to prescribers and dispensers in Massachusetts. We strongly support initial regulations which call upon physicians to use their professional judgment and access the PMP when there are indications that it may have value in preventing drug abuse and improving care. We strongly support the meaningful outreach of the Department to convene its advisory boards to craft specific means to address opiate abuse. We strongly urge the Public Health Council to send these proposed regulations back for further refining, preferably until the work of the legislatively mandated joint policy working group has been done.
The proposed regulations and the existing prescription monitoring program (PMP) are quite extensive and their potential impact on providers and patients is varied. This testimony will work through specific provisions of the proposed regulations and relevant statutes in great detail with a hope that the full impact of the regulations as drafted will become clear and the rational basis for proposed alternative approaches will significantly influence the final outcome of the hearing process.
To that end, the MMS offers the following comments and concerns:
Legislative Language in Chapter 244
Section 8 of Chapter 244 of the Acts of 2012 states: "The department, in consultation with all relevant licensing authorities, shall promulgate regulations that require participants to utilize the prescription monitoring program prior to seeing a new patient, including circumstances where participants would not be required to utilize the prescription monitoring program prior to seeing a new patient;".
Section 21 of the act requires the establishment of a broad based policy group by the Department to advise it. It further requires:
"The commissioner, after reviewing the policy working group's findings and recommendations, shall promulgate regulations relative to safe and responsible opioid prescribing and dispensing practices with the goal of reducing diversion, abuse and addiction and protecting access for patients suffering from acute and chronic pain not later than 6 months after the joint policy working group submits its report."
DPH Responses to Chapter 244
To date this group has not been formed and proposed regulations were brought forward with little or no consultation with the PMP Advisory Council, Medical Review Group, relevant licensing Boards, or the thousands of physicians and dentists these regulations affect, regarding how the PMP may be improved.
The primary proposed regulatory approach of the Department to the mandate of section 8 above to develop regulations on when the PMP should be utilized and not utilized is the following:
"A participant, including an attending physician in a hospital or other inpatient facility, must utilize the prescription monitoring program prior to seeing a new patient. Compliance with this provision shall be met by a review of the most recent 12-month prescription history of the new patient."
Issue by Issue Review of the Proposed Approach
Application of the PMP to Inpatients
Chapter 244's language, quoted at the top of the page, does not mention inpatients and attending physicians. Existing law governing the PMP. Chapter 94C Section 24A contains the following exemption "(b) The requirements of this section shall not apply to the dispensing of controlled substances to inpatients in a hospital."
The PMP has never involved inpatient services because inpatients receive hospital orders which are not recorded by the PMP which only records prescriptions filled by pharmacies by outpatients. Nothing in the logic or specific language of Chapter 244 warrants the Department's requirement that all attending physicians are subject to the provisions of the PMP. The approach of the Department in this matter is a good example of the disconnect that has been made in the regulations between prescribing and participation in the prescription monitoring program and between statutory language and the proposed regulations.
Recommendation:
The MMS suggests that all references to attending physicians and inpatients be deleted from the proposed regulations.
Applicability to Physicians, Dentists and Podiatrists only
The Regulations place the responsibility to review the PMP records prior to seeing a new patient on "participants".
The regulation's definition is: "Participant means a registered individual practitioner or other person who is duly authorized to prescribe or dispense a controlled substance by a Massachusetts Board of Registration and is authorized by the Department to utilize the prescription monitoring program."
A footnote of a briefing to the Public Health Council states: "Practitioners who prescribe controlled substance drug products in Schedule II-V are physicians, dentists and podiatrists. The Department will soon analyze the policies and operations for automatically enrolling mid-level prescribers and pharmacists."
Massachusetts does not limit the schedules for which NP's and PA's may prescribe drugs. Nothing in Chapter 244 differentiates among participants in the PMP in a way that supports the DPH's exclusion of mid-level practitioners.
Certainly there is no rational reason to require a physician to look up a pediatric patient but not require a nurse practitioner to look up a pain clinic patient. The proposed regulations apply to participants in the PMP. The proposed definition of participant above apparently allows the Department to decide among professions and even among individuals within the same profession the applicability of the law to them. So physicians whom the Department has not enrolled in the PMP don't have to use it. If the Department decides not to enroll nurse practitioners, then they don't have to use the program. If the Department decides not to enroll pharmacists then they don't have to use the program. The logic is circular here.
There are statutory provisions in Chapter 94C Section 7 which require the Department to register NP's and PA's as drug prescribers and dispensers. If the statute requires registration and the language from the regulations above applies to those "registered" and duly authorized to prescribe and dispense, then the decision not to apply its regulations to NP's and PA's seems to be solely based on the Department's decision not to "authorize" NP's and PA's to participate. This makes no sense given that nationally in 2009 NP's and PA's prescribed 7.5% of all opioids (FDA, SDI; Vector One, extracted June 2010).
The language of Chapter 244 Section 1 amends Chapter 94c to state:
"Section 7A. 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."
There is no exemption in this new statutory language for any prescriber except veterinarians. Therefore the MMS suggests that Nurse Practitioners and Physician Assistants be included in the final regulations. We have attached excerpts from the existing law to show how NP's and PA's qualify as registrants under section 7.1
Recommendation:
The MMS suggests that the regulations, regardless of their final format, be clarified to apply to all prescribers except veterinarians.
Definition of a new patient
The proposed regulations define a new patient as one who has not been seen in the preceding 12 months by the practitioner. The MMS suggests this is an unreasonable definition. For example, long standing patients of a physician or group are not covered for preventive visits more than once in a 12 month period. As written, this period would make the regulations apply to virtually all patients and contradicts the plain meaning of the word new.
Recommendation:
The MMS suggests the definition of "new patient" be consistent with the Medicare's definition of "having not received any professional services from the physician/non-physician practitioner (NPP) or another physician of the same specialty who belongs to the same group practice within the previous three years."
Application of proposed regulations to all new patients
The MMS has the strongest of objections to the basic approach of the DPH in applying the legislative mandate to create regulations on use and non-use of the program for new patients to all patients and then working backwards by creating exemptions. This approach shows a lack of focus in the regulations and a lack of understanding of the value of time during a physician patient encounter or of the appropriate use of support staff in efficiently facilitating patient visits.
The MMS has reviewed data from the National Alliance for Model State Drug Laws regarding PMP's in other states. Virtually every state has a PMP but MA is one of only 12 states to require access to the program under certain circumstances. Most states recognize that the PMP is a valuable tool which providers will use if it is made readily available. Most states recognize that the PMP gives state agencies the power to review data in the aggregate, not one patient at a time, and address patterns of abuse in regions, among provider groups and among specific patients.
No state other than Massachusetts disconnects use of the PMP from actual prescribing actions and requires review of all patients. No state should require review of the PMP for infants but Massachusetts proposes to do so. No other state would require review of all geriatric patients regardless of the purpose of a visit. No other state would suggest that a radiologist with prescribing authority should look up a patient prior to discussing with that patient the interpretation of x-rays and a possible cancer diagnosis. The examples are endless.
Recommendation:
The MMS suggests the Department eliminate its approach of presuming all new patients should be reviewed prior to a visit and adopt specific criteria which are related to addressing prescription drug abuse as the elements of when the PMP must be utilized.
Other State Approaches Respect-Professional Judgment
As noted above, about 11 other states have mandates regarding use of the PMP.
Nevada requires review of new patients' PMP reports "before writing a prescription for a controlled substance when " the prescriber has a reasonable belief that the patient may be seeking the controlled substance, in whole or in part, for any reason other than the treatment of an existing medical condition."
This approach, and a similar approach in Delaware is reasonable in that it does not require meaningless administrative activity and review of reports with no entries regarding controlled substances on patients with visits which anticipate no prescribing of controlled substances.
Ohio requires if "a physician believes or has reason to believe that a patient may be abusing or diverting drugs, the physician shall use sound clinical judgment in determining whether or not the reported drug should be prescribed or personally furnished to the patient".
Other State Approaches Focus on Drugs which are causing significant public health problems
Kentucky requires review prior to the initial prescribing or dispensing of a Schedule II or III drug containing hydrocodone.
Louisiana requires medical directors of pain management clinics to use the PMP as part of a quality assurance program.
North Carolina requires medical directors of opiod treatment programs to use the PMP.
Oklahoma requires use of the program in methadone programs.
West Virginia requires use of the program for initial prescribing to patients receiving "pain-relieving controlled substances as part of a course of treatment for chronic, nonmalignant pain but who are not suffering from a terminal disease."
The Exemption Approach
New York has new rules which will require review prior to prescribing but exempts most patients by exempting supplies under 5 days, hospice patients and issues of access and priorities in patient care.
The Massachusetts Approach of Making Physicians Review the Data for the DPH is Unwarranted Given Our Statistics and Resources
As noted above, Massachusetts law gives the Department the responsibility and authority to determine, within certain limits, when the PMP should be used and not used. The proposed approach to use it all the time and carve out specific exemptions and waivers suffers by comparison to the approaches in other states. Massachusetts in CDC data ranked in the lowest category, with 11 other states, for the rate of prescription painkillers sold per 10,000 people in 2010. Our rate is less than half that of states with significant problems such as Florida.2
Massachusetts has significant Medicaid participation and has active managed care organizations and insurers with prior authorization processes which significantly impede overprescribing and dispensing of narcotics. Massachusetts has large provider groups and HMO's with electronic medical records which include all prescriptions written and dispensed as part of the patient's participation in the group or HMO. These records are routinely reviewed as part of medication reconciliation processes in most patient visits. In most cases the PMP data is far less accurate and comprehensive than the data already in use in Massachusetts.
The PMP database is underutilized by its staff according to its own reports to the Public Health Council.
"In CY 2011, over 460 case reports were provided to investigative agencies, mostly in response to requests for information in support of ongoing investigations."
"MA PMP data indicated that in CY 2011 over 17,600 individuals showed questionable activity for Schedule II -V opioids and over 11,000 showed such activity for Schedule II opioids alone"
"In CY 2011, DCP issued 845 reports to prescribers concerning 25 patients"
The PMP notified prescribers and pharmacists on .2% of the potential problem patients it had identified itself. It does little to reach out as required to licensing boards to alert them of questionable activity by prescribers and pharmacists.
Recommendation:
The MMS recommends that the Department delete Section H of its proposed regulations and replace it with a requirement that is focused on review of new patients when, in the prescriber's sound clinical judgment the patient may be seeking drugs for illegitimate purposes .
Advisory Group
Section 21 of Chapter 244 creates an advisory group and requires the following:
"The commissioner, after reviewing the policy working group's findings and recommendations, shall promulgate regulations relative to safe and responsible opioid prescribing and dispensing practices with the goal of reducing diversion, abuse and addiction and protecting access for patients suffering from acute and chronic pain not later than 6 months after the joint policy working group submits its report."
Clearly the legislature anticipated that the Department would form this advisory group more expeditiously than has occurred. The group has not been formed as of the writing of this testimony although initial efforts to form the group occurred this month. The MMS suggests that initial regulations should focus on professional judgment and that the next round of regulations should specifically address opioid issues in a manner that is consistent with current medical standards.
Recommendation:
The MMS strongly recommends initial regulations wait until the advisory group is formed, engages in significant work and research and proposes new regulations or that initial regulations reflect the prior suggestion of professional judgment as the initial determiner of program use.
The Waiver Process
As noted, the MMS strongly opposes the proposed approach to mandate program use all the time with new patients, regardless of whether prescriptions are anticipated. The regulations propose a waiver system that is administratively burdensome and unnecessarily costly to physicians, the Department and the health care system. The regulations require the use of the system but appear to allow for only formal requests, even for circumstances where the system is down or patients would be harmed by the delay entailed in accessing the system. The proposed regulations state:
"The Department may waive the requirements established in 105 CMR 700.012(H)(1) for a participant who submits a request in a manner and form determined by the Department, if the Department determines that a waiver is appropriate based on the criteria listed in 105 CMR 700.012(I)(2)."
The criteria established in 700.012(1) (2) include:
"d) An instance in which it is not reasonably possible to utilize the prescription monitoring program, including when the system is not operational due to temporary technological or electrical failure;
(e) An instance in which acute care is required and utilization of the prescription monitoring program would result in patient harm;"
Does the Department really mean to require a formal waiver for each instance of a participant's non-compliance with the regulations? Is this intended to be situational or is the Department envisioning a system based waiver process whereby a statewide medical specialty society or large group practice applies for a permanent waiver? The Department does not seem to be crediting the legislative intent of specifying when the PMP does not have to be used.
The Waiver Criteria
"A request for a waiver of the requirements in 105 CMR 700.012(H) (1) shall include a description of the following:
(a) The participant's history of compliance with laws and regulations related to controlled substances;
(b) A substantial hardship created by a natural disaster or other emergency beyond the control of the participant;
(c) Technological limitations not reasonably within control of the participant; and
(d) Temporary technological limitations within the control of the participant that will be rectified within six months."
Clearly the Department envisions a lengthy, cumbersome and little used process for waivers. Also the Department, in its small business impact statement, has not covered the possibility that mandated availability of secure internet access may require investments on the part of providers.
Recommendation:
The MMS recommends that the Department delete sections (H)(2) and (I) and come up with narrow and focused criteria for use of the program and comprehensive automatic exemptions for large areas of patient care where use of the program is not clinically indicated.
Delegation of Sub-Accounts
This is a major issue. Here again the Department is creating a bureaucratic process which wastes resources for no discernible purpose. Chapter 244 states that Department regulations shall include: "a requirement that allows authorized support staff to use the prescription monitoring program on behalf of a registered participant."
The approach of the proposed regulations is to interpret "authorized" to mean individually authorized by the Department in a formal process allowing each individual registered physician in the program to have no more than two support staff eligible to use the program on behalf of that physician.
Here is the proposed language: "A primary account holder may submit a written request to create sub-accounts, in a manner and form determined by the Department, for up to two delegates to utilize the prescription monitoring program on behalf of the primary account holder. An individual eligible to be a primary account holder may not be a delegate."
The application of such a rule would be extremely inefficient. Take for example a group of six pediatricians who anticipate using two support staff to review PMP records prior to pediatric visits for new patients. Under the vision of the DPH, it appears that each physician would have to apply in writing to the Department to create sub-accounts for the same support staff. Thus the DPH would receive 12 written applications to authorize two support staff in one small group. Apparently the DPH vision would be that each support staff would log in and log out for each physician's patients under that subaccount rather than logging in once to review all new patients for the group. No provision is apparently made for substitutes. A physician who works in two sites could apparently only have one sub-account per site with one staff person. A physician who works in three or more sites could have no staff support in some sites.
A physician may only look up his or her own patients. Why can't a physician in a small practice look up another physician's patients to assist his colleague if support staff is unavailable or their applications are pending at the DPH?
Why aren't HIPAA requirements sufficient to protect the PMP data, which for the vast majority of the patients in many specialties will contain few or no recent entries? The DPH makes PMP data available to law enforcement staff without registration. Why couldn't the DPH simply remind physicians that PMP data is patient specific and must be treated similarly to any medical record and that failure to follow the law in this matter may be referred to the Board of Medicine for further action?
Recommendation:
The MMS recommends that section (J) on delegate sub accounts be struck and that language inserted reminding practitioners that in authorizing review of the PMP database by their support staff, practitioners are responsible to their licensing agencies for violations of patient confidentiality.
Further Issues In DPH Actions
Automatic Registration in the PMP
In response to MMS concerns expressed to legislators that the Department's process to allow access to the PMP was cumbersome and bureaucratic, language was included in the first section of Chapter 244 which states the following:
"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."
The Department's proposed regulations 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).
(2) To complete a Massachusetts Controlled Substance Registration, a practitioner must accept the Terms and Conditions of use for the prescription monitoring program."
Clearly there is a significant difference between the legislative intent to require action on the Department's part to simplify enrollment for practitioners and the Department's regulatory language. The Department has, even prior to the public hearing on the regulatory language above, recalled some drug registrations and required extensive attestations by physicians that they accept conditions connected to the PMP as part of the drug registration process. One example of the many requirements in the Department's newly revised drug registration application includes the following statement to which physicians must assert their agreement:
"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."
The MMS is concerned that legislative mandates for the Department to step up and assist participants in accessing the PMP database have been ignored. Instead the Department is asserting the ability to set requirements and to discipline physicians with no statutory basis.
If a drug registration is revoked, a DEA license will quickly follow. The MMS strongly objects to the Department's assertion of its authority to effectively put a physician out of practice, without any specific due process protections or limit on the criteria the Department may chose to include in future actions. The Department has neither the resources nor the experience to engage in actions which remove licensed practitioners from treating patients and they should not venture into this complex area with so little statutory or regulatory basis.
Recommendation:
The MMS strongly recommends that the Department immediately reverse its current practice of linking drug registration with requirements for participation in the PMP. We further recommend that the Department immediately issue registrations and access codes to all practitioners with prescribing and dispensing authority. The Department should work with licensing boards on amendments to their regulations which assert specific patient confidentiality protections for the PMP data in clinical practice and which will enlist the disciplinary resources of licensing Board's in enforcing patient protections.
Conclusion
The MMS greatly appreciates the devotion of the time volunteer members of the Public Health Council will spend in reviewing the proposed regulations and the comments of the public. We respectfully request the hearing officers to provide the full MMS testimony to the members of the Public Health Council well prior to their scheduled vote on the final regulations. We look forward to working with the Department and the Patrick Administration on establishing a PMP that is effective and efficient.
Notes
1 Chapter 94C contains provisions for registration by the Department. These are listed here with excerpts.
"Section 7. (a) Except in the case of a pharmacy or wholesale druggist, every person who manufactures, distributes or dispenses, ….any controlled substance within the commonwealth shall upon payment of a fee, ….register with the commissioner of public health, in accordance with his regulations, said registration to be effective for one year from the date of issuance………
… The commissioner shall promulgate regulations which provide for the registration of nurse practitioners and for psychiatric nurse mental health clinical specialists, as defined in section eighty B of chapter one hundred and twelve, to issue written prescriptions for patients pursuant to guidelines mutually developed and agreed upon by the nurse and supervising physician.
The commissioner shall promulgate regulations which provide for the registration of certified nurse-midwives, as provided in section 80C of chapter 112, to issue written prescriptions in accordance with regulations under said section 80G of said chapter 112.
Specific Registration Requirements for NP's
Chapter 94C
Section 7. (a) Except in the case of a pharmacy or wholesale druggist, every person who manufactures, distributes or dispenses, or possesses with intent to manufacture, distribute or dispense any controlled substance within the commonwealth shall upon payment of a fee, the amount of which shall be determined annually by the commissioner of administration under the provision of section three B of chapter seven, register with the commissioner of public health, in accordance with his regulations, said registration to be effective for one year from the date of issuance…
The commissioner shall promulgate regulations which provide for the registration of certified nurse-midwives, as provided in section 80C of chapter 112, to issue written prescriptions in accordance with regulations under said section 80G of said chapter 112. Prior to promulgating such regulations, the commissioner shall consult with the board of registration in nursing and the board of registration in medicine with regard to those schedules of controlled substances for which certified nurse-midwives may be registered.
The commissioner shall promulgate regulations which provide for the registration of physicians assistants to issue written prescriptions for patients pursuant to guidelines mutually developed and agreed upon by the supervising physician and the physician assistant. Prior to promulgating such regulations, the commissioner shall consult with the board of registration of physician assistants, the board of registration in medicine and the board of registration in pharmacy with regard to those schedules of controlled substances for which physician assistants may be registered to issue written prescriptions therefore; provided, however, that a physician assistant who has not successfully passed the national certification examination for physician assistants or who does not meet all of the current requirements for obtaining an initial physician assistant's registration as listed in section nine I of chapter one hundred and twelve may not be authorized to write prescriptions under any circumstances.
Exemptions from registration:
(7) any person covered by clauses (1), (2), (3) and (5) of section eighty B of chapter one hundred and twelve when any such person is acting under the supervision of a practitioner;
Automatic Enrollment
Section 7A. 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 section24A. 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.
Mandated role of the Department
(e) The department shall review the prescription and dispensing monitoring information. If there is reasonable cause to believe a violation of law or breach of professional standards may have occurred, the department shall notify the appropriate law enforcement or professional licensing, certification or regulatory agency or entity and provide prescription information required for an investigation.
Exemption of inpatients
94C 24A
(b) The requirements of this section shall not apply to the dispensing of controlled substances to inpatients in a hospital.
2 http://www.cdc.gov/vitalsigns/painkillerOverdoses/index.html
