THE GENERAL ASSEMBLY OF PENNSYLVANIA

HOUSE BILL

INTRODUCED BY REICHLEY, CLYMER, CUTLER, EVERETT, GILLESPIE, GODSHALL, GROVE, HARHART, HESS, LONGIETTI, MILLER AND WATSON, MAY 23, 2011

REFERRED TO COMMITTEE ON HEALTH, MAY 23, 2011  

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

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.

"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

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

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

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

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

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.

(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

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.  Sections 809(a) and (d) and 810(a) 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;

(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 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 4.  This act shall take effect in 60 days.