PRINTER'S NO.  257

  

THE GENERAL ASSEMBLY OF PENNSYLVANIA

  

HOUSE BILL

 

No.

247

Session of

2009

  

  

INTRODUCED BY MUNDY, DeLUCA, EACHUS, BELFANTI, BISHOP, BRENNAN, BUXTON, CALTAGIRONE, CARROLL, COHEN, DePASQUALE, FRANKEL, FREEMAN, GEORGE, GIBBONS, GINGRICH, GOODMAN, GRUCELA, HARKINS, HESS, HORNAMAN, JOSEPHS, KIRKLAND, KORTZ, KULA, MANDERINO, MANN, McGEEHAN, McILVAINE SMITH, PALLONE, PASHINSKI, SANTONI, SCAVELLO, SIPTROTH, K. SMITH, SOLOBAY, WALKO, WANSACZ AND WHEATLEY, FEBRUARY 4, 2009

  

  

REFERRED TO COMMITTEE ON INSURANCE, FEBRUARY 4, 2009  

  

  

  

AN ACT

  

1

Amending the act of July 19, 1979 (P.L.130, No.48), entitled "An

2

act relating to health care; prescribing the powers and

3

duties of the Department of Health; establishing and

4

providing the powers and duties of the State Health

5

Coordinating Council, health systems agencies and Health Care

6

Policy Board in the Department of Health, and State Health

7

Facility Hearing Board in the Department of Justice;

8

providing for certification of need of health care providers

9

and prescribing penalties," reenacting and amending

10

provisions relating to definitions, powers and duties of

11

Department of Health and State health services plan;

12

reenacting provisions relating to regulations; reenacting and

13

amending provisions relating to certificates of need and

14

issuance of license; prohibiting certain referrals and claims

15

of payment; and repealing sunset provisions.

16

The General Assembly of the Commonwealth of Pennsylvania

17

hereby enacts as follows:

18

Section 1.  Section 103 of the act of July 19, 1979 (P.L.130,

19

No.48), known as the Health Care Facilities Act, amended

20

December 18, 1992 (P.L.1602, No.179) and October 16, 1998 (P.L.

21

777, No.95), is reenacted and amended to read:

22

Section 103.  Definitions.

 


1

The following words and phrases when used in this act shall

2

have, unless the context clearly indicates otherwise, the

3

meanings given to them in this section:

4

"Act."  The comprehensive Health Care Facilities Act.

5

"Board."  The Health Policy Board established under section

6

401.1.

7

"Certificate of need."  A notice of approval issued by the

8

[department] Department of Health under the provisions of this

9

act, including those notices of approval issued as an amendment

10

to an existing certificate of need.

11

"Certification of need (CON) review board."  The CON review

12

board which consists of technical experts in the fields of

13

medicine, health facility administration, health economics,

14

health care cost inflation and the like, including experts from

15

within the Commonwealth agencies, together with consumers of

16

health care, all of whom are appointed by the Secretary of

17

Health.

18

"Clinically related health service."  Certain diagnostic,

19

treatment or rehabilitative services as determined in section

20

701.

21

["Community-based health services planning committee."  A

22

committee established in accordance with procedures approved by

23

the Department of Health which includes representatives of local

24

or regional groups of consumers, business, labor, health care

25

providers, payors or other affected interests.]

26

"Conflict of interest."  [For the purpose of section 501,

27

the] The interest of any person, whether financial, by

28

association with, or as a contributor of money or time to, any

29

nonprofit corporation or other corporation, partnership,

30

association, or other organization, and whenever a person is a

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1

director, officer or employee of such organization, but shall

2

not exist whenever the organization in which such person is

3

interested is being considered as part of a class or group for

4

whom regulations are being considered, if the material facts as

5

to the relationship or interest are disclosed or are known to

6

the board.

7

"Consumer."  A natural person who is not involved in the

8

provision of health services or health insurance. For the

9

purpose of this act, any person who holds a fiduciary position

10

in any health care facility, health maintenance organization or

11

third party payor shall not be considered a consumer.

12

"Council."  The Health Care Cost Containment Council.

13

"Department."  The Department of Health of the Commonwealth.

14

"Develop."  When used in connection with health services or

15

facilities, means to undertake those activities which on their

16

completion will result in the offer of a new health service or

17

the incurring of a financial obligation in relation to the

18

offering of such a service.

19

"Health care facility."  [For purposes of Chapter 7, any] A 

20

health care facility providing clinically related health

21

services, including, but not limited to, a general or special

22

hospital, including psychiatric hospitals, rehabilitation

23

hospitals, ambulatory surgical facilities, diagnostic imaging

24

centers, MRI facilities, long-term care nursing facilities,

25

cancer treatment centers using radiation therapy on an

26

ambulatory basis and inpatient drug and alcohol treatment

27

facilities, both profit and nonprofit and including those

28

operated by an agency or State or local government. The term

29

shall also include a hospice. The term shall not include an

30

office used primarily for the private or group practice by

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1

health care practitioners where no reviewable clinically related

2

health service is offered, a facility providing treatment solely

3

on the basis of prayer or spiritual means in accordance with the

4

tenets of any church or religious denomination or a facility

5

conducted by a religious organization for the purpose of

6

providing health care services exclusively to clergy or other

7

persons in a religious profession who are members of the

8

religious denominations conducting the facility.

9

"Health care practitioner."  An individual who is authorized

10

to practice some component of the healing arts by a license,

11

permit, certificate or registration issued by a Commonwealth

12

licensing agency or board.

13

"Health care provider" or "provider."  An individual, a trust

14

or estate, a partnership, a corporation (including associations,

15

joint stock companies and insurance companies), the

16

Commonwealth, or a political subdivision or instrumentality

17

(including a municipal corporation or authority) thereof, that

18

operates a health care facility.

19

"Health planning area." A geographic area within the

20

Commonwealth designated by the Department of Health for purposes

21

of health planning.

22

"Hearing board."  The State Health Facility Hearing Board

23

created in the Office of General Counsel under the provisions of

24

this act.

25

"Interested person" or "person expressing an interest." [For

26

the purposes of Chapter 7, a] A member of the public who is to

27

be served by the proposed new health service in the area to be

28

served by the applicant, a health care facility or health

29

maintenance organization or any health care provider providing

30

similar services in the area to be served by the applicant or

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1

who has received a certificate of need to provide services in

2

the area to be served by the applicant or who has formally filed

3

with the [department] Department of Health a letter of intent to

4

provide similar services in the area in which the proposed

5

service is to be offered or developed and any third party payor

6

of health services provided in that area who provides written

7

notice to the [department] Department of Health that the person

8

is interested in a specific certificate of need application

9

before the [department] Department of Health.

10

"Local review committee."  A committee established in

11

accordance with procedures approved by the Department of Health

12

which includes representatives of local or regional groups of

13

consumers, business, labor, health care providers, payors or

14

other affected interests.

15

"Offer."  Make provision for providing in a regular manner

16

and on an organized basis clinically related health services.

17

"Patient."  A natural person receiving health care in or from

18

a health care provider.

19

"Person."  A natural person, corporation (including

20

associations, joint stock companies and insurance companies),

21

partnership, trust, estate, association, the Commonwealth, and

22

any local governmental unit, authority and agency thereof.

23

"Policy board."  The Health Policy Board created in the

24

Department of Health under the provisions of this act.

25

"Public meeting."  A meeting open to the public where any

26

person has an opportunity to comment on a certificate of need

27

application or proposed State health [services] improvement plan

28

amendment.

29

"Secretary."  The Secretary of [the Department of] Health of

30

the Commonwealth of Pennsylvania.

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1

["State health services plan."  A document developed by the

2

Department of Health, after consultation with the policy board

3

and approved by the Governor, that is consistent with section

4

401.3, that meets the current and projected needs of the

5

Commonwealth's citizens. The State health services plan shall

6

contain, in part, the standards and criteria against which

7

certificate of need applications are reviewed and upon which

8

decisions are based.]

9

"Third party payor."  A person who makes payments on behalf

10

of patients under compulsion of law or contract who does not

11

supply care or services as a health care provider or who is

12

engaged in issuing any policy or contract of individual or group

13

health insurance or hospital or medical service benefits. The

14

term shall not include the Federal, State, or any local

15

government unit, authority, or agency thereof or a health

16

maintenance organization.

17

Section 2.  Sections 201 and 401.3 of the act, amended or

18

added December 18, 1992 (P.L.1602, No.179), are reenacted and

19

amended to read:

20

Section 201.  Powers and duties of the department.

21

The Department of Health shall have the power and its duties

22

shall be:

23

(1)  To exercise exclusive jurisdiction over health care

24

providers in accordance with the provisions of this act.

25

(2)  To issue determinations of reviewability or

26

nonreviewability of certificate of need proposals.

27

(2.1)  To develop qualitative and quantitative standards

28

and criteria for the review and approval of certificate of

29

need applications.

30

(3)  To issue certificates of need and amended

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1

certificates of need in accordance with the provisions of

2

this act.

3

(4)  To withdraw expired certificates of need.

4

(5)  To require, pursuant to regulation, submission of

5

periodic reports by providers of health services and other

6

persons subject to review respecting the development of

7

proposals subject to review.

8

[(6)  Upon consultation with the policy board, to

9

research, prepare and, after approval by the Governor,

10

publish, no later than 18 months after the effective date of

11

this act and annually thereafter, a revised State health

12

services plan for the Commonwealth as defined under this act.

13

Until the State health services plan as defined in section

14

401.3 is adopted, the department shall apply the State health

15

plan in existence on the effective date of this act, along

16

with any subsequent updates to that plan.]

17

(6.1)  To develop a certificate of need exceptions

18

process which permits exceptions to be granted to the

19

standards and criteria in order to reflect local experience

20

or ensure access or to respond to circumstances which pose a

21

threat to public health and safety. The exceptions process

22

shall begin only after the department issues a denial of a

23

certificate of need application. All exceptions must be

24

publicly disclosed. This provision creates no right or

25

entitlement to an exception.

26

(7)  To collect and disseminate such other information as

27

may be appropriate to determine the appropriate level of

28

facilities and services for the effective implementation of

29

certification of need under this act. Where such information

30

is collected by any other agency of State government,

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1

duplication shall be avoided by coordination of data

2

collection activities[.], if such coordination does not

3

otherwise unduly burden those State agencies.

4

[(8)  To furnish such staff support and expertise to the

5

policy board as may be needed to perform its

6

responsibilities.]

7

(9)  To receive, log and review all applications for

8

certificates of need or amendments thereof and approve or

9

disapprove the same.

10

(10)  To minimize the administrative burden on health

11

care providers by eliminating unnecessary duplication of

12

financial and operational reports and to the extent possible

13

and without undue burden coordinating reviews and inspections

14

performed by Federal, State, local and private agencies.

15

(11)  To adopt and promulgate regulations necessary to

16

carry out the purposes and provisions of this act relating to

17

certificate of need.

18

(12)  To enforce the rules and regulations promulgated by

19

the department as provided in this act.

20

(13)  To provide technical assistance to individuals and

21

public and private entities in filling out the necessary

22

forms for the development of projects and programs.

23

(14)  To establish and publish in the Pennsylvania

24

Bulletin a fee schedule for certificate of need applications

25

and letters of intent in accordance with section 902.1.

26

(15)  To coordinate any data collection activities

27

necessary for administration of this act so as not to

28

duplicate unnecessarily the data collection activities of

29

other Federal and State agencies.

30

(16)  To modify the list of reviewable clinically related

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1

health services established under section 701.

2

(17)  To establish and publish in the Pennsylvania

3

Bulletin a detailed schedule of the review process for each

4

certificate of need application submitted to the department.

5

Section 401.3.  State health [services] improvement plan.

6

The State health [services] improvement plan shall consist of

7

at a minimum:

8

(1)  An identification of the clinically related health

9

services necessary to serve the health needs of the

10

population of this Commonwealth, including those medically

11

underserved areas in rural and inner-city locations.

12

(2)  An analysis of the availability, accessibility and

13

affordability of the clinically related health services

14

necessary to meet the health needs of the population of this

15

Commonwealth.

16

[(3)  Qualitative and quantitative standards and criteria

17

for the review of certificate of need applications by the

18

department under this act.

19

(4)  An exceptions process which permits exceptions to be

20

granted to the standards and criteria in order to reflect

21

local experience or ensure access or to respond to

22

circumstances which pose a threat to public health and

23

safety.]

24

Section 3.  Section 602 of the act is reenacted to read:

25

Section 602.  Regulations.

26

The department is hereby authorized and empowered pursuant to

27

the provisions of this act to adopt rules and regulations

28

establishing procedures required by this act for administration

29

of certificate of need.

30

Section 4.  Sections 603, 701 and 702 of the act, amended

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1

December 18, 1992 (P.L.1602, No.179), are reenacted and amended

2

to read:

3

Section 603.  Enforcement of orders relating to certificate of

4

need.

5

(a)  (1)  No certificate of need shall be granted to any

6

person for a health care facility or reviewable clinically

7

related health service unless such facility or clinically

8

related health service is found by the department and CON

9

review board to be needed.

10

(2)  No person shall offer or develop a health care

11

facility or reviewable clinically related health service

12

without obtaining a certificate of need as required by this

13

act.

14

(3)  No binding arrangement or commitment for financing

15

the offering or development of a health care facility or

16

reviewable clinically related health service shall be made by

17

any person unless a certificate of need for such clinically

18

related health service or facility has been granted in

19

accordance with this act.

20

(b)  Orders for which the time of appeal has expired shall be

21

enforced by the department and the CON review board in summary

22

proceedings or, when necessary, with the aid of the court.

23

(c)  No [collateral attack on any order, including] questions

24

relating to jurisdiction shall be permitted in the enforcement

25

proceeding, but such relief may be sought when such relief has

26

not been barred by the failure to take a timely appeal.

27

(d)  Any person operating a reviewable clinically related

28

health service or health care facility within this Commonwealth

29

for which no certificate of need has been obtained, after

30

service of a cease and desist order of the department, [or after

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1

expiration of the time for appeal of any final order on appeal,

2

upon conviction thereof,] shall be [sentenced to pay] subject to 

3

a fine of not less than [$100] $1,000 or more than [$1,000]

4

$10,000 and costs of [prosecution] enforcement. Each day of

5

operating a clinically related health service or health care

6

facility after issuance of a cease and desist order shall

7

constitute a separate offense.

8

(e)  Any person who violates this act by failing to obtain a

9

certificate of need, by deviating from the provisions of the

10

certificate, by beginning construction, by providing services,

11

or by acquiring equipment after the expiration of a certificate

12

of need shall be subject to a penalty of not less than [$100]

13

$1,000 per day and not more than [$1,000] $10,000 per day. Each

14

day of each such violation shall be considered a separate

15

offense.

16

(f)  The department may seek injunctive relief to prevent

17

continuing violations of this act. In seeking such relief, the

18

department need not prove damages or irreparable harm.

19

(g)  No license to operate a health care facility or

20

reviewable clinically related health service by any person in

21

this Commonwealth shall be granted and any license issued shall

22

be void and of no effect as to any facility, organization,

23

service or part thereof for which a certificate of need is

24

required by this act and not granted.

25

Section 701.  Certificate of need required; clinically related

26

health services subject to review.

27

(a)  Any person, including, but not limited to, a health care

28

facility, health maintenance organization or health care

29

provider who offers, develops, constructs, renovates, expands or

30

otherwise establishes or undertakes to establish within the

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1

State a clinically related health service that is included in

2

the department's list of reviewable services developed under

3

subsections (d) and (e) or a health care facility as defined in

4

section 103 must obtain a certificate of need from the

5

department and CON review board if one or more of the following

6

factors applies:

7

(1)  [The proposal requires a capital expenditure in

8

excess of $2,000,000 under] Under generally accepted

9

accounting principles, consistently applied[.], the proposal

10

requires a capital expenditure in excess of:

11

(i)  for a new high-cost technology or high-cost

12

replacement technology in any health care facility,

13

$500,000;

14

(ii)  for equipment or other facility improvements in

15

an ambulatory surgical facility, or in an office where

16

reviewable clinically related health care services are

17

offered, whether a free-standing facility or office

18

within a hospital, $1,000,000; or

19

(iii)  for any other hospital-based improvement,

20

$2,000,000.

21

(2)  The proposal involves the establishment of a health

22

care facility or a reviewable clinically related health

23

service.

24

(3)  The proposal increases the number of licensed beds

25

by more than ten beds or 10%, whichever is less, every two

26

years.

27

(i)  If the additional beds are acute care beds and

28

are not beds in a distinct-part psychiatric,

29

rehabilitation or long-term care unit, all licensed beds

30

of the acute-care facility shall be counted in

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1

determining whether the increased number of beds exceeds

2

10%.

3

(ii)  If the additional beds are beds in a distinct-

4

part psychiatric, rehabilitation or long-term care unit

5

of an acute care facility, only the beds within that unit

6

shall be counted in determining whether the increased

7

number of beds exceeds 10%.

8

(iii)  If the additional beds are in a freestanding

9

psychiatric, rehabilitation or long-term care facility,

10

all licensed beds of the freestanding facility shall be

11

counted in determining whether the increased number of

12

beds exceeds 10%.

13

(4)  The proposal substantially expands an existing

14

clinically related health service as determined by the

15

department [in the State health services plan].

16

(b)  For the purposes of this act, an expenditure for the

17

purpose of acquiring an existing health care facility [or

18

replacement of equipment where there is no change in service]

19

shall not be considered to be a capital expenditure subject to

20

review. Expenditures for nonclinical activities or services,

21

such as parking garages, computer systems or refinancing of

22

debt, and research projects involving premarket approval of new

23

equipment shall not be subject to review.

24

(c)  The capital expenditure threshold identified in

25

subsection (a)(1) may be modified periodically by the department

26

to reflect any increase in the construction cost or other

27

factors influencing health care-related capital expenditures.

28

The department shall publish a modification of the expenditure

29

threshold through the regulatory review process.

30

(d)  A list of reviewable clinically related health services

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1

shall be published by the department and the CON review board 

2

within 30 days of the effective date of this act and may be

3

modified by regulation on an annual basis. Exclusive of new

4

high-cost technology, the initial list published by the

5

department and the CON review board as required under this

6

subsection shall be no more extensive than those services

7

reviewable on the effective date of this act. Criteria for

8

inclusion of reviewable services shall include, but not be

9

limited to:

10

(1)  the quality of the service to be offered is likely

11

to be compromised through insufficient volumes or

12

utilization;

13

(2)  the service is dependent upon the availability of

14

scarce natural resources such as human organs;

15

(3)  the operating costs associated with the service are

16

reimbursed by major third party payors on a cost

17

reimbursement basis; or

18

(4)  the service involves the use of new technology.

19

(e)  Any changes to the list required under subsection (d)

20

and proposed by regulation shall be developed by the department

21

[after consultation with the policy board.] and the CON review

22

board.

23

(f)  A facility providing treatment solely on the basis of

24

prayer or spiritual means in accordance with the tenets of any

25

church or religious denomination or a facility conducted by a

26

religious organization for the purpose of providing health care

27

services exclusively to clergy or other persons in a religious

28

profession who are members of the religious denomination

29

conducting the facility shall not be considered to constitute a

30

health service subject to review under this act.

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1

(g)  As used in this section, "new high-cost technology"

2

means new technological equipment with an aggregate purchase

3

cost of greater than $500,000. The department and the CON review

4

board shall consult with national medical and surgical

5

speciality organizations recognized by the American Board of

6

Medical Specialities (ABMS) and other nationally recognized

7

scientific resources in the determination of what constitutes

8

new technological equipment.

9

Section 702.  Certificates of need; notice of intent;

10

application; issuance.

11

(a)  Projects requiring a certificate of need shall, at the

12

earliest possible time in their planning, but not later than

13

April 1 of the calendar year prior to the year of the proposed

14

project start date, be submitted to the department and the CON

15

review board in a letter of intent in such detail advising of

16

the scope and nature of the project as required by regulations.

17

Within 30 days after receipt of the letter of intent, the

18

department and the CON review board shall inform the applicant

19

providing the letter of intent whether the proposed project is

20

subject to a certificate of need review or if additional

21

information is required to make that determination. If the

22

department [determines] and the CON review board determine that

23

the project is subject to a certificate of need review, the

24

project shall be subject to the remaining provisions of this

25

act.

26

(b)  A person desiring to obtain or amend a certificate of

27

need shall apply in writing to the department, supplying such

28

information as is required by the department and the CON review

29

board, including, but not limited to, a cost impact analysis as

30

further defined by the department in regulations implementing

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1

this act, and certifying that all data, information and

2

statements are factual to the best of their knowledge,

3

information and belief. The department and the CON review board 

4

shall have 60 days after receipt of the application within which

5

to assess the application and in which to request specific

6

further information. If further information is requested, the

7

department and the CON review board shall complete its

8

preliminary assessment of the application within 45 days of

9

receipt of the same. No information shall be required that is

10

not specified in the rules and regulations promulgated by the

11

department.

12

(c)  Timely notice of the beginning of review of the

13

application by the department shall be published after

14

preliminary assessment of the application is completed by the

15

department and the CON review board. The "date of notification"

16

of the beginning of review shall be the date such notice is

17

sent, or the date such notice is published in the Pennsylvania

18

Bulletin or in a newspaper of general circulation, whichever is

19

latest.

20

(d)  The department and the CON review board shall approve or

21

disapprove the application within 90 days from the date of

22

notification of the beginning of the review unless the period

23

for review is extended by the applicant in writing.

24

(e)  (1)  Certificates of need shall be granted or refused by

25

the department. They shall not be conditioned upon the

26

applicant changing other aspects of its facilities or

27

services or requiring the applicant to meet other specified

28

requirements, and no such condition shall be imposed by the

29

department in granting or refusing approval of certificates

30

of need.

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1

(2)  A certificate of need shall state the maximum amount

2

of expenditures which may be obligated under it and

3

applicants proceeding with an approved project may not exceed

4

this level of expenditure except as allowed under the

5

conditions and procedures established by the department

6

through regulation.

7

(f)  (1)  The department and the CON review board shall make

8

written findings which state the basis for any final decision

9

made by the department. Such findings shall be served upon

10

the applicant and provided to all persons expressing an

11

interest in the proceedings and shall be made available to

12

others upon written request.

13

(2)  All decisions of the department and the CON review

14

board shall be based solely on the record. No ex parte

15

contact regarding the application between any employee of the

16

department or the CON review board who exercises

17

responsibilities respecting the application and the

18

applicant, any person acting on behalf of the applicant or

19

any person opposed to the issuance of the certificate of need

20

shall occur after the commencement of a hearing on the

21

application and before a decision is made by the department.

22

(g)  Modification of the application at any stage of the

23

proceeding shall not extend the time limits provided by this act

24

unless the department and the CON review board expressly [finds]

25

find that the modification represents a substantial change in

26

the character of the application.

27

(h)  The responsibility of performing certificate of need

28

review may not be delegated by the department and the CON review

29

board. The department and the CON review board shall consider

30

recommendations of [one or more community-based health services

- 17 -

 


1

planning committees] the local review committees whose

2

localities are affected by specific applications in reviewing

3

the applications.

4

(i)  The department and the CON review board may provide that

5

categories of projects shall receive simultaneous and

6

comparative review.

7

(j)  Once the department and the CON review board have

8

finished the initial review of an application and determined

9

that the application shall be reviewed by a local review

10

committee, the department and the CON review board shall notify

11

the council in writing that a community review is pending and

12

request analyses to assist the review process. The council shall

13

offer its analyses to the department and the CON review board

14

prior to the completion of the review process. The department

15

and the CON review board shall share these analyses with the

16

local review committee. If the council determines that it does

17

not have the requisite data and information to provide analyses

18

to the department and the CON review board, the council shall

19

notify the department in writing. The department and the CON

20

review board shall notify the local review committee about the

21

council's determination. In carrying out its responsibilities,

22

the council shall have all the powers and duties of the council

23

enumerated by the act of July 8, 1986 (P.L.408, No.89), known as

24

the "Health Care Cost Containment Act."

25

Section 5.  Section 703 of the act, amended July 12, 1980

26

(P.L.655, No.136), is reenacted and amended to read:

27

Section 703.  Notice and hearings before [health systems

28

agencies] the department and CON review board.

29

(a)  Notice of completed applications for certificates of

30

need or amendment thereto and of the beginning of review shall

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1

be published by the [health systems agency] department in the

2

appropriate news media and by the department in the Pennsylvania

3

Bulletin in accordance with 45 Pa.C.S. [Chap. 7B] Ch. 7 Subch. B 

4

(relating to publication of documents), and the [health systems

5

agency] department shall notify all affected persons with notice

6

of the schedule for review, the date by which a public hearing

7

must be demanded, and of the manner notice will be given of a

8

hearing, if one is to be held. Notice to affected persons (other

9

than members of the public who are to be served by the proposed

10

new institutional health service) shall be by mail (which may be

11

part of a newsletter). Members of the public may be notified

12

through newspapers of general circulation. Directly affected

13

persons may file objections within 15 days of such publication

14

with the [local health systems agency] department setting forth

15

specifically the reasons such objections were filed. Persons

16

filing the objections shall be parties to the proceeding, unless

17

and until such objections are withdrawn.

18

(b)  Affected persons may request a public hearing or the

19

[health systems agency] department may require a public hearing

20

during the course of such review. Fourteen days written notice

21

of the hearing shall be given to affected persons in the same

22

manner as a notice of a completed application is provided in

23

subsection (a). In the hearing, any person shall have the right

24

to be represented by counsel and to present oral or written

25

arguments and relevant evidence. Any person directly affected

26

may conduct reasonable questioning of persons who make relevant

27

factual allegations. A record of the hearing shall be

28

maintained.

29

Section 6.  Sections 704 and 705 of the act, amended December

30

18, 1992 (P.L.1602, No.179), are reenacted to read:

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1

Section 704.  Notice of public meetings.

2

(a)  Notification of the beginning of review of a certificate

3

of need application shall be published by the department in the

4

appropriate news media and in the Pennsylvania Bulletin in

5

accordance with 45 Pa.C.S. Ch. 7 Subch. B (relating to

6

publication of documents). The notice shall identify the

7

schedule for review, the date by which a public meeting must be

8

requested and the manner in which notice will be given of a

9

meeting, if one is held.

10

(b)  Interested persons may request a public meeting within

11

15 days of publication, and the department shall hold such a

12

meeting or the department may require a public meeting during

13

the course of such review. The department shall publish written

14

notice of the meeting in the appropriate news media and the

15

Pennsylvania Bulletin at least 14 days prior to the public

16

meeting date. In the meeting, the applicant and any interested

17

person providing prior notice to the department shall have the

18

right to present oral or written comments and relevant evidence

19

on the application in the manner prescribed by the department.

20

The department shall prepare a transcript of the oral testimony

21

presented at the meeting. Meetings shall be held in accordance

22

with the guidelines and procedures established by the department

23

and published in the Pennsylvania Code as a statement of policy.

24

The department may require the applicant to provide copies of

25

the application to any interested person making a request for

26

such application, at the expense of the interested person.

27

(c)  The applicant may, for good cause shown, request in

28

writing a public hearing for the purpose of reconsideration of a

29

decision of the department within ten days of service of the

30

decision of the department. The department shall treat the

- 20 -

 


1

request in accordance with the provisions of 1 Pa. Code § 35.241

2

(relating to application for rehearing or reconsideration). The

3

department shall set forth the cause for the hearing and the

4

issues to be considered at such hearing. If such hearing is

5

granted, it shall be held no sooner than six days and no later

6

than 30 days after the notice to grant such a hearing and shall

7

be limited to the issues submitted for reconsideration. A

8

transcript shall be made of the hearing and a copy of the

9

transcript shall be provided at cost to the applicant. The

10

department shall affirm or reverse its decision and submit the

11

same to the person requesting the hearing within 30 days of the

12

conclusion of such hearing. Any change in the decision shall be

13

supported by the reasons for the change.

14

(d)  Where hearings under subsection (b) are held on more

15

than two days, consecutive days of hearings and intervening

16

weekends and holidays shall be excluded in calculating the time

17

permitted for the department to conduct its review, and, if

18

briefs are to be filed, ten days subsequent to the adjournment

19

of the hearing shall also be excluded.

20

Section 705.  Good cause.

21

Good cause shall be deemed to have been shown if:

22

(1)  there is significant, relevant information not

23

previously considered;

24

(2)  there is significant change in factors or

25

circumstances relied on in making the decision;

26

(3)  there has been material failure to comply with the

27

procedural requirements of this act; or

28

(4)  good cause is otherwise found to exist.

29

Section 7.  Sections 706, 707 and 708.1 of the act, amended

30

or added December 18, 1992 (P.L.1602, No.179), are reenacted and

- 21 -

 


1

amended to read:

2

Section 706.  Information during review.

3

During the course of review the department and the CON review

4

board shall upon request of any person set forth the status, any

5

findings made in the proceeding and other appropriate

6

information requested. The department and the CON review board 

7

may require such request in writing.

8

Section 707.  Criteria for review of applications for

9

certificates of need or amendments.

10

(a)  An application for certificate of need shall be

11

considered for approval when the department [determines] and the

12

CON review board determine that the application substantially

13

meets the requirements listed below:

14

(1)  There is need by the population served or to be

15

served by the proposed service or facility.

16

(2)  The proposed service or facility will provide care

17

consistent with quality standards established by the [State

18

health services plan] department.

19

(3)  The proposed service or facility will meet the

20

standards identified [in the State health services plan] by

21

the department for access to care by medically underserved

22

groups, including individuals eligible for medical assistance

23

and persons without health insurance.

24

(4)  The applicant has submitted a data-based cost

25

analysis that includes an analysis demonstrating that:

26

(i)  There is not a more appropriate, less costly or

27

more effective alternative method of providing the

28

proposed services.

29

(ii)  The service or facility is financially and

30

economically feasible, considering anticipated volume of

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1

care and the availability of reasonable financing based

2

on information from the applicant and other sources

3

during the review process.

4

(iii)  The proposed service or facility will not have

5

an inappropriate, adverse impact on the overall level of

6

health care expenditures in the area.

7

(iv)  The proposed service or facility does not

8

adversely impact the maintenance and development of rural

9

and inner-city health services generally and, in

10

particular, those services provided by health care

11

providers which are based in rural and inner-city

12

locations and which have an established history of

13

providing services to medically underserved populations.

14

[(b)  The department shall issue a certificate of need if the

15

project substantially meets the criteria of subsection (a)(1),

16

(2) and (3) and the project is consistent with the State health

17

services plan unless the department can demonstrate:

18

(1)  There is a more appropriate, less costly or more

19

effective alternative method of providing the proposed

20

services.

21

(2)  The service or facility is not financially and

22

economically feasible, considering anticipated volume of care

23

and the availability of reasonable financing based on

24

information received from the applicant and other sources

25

during the review process.

26

(3)  The proposed service or facility will have an

27

inappropriate, adverse impact on the overall level of health

28

care expenditures in the area.

29

(4)  The proposed service or facility adversely impacts

30

the maintenance and development of rural and inner-city

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1

health services generally and, in particular, those services

2

provided by health care providers which are based in rural

3

and inner-city locations and which have an established

4

history of providing services to medically underserved

5

populations.]

6

(c)  Notwithstanding the provisions of [subsections (a) and

7

(b)] subsection (a), applications for projects described in

8

subsection (d) shall be approved unless the department [finds]

9

and the CON review board find that the facility or service with

10

respect to such expenditure as proposed is not needed [or that

11

the project is not consistent with the State health services

12

plan]. An application made under this subsection shall be

13

approved only to the extent that the department [determines] and

14

the CON review board determine it is required to overcome the

15

conditions described in subsection (d).

16

(d)  Subject to the provisions of subsection (c),

17

[subsections (a) and (b)] subsection (a) shall not apply to

18

capital expenditures required to:

19

(1)  eliminate or prevent imminent safety hazards as a

20

result of violations of safety codes or regulations;

21

(2)  comply with State licensure standards; or

22

(3)  comply with accreditation standards, compliance with

23

which is required to receive reimbursement or payments under

24

Title XVIII or XIX of the Federal Social Security Act.

25

Section 708.1.  Monitoring certificate of need; expiration of a

26

certificate of need.

27

A certificate of need or an amendment to it shall expire two

28

years from the date issued unless substantially implemented, as

29

defined by regulation. The department and the CON review board 

30

may grant extensions for a specified time upon request of the

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1

applicant and upon a showing that the applicant has or is making

2

a good faith effort to substantially implement the project. An

3

expired certificate of need shall be invalid, and no person may

4

proceed to undertake any activity pursuant to it for which a

5

certificate of need or amendment is required. The applicant

6

shall report to the department, on forms prescribed by the

7

department, the status of the project until such time as the

8

project is licensed or operational, if no license is required.

9

Section 8.  Section 709 of the act, amended December 18, 1992

10

(P.L.1602, No.179), is reenacted to read:

11

Section 709.  Emergencies.

12

Notwithstanding any other provision of this act, in the event

13

of an emergency the department may suspend the foregoing

14

application process and permit such steps to be taken as may be

15

required to meet the emergency including the replacement of

16

equipment or facilities.

17

Section 9.  Section 710 of the act is reenacted to read:

18

Section 710.  Notice of termination of services.

19

For informational purposes only, at least 30 days prior to

20

termination or substantial reduction of a service or a permanent

21

decrease in the bed complement, the provider shall notify the

22

[health systems agency and the] department of its intended

23

action.

24

Section 10.  Section 711 of the act, amended December 18,

25

1992 (P.L.1602, No.179), is reenacted and amended to read:

26

Section 711.  Review of activities.

27

(a)  The department and the CON review board shall prepare

28

and publish not less frequently than annually reports of reviews

29

conducted under this act, including a statement on the status of

30

each such review and of reviews completed by it and statements

- 25 -

 


1

of the decisions made in the course of such reviews since the

2

last report. The department and the CON review board shall also

3

make available to the general public for examination at

4

reasonable times of the business day all applications reviewed

5

by it. Such reports and applications shall be considered public

6

records.

7

(b)  The department's and the CON review board's report which

8

shall be submitted to the members of the Health and Welfare

9

Committees of the Senate and House of Representatives shall

10

contain the following information:

11

(1)  The volume of applications submitted, by project

12

type, their dollar value, and the numbers and costs

13

associated with those approved and those not approved.

14

(2)  The assessment of the extent of competition in

15

specific service sectors that guided decisions.

16

(3)  A detailed description of projects involving

17

nontraditional or innovative service delivery methods or

18

organizational arrangements and the decisions made on each of

19

these projects.

20

(4)  The average time for review, by level of review.

21

(5)  The fees collected for reviews and the cost of the

22

program.

23

Section 11.  Section 712 of the act, added July 12, 1980

24

(P.L.655, No.136) and repealed in part December 20, 1982 (P.L.

25

1409, No.326), is reenacted and amended to read:

26

Section 712.  Actions against violations of law and rules and

27

regulations[; bonds].

28

(a)  Whenever any person, regardless of whether such person

29

is a licensee, has willfully violated any of the provisions of

30

this act or the rules and regulations adopted thereunder, the

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1

department may maintain any action in the name of the

2

Commonwealth for an injunction or other process restraining or

3

prohibiting such person from engaging in such activity.

4

Section 12.  Section 808 of the act, amended December 18,

5

1992 (P.L.1602, No.179) and July 7, 2006 (P.L.334, No.69), is

6

reenacted and amended to read:

7

Section 808.  Issuance of license.

8

(a)  Standards.--The department shall issue a license to a

9

health care provider when it is satisfied that the following

10

standards have been met:

11

(1)  that the health care provider is a responsible

12

person;

13

(2)  that the place to be used as a health care facility

14

is adequately constructed, equipped, maintained and operated

15

to safely and efficiently render the services offered;

16

(3)  that the health care facility provides safe and

17

efficient services which are adequate for the care, treatment

18

and comfort of the patients or residents of such facility;

19

(4)  that there is substantial compliance with the rules

20

and regulations adopted by the department pursuant to this

21

act; and

22

(5)  that a certificate of need has been issued if one is

23

necessary.

24

(b)  Separate and limited licenses.--Separate licenses shall

25

not be required for different services within a single health

26

care facility except that home health care, home care, hospice

27

or long-term nursing care will require separate licenses. A

28

limited license, excluding from its terms a particular service

29

or portion of a health care facility, may be issued under the

30

provisions of this act.

- 27 -

 


1

(c)  Addition of services.--When the certificate of need for

2

a facility is amended as to services which can be offered, the

3

department shall issue an appropriate license for those services

4

upon demonstration of compliance with licensure requirements.

5

(d)  Monitoring.--

6

(1)  One year after the certificate of need has been

7

issued, the department shall monitor quality of the facility

8

or service by requesting from the council relevant data,

9

which may include mortality rates and the number of

10

procedures performed.

11

(2)  If the department finds that the facility or service

12

is not meeting the standards set forth in subsection (a), the

13

department shall take disciplinary action pursuant to this

14

act and existing regulations.

15

Section 13.  The act is amended by adding a section to read:

16

Section 808.1.  Prohibition of referrals and claims of payment.

17

(a)  Referrals.--A provider may not:

18

(1)  Refer a person for treatment and services if the

19

provider has a financial interest with the person or in the

20

entity that receives the referral.

21

(2)  Enter into an arrangement or scheme, including, but

22

not limited to, a cross-referral arrangement, that the

23

provider knows or should know has a principal purpose of

24

assuring referrals by the provider to a particular entity

25

which, if the provider directly made referrals to the entity,

26

would be in violation of this act.

27

(b)  Claim for payment.--No claim for payment may be

28

presented by an entity to any individual, third-party payor or

29

other entity for a service furnished pursuant to conduct

30

prohibited under subsection (a).

- 28 -

 


1

(c)  Refund.--If an entity collects any amount that was

2

billed in violation of this section, the entity shall refund

3

that amount on a timely basis to the payor or individual.

4

Section 14.  Section 901 of the act, amended July 12, 1980

5

(P.L.655, No.136), is reenacted and amended to read:

6

Section 901.  Existing facilities and institutions.

7

(a)  (1)  No certificate of need shall be required for any

8

buildings, real property and equipment owned, leased or being

9

operated, or under contract for construction, purchase, or

10

lease and for all services being rendered by licensed or

11

approved providers [on April 1, 1980.] prior to the effective

12

date of this paragraph.

13

(2)  Nor shall a certificate of need be required for any

14

new institutional health services for which an approval has

15

been granted under section 1122 of the Social Security Act or

16

for which an application is found pursuant to such section to

17

be in conformity with the standards, criteria or plans to

18

which such section refers, or as to which the Federal

19

Secretary of Health and Human Services makes a finding that

20

reimbursement shall be granted.[: Provided, however, That

21

such approval is in force on August 1, 1980 or such

22

application shall have been filed prior to August 1, 1980 or

23

the acceptance of applications for reviews under this act,

24

whichever shall last occur.]

25

(b)  Existing facilities and institutions shall be required

26

to obtain a certificate of need for projects outlined in section

27

701.

28

Section 15.  Section 902.1 of the act, added December 18,

29

1992 (P.L.1602, No.179), is reenacted and amended to read:

30

Section 902.1.  Fees for review of certificate of need

- 29 -

 


1

applications.

2

(a)  The department shall charge a fee of [$150] $500 for

3

each letter of intent filed. The letter of intent fee shall be

4

deducted from the total application fee required under

5

subsection (b) if an application is submitted on the project

6

proposed in the letter of intent.

7

(b)  For each application the department shall charge a fee,

8

payable on submission of an application. The fee shall not be

9

less than $500 plus up to [$3] $10 per $1,000 of proposed

10

capital expenditure and shall not be more than [$20,000]

11

$50,000.

12

(c)  The department shall publish a fee schedule in the

13

Pennsylvania Bulletin which shall explain the procedure for

14

filing fees.

15

(d)  All fees payable under this section are due upon the

16

date of filing a letter of intent or application. If a person

17

fails to file the appropriate fee, all time frames required of

18

the department under this act, with respect to review of a

19

letter of intent or application, are suspended until the

20

applicable fee is paid in full.

21

(e)  Each local review committee may apply for up to $10,000

22

in funding from the department for administrative functions

23

associated with reviewing certificate of need proposals. This

24

funding is to be allocated from the Patient Safety Authority

25

appropriation.

26

Section 16.  Section 904.1 of the act, added December 18,

27

1992 (P.L.1602, No.179), is repealed:

28

[Section 904.1.  Sunset.

29

The authority, obligations and duties arising under Chapter 7

30

and all other provisions of this act pertaining to certificates

- 30 -

 


1

of need shall terminate four years after the effective date of

2

this section. Twelve months prior to this expiration, the

3

Legislative Budget and Finance Committee shall commence a review

4

of the impact of the certificate of need program on quality,

5

access and cost of health care services, including the costs of

6

appeals, reviewable under this act.]

7

Section 17.  This act shall take effect immediately.

- 31 -