Testimony In Opposition to H.2009/S.1709 And H.2008/S.1081

Testimony In Opposition to H.2009/S.1709 An Act Improving the Quality of Health Care and Reducing Costs And H.2008/S.1081, An Act Relative to Certified Professional Midwives

Before the Joint Committee on Public Health

H.2009/S.1709, “An Act Improving the Quality of Health Care and Reducing Costs”

The Massachusetts Medical Society wishes to raise several points concerning House 2009 and Senate 1709 relative to their impact on the delivery of patient care in the Commonwealth. This legislation, if enacted would remove the statutory structure underlying the physician led teams that form the basis of quality health care in clinics, long term care, hospitals, surgery centers, limited service clinics, primary care office settings and everywhere that patients receive medical care. 

The primary impact of these bills would be to eliminate requirements for collaboration between the Boards of Medicine and Nursing in structuring how physicians and nurse practitioners are to integrate their practices. Advanced practice nurses would be subject solely to the oversight of the Nursing Board which is underfunded and understaffed. Recently the Nursing Board has offered regulations on the oversight of advanced practice nursing which appear to conflict with existing law regarding certification of patients for marijuana use and the ordering of tests and therapeutics. The latter provision would be enabled by the bills you are hearing today, but the Nursing Board has moved on it without legislative action. This activity by the nursing board does not support the elimination of statutory requirements for physician supervision or elimination of the role of the Board of Medicine in the practice of medicine by nurse practitioners.

Currently Nurse Practitioners must have individualized written guidelines mutually developed with their supervising physician in order to write prescriptions and must be supervised in ordering tests and therapeutics. Under regulations of the Board of Medicine a supervising physician must be “Board certified in a specialty area appropriately related to the APN's area of practice, or have hospital admitting privileges in a specialty area appropriately related to the APN’s area of practice”.

Written guidelines for prescribing supervision must “describe the nature and scope of the APN's prescribing practice.” The regulations also require supervision consistent with the nature of the nurse practitioner’s work, malpractice coverage and other patient protections.  These regulations would be eliminated if these bills pass. They are the major connection between what a nurse practitioner’s area of work is and their training. Without connection to a physician led team, as required now in law and regulations, nurse practitioners may engage in solo practice with no limits on the medical services they provide and without the resources and safety net inherent in teams. 

These bills are written to insert nurse practitioners into every part of the law where physicians are named except provisions which require specific performance or quality standards of physicians. For example, the bill would amend section 18 of Chapter 94C governing recognition of prescriptions by out of state physicians by including recognition of out of state nurse practitioners. Given the legislature’s overwhelming interest in oversight of prescriptions by in state physicians, in what way does recognizing out of state nurse practitioners who are subject to unknown standards improve quality and cost in the Commonwealth? Who benefits from these provisions other than the national nursing advocacy organizations?

Section 23 would amend provisions enacted just last year allowing nurse practitioners to sign documents requiring a physician signature. The section would eliminate limits on signatory authority that expanded scope of practice. Do we really want to replace all statutory requirements for physician review and action, without any consideration of the impact? As one example, do we want nurse practitioners to certify patients for marijuana use in spite of the specific use of the term physician in the law? 

As we move towards accountable care organizations and a team approach to comprehensive care, implementing this bill would further compartmentalize and promote the fragmented system we are striving to transition away from today. The intent of both healthcare delivery reform and alternative payment methodologies is to develop a more quality-based patient-centered delivery system that reduces healthcare-related expenditures. In order to achieve this goal, Massachusetts must shift towards providing consumer-driven care by encouraging the development of physician-led team-based care models that promote collaboration among all clinicians and staff.

Recent provisions of the affordable care act require physician oversight. For example, final federal regulations were published November 16th, 2012 to implement a provision of ACA that require orders for certain types of durable medical equipment to be written pursuant to a physician documenting that a nurse practitioner or other qualified health professional has had a face-to-face encounter with the patient during the six-month period preceding the order. Even in states that allow ANPs to practice independently, such Medicare policies reportedly pose significant barriers to care delivery, making it difficult to practice without a collaborating physician.  The rationale behind this provision is clear. The federal government believes physician oversight is a clear measure to ensure quality and control costs in an area of significant overuse of scarce resources.

The rationale behind most proposals to allow NPs to practice independently is that the nation is facing a primary care physician shortage. This is true. But substituting NPs for doctors cannot be the answer. Nurse practitioners are not doctors, and responsible leaders of nursing acknowledge this fact. Dr. Kathleen Potempa, the dean of the University of Michigan School of Nursing and president of the American Association of Colleges of Nursing told the New York Times that, “Nurses are very proud of the fact that they’re nurses, and if nurses had wanted to be doctors, they would have gone to medical school.” Nurse practitioners do not have the substance of doctor training or the length of clinical experience required to be doctors. For example, for licensure, NPs receive only 5-7 years of education compared with 11 years for a physician. Generally, NPs are trained to provide services similar to primary care physicians, though they do not complete a post-graduate residency training program and usually focus on chronic and preventive care management rather than complex diagnoses.  Nothing in the legislation before you today recognizes these limits in training and experience.

A recent presentation to the American Society for Healthcare Risk Management's annual conference included data from nearly 1,900 professional liability claims against nurse practitioners that were covered and closed between 2007 and 2011 by CNA HealthPro, a leader in providing comprehensive insurance coverage for the healthcare industry. Nearly 43% of those professional liability claims were related to diagnosis problems, such as failure to diagnose or a delay in diagnosis. 

Treatment and care management-related problems and medication prescribing issues were also prevalent in claims against nurse practitioners, representing 29.5% and 16.5% respectively of CNA's professional liability claims during the study period. Failure to diagnose infections and abscesses that led to sepsis and failures or delays in diagnosing cancer represented significant portions of claims against nurse practitioners in CNA's data. Such cases should provide a lesson in encouraging nurse practitioners to partner with other health care providers who could help identify medical conditions in treatable stages. The study concluded that APNs should be encouraged to collaborate with other health care practitioners and provided with training in certain procedures to help reduce professional liability claims against them.

Patient safety associated with the proper diagnosis from a physician is more important than the cost savings that an ANP can provide. A study from the Archives Psychiatric Nursing found that a high percentage of APN prescribers sought physician collaboration in spite of regulations allowing independent prescribing practices. Study respondents emphasized that additional educational resources were highly valued, particularly from conferences, continuing education, and drug textbooks—indicating APNs are not well trained to deliver care without supervision. 1  

APNs, through a controversial interpretation of the language of Chapter 244 of the Acts of 2012 by the DPH, are currently not required to participate in the Prescription Monitoring Program, as are physicians, despite the fact that they can prescribe opioids. These bills create no provisions for the Board of Registration in Medicine to regulate NP’s despite the fact that they will be practicing medicine with no defined limits. Nurses are not subject to the same online transparency requirements as physicians, including physician profiles.  So a patient has no ability to look up the malpractice history, disciplinary record, or education and training of an NP. Additionally, Nurse practitioners are not required to demonstrate meaningful use of electronic health records, as are physicians. Nurse practitioners are not required to have a minimum of a two year clinical residency program as are US trained physicians or a three year program as required for foreign trained medical graduates. 

The intent of healthcare delivery and payment reform models are to develop a more patient-centered approach to care while improving quality and reducing costs. This requires collaboration among all clinicians and staff to improve care within a team-based model—a team led by physicians. This bill does not foster integration and coordination but rather undermines the model of care that is patient-centered. The MMS does not support an increased scope of practice for advanced practice nurses. We believe the current laws are sufficient to support the ideal, which is team based, physician led model of health care delivery.  

The nation can fill the primary care gap through the continuing transition to team-based care in medical homes, with all health professionals playing valuable and appropriate roles. Studies show that the ideal practice ratio of NPs to physicians is approximately 4:1; with PCMHs built around that ratio, everyone can have a primary care doctor and receive the benefits of team-based care.2  The central goal of an integrated health care practice is to provide the most effective, accessible, and efficient care to the patient, based upon clinical and patient-focused outcome measures or assessments. The team member assuming lead responsibility for various aspects of patient care will ultimately be determined by matching team members’ clinical competencies and skills with patient needs. A nurse practitioner, for example, may take the lead to manage care for a patient with stable diabetes. For example, family physicians are trained to make complex diagnoses, often when a patient presents confusing symptoms. Nurse practitioners, on the other hand, are specifically trained to follow through on the treatment of a patient after a diagnosis and to implement protocols for chronic disease management. Granting independent practice to nurse practitioners would be creating two classes of care: one run by a physician-led team and one run by less-qualified health professionals. Substitution of nurses—even advanced practice nurses—for licensed physicians cannot be the answer in a system build around medical homes. 

The IOM report, Crossing the Quality Chasm, stresses that if innovative programs are to flourish, regulatory environments will be required to foster innovation in organizational arrangements, work relationships, and use of technology. Current NP laws currently lack any clear framework or congruence amongst each other. This high degree of variation suggests that the regulatory framework for APN practice is not evidence-based. Likewise, the regulatory bodies overseeing APN practice are slow or unable to keep pace with changes in health care.

Implementing this bill would undermine all legislative and regulatory efforts to promote provider collaboration. MMS believes that there is a need to help nurse practitioners and collaborating physicians to establish some protocols and guidelines as to when additional testing is needed, when they should and must collaborate, when consultations are needed. We need to be aware that changes in the law will allow nurse practitioners to work and do things that they may not have the clinical skills, experience and competency to do.3  “Maybe we need to help nurse practitioners and the collaborating physicians that they're working with establish some protocols and guidelines as to when additional testing is needed, when they should and must collaborate, when consultations are needed,” Ms. Cutler of CNA Healthcare said. “We don't always think of nurse practitioners getting involved in procedures and wounds, so we need to be aware that people are hiring these nurse practitioners to work and do things that they may not have the clinical skills, experience and competency to do.”

In summary, the MMS asks the Committee on Public Health to consider the implications of the language of these bills. This legislation does not serve the public and we ask that it not be advanced.

H.2008/S.1081,“An Act Relative to Certified Professional Midwives” 

The MMS would like to address H 2008 and S 1081 which purport to involve the Board of Registration in Medicine in the practice of midwifery by non-nurse midwives. 

These identical bills require the Board of Registration in Medicine to establish a Committee on Midwifery to license and regulate professional midwives.  As you have heard in testimony, the MMS strongly supports a role for the Board of Registration in Medicine in oversight of the practice of medical care by non-physicians.  However, only one of the eight members of the Midwifery Committee would be a physician and that physician would have no role within the Board of Medicine.  Placement in the Board of Medicine is presumably to lend credence to midwives and to use physician licensing fees to underwrite the cost of the midwifery committee. This is not responsible oversight of currently unregulated lay midwifery but is rather the legalization of practices currently prohibited in the interest of women and children.

Under the proposed law midwives would be allowed to order and interpret clinical tests and to obtain and administer certain medications. It does not require midwives to carry malpractice insurance. The DPH would be required to assist the committee in facilitating access to hospital training for approved programs. The bill refers to certified professional midwives (CPMs) -- but these individuals are in reality lay midwives with no nursing or medical training. Some states refer to them as licensed or direct entry midwives and thus avoid the implications of the terms certified and professional.  The training standards for meeting the designation as a certified professional are remarkably lower than the academic standards for training and certification of physicians, as well as for certified nurse-midwives (CNMs) and certified midwives (CM) credentialed by the American College of Nurse Midwives.  Moreover, CPM training requirements fall short of internationally established standards for midwives and traditional birth attendants.

Inadequately trained midwives should not be permitted to order laboratory tests, diagnose disease, perform surgeries (episiotomies) or surgical repair (vaginal/cervical lacerations), and provide medications (antibiotics for infections, oxytocin or methergine to stop postpartum hemorrhage). What are the standards for proposed state licensure as competent to provide midwifery services?  An individual without a high school degree could be licensed as a CPM if he or she passed the certifying exam of the newly established committee and had a certificate from the North American Registry of Midwives. The North American Registry of Midwives’ Portfolio Evaluation Process (PEP) requires training as the primary attendant under supervision of another midwife in only 20 births. The experience required also includes observing 10 births as a friend, family member etc. and 20 assisting another midwife. While the total claims to be “training” in 50 births, clearly no more than 20 have any significant role for the trainee. Keep in mind that the trainee is not being trained by an obstetrical team but by another midwife with no medical training.

The average intern in obstetrics and gynecology gets this much experience in 1 month. The bill allows the Committee to establish minimal training beyond this certificate but does not specify experience with a specific number of births. Even these minimal requirements could change by decision of NARM without legislative approval however. The curriculum, clinical skills training, and experiences of CPMs have not been approved by any authority recognized in certifying knowledge and skills associated with the practice of obstetrics, including the American Board of Obstetrics and Gynecology, the American Midwifery Certification Board (AMCB), and the American Board of Family Medicine.

CPMs have not adopted a set of criteria based on generally accepted medical evidence or public safety for patients who may be appropriate candidates for home birth, relying instead on the decision of the individual midwife and patient. 

Accredited education which meets the clinical needs of all patients and meaningful professional certification must be prerequisites of any state license. The state’s historical role protecting the health and safety of citizens must be rigorously defended and maintained, as must the state’s role in the collection and reporting of reliable, uniform, and accurate birth data.   The accurate collection and reporting of safety statistics and birth outcomes in different birth settings is critical to our ability to make progress on shared health care safety goals: to improve our monitoring of maternal and infant health outcomes and better inform prevention and intervention strategies.  The Commonwealth must not undermine the quality of health care through licensing poorly trained individuals.

The MMS respects a woman's right to choose, but also recognizes the safest location for birth is a hospital or birthing center due to the unforeseen and life-threatening crises that could cause serious injury and harm to a woman and her newborn, such as severe maternal bleeding and fetal delivery problems.  A free choice is an informed choice. By providing state licensure to untrained or minimally trained midwives, the state is inserting its stamp of approval and influencing the choice of prospective mothers in an unsafe and deceptive way. We urge the Committee not to approve House 2008 and Senate 1081.

This concludes the MMS’s testimony on these related legislative initiatives to expand the scope of practice of nurses and midwives and to reduce the prevalence of physician led teams in the Commonwealth.

1  Richens, S and Talley, S. (2001). Prescribing Practices of Advanced Practice Psychiatric Nurses: Part I—Demographic, Educational, and Practice Characteristics. Archives of Psychiatric Nursing. Vol. XV: pp. 205-213.

2  http://www.aafp.org/dam/AAFP/documents/about_us/initiatives/AAFP-PCMHWhitePaper.pdf?cmpid=npp12_ad_com_na_van_1 

3 http://www.businessinsurance.com/article/20131028/NEWS06/131029828?tags=%7C338%7C75%7C302%7C342#

4 http://www.businessinsurance.com/article/20131028/NEWS06/131029828?tags=%7C338%7C75%7C302%7C342#
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