PRINTER'S NO. 288
No. 267 Session of 1987
INTRODUCED BY WILSON, BURNS AND RICHARDSON, FEBRUARY 10, 1987
REFERRED TO COMMITTEE ON HEALTH AND WELFARE, FEBRUARY 10, 1987
AN ACT
1 Amending the act of June 23, 1970 (P.L.419, No.140), entitled
2 "An act establishing in the Department of Health a program
3 for the care of persons suffering from chronic renal
4 diseases, providing for an advisory committee in connection
5 therewith, designating powers and duties in relation thereto,
6 and making an appropriation therefor," further providing for
7 the advisory committee; providing for audits of expended
8 funds; providing for reprocessed dialysis devices or
9 supplies; and providing for the expiration of the act.
10 The General Assembly of the Commonwealth of Pennsylvania
11 hereby enacts as follows:
12 Section 1. Sections 4 and 8 of the act of June 23, 1970
13 (P.L.419, No.140), referred to as the Renal Disease Treatment
14 Act, are amended to read:
15 Section 4. (a) The Governor shall nominate and, by and with
16 the advice and consent of two-thirds of all the members of the
17 Senate, appoint a Renal Disease Advisory Committee, hereafter
18 referred to as the committee, to consult with the department in
19 the administration of this act. [The]
20 (1) Until December 31, 1987, the committee shall be composed
21 of eleven persons representing hospitals and medical schools
1 which establish dialysis centers, voluntary agencies interested
2 in kidney diseases, local public health agencies, physicians
3 licensed to practice medicine in all of its branches, and the
4 general public.
5 (2) On December 31, 1987, the terms of incumbent members of
6 the committee shall expire.
7 (3) After December 31, 1987, the committee shall be composed
8 of eleven persons chosen as follows:
9 (i) Two representatives of hospitals, appointed by the
10 Governor from a list of three qualified representatives from
11 hospitals with established dialysis centers, recommended by the
12 Hospital Association of Pennsylvania.
13 (ii) Two representatives of physicians, appointed by the
14 Governor from a list of three qualified physicians recommended
15 jointly by the Pennsylvania Medical Society and the Pennsylvania
16 Osteopathic Medical Society.
17 (iii) Two qualified representatives of local public health
18 agencies, appointed by the Governor from a list of three
19 qualified persons experienced in kidney disease treatment
20 programs recommended by the department's Deputy Secretary for
21 Community Health.
22 (iv) One representative of Blue Cross and Blue Shield plans
23 in Pennsylvania, appointed by the Governor from a list of three
24 qualified persons recommended jointly by Blue Cross and Blue
25 Shield plans of Pennsylvania.
26 (v) Two patient representatives, appointed by the Governor
27 from a list of three kidney dialysis patients or advocates
28 recommended by established kidney patient organizations in
29 Pennsylvania.
30 (vi) One representative from the department's Chronic Renal
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1 Disease Program, appointed by the Governor from a list of three
2 qualified persons submitted by the secretary.
3 (vii) One representative from the Health Care Cost
4 Containment Council, appointed by the Governor from a list of
5 three members of the council.
6 (b) The members of the committee shall serve for a two year
7 period and may be reappointed. The committee shall serve without
8 compensation, but shall receive necessary travel expenses. The
9 chairman of the committee shall be elected by the committee. The
10 committee, with the approval of the secretary, shall establish
11 standards for the expenditure of State funds which are provided
12 for the support of persons suffering from renal diseases to
13 assure the availability of specialized personnel, resources, and
14 equipment necessary to enable such persons to function and to
15 care for patients with severe uremia. The secretary shall choose
16 from a list provided by the advisory committee, the institutions
17 which qualify under the standards established to receive grants
18 of State funds to provide care for renal disease patients.
19 (c) A nominee to the advisory committee shall file a
20 financial interest statement with the Rules and Executive
21 Nominations Committee of the Senate prior to confirmation by the
22 Senate and with the State Ethics Commission annually in
23 accordance with the filing procedures set forth in the act of
24 October 4, 1978 (P.L.883, No.170), referred to as the Public
25 Official and Employee Ethics Law.
26 Section 8. (a) The funds which are provided by the State
27 shall only be expended for the care and treatment of persons
28 suffering from renal diseases including home dialysis care;
29 training of personnel and other expenses incident to providing
30 proper care and treatment; extend financial assistance to
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1 persons suffering from renal diseases in obtaining the medical,
2 nursing, pharmaceutical, and technical services necessary in
3 caring for such diseases including the renting of home dialysis
4 equipment; and treatment of complications which may result from
5 dialysis. These funds shall not be utilized to pay for general
6 medical care services which should come from private, local,
7 other State or Federal sources.
8 (b) The proper expenditure of these funds shall be examined
9 and verified by the Auditor General in the course of regular
10 audits of all State agencies.
11 Section 2. The act is amended by adding sections to read:
12 Section 8.1. (a) (1) No provider or facility may provide
13 or utilize reprocessed dialysis devices or supplies for the
14 dialysis of an individual entitled to benefits under this act
15 unless the provider or facility has obtained the informed,
16 written consent of the individual in accordance with clause (2).
17 (2) (i) A provider or facility that proposes to provide or
18 utilize any reprocessed dialysis devices or supplies for the
19 dialysis of an individual entitled to benefits under this act
20 shall furnish the individual or a legal guardian with a written
21 document which informs the individual or guardian of the
22 specific reprocessed dialysis devices and supplies the provider
23 or facility proposes to provide or utilize, the specific
24 substances and materials to be utilized in reprocessing each
25 such device or supply and the number of times it previously has
26 been used, and the potential and known risks and benefits of
27 utilizing each such device or supply including, but not limited
28 to, any increased risk of infection and any harmful long-term
29 effects that the substances and materials utilized in
30 reprocessing the device or supply may have. The written document
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1 shall provide assurances to the individual or guardian that the
2 provider or facility will not penalize the individual in any way
3 for refusal to consent to the provision or utilization of
4 reprocessed dialysis devices or supplies for the dialysis of the
5 individual, and will not refuse to provide or utilize dialysis
6 devices and supplies that have not been reprocessed for the
7 dialysis of the individual. The written document shall inform
8 the individual or guardian of the grievance mechanisms available
9 to him or her under this act.
10 (ii) The consent of an individual or legal guardian shall be
11 evidenced by his or her signature on a copy of the document
12 furnished to the individual. The signature shall be in addition
13 to any signature indicating that consent is given for the
14 individual to enter dialysis.
15 (iii) An individual or legal guardian may terminate consent
16 by notifying a provider or facility, in writing, that the
17 consent is terminated. A termination of consent shall be
18 effective on the date on which the provider or facility receives
19 written notice of the termination.
20 (3) (i) A provider or facility shall allow the secretary
21 full access to all records of the provider or facility relating
22 to the provision or utilization of reprocessed dialysis devices
23 or supplies for the dialysis of individuals entitled to benefits
24 under this act, including any written consent forms obtained.
25 (ii) If the secretary determines that a provider or facility
26 has failed to comply with any of the requirements of this
27 subsection, the secretary may terminate or withhold
28 certification of the provider or facility for purposes of
29 payment for services, devices or supplies furnished to
30 individuals entitled to benefits under this act.
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1 (4) For purposes of this subsection, the term "reprocessed
2 dialysis device or supply" shall include, but is not limited to,
3 any hemodialyzer, blood line, transducer filter and dialyzer cap
4 that has been used in dialysis and processed for reuse in
5 dialysis.
6 (b) The secretary, or his designee, shall have the power and
7 duty to promulgate regulations containing specific requirements
8 and standards for the reprocessing of such disposable dialyzers
9 which shall include, but not be limited to, the following:
10 (1) Requiring that a dialysis facility utilize department
11 approved methods in the rinsing, cleansing, sterilizing, storing
12 and labeling of such dialyzers.
13 (2) Requiring that the dialysis facility utilize the most
14 effective methods, as determined by the department for detecting
15 the presence of cleansing agents on the dialyzer filter.
16 (3) Prohibiting the reuse of a dialyzer when tests indicate
17 the presence of formaldehyde or other impurities following
18 cleansing.
19 (4) Establishing specific standards for each type of single-
20 use dialyzer and prohibiting reuse upon a specific reduction of
21 total capacity for each type of dialyzer.
22 (c) This section may be enforced by the department pursuant
23 to sections 811(1), 813, 814, 815, 817 and 818 of the act of
24 July 19, 1979 (P.L.130, No.48), known as the "Health Care
25 Facilities Act."
26 Section 9.1. This act shall expire on December 31, 1991,
27 unless extended by the General Assembly.
28 Section 3. This act shall take effect immediately.
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