Comprehensive Renal Replacement Act

omise of thes TWENTIETH CONGRESS OF THE REPUBLIC OF THE PHILIPPINES First Regular Session 25 JUL 21 P1:40 SENATE RECEIVES S. No._ 739 Introduced by Senator JV Ejercito AN ACT MANDATING THE PROVISION OF COMPREHENSIVE RENAL REPLACEMENT THERAPY (RRT) TO PATIENTS 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 EXPLANATORY NOTE Thousands of Filipinos suffer from kidney failure every year. Not that there is no treatment available but sadly because of the expensive cost of surviving the disease. Many have died silently losing their battle with chronic kidney disease (CKD). Cases of CKD in the Philippines have risen to 35.94% far above the global average of 9.1- 13.4%.1 While the efforts of the government in providing and improving dialysis accessible to the greatest number of patients are commendable, it should not be seen as the end goal of the whole treatment process. Transplant remains to be the best option for every patient to fully recover. We believe that government intervention is an essential element in prolonging the life of a patient. However, whether it be dialysis or transplant, both paths bring so much burden, emotionally and financially to both the patient and his or her family. Dialysis is a long and hard battle to be won until the option becomes more viable for the patient. 1 https://capitolmedical.com.ph/articles-and-blogs/chronic-kidney-disease-in-the-philippines-a-silent- epidemic/#:~:text=A%202022%20study%20in%20revealed,average%20of%209. 1%2D13.4%25.

End-stage renal disease (ESRD) is fatal and unforgiving. It does not distinguish if the patient is rich or poor, making the fighting chance of the less fortunate slimmer. The poor becomes poorer as they are forced to sell and pawn whatever little possession they have to carry on with treatment. This bill seeks to change that. The increasing number of recorded CKDs have become very alarming and a piece of legislation that focuses on strengthening government programs to treat such disease is now more than ever, necessary. While there is a welcomed development in the attention that PhilHealth has given in improving benefit packages in dialysis session, this measure intends to be a more specialized approach in the way we treat kidney disease. We maintain our position that comprehensive renal replacement therapy services should be accessible available to all Filipinos who suffer from End Stage Kidney Disease (ESKD) by including it in the coverage of treatment services provided by the PhilHealth. Moreover, all national, provincial, and regional government hospitals, including stand- alone dialysis facilities are required to establish, operate and maintain a dialysis service facility in their hospitals. Refiling this measure is not only a simple policy decision but a moral obligation to help lessen the agony of our people who had to live with failing kidneys limiting their full potential as human beings. We are committed to be right beside every patient along the way with every dialysis session; successful transplant; all the way to full recovery. In view of the foregoing, the passage of this bill is earnestly sought. OU=" JV EJERCITO

TWENTIETH CONGRESS OF THE ) REPUBLIC OF THE PHILIPPINES First Regular Session JUL 21 P1:40 SENATE RECENSUEY S. No._ 739 Introduced by Senator JV Ejercito AN ACT MANDATING THE PROVISION OF COMPREHENSIVE RENAL REPLACEMENT THERAPY (RRT) TO PATIENTS 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 the House of Representatives of the Philippines in Congress assembled:

Section 1. Short Title. - This Act shall be known as the "Comprehensive Renal

Replacement Act."

Sec. 2. Declaration of Policy. - It is 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).

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

a. Dialysis facility refers to a health facility that provide treatment for ESRD to indigent patients and disseminates information on the various forms of RRT such as kidney transplantation, peritoneal dialysis and hemodialysis; b. End Stage Renal Disease (ESRD) refers to the final state of chronic kidney disease in which the kidneys no longer function well enough to support the

needs of a patient's daily life; c. Hemodialysis (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"; d. 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; e. Kidney Transplant refers to a surgical procedure to a 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; f. Peritoneal dialysis (PD) refers to a treatment for kidney failure and a type of dialysis that uses the person's peritoneum of the lining of the abdominal cavity, as the membrane through which fluid and toxic substances are exchanged with blood; g. PD first policy refers to policy where peritoneal dialysis, when feasible, is offered as the first dialysis modality to RRT patients; h. Renal Replacement Therapy (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.

Sec. 4. Establishment of Dialysis Services Wards or Units in National, Regional

Provincial Government Hospitals. - Within five (5) years from effectivity of this Act, all national, regional, and provincial government hospitals, including all stand-alone dialysis facilities shall establish, operate and maintain a dialysis services 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 stand- alone dialysis facilities shall have a dialysis service area that is compliant with the licensing and accreditation requirements imposed by the Department of Health (DOH) and Philippine Health Insurance Corporation (PhilHealth). The dialysis service area

shall have the necessary personnel, dialysis equipment and supplies for both 2 hemodialysis and peritoneal dialysis, as required by DOH and the PhilHealth of private dialysis clinics. The dialysis facilities shall further have a non-treatment place, which shall serve as a waiting are for chronic kidney disease (CKD) patients and a business area 6 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. 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.

Sec. 5. Chronic Kidney Disease (CKD) Prevention and Health Promotion. - Al!

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 material 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.

Sec. 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 safety and quality standards of dialysis or transplant services, which shall be strictly monitored by the Philhealth and the Health

1 Facilities and Services Regulatory Bureau of the Department of Health (DOH).

Sec. 7. Philippine Renal Disease Registry. - Private and public hospitals, dialysis

3 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 5 and prevalence of patients receiving peritoneal dialysis or hemodialysis treatments, 6 and who have received a kidney transplant as a requirement for the renewal of their 7 respective DOH licenses to operate a dialysis center or transplant facility. Registration 8 of all dialysis patients in the PhilHealth dialysis database shall be required prior to the availment of both peritoneal dialysis and hemodialysis.

Sec. 8. PhilHealth Benefit for Kidney Transplantation. - The PhilHealth benefit

for kidney transplantation from living donors shall be expanded accordingly. This shall include cost of laboratory work-up for both receipt 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 once (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 Transplant Program for all organ procurement organizations or organ and tissue retrieval units. The PhilHealth benefit package for kidney transplantation as the best treatment option that provided the highest quality of life for ESRD patients and ensure 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).

Sec. 9. PhilHealth Benefit for Dialysis Treatment. - The PhilHealth shall increase

the benefit package rate for the principal member and the members' qualified

1 dependents for maintenance peritoneal dialysis covering three (3) peritoneal dialysis 2 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 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 6 be included in the PhilHealth benefits 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 9 the government is hereby provided for indigents. The breakdown of the PHIC hemodialysis benefit package shall include standard 11 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 (Antis-HCV). The laboratory tests shall be done at a frequency of at least four (4) tests per year for the first six (6) tests, and twice a year for the last 16 two (2) tests. The schedule of these tests shall be determined by the attending physician during the course of the annual dialysis treatment sessions.

Sec. 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.

Sec. 11. Free Dialysis Treatment to Indigent Patients. - Dialysis treatment in all

national, regional, and provincial government hospitals shall be provided free of charge to indigent patients. A PD First Policy shall be observed for all indigent patients, under there is a contraindication for its use in a particular patient.

Sec. 12. Treatment Options. -The PhilHealth shall develop a case rate package

that shall provide the highest benefit for a kidney 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 the donor and recipient shall include:

1) For the donor, screening test shall include blood typing, complete blood count, fasting blood sugar, creatinine, hepatitis C antibody, urinalysis, chest x-ray and ultrasound of the kidneys, ureter, and urinary bladder; 2) 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 6 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 have a kidney transplant 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. the

Sec. 13. Rehabilitation Program. - The DOH, in coordination with

Department of Labor and Employment (DOLE), the Technical Education and Skills Development Authority (TESDA), 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 physiologic or anatomic condition, environmental limitations, life plans and desires.

Sec. 14. Dialysis Facility. - A dialysis facility shall be compliant with the licensing

requirements imposed by DOH for hemodialysis. Hospitals without dialysis facilities shall provide the necessary equipment and qualified staff to perform peritoneal dialysis services. Hospitals with existing hemodialysis facilities only, shall immediately establish a peritoneal dialysis unit to provide cost-effective dialysis option to patients. Hospitals shall equip itself with the necessary personnel, equipment and supplies as required by PhilHealth.

Sec. 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 take charge of the hemodialysis and

peritoneal dialysis centers, operating rooms, transplant wards, and for non-medical barangay health workers who shall assist home based peritoneal dialysis. The NKTI shall accredit the centers that can provide training for these personnel and the training shall include hands-on workshops for dialysis.

Sec. 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 10 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.

Sec. 17. Availment of Persons with Disability (PWD) Benefits by CKD Patients. -

17 CKD patients shall be classified as PWD, who 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 affected with kidney disease and to undergo treatment for it.

Sec. 18. Creation of Rena! Disease Controi Program (REDCOP). - All RRT

facilities shall create a Renal Disease Control Program (REDCOP) 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.

Sec. 19. Penalty. - Any hospital chief, administrator or officer-in-charge of

hospitals, dialysis centers, and health facilities 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) but not

more than 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 medications or services instead of using them for their own treatment, shall be penalized with the suspension of their PhilHealth membership and other government 6 agencies for a period of six (6) months, upon due process and hearing. 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 permanently ineligible to receive government assistance.

Sec. 20. Appropriations. - The initial amount necessary to implement the

provisions of this Act shall be charged against the current year's appropriations of the DOH. Thereafter, such sum as may be necessary for the continued implementation of this Act shall be included in the annual General Appropriations Act.

Sec. 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 implement rules and regulations to implement the provisions of this Act.

Sec. 22. Separability Clause. - If any provision of this Act is declared invalid or

unconstitutional, the provisions not affected thereby shall continue to be in full force and effect.

Sec. 23. Repealing Clause. -All laws, decrees, orders, rules and regulations or

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

Sec. 24. Effectivity. - This Act shall take effect immediately after fifteen (15)

days from its publication in the Official Gazette or in a newspaper of general circulation. Approved,