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RULES AND REGULATIONS

Title 28—HEALTH
AND SAFETY

DEPARTMENT OF HEALTH

[ 28 PA. CODE. CH. 211 ]

Program Standards for Long-Term Care Nursing Facilities

[40 Pa.B. 5578]
[Saturday, October 2, 2010]

 The Department of Health (Department), following consultation with the Health Policy Board, amends § 211.7 (relating to physician assistants and certified registered nurse practitioners) to read as set forth in Annex A.

A. Purpose of the Final-Omitted Rulemaking

 This final-omitted rulemaking amends § 211.7 to address unnecessarily proscriptive procedures applicable to the provision of care by a certified registered nurse practitioner (CRNP) to a resident of a long-term care nursing facility (nursing home). Specifically, the final-omitted rulemaking amends § 211.7(c) as it applies to CRNPs because the subsection placed an unnecessary and broad restriction on how the CRNP, the collaborating physician and the nursing home determine the specifics of their relationship, and results in a barrier to a nursing home resident's access to qualified health care practitioners and increased health care costs. Although § 211.7(c) uses the term ''supervising physician,'' the relationship between a CRNP and a physician is one of collaboration.

 Section 211.7(a) and (b) set forth broad parameters for the use of CRNPs in nursing homes. Section 211.7(a) provides that CRNPs may be utilized in nursing homes in accordance with their training and experience and the requirements in statutes and regulations governing their practice. Section 211.7(b) requires, among other things, that the nursing home establish written policies indicating the manner in which the CRNPs shall be used and the responsibilities of the collaborating physicians. Section 211.7(c), however, further requires that the collaborating physician countersign a CRNP's documentation on a resident's record within 7 days. This includes progress notes, physical examination reports, treatments, medications and other notations made by the CRNP. Subsection (c) unnecessarily restricts the CRNP's and collaborating physician's ability to specify how often and in what circumstances the physician's countersignature will be required on the CRNP's orders and other documentation.

 Section 211.7(c) is amended by removing this unnecessary restriction on the CRNP/physician collaborative relationship. Given the CRNP's recently expanded scope of practice and the emphasis on the definition of a CRNP's practice through the collaborative agreement that now exists in The Professional Nursing Law (PNL) (63 P. S. §§ 211—225.5) and the regulations in 49 Pa. Code Chapter 21, Subchapter C (relating to certified registered nurse practitioners) promulgated under the PNL by the State Board of Nursing (Board) regarding CRNPs, it is unnecessary for the Department to define this particular element of the CRNP/physician relationship with so much specificity. Rather, as required under § 211.7(b) and recognized in section 8.2(c.2)(2) of the PNL (63 P. S. § 218.2(c.2)(2)), a nursing home should have the flexibility to determine the supervision or other oversight requirements for physicians and CRNPs practicing within its facility based on the needs of the nursing home's residents. Within these parameters, CRNPs and collaborating physicians should have the ability to establish their responsibilities to each other within the context of the collaborative agreement between them and without undue direction from the Department.

 The PNL and the regulations promulgated by the Board provide that the collaboration process shall incorporate the availability of the physician for cosigning records, when appropriate. Placing specific restrictions on this aspect of the collaborative relationship inhibits the physician and the nursing home from fully recognizing the individual CRNP's training and experience, unnecessarily restricts the physician's and nursing home's utilization of CRNPs in providing medical care to nursing home residents and ultimately negatively interferes with a nursing home resident's medical care.

 Section 211.7 was last revised in 1999, over a decade ago. Since that time, health care practice has evolved to refine and expand the scope of practice of nonphysician health care practitioners, in particular CRNPs, to increase health care access and quality and contain or reduce health care costs. CRNPs continue to receive advanced education and training to provide them the knowledge necessary to deliver this expanded care. The recent amendments to the Board's regulations regarding CRNPs, published at 39 Pa.B. 6994 (December 12, 2009), recognized the need to update requirements regarding the practice of CRNPs because ''existing regulations prevented the effective use of CRNPs to the full extent of their education, skills and abilities, thereby depriving the citizens of this Commonwealth necessary, high quality care.'' It is for these same reasons that the Department amends § 211.7(c).

 Amendments to the PNL and to the Board's regulations now provide the appropriate rules regarding the collaborative relationship between the CRNP and the physician and there is no reasonable basis for continuing the requirement applicable to CRNPs in § 211.7(c). Section 211.7(a) and (b) provide more than adequate requirements for nursing homes regarding the CRNP's practice and in addition allow for the appropriate flexibility in the relationship between the CRNP and the collaborating physician. Section 211.7(c) is a specific requirement that may or may not suit the circumstances in the individual CRNP/physician collaborative agreement or the nursing home resident's medical needs.

 Section 8.2(b) of the PNL permits a CRNP to perform acts of medical diagnosis in collaboration with a physician and in accordance with regulations promulgated by the Board. Specifically, the PNL permits a CRNP to prescribe medical or therapeutic corrective measures, including pharmaceuticals, if the CRNP is acting in accordance with section 8.3(c) of the PNL (63 P. S. § 218.3(c)). In addition, the act of July 20, 2007 (P. L. 318, No. 48) (Act 48) amended the PNL to further express the General Assembly's intent to broaden the scope of the CRNP's practice and authority by specifically authorizing the CRNP to issue or conduct certain kinds of orders, referrals, assessments and certifications, traditionally reserved to physicians, if the CRNP is acting within the scope of the CRNP's specialty certification and the collaborative agreement with the physician. See section 8.2(c.1) of the PNL. By its passage of the amendments to the PNL, the General Assembly expressed its confidence in the ability of CRNPs to provide medical services without excessive restrictions.

 Section 8.2(b) of the PNL specifies that a CRNP may prescribe medical therapeutic or corrective measures (including pharmaceuticals) if the nurse is acting in accordance with section 8.3 of the PNL, regarding prescriptive authority for CRNPs. Section 8.3 of the PNL details the conditions under which a CRNP may exercise prescriptive authority. This includes acting in collaboration with a physician as set forth in a written agreement. The agreement must identify the area of practice in which the CRNP is certified, the categories of drugs from which the CRNP may prescribe and the circumstances and how often the collaborating physician will personally see the patient. See section 8.3 of the PNL. Furthermore, under the PNL and the Board's new regulations applicable to CRNPs, the CRNP and the collaborating physician are to incorporate into the collaboration process the availability of the physician for cosigning records when necessary to document accountability by both parties. See 49 Pa. Code § 21.251 (relating to definitions).

 Thus, § 211.7(c) unnecessarily dictates the terms of the CRNP/physician collaborative relationship for assuring physician involvement in the medical care of the resident by requiring a countersignature by the collaborating physician in all cases and within 7 days. This requirement may not best serve the needs of the individual resident and represents a direct barrier to the implementation of health care innovations that are intended to increase health care access and quality and contain or reduce costs. Section 211.7(c) rigidly applies in all circumstances and is contrary to the need to provide care to residents based on their individual needs and as governed by the protocols agreed to by the physician, CRNP and the nursing home.

 Section 211.7(c) was originally intended to regulate how a nursing home would ensure that a nursing home resident's physician would remain primarily involved in the medical care planning and delivery for the resident. Currently, however, physician involvement is not only required by the PNL and the Board's regulations but also by Federal regulations applicable to nursing homes. For example, see 42 CFR 483.40 (relating to physician services). The unnecessary rigidity of the Department's regulation has the unfortunate effect of discouraging CRNP/physician collaborative practice in nursing homes, which has a deleterious effect on nursing home residents by limiting their access to qualified health care practitioners. This is compounded by the fact that the number of primary care physicians who are able to provide services to nursing home residents is becoming more limited. Consequently, CRNPs, in collaboration with physicians, perform an invaluable service to these most vulnerable of citizens, which should not be impeded by an outdated, burdensome regulation.

 With the enactment of Act 48 amending the PNL and with the promulgation of the Board's regulations in December 2009, the issue of the CRNP/physician relationship has been thoroughly reviewed, discussed and commented upon by the public, specifically including various associations and other groups that represent various entities affected by the regulation. Consistently, the conclusion has been that the collaborative agreement in conjunction with the health care facility's protocols for patient care should control the provision of medical services by CRNPs.

 In particular, with respect to the Department's regulation, the three nursing home associations, Pennsylvania Health Care Association, Pennsylvania Association of Non-Profit Homes for the Aging and Pennsylvania Association of County Affiliated Homes, as well as the CRNP association, Pennsylvania Coalition of Nurse Practitioners, have argued that the regulation undermines the ability to best utilize the expanded scope of practice for CRNPs. These stakeholders, directly affected by § 211.7(c), believe that the collaborating physician needs to use his professional judgment regarding the level of oversight needed by the CRNP and that an inflexible oversight requirement creates additional paperwork with no commensurate benefit to the nursing home resident. In addition to the objections of the nursing homes and CRNPs, the Department has also been presented with comments from physicians who practice in nursing homes and that similarly object to the unnecessary requirement.

 Since the promulgation of the Board's regulations, the Department has received over 70 exception requests from nursing homes seeking relief from the Department's regulation. Given the consensus by those who have considered the issue, including major stakeholders directly affected by the regulation, deferring to the scope of practice defined in the collaborative agreement in conjunction with a nursing home's protocols for provision of medical care to its residents is in the public interest. Delay in allowing CRNPs to practice as contemplated by the amendments to the PNL and the Board's regulations will result in the provision of less than adequate care to nursing home residents and increases in health care costs. Physicians have limited availability for nursing home practice and nursing homes are relying on CRNPs to provide needed care to residents, for which they are well qualified.

 The collaborative agreement, existing law and the more recent developments in the CRNP's scope of practice more than sufficiently protect the needs of nursing home residents. Requiring countersignatures on orders and all within 7 days creates an unreasonable burden upon CRNPs and physicians practicing in nursing homes.

 Under section 204 of the act of July 31, 1968 (P. L. 769, No. 240) (45 P. S. § 1204), known as the Commonwealth Documents Law (CDL), notice of proposed rulemaking may be omitted if the agency for good cause finds that the procedures specified in sections 201 and 202 of the CDL (45 P. S. §§ 1201 and 1202) are in the circumstances impracticable, unnecessary or contrary to the public interest. The Department finds justification for omitting notice of proposed rulemaking to amend § 211.7(c) as it relates to CRNPs, because in these circumstances it is unnecessary and contrary to the public interest. See section 204(3) of the CDL.

B. Requirements of the Regulation

 The Department amends § 211.7(c) which required that a CRNP's documentation on the resident's record, including progress notes, physical examination reports, treatments, medications and other notations made by the CRNP be countersigned by the supervising physician within 7 days. The Department amends § 211.7(c) by removing references to CRNPs.

C. Affected Persons

 The final-omitted rulemaking amends an existing regulation that governs the operation of nursing homes in this Commonwealth. However, as the final-omitted rulemaking does not impose new requirements on the nursing homes and instead removes an unnecessary requirement, nursing homes would not be negatively affected by the final-omitted rulemaking.

D. Cost and Paperwork Estimate

 There are no additional costs or paperwork requirements for the Commonwealth, the regulated community, local governments or the general public associated with the final-omitted rulemaking. The Department expects a reduction in cost and paperwork to various stakeholders. The Department is not able to accurately quantify the expected reduction in cost and paperwork.

E. Statutory Authority

 Sections 601 and 803(2) of the Health Care Facilities Act (HCFA) (35 P. S. §§ 448.601 and 448.803(2)) authorize the Department to promulgate, after consultation with the Health Policy Board, regulations necessary to carry out the purposes and provisions of the HCFA. Section 801.1 of the HCFA (35 P. S. § 448.801a) seeks to promote the public health and welfare through the establishment of regulations setting minimum standards for the operation of health care facilities and that the minimum standards are to assure safe, adequate and efficient facilities and services, and promote the health, safety and adequate care of patients or residents of these facilities. Section 102 of the HCFA (35 P. S. § 448.102) states that the General Assembly finds that a purpose of the HCFA is, among other things, to assure that citizens receive humane, courteous and dignified treatment. Finally, section 201(12) of the HCFA (35 P. S. § 448.201(12)) provides the Department with explicit authority to enforce its rules and regulations promulgated under the HCFA.

 The Department also has the duty to protect the health of the people of this Commonwealth under section 2102(a) of The Administrative Code of 1929 (71 P. S. § 532(a)). The Department has general authority to promulgate regulations under section 2102(g) of The Administrative Code of 1929 for this purpose.

 Act 48 also directs the Department to make amendments to its regulations to implement the additions and amendments to the PNL by Act 48. See Act 98, Section 3.

F. Effectiveness/Sunset Dates

 The final-omitted rulemaking will become effective upon its publication in the Pennsylvania Bulletin. A sunset date has not been established. The Department will continually review and monitor the effectiveness of this regulation.

G. Regulatory Review

 Under section 5.1(c) of the Regulatory Review Act (71 P. S. § 745.5a(c)), on July 27, 2010, the Department submitted a copy of the final-omitted rulemaking and a copy of a Regulatory Analysis Form in compliance with Executive Order 1996-1, ''Regulatory Review and Promulgation'' to the Independent Regulatory Review Commission (IRRC) and to the House Health and Human Services Committee and the Senate Public Health and Welfare Committee (Committees). On the same date, the regulation was submitted to the Office of Attorney General for review and approval under the Commonwealth Attorneys Act (71 P. S. §§ 732-101—732-506). A copy of this material is available to the public upon request.

 Under section 5.1(j.2) of the Regulatory Review Act, on September 15, 2010, the final-omitted rulemaking was deemed approved by the Committees. Under section 5.1(e) of the Regulatory Review Act, IRRC met on September 16, 2010, and approved the final-omitted rulemaking.

H. Contact Person

 Questions or comments regarding the final-omitted rulemaking may be submitted to Melanie Waters, Director, Bureau of Facility Licensure and Certification, Department of Health, Room 932, Health and Welfare Building, 625 Forster Street, Harrisburg, PA 17120-0701, (717) 787-8015. Comments submitted by facsimile or e-mail will not be accepted. Persons with a disability may submit questions in alternative formats such as audio tape or Braille or by using V/TT, (717) 783-6514 for speech or hearing impaired persons or the Pennsylvania AT&T Relay Service, (800) 654-5984 (TT). Persons who require an alternative format of this document (that is, large print, audio tape or Braille) should contact Melanie Waters at the previous address or telephone numbers to make necessary arrangements. The Department will accept comments in response to the amendment at any time following the effective date of the final-omitted rulemaking.

I. Findings

 The Department finds that:

 (1) This final-omitted rulemaking complies with section 204 of the CDL. Notice of proposed rulemaking is impractical, unnecessary or contrary to the public interest because the 7-day countersignature requirements for CRNP documentation in a resident's clinical record in § 211.7(c) inhibits access to qualified health care practitioners by nursing home residents and interferes with the physician/CRNP collaborative relationship established in the PNL and the Board's regulations.

 (2) The adoption of the final-omitted rulemaking in the manner provided by this order is necessary and appropriate for the administration of the authorizing statutes and is in the public interest.

J. Order

 The Department, acting under the authorizing statutes, orders that:

 (a) The regulations of the Department, 28 Pa. Code Chapter 211, are amended by amending § 211.7 to read as set forth in Annex A.

 (b) The Secretary shall submit this order and Annex A to the Office of General Counsel and the Office of Attorney General for approval as to form and legality as required by law.

 (c) The Secretary shall submit this order, Annex A and a Regulatory Analysis Form to IRRC, the House Committee on Health and Human Services and the Senate Committee on Public Health and Welfare for their review and action as required by law.

 (d) The Secretary shall certify this order and Annex A and deposit them with the Legislative Reference Bureau as required by law.

 (e) This order shall take effect upon publication in the Pennsylvania Bulletin.

EVERETTE JAMES, 
Secretary

 (Editor's Note: For the text of the order of the Independent Regulatory Review Commission relating to this document, see 40 Pa.B. 5655 (October 2, 2010).)

Fiscal Note: 10-191. No fiscal impact; (8) recommends adoption.

Annex A

TITLE 28. HEALTH AND SAFETY

PART IV. HEALTH FACILITIES

Subpart C. LONG-TERM CARE FACILITIES

CHAPTER 211. PROGRAM STANDARDS FOR LONG-TERM CARE NURSING FACILITIES

§ 211.7. Physician assistants and certified registered nurse practitioners.

 (a) Physician assistants and certified registered nurse practitioners may be utilized in facilities, in accordance with their training and experience and the requirements in statutes and regulations governing their respective practice.

 (b) If the facility utilizes the services of physician assistants or certified registered nurse practitioners, the following apply:

 (1) There shall be written policies indicating the manner in which the physician assistants and certified registered nurse practitioners shall be used and the responsibilities of the supervising physician.

 (2) There shall be a list posted at each nursing station of the names of the supervising physician and the persons, and titles, whom they supervise.

 (3) A copy of the supervising physician's registration from the State Board of Medicine or State Board of Osteopathic Medicine and the physician assistant's or certified registered nurse practitioner's certificate shall be available in the facility.

 (4) A notice plainly visible to residents shall be posted in prominent places in the institution explaining the meaning of the terms ''physician assistant'' and ''certified registered nurse practitioner.''

 (c) Physician assistants' documentation on the resident's record shall be countersigned by the supervising physician within 7 days with an original signature and date by the licensed physician. This includes progress notes, physical examination reports, treatments, medications and any other notation made by the physician assistant.

 (d) Physicians shall countersign and date their verbal orders to physician assistants or certified registered nurse practitioners within 7 days.

 (e) This section may not be construed to relieve the individual physician, group of physicians, physician assistant or certified registered nurse practitioner of responsibility imposed by statute or regulation.

[Pa.B. Doc. No. 10-1877. Filed for public inspection October 1, 2010, 9:00 a.m.]



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