Section 448.806 - Licensure(a) License required.--No person shall maintain or operate or hold itself out to be a health care facility without first having obtained a license therefor issued by the department. No health care facility can be a provider of medical assistance services unless it is licensed by the department and certified as a medical assistance provider.(b) Development of regulations.--In developing rules and regulations for licensure the department shall take into consideration Federal certification standards and the standards of other third party payors for health care services and such national accreditation organizations as the department may find appropriate.(c) Fire and emergency standards.--Notwithstanding any other provision of law other than standards required for Federal certification by that type of health care facility in the Medicare or Medicaid program, no health care facility shall be required to satisfy any regulation relating to fire or similar emergency circumstance more stringent than those required of hospitals by the Joint Commission on Accreditation of Health Organizations or such national accreditation organizations as the department may find appropriate, and the department shall adopt and enforce the appropriate standards.(d)Home health care agency regulations.-- (1) In developing rules and regulations for licensure of home health care agencies the department shall take into consideration the standards of national accreditation organizations as the department may find appropriate.(2) Home health care services may be ordered by nurse practitioners and physician assistants as provided under sections 1814(a) and 1835(a) of the Social Security Act (49 Stat. 620, 42 U.S.C. § 1395 et seq.), if the nurse practitioner's or physician assistant's collaborating or supervising physician is identified in the patient's written plan of treatment. Upon receipt of the necessary Federal waivers or approvals for medical assistance programs under paragraph (3), home health care services for individuals eligible for medical assistance may also be ordered by nurse practitioners and physician assistants if the nurse practitioner's or physician assistant's collaborating or supervising physician is identified in the patient's written plan of treatment.(3) The Department of Human Services shall submit a request for Federal waivers or approvals for medical assistance programs to the Federal Government as necessary to implement paragraph (2) and to ensure compliance with Federal law.(4) Within 30 days of issuance, an order of home health care services must be signed and dated by a physician, nurse practitioner or physician assistant.(5) The department shall require home health care agencies providing home health aide services to comply with 42 CFR 484.80 (h) (relating to condition of participation: home health aide services) for the purposes of this subsection.(6) Home health care agencies certified as providers by the department to the Federal Government for purposes of the Medicare program shall be deemed to comply with and satisfy the department's regulations governing home health care agencies.(d.1) Home care agency and home care registry licensure requirements.--(1) An individual with direct consumer contact employed by the home care agency and an individual referred to a consumer by a home care registry after the effective date of this subsection shall meet at least one of the following requirements prior to referral to consumers:(i) A valid nurse's license in this Commonwealth.(ii) The successful completion of a nurse aide training program approved by the department.(iii) The successful completion of a home health aide training program as provided in 42 CFR 484.36 (relating to condition of participation: home health aide services) approved by the department.(iv) The successful completion of a personal care worker training credentialing program approved by the department.(v) The successful completion of a competency examination for persons performing only activities of daily living services.(2) An individual employed by a home care agency or referred by a home care registry on the effective date of this subsection shall successfully complete one of the training requirements set forth in paragraph (1) within two years of the effective date of this subsection.(3) Documentation of compliance with at least one of the training requirements under paragraph (1) shall be maintained in each individual's file in the home care agency or home care registry office. Documentation of applicable State licensure for any health care practitioner shall also be maintained on file in the home care agency or registry office.(4)(i) Prior to licensing a home care agency or a home care registry, the department shall determine that all individuals employed by an agency or referred by a registry, staff working within each entity and the owner or owners have obtained criminal history record information, in accordance with the requirements of section 503 of the act of November 6, 1987 (P.L. 381, No. 79) , known as the "Older Adults Protective Services Act," and maintain that information on file in the home care agency or registry office.(ii) Prior to licensing a home care agency or a home care registry which provides services to persons under 18 years of age, the department shall determine that all individuals employed by an agency or referred by a registry, all office staff working within each entity and the owner or owners have obtained clearance from the child abuse registry, in accordance with 23 Pa.C.S. Ch. 63 (relating to child protective services), and maintain that information on file in the home care agency or registry office.(5) Prior to referral to consumers, all individuals and any other office staff or contractors with direct consumer contact must obtain documentation from a physician or other appropriate health care professional that the individual is free from communicable disease, including, at a minimum, a tuberculosis screening as outlined by the screening guidelines of the department. Such documentation must be maintained on file in the home care agency or home care registry office.(6) Ongoing supervision of an employee by a home care agency or ongoing documentation of the referral of an independent contractor by a home care registry shall be maintained to ensure that the employee has the skills necessary to provide the care required by the consumer.(e) Public disclosure.--The department shall require disclosure of the persons owning 5% or more of the health care facility as well as the health care facility's officers and members of the board of directors.(f) Ambulatory surgical facilities standards.--Within one year of the effective date of this act, to the extent possible, the department shall publish in the Pennsylvania Bulletin proposed regulations establishing revised standards for licensure of ambulatory surgical facilities. Such standards shall provide for separate licensure criteria for office-based surgical facilities and for comprehensive freestanding ambulatory surgical facilities, including, but not limited to: (1) fire and safety standards;(2) personnel and equipment requirements; and(3) quality assurance procedures. The purpose of such criteria shall be to assure quality care delivery in said facilities. Until such time the revised regulations are adopted, the existing rules and regulations governing the licensure of ambulatory surgical facilities shall apply.
(g) Hospices.--(1) The department shall promulgate regulations to provide for a fee for application for the licensure of hospices. The fee shall be an amount sufficient to offset all costs incurred by the department related to the licensure and inspection of hospices. The department shall from time to time, as may be necessary, increase or decrease the fee to reflect actual expenditures related to hospices. Until such time as the department provides for the fee by regulation, an application for a hospice license shall be accompanied by a fee of $250.(2) The department shall promulgate regulations for licensure of hospices. The regulations shall, at a minimum, contain the standards set forth in regulations for hospices certified as providers of the Medicare program under Title XVIII of the Social Security Act (49 Stat. 620, 42 U.S.C. § 1395 et seq.). The department may develop additional regulations as necessary to administer the licensure program and to protect the health and safety of the citizens of this Commonwealth. Until final regulations are adopted, the department shall operate the licensing program pursuant to interim guidelines consistent with this paragraph.(2.1) Within 180 days following the effective date of this paragraph, the department shall promulgate proposed regulations, and, within 270 days following the effective date of this paragraph, the department shall promulgate final regulations for the licensure and operation of small residential hospices with 22 or fewer beds. Subject to Federal approval under 42 CFR 418.100(d)(3) (relating to condition of participation hospices that provide inpatient care directly), the regulations shall create an alternative to the fire and safety regulations for hospices certified as providers of the Medicare program under Title XVIII of the Social Security Act (49 Stat. 620, 42 U.S.C.§ 1395 et seq.) that currently require hospices to meet standards for nursing homes contained in the 2000 edition of the Life Safety Code of the National Fire Protection Association. In developing the alternative for fire and safety regulations, the department shall consider as a minimum the requirements for residential board and care occupancies set forth in the 2006 edition of the Life Safety Code and other applicable codes.(3) Notwithstanding any provision to the contrary, any organization which provides or coordinates the provision of volunteer services for Medicare-certified hospice providers in the hospice delivery systems of its community and which: (i) used "hospice" in its name prior to January 1, 1990;(ii) qualified for exemption from Federal income taxation under section 501(c)(3) of the Internal Revenue Code of 1986 ( Public Law 99-514, 26 U.S.C.§ 1 et seq.) prior to the effective date of this subsection; and(iii) registered with the Department of State pursuant to the act of December 19, 1990 (P.L. 1200, No. 202), known as the "Solicitation of Funds for Charitable Purposes Act," prior to the effective date of this subsection; may continue to use its name as heretofore.(h)Abortion facilities.--(1)The department shall apply the same regulations promulgated under subsection (f) to abortion facilities that are applied to ambulatory surgical facilities. These regulations include classification of the facilities in the same manner as ambulatory surgical facilities.(2)The department shall apply to abortion facilities any other provision of this chapter governing health care facilities insofar as they are applicable to ambulatory surgical facilities.(3)For the purpose of applying the rules applicable to ambulatory surgical facilities, all of the following apply: (i) The department shall allow the abortion facility to request an exception.(ii)The request must identify with specificity the reasons for which the exception is sought.(iii)In considering a petition under this paragraph, the department shall apply the same procedures and criteria that are applicable to other health care facilities.(iv)The department shall issue a written determination stating the reasons for a decision under this paragraph.(4) None of the following shall apply to an abortion facility: (i)The definition of "ambulatory surgical facility" in section 802.1.(ii) The definition of "ASF--Ambulatory Surgical Facility" in 28 Pa. Code§ 551.3 (relating to definitions).(5)Notwithstanding the definition of "abortion facility" in section 302 of the act of March 20, 2002 (P.L. 154, No. 13), known as the Medical Care Availability and Reduction of Error (Mcare) Act, an abortion facility shall continue to comply with applicable provisions of the Medical Care Availability and Reduction of Error (Mcare) Act.(6)An abortion facility shall comply with Federal privacy statutes, including the Health Insurance Portability and Accountability Act of 1996 (Public Law 104-191, 110 Stat. 1936).(i) Hospitals.-- (1) In issuing a license to a hospital, the department shall, at the request of the hospital, rely on the reports of national accreditation organizations designated as acceptable to the department pursuant to the requirements set forth in section 810.1 and shall issue a license to a hospital that received approval or accreditation from the designated organization.(2) A hospital that is not accredited by a national accreditation organization or does not request that the department rely on the accreditation shall be required to comply with 28 Pa. Code Chs. 51 (relating to general information) and 101 (relating to general information).(3) This subsection shall not be construed as a limitation on the department's right of inspection permitted under section 813, including the right to inspect in response to complaints or other reports made to the department.(4) A hospital that is deemed shall comply with the standards established by a national accreditation organization that accredits the hospital. Any licensure survey of a deemed hospital shall be based on the standards established by the national accreditation organization that accredits the hospital and State law.(5) All hospitals, whether licensed through accreditation or compliance with the department's regulations, shall submit plans for new construction and renovation of facilities to the department and must receive approval from the department before providing services in the newly constructed or renovated areas.Amended by P.L. TBD 2022 No. 30, § 1, eff. 6/30/2022.Amended by P.L. 422 2013 No. 60, § 3, eff. 1/5/2014.1979, July 19, P.L. 130, No. 48, § 806, added 1980 , July 12, P.L. 655, No. 136, §7, imd. effective. Amended 1992, Dec. 18, P.L. 1602, No. 179, § 21, imd. effective; 1998, Oct. 16, P.L. 777, No. 95, § 3, effective in 90 days; 2006, July 7, P.L. 334, No. 69, § 2, effective upon publication of regulations under 35 P.S. § 448.809a at 39 Pa.B. 6958 [Dec. 12, 2009]; 2008, Oct. 9, P.L. 1505, No. 120, § 1, imd. effective; 2011, Dec. 22, P.L. 563, No. 122, § 2, effective in 180 days [June 19, 2012]