Bill Text: PA HB2151 | 2009-2010 | Regular Session | Introduced

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Bill Title: In licensing of health care facilities, further providing for definitions, for licensure, for term and content of license and for reliance on accrediting agencies and Federal Government.

Spectrum: Moderate Partisan Bill (Republican 22-5)

Status: (Introduced - Dead) 2009-12-08 - Referred to HEALTH AND HUMAN SERVICES [HB2151 Detail]

Download: Pennsylvania-2009-HB2151-Introduced.html

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PRINTER'S NO. 2979
THE GENERAL ASSEMBLY OF PENNSYLVANIA
HOUSE BILL
No. 2151 Session of2009
INTRODUCED BY REICHLEY, ADOLPH, BEYER, BOYD, CLYMER, CREIGHTON, CUTLER, DALLY, EVERETT, FAIRCHILD, GILLESPIE, GINGRICH, GRELL, GROVE, HARHART, HARRIS, HENNESSEY, HESS, HORNAMAN, LONGIETTI, MILLER, PICKETT, RAPP, SIPTROTH, SOLOBAY AND YOUNGBLOOD, DECEMBER 8, 2009
REFERRED TO COMMITTEE ON HEALTH AND HUMAN SERVICES, DECEMBER 8, 2009
AN ACT
Amending the act of July 19, 1979 (P.L.130, No.48), entitled "An
act relating to health care; prescribing the powers and
duties of the Department of Health; establishing and
providing the powers and duties of the State Health
Coordinating Council, health systems agencies and Health Care
Policy Board in the Department of Health, and State Health
Facility Hearing Board in the Department of Justice;
providing for certification of need of health care providers
and prescribing penalties," in licensing of health care
facilities, further providing for definitions, for licensure,
for term and content of license and for reliance on
accrediting agencies and Federal Government.
The General Assembly of the Commonwealth of Pennsylvania
hereby enacts as follows:
Section 1. The definition of "health care facility" in
section 802.1 of the act of July 19, 1979 (P.L.130, No.48),
known as the Health Care Facilities Act, amended July 7, 2006
(P.L.334, No.69), is amended and the section is amended by
adding definitions to read:
Section 802.1. Definitions.
The following words and phrases when used in this chapter
shall have, unless the context clearly indicates otherwise, the
meanings given them in this section:
* * *
"Health care facility." [For purposes of Chapter 8, a health
care facility includes, but is not limited to, a general,
chronic disease or other type of hospital, a home health care
agency, a home care agency, a hospice, a long-term care nursing
facility, cancer treatment centers using radiation therapy on an
ambulatory basis, an ambulatory surgical facility, a birth
center regardless of whether such health care facility is
operated for profit, nonprofit or by an agency of the
Commonwealth or local government. The department shall have the
authority to license other health care facilities as may be
necessary due to emergence of new modes of health care. When the
department so finds, it shall publish its intention to license a
particular type of health care facility in the Pennsylvania
Bulletin in accordance with the act of June 25, 1982 (P.L.633,
No.181), known as the "Regulatory Review Act." The term health
care facility shall not include an office used primarily for the
private practice of a health care practitioner, nor a program
which renders treatment or care for drug or alcohol abuse or
dependence unless located within a health facility, nor a
facility providing treatment solely on the basis of prayer or
spiritual means. The term health care facility shall not apply
to a facility which is conducted by a religious organization for
the purpose of providing health care services exclusively to
clergymen or other persons in a religious profession who are
members of a religious denomination.] For the purposes of this
act, the term shall include hospitals, cancer treatment centers
using radiation therapy on an ambulatory basis, ambulatory
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surgical facilities, specialized health care services and
outpatient health care facilities regardless of whether the
health care facility is operated for profit, nonprofit or by an
agency of the Commonwealth or local government. The term shall
not include an office used primarily for the private practice of
a health care practitioner nor a program which renders treatment
or care for drug or alcohol abuse or dependence unless located
within a health care facility, nor a facility providing
treatment solely on the basis of prayer or spiritual means. The
term shall not apply to a facility which is conducted by a
religious organization for the purpose of providing health care
services exclusively to the clergymen or other persons in a
religious profession who are members of a religious
denomination.
* * *
"Outpatient health care facility." For the purposes of this
act, the term shall be defined as a facility, whether fixed or
mobile, providing diagnostic, therapeutic, treatment or
rehabilitation services on an outpatient basis or to individual
patients for less than a 24-hour consecutive period, by or under
the supervision of physicians or other clinical staff in
accordance with their scope of practice. The term does not
include an office used primarily for the private practice of a
health care practitioner, but does include clinics and group
practice facilities providing diagnostic and treatment services
other than primary care in a specific specialized area of
medicine. Outpatient health care services provided under the
license of a hospital are excluded from this definition.
Outpatient services on the site of a hospital but not provided
under the hospital license are included.
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"Outpatient health care services." The term includes
emergency services, cardiac catheterization, cancer treatment
services involving radiation therapy, imaging services, pain
management services, burn center services, ambulatory surgery
services, dialysis services or any other clinical service deemed
by the Department of Health and published in the Pennsylvania
Bulletin to be subject to this act.
"Physical status." The American Society of Anesthesiologists
Physical Status Classification System.
"Specialized health care services." Certain diagnostic,
treatment or rehabilitative services which involve highly
technical medical procedures and require extraordinary expertise
and resources to be effective and safe as determined by the
Department of Health.
Section 2. Section 806(a), (b) and (c) of the act, amended
December 18, 1992 (P.L.1602, No.179) and October 16, 1998
(P.L.777, No.95), are amended and the section is amended by
adding subsections to read:
Section 806. Licensure.
(a) License required.--No person shall maintain or operate
or hold itself out to be a health care facility or provide
specialized services 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.]:
(1) Facilities or specialized health care services
accredited by a national accrediting organization approved by
the Centers for Medicare and Medicaid Services (CMS) shall be
deemed to meet licensure requirements and shall be issued a
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license by the department.
(2) Facilities not accredited by a CMS-approved national
accrediting organization shall be required to meet the
applicable Medicare Conditions of Participation or Medicare
Conditions of Coverage.
(3) Facilities or specialized health care services that
are not accredited and do not participate in Medicare shall
be required to comply with regulations adopted by the
department.
(a.1) Additional requirements.--Specific facilities or
specialized health care services shall be required, as a
condition of licensure, to do the following:
(1) Class A ambulatory surgical facilities (ASF) shall
meet the following criteria:
(i) A license is not required for the operation of a
Class A ASF; however, the facility shall be accredited by
the Accreditation Association for Ambulatory Health Care,
the Joint Commission on the Accreditation of Health Care
Organizations, the American Association for the
Accreditation of Ambulatory Surgical Facilities or
another nationally recognized accrediting organization
acknowledged by the Medicare program in order to be
identified as providing ambulatory service.
(ii) A Class A ASF shall register with the
department and shall forward a copy of its accreditation
survey to the department.
(iii) The Class A ASF must provide the following
information with the registration form and update the
department on an annual basis:
(A) A list of operative procedures proposed to
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be performed at the facility and the ages of the
patients to be served.
(B) The type of anesthetic proposed to be used
for each operative procedure.
(C) The facility's current accreditation survey
and the designation of accreditation status by the
nationally recognized accrediting organization.
(D) Other information the department deems
necessary for registration.
(2) A license shall be obtained to operate a
freestanding Class B or Class C ASF.
(3) An ASF license shall designate the licensed facility
as either a Class B or Class C ASF.
(4) An applicant for a license to operate an ASF shall
request licensure by the department by means of a written
communication which sets forth:
(i) A list of operative procedures proposed to be
performed at the facility and the ages of the patients to
be served.
(ii) The highest level of anesthetic proposed to be
used for each proposed operative procedure.
(iii) The highest physical status proposed to
receive ambulatory surgery at the facility.
(iv) A statement from the applicant which may be
accompanied by a written opinion from a nationally
recognized accrediting body stating the most appropriate
facility class.
(5) If a facility desires to change its classification
level from a Class B enterprise to a Class C enterprise, the
facility shall request and obtain a license prior to
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providing services to patients with a physical status of ASF
Class III or level III.
(6) The department may enter and inspect an ASF Class A,
B or C, at any time, announced or unannounced, to investigate
any complaints. The department may mandate closure of an ASF
that the department determines to be providing substandard
care or for any other lawful reason.
(7) Criteria for ambulatory surgery:
(i) Ambulatory surgical procedures are limited to
those procedures that do not exceed a total of four hours
of operating time and four hours of directly supervised
recovery.
(ii) The time limits may be exceeded only if the
patient's condition demands care or recovery beyond the
four-hour limit and the need for additional time could
not have been anticipated prior to surgery.
(iii) The surgical procedure shall not require more
than local or regional anesthesia or less than four hours
of general anesthesia.
(iv) The procedure may not be of a type that is
associated with the risk of extreme blood loss or
directly involves major blood vessels.
(v) The surgery may not require major or prolonged
invasion of body cavities.
(vi) The procedure may not be an emergency or be
life threatening in nature unless no hospitals are
available for the procedure and the need for surgery
could not have been anticipated.
(vii) The practitioner performing the surgery is
responsible for obtaining the informed consent of the
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patient for disclosure to the patient of the risks,
benefits and alternatives associated with the anesthesia
which will be administered, the procedure that will be
performed and the comparative risks, benefits and
alternatives to performance of the procedure in the ASF.
(viii) The department may issue interpretations of
this subsection, which apply to the question of whether
the performance of certain surgical procedures will
require licensure as an ASF.
(ix) Interpretations adopted by the department shall
be submitted to the Legislative Reference Bureau for
publication in the Pennsylvania Bulletin and the
Pennsylvania Code as a statement of policy of the
department.
(a.2) Pediatric patients.--The following criteria must be
met to perform ambulatory surgery on patients that are under 18
years of age:
(1) A child under six months of age shall not be treated
in an ASF.
(2) The medical record shall include documentation that
the child's primary care provider was notified by the surgeon
in advance of the performance of a procedure in an ASF and
that an opinion was sought from the primary care provider
regarding the appropriateness of the use of an ASF for the
proposed procedure. When an opinion from the child's primary
care provider is not obtainable, the medical record shall
include documentation which explains why an opinion could not
be obtained.
(3) Anesthesia services shall be provided by an
anesthesiologist who is a graduate of an anesthesiology
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residency program accredited by the Accreditation Council for
Graduate Medical Education or its equivalent or by a
certified registered nurse anesthetist trained in pediatric
anesthesia either of whom shall have documented demonstrated
historical and continuous competence in the care of these
patients.
(4) The practitioner performing the surgery shall be
either board certified by or have obtained preboard
certification status with the American Board of Medical
Specialties, the American Osteopathic Board of Surgery, the
American Board of Podiatric Surgery or the American Board of
Oral and Maxillofacial Surgery.
(5) A medical professional who has successfully
completed a course in advanced pediatric life support offered
by the American Academy of Pediatrics and either the American
College of Emergency Physicians or the American Heart
Association shall be present in the facility.
(a.3) Specialized health care services.--The department
shall annually determine the types of specialized health care
services to be licensed under the provisions of this chapter:
(1) The department shall base its determination on the
following factors:
(i) Whether the quality of the services to be
offered is likely to be compromised through insufficient
volumes or utilization.
(ii) The cost and specialized expertise necessary
for safe and effective care.
(iii) Whether the service dependent is upon the
availability of scarce natural resources such as human
organs.
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(iv) Whether the service involves the use of new
medical technology.
(v) Consideration shall be given to the availability
and accessibility of specialized health care services to
accommodate populations in this Commonwealth.
(2) Exceptions may be granted by the department to
accommodate populations in this Commonwealth based on
availability and accessibility of health care services.
(b) Development of regulations.--In developing rules and
regulations for licensure of facilities or specialized health
care services not accredited and who do not participate in
Medicare, the department shall [take] adopt reasonable rules and
regulations, taking into consideration [Federal certification
standards and the standards of other third party payors for
health care services and such nationally recognized accrediting
agencies as the department may find appropriate.] applicable
standards of nationally recognized accrediting organizations
applicable to the service or setting. At a minimum, the
regulations shall address the following areas:
(1) The care of patients.
(2) The medical supervision of patients.
(3) The physical environment.
(4) Infection control.
(5) Quality assurance.
(6) Transfer protocols or procedures with receiving
facilities, where applicable.
(7) Sanitation.
(8) Safety.
(9) Dietary matters.
(c) Fire and emergency standards.--Notwithstanding any other
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provision of law other than standards required for Federal
certification by that type of health care facility in the
Medicare or Medicaid program[, no]:
(1) 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 nationally recognized accrediting
agencies as the department may find appropriate, and the
department shall adopt and enforce the appropriate] by the
accrediting organization, and the department shall adopt and
enforce these standards.
(2) Nonaccredited, non-Medicare participating facilities
shall comply with the Life Safety Code standards for medical
facilities defined by the National Fire Protection
Association.
* * *
Section 3. Section 809(a) and (d) of the act, amended
December 18, 1992 (P.L.1602, No.179), are amended to read:
Section 809. Term and content of license.
(a) Contents.--All licenses issued by the department under
this chapter shall:
(1) be issued for a specified length of time as follows,
including the provision of section 804(b):
(i) all accredited health care facilities [other
than hospitals for a period of one year, and for
hospitals for a period of two years], for the duration of
the accreditation cycle in good standing with the
expiration date to be the last day of the month in which
license is issued;
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(ii) provisional licenses for the length of time to
be determined by the department upon issuance of the
provisional license; and
(iii) all nonaccredited facilities' time frames
shall correspond to the time frames for accredited
facilities;
(2) be on a form prescribed by the department;
(3) not be transferable except upon prior written
approval of the department;
(4) be issued only to the health care provider and for
the health care facility [or], facilities or specialized
health care services named in the application;
(5) specify the maximum number of beds, if any, to be
used for the care of patients in the facility at any one
time; and
(6) specify limitations which have been placed on the
facility.
* * *
(d) Use of beds in excess of maximum.--Except in case of
[extreme emergency] natural disasters, catastrophes, acts of
bio-terrorism, epidemics or other emergencies, no license shall
permit the use of beds for inpatient use in the licensed
facility in excess of the maximum number set forth in the
license [without first obtaining written permission from the
department: Provided, That during the period of a license, a
health care facility may without the prior approval of the
department increase the total number of beds by not more than
ten beds or 10% of the total bed capacity, whichever is less].
Section 4. Section 810(a) of the act, amended December 18,
1992 (P.L.1602, No.179), is amended to read:
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Section 810. Reliance on accrediting agencies and Federal
Government.
(a) Reports of other agencies.--After a provider has been
licensed or approved to operate a health care facility or
provide specialized health care services for at least [two]
three years under this or prior acts, none of which has been
pursuant to a provisional license, the department [may] shall
rely on the reports of the Federal Government or nationally
recognized accrediting [agencies to the extent those standards
are determined by the department to be similar to regulations of
the department and if] agencies' current applicable standards as
long as the provider agrees to:
(1) direct the agency or government to provide a copy of
its findings to the department; and
(2) permit the department to inspect those areas or
programs of the health care facility [not covered by the
agency or government inspection or] where the agency or
government report discloses more than a minimal violation of
[department regulations] current standards.
* * *
Section 5. This act shall take effect in 60 days.
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