REPUBLIC OF THE PHILIPPINES
HOUSE OF REPRESENTATIVES
Quezon City

NINETEENTH CONGRESS
First Regular Session

HOUSE BILL NO. 533_

Introduced by Representative MARLYN L. PRIMICIAS-AGABAS

EXPLANATORY NOTE

This bill seeks to establish and provide a comprehensive renal
replacement therapy for patients with end stage renal disease in
national, regional, and provincial government hospitals, increasing the
Philippine Insurance Corporation’s package rate for renal replacement
therapy of members. This bill has already been approved by the House of
Representatives on its 3 and final reading in the 18' Congress.
However, it has not yet ripened into a law. On account of its importance
to the delivery of healthcare packages to renal or kidney patients, this bill
is respectfully filed.

The State shall protect and promote the right to health of the
people and instill health consciousness among them (Section 15, Article
Il of the 1987 Constitution). Consistent with this mandate, the State
shall provide health mechanisms through which patients with renal or
kidney diseases can come to or rely upon. It is of common knowledge
renal disease is among the top ten (10) causes of death among Filipinos.
And it is getting worse. Sixty percent (60) of patients with chronic kidney
failure are service patients. Of the 60% patients mortality rate is very
high. Among the biggest attributes to mortality is the incapacity of poor
patients to afford and sustain the high cost of hemodialysis, peritoneal
dialysis, kidney transplant, or renal replacement therapy.
There is a need to step up the provision of additional renal healthcare
packages in government hospitals inclusive of increased Philhealth
package rate to narrow the gap of healthcare opportunities between the
rich and the poor. Of the different regions in the country, only few
hospitals are offering dialysis services, most of which are private


hospitals, thus pre-empting our poor patients of the much needed renal
care.

Additional government intervention is thus highly needed. Hence,
the urgent request for the approval of this bill.

fied /
M. L. (MICIAS-AGABAS


Republic of the Philippines
HOUSE OF THE REPRESENTATIVE
Quezon City

NINETEENTH CONGRESS
First Regular Session

83

5
HOUSE BILL NO.

Introduced by Representative MARLYN L. PRIMICIAS-AGABAS

AN ACT PROVIDING A COMPREHENSIVE RENAL REPLACEMENT THERAPY
(RRT) FOR PATIENTS WITH END STAGE RENAL DISEASE IN NATIONAL,
REGIONAL, AND PROVINCIAL GOVERNMENT HOSPITALS, INCREASING
THE PHILHEALTH PACKAGE RATE FOR RENAL REPLACEMENT THERAPY
OF MEMBERS AND APPROPRIATING FUNDS THEREFOR.

Be it enacted by the Senate and House of Representatives of the Philippines in
Congress assembled:

SECTION 1. Short Title. - “This Act shall be known as the “Comprehensive
Renal Replacement Therapy Act.”

SECTION 2. Declaration of Policy. — It is a declared policy of the State to adopt
an integrated and comprehensive approach to health development that will
provide Comprehensive Renal Replacement Therapy (RRT) to improve the
delivery of health care services to patients diagnosed with End Stage Renal
Disease (ESRD), and to encourage them to have a kidney transplant, primarily
within the first two (2) years of starting dialysis.

The State shall endeavour to make essential goods, health and other
social services available to ali the people at affordable cost. There shall be
priority for the needs of the underprivileged sick, elderly, disabled, women and
children. The state shall endeavour to provide free medical care to paupers.

It is also hereby declared as a policy of the State to improve the delivery
of health care services to the people and to ensure hospital facilities are
available, affordable and accessible to the people.

SECTION 3. Definition of Terms. — As used in this Act:


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. Dialysis facility refers to a health facility that provides treatment for

ESRD to indigent patients and disseminates information on the
various forms of RRT such as kidney transplantation, peritoneal
dialysis and hemodialysis;

End Stage Renal Disease or ESRD refers to the final stage of
chronic kidney disease in which the kidneys no longer function well
enough to meet the needs of daily life;

Hemodialysis or HD refers to a medical procedure to remove fluid
and waste products from the blood and to correct electrolyte
imbalances. This is accomplished using a synthetic membrane or
dialyzer which is also referred to as an “artificial kidney”;

Indigent refers to a patient who has no source of income or whose
income is not sufficient for family subsistence as identified by the
Department of Social Welfare and Development (DSWD) through
the National Household Targeting System (NHTS) for Poverty
Reduction, or those patients who are indigents but are not listed in
the NHTS as assessed by the municipal social development
officer;

Kidney Transplant or KT refers to a surgical procedure to place a
kidney from a live or deceased donor into a person whose kidneys
no longer function sufficiently to sustain the person's life:

National, Regional and Provincial Hospitals refer to hospitals and
stand alone dialysis facilities operated and maintained either
partially or wholly by the national, regional and provincial
government, division, board or other agency thereof,

No Balance Billing refers to the government policy of not charging
the medical expenses incurred over and beyond the PhilHealth
package rates to a PhilHealth member who has undergone medical
treatment;

Peritoneal Dialysis or PD refers to a treatment for kidney failure
and a type of dialysis that uses the person's peritoneum (lining of
abdominal cavity) as the membrane through which fluid and toxic
substances are exchange with blood:

PD First Policy refers to the policy where peritoneal dialysis, when
feasible, is offered as the first dialysis modality to RRT patients;

Renal Replacement Therapy or RRT refers to therapy that partially
replaces the functions of the normal kidney. This may be in the


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form of kidney transplantation, peritoneal dialysis and
hemodialysis.

SECTION 4. Establishment of Dialysis Services Wards or Units in National,
Regional, Provincial Government Hospitals. — Within five (5) years from the
effectivity of this Act, all national, provincial, and regional hospitals, including all
stand alone dialysis facilities are hereby required to establish, operate and
maintain a dialysis service facility in their hospital, including both peritoneal
dialysis and hemodialysis. The same hospitals and dialysis facilities should
also be mandated to train nephrologist, dialysis nurses, dialysis technicians,
and operating room nurses in both peritoneal dialysis and hemodialysis.

All national, provincial and regional government hospitals, including stand
alone dialysis facilities shall have a dialysis service area compliant with the
licensing and accreditation requirements imposed by the Department of Health
(DOH) and Philippine Health insurance Corporation (PhilHealth), respectively,
for private dialysis clinics. It shall further be provided with the necessary
personnel and equipped with complete dialysis equipment and supplies for
both hemodialysis and peritoneal dialysis, as required by the DOH and the
PhilHeaith from private dialysis clinics.

All patients diagnosed with ESRD must be referred to a DOH-accredited
transplant facility to attend a pre-transplant orientation and to be counseled on
the advantages of undergoing transplantation as the best treatment for kidney
failure. They will undergo medical evaluation for suitability for transplantation,
all potential organ donors of the patient shall be evaluated to determine
compatibility and medical suitability. If no living donors are available then the
patient will be enrolled in the deceased organ donor waiting list. This will
ensure that all patients with ESRD are offered the option of kidney
transplantation

SECTION 5. Chronic Kidney Disease (CKD) Prevention and Health Promotion.
— all national, provincial, and regional government hospitals, and stand-alone
dialysis facilites should establish CKD prevention strategies and health
promotion activities which include: advocacy activities targeting relatives of
dialysis patients who are at high risk for developing CKD themselves, the
provision of instructional materials and regular educational activities on the
common symptoms of kidney disease such as its risk factors, healthy diet and
lifestyle, common test to diagnose kidney disease, the most common causes of
kidney failure, and advisories on the appropriate protocols for the diagnostic
evaluation of possible kidney disease

Patients and their relatives should be informed about the availability of the
proper medicines from government health centers such as those for diabetes
and hypertension, and the importance of the regular intake of medicines and
monitoring of kidney function through regular laboratory testing and regular


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clinic follow-up with a qualified physician. All activities pertaining to the
aforementioned programs should be documented accordingly.

SECTION 6. Quality Standards of Dialysis Services and Transplant Facilities. —
Hospitals, dialysis centers for both hemodialysis and peritoneal dialysis, and
transplant facilities shall comply with the safety and quality standards of
dialysis or transplant services which shall be strictly monitored by the
PhilHealth and the Health Facilities and Services Regulatory Bureau of the
DOH

SECTION 7. Philippine Renal Disease Registry. — Private and public hospitals,
dialysis centers for both hemodialysis and peritoneal dialysis, and transplant
facilities shall be mandated to report to the Philippine Renal Disease Registry
of the DOH the incidence and prevalence of patients receiving peritoneal
dialysis or hemodialysis treatment, and who have received a kidney transplant
as a requirement for the renewal of their respective DOH licenses to operate a
dialysis center or transplant facility. Registration of all dialysis patients in the
PhilHealth dialysis database will be required prior to the availment of benefits
for both peritoneal dialysis and hemodialysis.

SECTION 8. PhilHealth Benefit for Kidney Transplantation — The PhilHealth
benefit for kidney transplantation from living donors shall be expanded
accordingly. This shall include the cost of laboratory work-up for both recipient
and donor candidate, hospitalization for the transplant operation including
induction immunosuppression and maintenance oral immunosuppression,
machine perfusion of procured organs, the cost for organ retrieval, all
medications required during the hospital stay, as well as post discharge
laboratories up to 1 month for the recipient, and up to 1 year for the donor.

The cost for organ retrieval and machine perfusion will be established by
the DOH-Philippine Organ Donation Program for all organ procurement
organizations.

The PhilHealth benefit package for kidney transplantation shall cover the
evaluation and screening of the kidney donor and recipient up to the transplant
procedure and post-transplantation procedures and remedies. This is inclusive
of both pre- and post- kidney transplantation measures for the benefit of End
Stage Renal Disease patients.

In order to support kidney transplantation as the best treatment option that
provides the highest quality of life for End Stage Renal Disease patients and
ensures the retum of the patient to full rehabilitation, the PhilHealth and the
Philippine Charity Sweepstakes Office (PCSO) shall provide support for all
maintenance immunosuppression for the lifetime of the transplant patient, as
long as the transplanted organ is functioning and the patient remains dialysis-
independent.


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All renal replacement therapy facilities shall be required to engaged in
regular organ donation advocacy activities that will provide education for all
Filipinos to carry the organ donor card. Facilities will likewise establish a
potential deceased organ donor referral system that will identify all potential
deceased organ donor to the Philippine Network for Organ Sharing

SECTION 9. PhilHealth Benefit for Dialysis Treatment. ~ The PhilHealth shall
increase the Z-benefit package rate for the principal member and each of one’s
qualified dependent on maintenance dialysis per year for peritoneal dialysis
covering three (3) peritoneal dialysis exchanges per day for three hundred sixty
five (365) days, while the package rate for hemodialysis treatment shall be
increased annually to cover a span of ninety (90) hemodialysis session per
year. The professional fee of the attending physician and hospital charges shall
be included in the PhilHelath benefits for dialysis treatment. The remaining
sessions for both peritoneal dialysis and hemodialysis shall be paid for by the
Philippine Charity Sweepstakes Office.

For purposes of providing optimal financial risk protection to the most
vulnerable groups including the poorest of the poor, the "No Balance Billing
Policy” of the government is hereby provided for indigent.

The breakdown of the PHIC hemodialysis benefit package shall include
standard HD treatment inclusive of the dialyzer and all other supplies needed
as well as the minimum basic laboratory tests consisting of complete blood
count, creatinine, calcium, phosphorous, potassium, albumin, hepatitis B
surface antigen (HBsAg) and anti-hepatitis C Virus (Anti-HCV). The laboratory
tests shall be done at a frequency of at least four (4) test per year for the first
six (6) tests, and twice a year for the last two (2) tests. The schedule of these
tests shall be determined by the attending physician during the course of the
annual dialysis treatment sessions

SECTION 10. Periodic Assessment and Benefit Package Adjustment for End
Renal Stage Disease Patients. — A periodic assessment and reasonable
adjustments of the benefit package for dialysis and transplant patients shall be
made by the PhilHealth after taking into consideration its financial sustainability
and changes in the socio-economic conditions of the country.

SECTION 11. Free Dialysis Treatment to Indigent Patients. — Dialysis
treatment in all national, regional, and provincial governments hospitals shall
be provided free of charge to indigent patients as identified by the Department
of Social Welfare and Development using the National Household Targeting
System for Poverty Reduction. A PD First Policy shall be established for all
indigent patients, unless there is a contraindication to its use in a particular
patient.


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SECTION 12. Treatment Options. — The PhilHealth shall develop a package
that will provide the highest benefit for kidney transplant, followed by peritoneal
dialysis, then hemodialysis

The benefit package shall include a screening test for both the donor and
recipient. The screening test for possible kidney transplantation of both the
donor and recipient shall include the following

1) For the donor, the screening testing include blood typing, complete
blood count, fasting blood sugar, creatinine, hepatitis B surface
antigen, anti-hepatitis C antibody, urinalysis, chest x-ray and
ultrasound of the kidneys, ureter, and urinary bladder.

2) For the recipient, cardiac evaluation and many other test as needed.

During the availment of the full benefits of dialysis within the first two (2)
years of dialysis initiation, the cost of dialysis treatment shall be paid by the
PhilHealth and the PCSO as described in Section 8. These options are
provided to encourage more patients to have a kidney transplant and attain full
rehabilitation

If the patient passes the criteria for the PhilHealth benefit package for
transplantation, the expenses for lab work-up shall be reimbursed to the patient
by the healthcare institution after the PhilHealth pays the benefit to the
healthcare institution.

The cost of the operation for transplantation shall be included in the
PhilHealth Z-benefit package which includes a month of post-hospital
discharge laboratory tests for the recipient and a one (1) year follow up
laboratory tests for the donor. The Z-benefit package shall be expanded
accordingly.

The immunosuppression medications needed by the transplant patient, if
there is no graft rejection, shall be lifelong. For PhilHealth patients, these
medicines shall be provided for one (1) year by PCSO. After the first year, the
patient may reapply with the PCSO for assistance for such medications.

SECTION 13. Rehabilitation Program. - The DOH, in coordination with the
Department of Labor and Employment, Technical Education and Skills
Development Authority, and the DSWD and other pertinent agencies, shall
establish a comprehensive rehabilitation program for ESRD patients who have
undergone kidney transplant in order to help them reach their fullest physical,
psychological, social, vocational, avocational, and educational potential
consistent with their physiologic or anatomic condition, environmental
limitations, life plans and desires.


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SECTION 14. Dialysis Facility, - A dialysis facility shall be compliant with the
licensing requirements imposed under DOH Administrative Order No. 2012-
0001 dated January 26, 2012 for hemodialysis, and PhilHealth-Accreditation
for peritoneal dialysis facilities. Hospitals without dialysis facilities first put up
the necessary equipment and qualified staff to perform peritoneal dialysis
services. For hospitals with existing hemodialysis facilities, a peritoneal dialysis
unit shall be established immediately so that this more cost-effective dialysis
option can be made available to patients. Hospitals shall preferentially be
provided with the necessary personnel, equipment and supplies as required by
PhilHealth for accredited facilities.

SECTION 15. Training for Peritoneal and Hemodialysis Treatment and
Services. - The DOH, National Kidney and Transplant Institute (NKTI) and the
Philippine Society of Nephrology (PSN) shall provide training for medical
personnel such as physician to take charge of the hemodialysis and peritoneal
dialysis centers, hemodialysis and peritoneal dialysis nurses, hemodialysis and
peritoneal dialysis technicians operating room nurses, transplant ward nurses,
transplant coordinators, and non-medical barangay health workers to support
home based peritoneal dialysis. The NKTI shall accredit the centers that can
provide training for the above personnel and training should include hands-on
workshops for dialysis

SECTION 16. Establishing a Chronic Kidney Disease (CKD) Counseling Clinic.
~All RRT facilities shall establish a chronic kidney disease (CKD) counseling
clinic with separate personnel trained to engage patients and explain to them
the normal functions of the kidney, the stages of CKD, the laboratories
routinely performed by CKD patients, the common medications required that
can control the progression of kidney disease, the metabolic complications of
ESRD, and the indications for renal replacement. These clinics shall monitor
the kidney function of patients so that a timely referral to a nephrologist or
internist/pediatrician with specialized training in CKD can be made, with the
timely initiation of Renal Replacement Therapy to prevent requiring emergency
treatment.

The NKTI shall provide education and training modules for the medical
staff of CKD counseling clinics.

SECTION 17. Creation of a Renal Disease Control Program (REDCOP). ~ All
RRT facilities shall create a Renal Disease Control Program (REDCOP),
following the model of the NKTI, that shall promote the early recognition of
kidney disease, identify persons at high risk for the development of kidney
disease and initiate preventive strategies to either prevent the development of
kidney disease (ie. from diabetes and hypertension) or to delay its progression
to end stage renal disease. The DOH will establish a database of these
patients to ensure that they are regularly monitored for disease progression
and that they are receiving appropriate treatment for CKD.


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SECTION 18. Authority to Receive Donations and Exemptions from Donor's
Taxes, Customs and Tariff Duties. - The DOH shall be authorized to receive
donations, gifts, and bequests in order to augment the funding for the
establishment of the dialysis wards/units created in accordance with this Act
All donations, contributions or endowments which may be made by persons or
entities to the dialysis wards/units in national, regional and provincial hospitals
and the importation of medical equipment and machineries, spare parts and
other medical equipment used solely and exclusively by the dialysis wards or
units shall be exempt from income or donor's taxes, any other direct or indirect
taxes, wharfage fees and other charges and restrictions

SECTION 19. Penalty. - Any hospital chief, administrator or officer-in-charge of
hospitals, dialysis centers, and health facilities who fails to comply with Section
5 and 6 of this Act shall be meted with a fine of Fifty Thousand pesos
(P50,000.00) but not more than One Hundred Thousand pesos (P100,000.00)

Likewise, persons receiving free treatment of medicines for End Stage
Renal Disease or PD or HD services from government hospitals and its
agencies (ie. PCSO, PHIC) who are found selling these medications or
services instead of using them for their own treatment, shail be penalized with
the suspension of their PhilHealth membership and shall be ineligible for
assistance from PCSO and other government agencies for a period of one (1)
year. If these persons are found to be engaged in the selling of medications or
services allotted for their care for the second time, they shall be made
permanently ineligible to receive government assistance

SECTION 20. Appropriations. ~ The initial amount necessary to implement the
provisions of this Act shall be charged against the current year's appropriation
of the DOH. Thereafter, such sum as may necessary for the continued
implementation of this Act shall be included in the Annual General
Appropriations Act.

SECTION 21. Implementing Rules and Regulations. — Within sixty (60) days
from the effectivity of this Act, the Secretary of Health, in coordination with the
President of PhilHealth, the Executive Director of the NKTI, and other relevant
stakeholders, shall issue the implementing rules and regulations to implement
the provision of this Act.

SECTION 22. Separability Clause. If any provision or part hereof is held invalid
or unconstitutional, the remainder of the law or the provision not otherwise
affected shall remain valid and subsisting.

SECTION 23. Repealing Clause. Any law, presidential decree or issuance,
executive order, letter of instruction, administrative order, rule or regulation


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contrary to or inconsistent with the provisions of this Act are hereby repealed,
modified or amended accordingly.

SECTION 24. Effectivity. - This Act shall take fifteen (15) days after its
publication in the Official Gazette or in a newspaper of general circulation.

Approved,