Republic of the Philippines.
HOUSE OF REPRESENTATIVES,
Quezon City

TWENTIETH CONGRESS
First Regular Session

HOUSE BILL NO. _1397

INTRODUCED BY REP. MAXIMO JR. Y. DALOG

EXPLANATORY NOTE

Section 11, Article XIII of the 1987 Constitution states:

The State shall adopt an integrated and comprehensive approach
to health development which shall endeavor to make essential goods,
health and other social services available to all the people at affordable
cost. There shall be priority for the needs of the underprivileged, sick,
elderly, disabled, women, and children. The State shall endeavor to
provide free medical care to paupers.

One of the diseases with an alarming rate of increase of patients per year
is Chronic Kidney Disease (CKD) which progresses to End Stage Renal Disease
(ESRD). Itis also one of the most expensive as the average cost of hemodialysis
in the country ranges from PhP2600- PhP4500 per session with an ideal
recommended treatment of one hundred fifty six (156) sessions per year. As a
result, the Philippine Health Insurance Corporation in past years implemented a
hemodialysis package which covers ninety (90) free sessions for each affected
member per year. However, due to lack of facilities and finance, patients are
forced to have one hundred four (104) sessions or less per year. In addition,
patients and their family caregivers are forced to relocate to nearby cities or areas
with dialysis treatment facilities adding to their financial burden. The quality of
health service availed of by patients is thus compromised.

This bill, which has been filed in two previous Congresses by Hon. Joseph
Stephen S. Paduano and Jose Christopher Y. Belmonte respectively seeks to
provide readily accessible facilities that offer free and quality health care services
for CKD and ESRD patients especially indigents. In addition, it also seeks to


promote kidney transplant as a primary option for treatment of ESRD patients
since dialysis whether it be peritoneal or hemodialysis treatment is a band aid
cure which when stopped will also lead to the deterioration of the health of CKD
and ESRD patients.

In view of the foregoing, the passa:



Republic of the Philippines
HOUSE OF REPRESENTATIVES
Quezon City

TWENTIETH CONGRESS
First Regular Session

HOUSE BILL NO. _1397

INTRODUCED BY REP. MAXIMO JR. Y. DALOG

AN ACT MANDATING THE PROVISION OF COMPREHENSIVE RENAL
REPLACEMENT THERAPY (RRT) TO PATIENT WITH END STAGE RENAL
DISEASE IN NATIONAL, REGIONAL, AND PROVINCIAL GOVERNMENT
HOSPITALS, INCREASING FOR THE PURPOSE THE PHILHEALTH
PACKAGE RATE FOR 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. - \t is the declared policy of the
State to make available essential goods, health and other social services to
all citizens at affordable cost and to deliver medical care to indigents free of
charge. Pursuant to this, the State shall continually improve the delivery of
health services and hospital facilities to make those accessible to all.

In line with this policy, the State shall adopt an integrated and
comprehensive approach to health service delivery that shall include
comprehensive renal replacement therapy for patients who are diagnosed
with End Stage Renal Disease (ESRD).

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

i. Dialysis facility refers to a health facility that provides
treatment for ESRD to indigent patients and disseminates


vi.

vii.

viii.

information on the various forms of renal replacement therapy
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 support the needs of a patient's daily life;

Hemodialysis or HD refers to a medical procedure to remove
fluid and waste products from the blood and to correct
electrolyte imbalances 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 and assessed by the social worker of the Department
of Social Welfare and Development (DSWD) or the social
worker of the concerned local government unit;

. Kidney transplant or KT refers to a surgical procedure to

place a healthy kidney from a living 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 or other political subdivisions, or any
department, division, board or 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 or the
lining of the abdominal cavity, as the membrane through which
fluid and toxic substances are exchanged 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 a therapy that

partially replaces the functions of the normal kidney. This may be


in the 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, regional, and provincial
government hospitals, including all stand-alone dialysis facilities shall
establish, operate and maintain a dialysis service facility in their hospitals.
These dialysis facilities shall have all the necessary dialysis machines,
equipment and supplies. The same hospitals and dialysis facilities are
mandated to train nephrologists, dialysis nurses, dialysis technicians, and
operating room nurses in both peritoneal dialysis and hemodialysis.

All national, regional, and provincial government hospitals, including all
stand- alone dialysis facilities shall have a dialysis service area that is
compliant with the licensing and accreditation requirements imposed by the
Department of Heaith (DOH) and Philippine Health Insurance Corporation
(PhilHealth). The dialysis service area shall have the necessary personnel,
dialysis equipment and supplies for both hemodialysis and peritoneal
dialysis, as required by the DOH and the PhilHealth of private dialysis clinics.

The dialysis facilities shall further have a non-treatment place, which shall
serve as a waiting area for chronic kidney disease (CKD) patients and a
business area dedicated to the provision, display and dissemination of
information on the prevention of CKD.

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

SECTION 5. Chronic Kidney Disease (CKD) Prevention and Health
Promotion. — All national, regional, and provincial government hospitals, and
stand-alone dialysis facilities shall establish CKD prevention strategies and
health promotion activities which shall include advocacy activities targeting
relatives of dialysis patients who are at high risk in developing CKD themselves,
the provision of instructional materials on the common symptoms of kidney
disease and regular conduct of educational activities such as healthy diet and
lifestyle, availment of regular tests to diagnose kidney disease, information on
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 shall be informed on 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 check-up by
a qualified physician. All activities pertaining to the aforementioned programs
shall be documented accordingly.

SECTION 6. Quality Standards of Dialysis Services and Transplant
Facilities. — Hospitals and 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 theincidence 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 shall be required prior to the availment of both
peritoneal dialysis and hemodialysis.

SECTION 8. PhilHealth Benefit for Kidney Transplantation - The
PhilHealth Z-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 hospitalization, and post
discharge laboratory examinations up to one (1) month for the recipient, and
up to one (1) year for the donor.

The cost of organ retrieval and machine perfusion shall be established
by the DOH-Philippine Organ Donation and Transplantation Program to be
observed by all organ procurement organizations or organ and tissue
retrieval units.

The PhilHealth benefit package for kidney transplantation shall cover
the evaluation and screening of the kidney donor and recipient up to the
transplant and post-transplantation procedures and remedies and shall
include cases involving ESRD patients.

In order to support kidney transplantation as the best treatment option
that provides the highest quality of life for ESRD patients and ensures the
return of the patient to full rehabilitation, the PhilHealth shall provide lifetime


support for all maintenance immunosuppression of the transplant patient, as
long as the transplanted organ is functioning and the patient remains dialysis-
independent.

All renal replacement therapy facilities shall be required to engage in
regular organ donation advocacy activities. All donor- Filipino citizens shall
carry the organ donor card to be prescribed by the DOH. Health RRT facilities
will likewise establish an organ and tissue donor referral system that will
identify all potential organ and tissue donors to the Philippine Network for
Organ Sharing (PhiINOS).

SECTION 9. PhilHealth Benefit for Dialysis Treatment. -The
PhilHealth shall increase the Z-benefit package rate for the principal member
and the members’ qualified dependents for maintenance 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 minimum of three (3) hemodialysis sessions
frequency a week, four (4) hours per session, or as may be necessary. The
professional fee of the attending physician and hospital charges shall be
incorporated in the PhilHealth benefit package for dialysis treatment.

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 shall be strictly observed in the case of indigent
patients.

The breakdown of the PHIC hemodialysis benefit package shall
include standard HD treatment, dialyzer and epoetin injection, and all other
supplies needed as well as the minimum basic laboratory tests consisting of
complete blood count, creatinine, calcium, phosphorus, potassium, albumin,
hepatitis B surface antigen (HBsAg) and anti-hepatitis C virus (Anti-HCV).
The laboratory tests shall be done ata frequency of at least four (4) tests 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
Adjustments for End Stage Renal 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 government
hospitals shall be provided for free of charge to indigent patients. A PD First


Policy shall be observed for all indigent patients, unless there is a
contraindication for its use in a particular patient.

SECTION 12. Treatment Options. - The PhilHealth shall develop a
care rate package that shall provide the highest benefit for akidney transplant
procedure, peritoneal dialysis, and hemodialysis procedures.

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

For the donor, screening test shall include blood typing, complete blood
count, fasting blood sugar, creatinine, hepatitis 8 surface antigen, anti-
hepatitis C antibody, urinalysis, chest x-ray and ultrasound of the kidneys,
ureter, and urinary bladder

For the recipient, cardiac evaluation and other tests as may be 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 for
by the PhilHealth as described in Section 8. These options are provided to
encourage more patients to undergo kidney transplantation and attain full
rehabilitation.

If the patient passes the criteria for the PhilHealth Z-benefit package
for transplantation, the expenses for selected laboratory tests may be
reimbursed to the patient by the healthcare institution after the PhilHealth
pays the benefit to the healthcare institution for such laboratory expenses.

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

SECTION 14. Dialysis Facility. - A dialysis facility shall comply with the
licensing requirements imposed by the DOH for hemodialysis services before it
Operates as such. Hospitals desiring to provide peritoneal dialysis treatment
services shall provide the necessary equipment and qualified staff to perform
such a procedure as prescribed by the PhilHealth. Hospitals with existing
hemodialysis facilities only shall immediately establish a peritoneal dialysis unit
to provide a cost-effective dialysis option to patients.


SECTION 15. Training for Peritoneal and Hemodialysis, and
Transplant Treatment and Services. - The DOH, National Kidney and
Transplant Institute (NKTI), Philippine Society for Transplant Surgeons (PSTS),
and the Philippine Society of Nephrology (PSN) shall provide training for medical
personnel such as physicians, surgeons, nurses, technicians and coordinators
who shall work in hemodialysis and peritoneal dialysis facilities, operating rooms,
transplant wards, and for non-medical barangay health workers who shall assist
home-based peritoneal dialysis treatment. The NKTI shall accredit the facilities
that may provide training for these personnel which training shall include
hands-on workshops for dialysis.

SECTION 16. Establishing a Chronic Kidney Disease (CKD)
Counseling Clinic. -All RRT facilities shall establish a CKD. counseling clinic and
shall separately provide personnel trained to engage patients and explain to
them the normal functions of the kidney, the stages of CKD, the laboratory
examinations routinely performed for 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.

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

SECTION 17. Availment of Persons with Disability (PWD) Benefits by
CKD Patients. -CKD patients shall be classified as PWD. They shall be
entitled to PWD benefits in accordance with Republic Act No. 7277, otherwise
known as the Magna Carta for Disabled Persons. The PhilHealth and DOH
Health Technology Assessment Council shall conduct an in-depth study on
both the direct and indirect cost of being afflicted with kidney disease and
undergoing treatment for it.

SECTION 18. Creation of a Renal Disease Control Program. - All RRT
facilities shall create a Renal Disease Control Program that shall promote the
early recognition of kidney disease, identify persons at high risk of developing
kidney disease and initiate preventive strategies to either prevent the
development of kidney disease 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.

SECTION 19. Penalty. - Any head or chief of hospital, administrator
or officer-in-charge of a hospital, dialysis center, and health facility who fails
to comply with Sections 5 and 6 of this Act shall be meted with a fine of Fifty
thousand pesos (P50,000.00) up to a maximum of One hundred thousand pesos


(P100,000.00).

Likewise, persons receiving free treatment of medicines for ESRD, PD or
HD services from government hospitals, such as the PHIC, who are found selling
these medicines or services instead of using them for their own treatment, shall
be penalized with the suspension of their PhilHealth membership and other
government assistance for a period of six (6) months, upon due process and
hearing. If these persons are found to have committed the same violation for
the second time, they shall be permanently ineligible to receive government
assistance.

SECTION 20. Appropriations. - The initial amount necessary to
implement the provisions of this Act for national and regional hospitals shall be
charged against the current year’s Appropriation of the DOH. Thereafter, such
sum as may be necessary for its continued implementation shall be included
in the annual General Appropriations Act.

For provincial hospitals, the local government concerned shall provide the
necessary funds for the establishment and operationalization of its dialysis
service units.

SECTION 21. implementing Rules and Regulations - Within ninety (90)
days from the effectivity of this Act, the DOH shall, in coordination with the
PhilHealth, the NKTI, and other relevant stakeholders, issue the
implementing rules and regulations to implement the provisions 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 contrary to or inconsistent with the provisions of this Act are hereby
repealed, modified or amended accordingly.

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

Approved,