Healthcare Alert May 2007 Author: Ruth E. Granfors +1.717.231.5835 ruth.granfors@klgates.com K&L Gates comprises approximately 1,400 lawyers in 22 offices located in North America, Europe and Asia, and represents capital markets participants, entrepreneurs, growth and middle market companies, leading FORTUNE 100 and FTSE 100 global corporations and public sector entities. For more information, please visit www.klgates.com. www.klgates.com Health Care Reform: How Much Medicine Can Pennsylvania Handle? (Part 2) Governor Rendell’s proposal, “Prescription for Pennsylvania,” highlights a three-pronged approach to reform: (1) affordability, (2) accessibility, and (3) quality. We focused our first alert in this series on a summary of the proposals the Governor has advanced as his affordability agenda. This alert will center on the Governor’s accessibility initiatives. Many of the ideas for reform are set forth in House Bill 700 (“HB 700”). We previously commented that the breadth of HB 700 would prevent its passage as a single bill. Predictably, portions of the massive proposal are now spinning off into separate bills. These “mini-bills” are more likely to receive serious attention and possible passage. The first of these address scope of practice for the following allied health professionals: HB 1250 (pharmacists), HB 1251 (physician assistants regulated by the Board of Medicine), HB 1252 (physician assistants regulated by the Board of Osteopathic Medicine), HB 1253 (certified registered nurse practitioners), HB 1254 (clinical nurse specialists), HB 1255 (nurse midwives), HB 1256 (nurse anesthetists), and HB 1257 (dental hygienists). Details of these bills are addressed below. Accessibility Reform The accessibility proposals fall into four main subject areas: (1) a legal mandate for the existing Pennsylvania Center for Health Careers, (2) extension of scope of practice for certain allied health professionals, (3) insurance payment reform for allied health professionals, and (4) hospice licensure. Pennsylvania Center for Health Careers HB 700 legislates the existence of the Pennsylvania Center for Health Careers (the “Center”), which currently operates within the Pennsylvania Workforce Investment Board of the Department of Labor & Industry. The Pennsylvania Workforce Investment Board was created by Executive Order in 2000. Added in 2004 as a component of the Workforce Investment Board, the Center is charged with: (1) increasing the capacity of Pennsylvania’s nursing education system, (2) retaining health care workers in health care professions, (3) responding to the demand for allied health practitioners providing critical care, and (4) addressing the needs of direct care workers. In addition to each of these duties, HB 700 also requires the Center to increase the diversity of health care workers. The Center receives direction from the leadership council, which is composed of representatives from health care-related professionals, employers, employees, educators and associations, and designees from the Departments of Labor & Industry, Health, State, and Public Welfare. HB 700 would also add a designee from each of the four caucuses of the General Assembly. Healthcare Alert Professional Practice of Allied Health Practitioners collaborative agreement or for whom the doctor may have primary responsibility. HB 700 generally purports to expand the scope of professional practice for allied health professionals working in physician offices, clinics and other outpatient settings, through the initial broad principle set forth in section 7303. Inpatient hospital settings are specifically exempted from this general rule. The rule states that any law using the terms “physician,” “medical doctor,” “doctor of osteopathy” or “dentist,” in connection with the authority to perform medical histories, physical or mental health examinations, or “acute illness, minor injury or chronic disease management care,” also must be interpreted to permit the performance of such activities by certified registered nurse practitioners (“CRNPs”), clinical nurse specialists, physician assistants, nurse midwives and independent dental hygienists. The limitation is that these activities must “fall within the individual’s specialty certification and scope of practice as determined by the applicable State licensing board.” Thus, the language of the bill does nothing to change the existing scope of practice. At most, it attempts to eliminate barriers in interpretation and implementation of existing law, which rests solely within the authority of the respective professional boards. HB 1253 also would lift the restriction on the number of collaborative agreements a physician may have with a CRNP with prescriptive authority. In addition, the CRNP bill would provide greater prescriptive authority to CRNPs, including Schedule II through V drugs. Lastly, HB 1253 would recognize specific activities as within the scope of practice of a CRNP, such as ordering home health and hospice care, ordering durable medical equipment, ordering respiratory and occupational therapy, performing and signing methadone treatment evaluations, and authorizing commitments under the Mental Health Procedures Act. Despite the circular language of HB 700’s general principle, other provisions of the bill would expand existing law. These scope of practice provisions are now in separate bills. For example, a current provision of the Pharmacy Act permits a pharmacist to manage drug therapy under a written agreement or protocol with a physician “in an institutional setting.” HB 1250 seeks to expand that ability by defining an “institutional setting” to include, among other things, physician group practice settings. This clarification would only raise more questions, i.e., how is a physician group practice “an institutional setting”? If the intent of HB 1250 is to expand the pharmacist’s ability to manage drug therapy in all settings, inpatient or outpatient, residential or not, the proposal could simply delete the existing reference to “institutional setting.” HB 1251 and HB 1252, amending provisions for physician assistants, are also offshoots of HB 700. These bills would remove the limit on the number of physician assistants, currently set at two, that a medical doctor or doctor of osteopathy may supervise under a Another bill, HB 1254, would amend the Professional Nursing Law to recognize a category of professional known as the “clinical nurse specialist” or “CNS.” The Board of Nursing would have authority to approve educational programs for CNS certification and to establish qualifications for becoming a CNS. The Board would be required to establish regulations to implement these amendments within eighteen months of the act’s effective date. The “practice of a clinical nurse specialist” is defined as “the provision of direct and indirect nursing care at the advanced level.” Similarly, HB 1256 would amend The Professional Nursing Law to create a certification program for nurse anesthetists. A certified registered nurse anesthetist (“CRNA”) functioning in this capacity at the time of passage of this proposal would be permitted to continue practicing. It is unclear whether the practicing CRNA must also obtain certification under the proposal or is effectively “grandfathered” for life, but it appears that eventually would be required. HB 1256 would obligate the CRNA to practice in collaboration with a physician or dentist. The bill further clarifies that if the “operating or anesthesia team consists entirely of nonphysicians, an anesthesiologist or consulting physician of the [CRNA’s] choice shall be available to the [CRNA] by physical presence or electronic communication.” The Board is required to establish regulations to implement the CRNA amendments within eighteen months of the effective date. HB 1255 would amend the Medical Practice Act to provide specific authorization to nurse midwives to provide primary care services to pregnant women, to May 2007 | Healthcare Alert manage childbirth and to provide office gynecological care and family planning. It also would expand the nurse midwife’s practice to allow prescriptive authority for Schedule II through V drugs when the individual meets certain training, education and certification requirements and has a collaborative agreement with a physician that outlines the limits of this prescriptive authority. Nurse midwives would also be allowed to order, dispense and administer medical devices, immunizing agents and “therapeutic, diagnostic and preventative measures.” The eighth “mini-bill,” HB 1257, amends The Dental Law to recognize expanded scope of practice for dental hygienists who are certified as independent dental hygiene practitioners. These independent dental hygiene practitioners would be permitted to practice without the supervision of a dentist in the following settings: (1) schools, (2) correctional facilities, (3) health care facilities, (4) personal care homes, (5) domiciliary care facilities, (6) older adult daily living centers, (7) continuing care retirement communities, (8) any institution under the jurisdiction of a federal, state or local agency, (9) day care programs, (10) head start programs and (11) free clinics. The practice of the independent dental hygiene practitioners would include all activities that a dental hygienist may perform, and also the ordering and administering of fluoride treatments and products and order dental equipment. The scope of practice of a dental hygienist, who must practice under a dentist’s supervision, would be extended to include, among other things, radiologic procedures, soft tissue curettage and filling of teeth. Each of these bills is intended to improve access to medical and dental care, by increasing the number of individuals who legally may provide basic preventive and therapeutic services. As separate bills, each proposal could be considered on its own merit. For now, these bills are the subject of various hearings throughout the state before the House Professional Licensure Committee. Allied Health Professionals and Payment Extending the scope of practice of the allied health professionals may have little effect unless health insurers reimburse for these services when performed by these providers. Each payor, including Medicare and Medicaid, sets their own policies for reimbursement, which do not always match licensing requirements. These payment reforms do not apply to Medicare, Medicaid or other government health insurance programs. HB 700 would require health insurers to: (1) include CRNPs, physician assistants, clinical nurse specialists in primary care, and nurse midwives as primary care practitioners (“PCPs”) for managed care plans, (2) pay these PCPs directly unless they specify otherwise, and (3) establish payment procedures and policies that not only recognize this PCP designation, but also provide incentives for “expanded primary care availability,” e.g., during evenings and weekends. These provisions provide support to the rapidly developing convenient care clinic model, found in retail establishments such as drug stores and grocery stores, as well as recognition to nurse-managed clinics, urgent care clinics, and federally qualified health centers. HB 700 would require plans to recognize these settings for primary care and include them in their networks “if they are geographically available to provide services to the insurer’s covered members.” However, these clinics would still need to meet credentialing requirements, and HB 700 calls for the Department of Health to approve such credentialing procedures. The Insurance Department could from time to time modify the list of primary care providers by publishing a notice in the Pennsylvania Bulletin. Insurers also would be responsible for “timely” payment to health care providers “at rates sufficient to assure the availability of and access to adequate health care providers.” In setting these rates, the insurer could take into account “the need for fiscal restraints.” Given the vague parameters of these payment mandates and no designation of an agency to administer, interpret or enforce them, these provisions would likely provide substantial work for trial lawyers and courts, as providers and payors wrestle with defining sufficiency of rates, limited by fiscal boundaries. As evidenced by litigation involving the adequacy of Medical Assistance rates and disputes over payment for emergency services by non-participating providers, legislation has never been adequate on its own to define fair reimbursement rates. May 2007 | Healthcare Alert In addition to these payment provisions, health insurers would have additional mandates with respect to behavioral health. Insurers would not be permitted to exclude: (1) from coverage, minor children with behavioral conditions, or (2) from covered services, behavioral therapy services for minor children. The term “behavioral conditions” is not defined, nor is the term “behavioral therapy services.” There is no clear authority given to the Insurance Department or another agency to define those terms or enforce this provision. In the general definitions section, the term “behavioral health services” is defined simply as “[m]ental health or substance abuse services.” safety. First, it requires the Department to promulgate proposed and then final regulations for residential hospices, within 180 days and 270 days, respectively. These regulations must address small (less than 23 beds) residential hospices and children’s hospices. Second, it requires the promulgation of an alternative to the Fire and Safety Code standards used for Medicare certification for small residential hospices. Hospice Licensure Questions about health care reform in Pennsylvania, and how you can get involved, may be directed to: HB 700 calls for the promulgation of regulations to license residential hospice facilities. The Health Care Facilities Act (the “Facilities Act”) has required the Department of Health to license hospices since 1999, and has mandated the promulgation of regulations for licensure. Under the Facilities Act, the regulations are required, at a minimum, to meet the standards for certification of a hospice under Medicare. The Department has not developed regulations for licensure of hospices. The Facilities Act states that until final regulations are adopted, the Department shall license hospices “pursuant to interim guidelines,” and the Department has done just that. The Department licenses hospices under interim guidelines that adopt the standards for Medicare certification of these providers. HB 700 seeks to cure issues related, in particular, to small residential hospices that have difficulty meeting certain Medicare standards for physical plant and fire More information about “Prescription for Pennsylvania” can be found on the Governor’s Office of Health Care Reform website: www.rxforpa.com. House Bill 700 and spin-off bills can be found at: http://www.legis. state.pa.us/. Public Law and Policy Practice: Peter A. Gleason 717.231.2892 peter.gleason@klgates.com Raymond P. Pepe 717.231.5988 raymond.pepe@klgates.com James D. Welty 717.231.5878 jim.welty@klgates.com Health Care Practice: Ruth E. Granfors 717.231.5835 ruth.granfors@klgates.com Patricia C. Shea 717.231.5870 patricia.shea@klgates.com Edward V. 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