Republic of the Philippines
HOUSE OF REPRESENTATIVES
Quezon City, Metro Manila

EIGHTEENTH CONGRESS,
First Regular Session

4011

House Bill No.

Introduced by HON. HENRY R. VILLARICA
4™ DISTRICT, BULACAN

EXPLANATORY NOTE

The State must ensure that health facilities are standardized to realize the delivery of
basic health services to those wanting in health care.

Presently, however, new types of health care facilities have emerged and developed
such as diagnostic, therapeutic and rehabilitative centers. A number of such types of facilities
no longer qualify under the regulatory mandate of the Department of Health (DOH).

This proposed bill seeks to strengthen the regulation of health facilities and services
by authorizing the Bureau of Health Facilities and Services (BHFS) of the DOH to establish
and prescribe rules, regulations, standards, etc.; inspect and monitor for continued
compliance; implement a classification system; approve building plans and construction
design; provide advise; collect fees; and conduct administrative hearings and impose
penalties,

During the 17" Congress, this bill was filed, approved by the Committee on Health
and referred to the Committee on Appropriations but due to time constraints was no longer
taken up.

Support for the enactment of this measure is earnestly requested.

REP. HENR) VILLARICA


Republic of the Philippines
HOUSE OF REPRESENTATIVES
Quezon City, Metro Manila

EIGHTEENTH CONGRESS
First Regular Session

House Bill No. 4011

Introduced by HON. HENRY R.VILLARICA
4™ DISTRICT, BULACAN

AN ACT
STRENGTHENING THE REGULATION OF HEALTH FACILITIES AND SERVICES
REPEALING FOR THE PURPOSE REPUBLIC ACT NO. 4226, OTHERWISE KNOWN
AS THE “HOSPITAL LICENSURE ACT” 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 “Health Facilities Regulation
Act”.

SEC. 2. Definition of Terms. — For purposes of this Act, the following terms are hereby
defined as follows:

a.) Health facilities are institutions whether stationary or mobile, land based or otherwise
and other health-related establishments which provide diagnostic, therapeutic,
rehabilitative, and other health oi services except medical radiation facilities and
hospital pharmacies;

) License is a formal authorization issued by the Department of Health (DOH) to an
individual, partnership, corporation or association to operate a health facility or
services. It is a prerequisite for accreditation of a hospital and other health facilities
by any accrediting body that is recognized by the DOH;

.) Licensee is a person, partnership, corporation, cooperative or association granted a
license to operate and maintain a health facility or services according to an approved
standard set by the Bureau;


d.) Department of Health-Permit to Construct (DOH-PTC) is a permit issued by DOH
through the Health Facilities and Services Regulatory Bureau (HFSRB) to an
applicant who will establish and operate a hospital or other health facility, upon
compliance with required documents prior to the actual construction of the said
facility. A DOH-PTC is also required for hospitals and other health facilities with
substantial alteration, expansion, renovation, increase in the number of beds or for
additional services (add-ons) beyond their service capability. It is a prerequisite for
License to Operate; and |

©.) Registration is the act or process of entering information about a health facility into
the records of the public health system;

SEC. 3. Bureau of Health Facilities\ and Services (BHFS). - The Health Facilities and
Services Regulatory Bureau (HFSRB) is hereby renamed as the Bureau of Health Facilities
and Services (BHFS) herein referred to as the Bureau shall be under the Office of the
Secretary of the DOH.

SEC. 4. Powers and Functions of the BHFS. — The Bureau shall have the following
powers and functions: |
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a.) Promulgate, establish and prescribe rules, regulations, standards, requirements and
specifications in the construction and operation of health facilities and impose
penalties for violations of such;

b.) Inspect and monitor all health facilities and other related facilities to ensure their
continued compliance with the rules and regulations in accordance with this Act and
to make recommendations to directors or administrators of health facilities for the
correction of deficiencies found during the inspection;

c.) Study and adopt a system of classifying health facilities and other related facilities in
the Philippines;

d.) Review and approve construction designs and plans for health facilities including
renovation or expansion of the same in accordance with the provisions of this Act;

e.) Determine, levy, assess and collect the appropriate permit fee, registration fee, license
fee and surcharges pertinent to the operation of facilities and services, except in cases
where charges or rates are established by international organizations recognized by
the Philippine government as the proper arbiter of such charges or rates;


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£) Coordinate and call the assistance of any department, office agency or instrumentality
of the national or local government and other entities concerned with any aspect
involving health facilities for the effective implementation of this Act;
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8.) Maintain a register of health facilities and other related facilities with licenses
indicating the name of the facility, address or location, classification, name of the
director or administrator, ownership, number of authorized beds and such other
pertinent data as may be necessary;

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h.) Promulgate and implement the rules and regulations governing the registration,
licensure and operations of health facilities and related facilities and to periodically
review and amend the same, subject to the approval of the Secretary of Health and in
consultation with the sectors concerned: Provided, That such rules and regulations
shall be in accordance with the provisions of this Act;

i.) Grant a certificate of license for the operation and maintenance of health facilities and
services, and to suspend or revoke the same, in accordance with the provisions of this
Act;

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Hire and train competent individuals and provide qualifications of personnel to be
designated as regulatory officers;

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k.) Submit yearly reports to the Secretary of Health and the Chairpersons of the
Committees on Health of both Houses of Congress; and

1) Perform such other functions as may be prescribed by law.

SEC. 5. Quasi-Judicial Powers. - The bureau shall be vested with the following quasi-
judicial powers:

a.) Investigate, hear and decide administrative cases initiated by the Bureau or filed by
any person against a health facility or health service establishment violating any
provision of this Act and its implementing rules and regulations and to impose
appropriate administrative sanctions or penalties provided under this Act;

b.) Promulgate rules governing the conduct of administrative hearings: Provided, That in
such proceedings, the Bureau shall not be bound by the technical rules of evidence of
the Rules of Court: Provided, further, That the latter may be applied in a suppletory
manner;


c.) Administer oaths and affiliations, and to issue subpoena duces tecum and ad
testificandum, requiring the production of such books, contracts, correspondence,
records, statement of accounts and other documents and the attendance and testimony
of parties and witnesses, as may be material to the investigation being conducted by
the Bureau; |

d.) Exercise contempt powers and impose appropriate penalties;

e.) Cause the ‘prosecution of all cases involving violations of this Act and its
implementing rules and regulations;

£) Summarily order the closure of health facilities and other related facilities operating
without a license; and

8.) Impose preventive suspension on health facilities found during inspection or
monitoring for gross violation of the standards or rules and regulations such as non-
compliance of the approved construction design; any fraudulent, unscrupulous
activities, false claims or misrepresentations; operating with unlicensed or unqualified
health personnel; and the commission or omission of any act which may result in
serious injury, permanent disability or loss of life of a patient or staff, or would
compromise public safety. |

SEC. 6. Mandatory Conciliation-Mediation. — The Bureau shall exert all efforts towards
the amicable settlement of an administrative case within its jurisdiction on or before the first
hearing. Towards this end, it shall have the power to ask the assistance of relevant
government officials and qualified private individuals to act as a compulsory mediator on
cases referred to it.

SEC. 7. Registration and License. ~ The Bureau shall facilitate the delivery of high-
quality and cost-effective health care by promoting competition among health facilities.
Towards this end, all hospitals and other health facilities, government or private, shall be
registered and duly licensed by the Bureau before such facilities are allowed to operate or be
opened to the public. Both public and private health facilities shall be required to apply for
the permit to construct and license to operate.

SEC. 8. Organization. — The Director of the Bureau shall, subject to the approval of the
Seretary of Health, organize its personne} in such divisions and units as will ensure efficiency
and effectiveness:

The Bureau shall establish, operate and maintain a regional office in each of the
administrative regions of the country to enforce regulatory policies and standards for the
licensing, accreditation and monitoring of health facilities to ensure quality health care.

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To carry out the functions and responsibilities of the Bureau, the Secretary of Health shall
hire additional personnel, as it deems necessary. The head of the Bureau shall make the
necessary recommendations to the Secretary of Health as to the competency and additional
number of personnel to be hired.

SEC. 9. Minimum Qualifications for Appointment as Chief Executive Officer, Chief
Operating Officer, of Administrative Officer — The Chief Executive Officer, Chief Operating
Officer or Administrative Officer of a hospital or health facility who shall be responsible for
the overall management and administration of the hospital; formulation of policies, plans,
programs and strategies to ensure implementation of health standards; and the day-to-day
supervision of the functional units shall possess any of the following minimum qualifications:
a.) formal baccalaureate degree, preferably with a masters’ degree in hospital administration
or related course; or b.) at least five (5) years experience in a supervisory or managerial
position.

SEC. 10. Classification of Hospitals and Other Health Facilities. — The existing
classification of hospitals and other health facilities including the system, rules and
regulations governing their classification shall be subject to automatic review by the Bureau,
in consultation with relevant stakeholders, within three (3) years from the effectivity of this
Act and thereafter, as it may deem necessary. It shall take into consideration the findings and
recommendations made by Congress, if any, and the actual situation in dealing with the
existing classification of hospitals and other health facilities for the purpose of protecting and
promoting the health of the public by ensuring a minimum quality of service rendered by
hospitals and other regulated health facilities and to assure the safety of patients and
personnel.

Classification of health facilities and other related facilities shall only be made upon the
approval of the Secretary of health aftet mandatory consultation with representatives from
government and private hospital associations and patient organizations.

SEC. 11. Construction Design. - The Bureau shall review and approve the construction
design and plans of health facilities and related facilities to be constructed or which shall
undergo renovation or expansion.

‘An application for the construction design of a health facility or other related facility shall
be submitted to the Bureau in a form prescribed by the latter and accompanied by a plan of
the facility proposed to be constructed. The approved construction design and plan issued by
the Bureau shall be a prerequisite for the issuance of a building permit by the official of the
municipality or city where the facility is proposed to be constructed.


All level II government hospitals to be constructed shall include in its design the
provision of geriatric ward. |

SEC. 12. Application, Inspection, and Issuance of License to Operate (LTO).— All health
facilities shall be duly licensed by the Bureau, in accordance with R.A. No. 11032 or the
“Ease of Doing Business Act” before such facilities are allowed to operate or be opened to
the public.

An application of a health facility for the issuance of a License to Operate, including its
medical ancillary services, shall be filed with the Bureau or its regional office using the
prescribed forms.

prescribed by the Bureau pursuant to the provisions of this Act: Provided, That the Bureau
has conducted a comprehensive on-site inspection and has certified that the applicant has
satisfactorily complied with the requisites prescribed in this Act and its implementing rules
and regulations (IRR). Provided, further, That an applicant shall also get the approval of the
Food and Drug Administration (FDA) for its pharmacy or Philippine Nuclear Research
Institute (PNRI) for medical radiation facility.

The LTO shall be issued upon due eee of the applicant with rules and regulations

The FDA, PNRI, Department of Environment and Natural Resources (DENR) and other
agencies involved in the regulation of health facilities shall employ a One-Stop-Shop strategy
in the processing of applications through systems that are accessible to the public

Upon issuance of the LTO, a health facility shall be included in the bureau's registry and
National Health Facility Registry upon the approval of the DOH.

All licensed health facilities shall be jautomatically allowed to participate in the National
Health Insurance Program. |

SEC. 13. Validity and Renewal of License. — The initial license to operate and maintain a
health facility or other related facility shall be valid for a period of three (3) years from its
date of issuance, and shall be renewed regularly, subject to the rules and regulations to be
issued by the Bureau.

SEC. 14. Suspension and Revocation of License. - The Bureau, after conducting an
administrative hearing with due notice to the licensee, may suspend or revoke the license to
operate and maintain a health facility or other related facility of any person, partnership,
corporation or association based on any of the following grounds:

a.) Violation by the licensee of any provision of this Act or any other existing law;

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b.) Violation of rules and regulations

©.) Failure to make necessary
improvement or maintenance of

SEC. 15 Appeal. ~ The orders, rulin;
the Secretary of Health.

SEC. 16. Separate Licenses Require
facilities and other felated facilities or
though they are operated under the

scribed in the implementation of this Act; and

ions or adjustments required by the Bureau in the
ilities and services.

or decisions of the Bureau shall be appealable to
1. — Separate licenses shall be required for health

iches thereof maintained in separate premises even
¢ management: Provided, however, That separate

licenses shall not be required for separate’ buildings in the same compound: Provided, further,
That the approval of the designs and plans for construction or renovation of buildings within
the same compound shall also be secured from the Bureau to determine compliance with

standards and requirements herein authorized,

SEC. 17. Non-transferability of Lice
or other related facility shall not be trans}
in ownership, change of name of the ht
location of the facility shall require an

SEC. 17. Penalties. — Any
establishes, operates, conducts, manages
within the meaning of this Act without

this Act or its Implementing Rules and

fifty thousand pesos (Php 50,000.00) bi
100,000.00) for the first offense, not les
but not to exceed five hundred thousand)
not less than five hundred thousand pe
pesos (Php 1,000,000.00) for the third
offense the license of the hospital shall

related facility operates after the first viol

In addition to the penalties speci
summarily order the closure of any he
without a license, or revoke the lice
facility after due process. Facilities m
revocation of its license.

SEC. 18. Income Retention. — To enst

e. ~ A license for the operation of a health facility
ferable. The Bureau shall be notified of any change

th facility or other related facility. Transfer of
lication for new license.

mn, partnership, association or corporation who
maintains a health facility or other related facility

t obtaining a license, or violates any provision of

-gulations shall be liable to a fine of not less than
it not to exceed one hundred thousand pesos (Php
than one hundred thousand pesos (Php 100,000.00)
[pesos (Php 500,000.00) for the second offense, and
s (Php 500,000.00) but not to exceed one million
offense and subsequent offenses. After the third
revoked. Each day that the health facility or other
tion shall be considered a subsequent offense.

ied in the preceding paragraph, the Bureau may
th facility or other related facility found operating

to operate of any health facility or other related
ty only re-apply for a new LTO one (1) year after

ure that the Bureau shall have full authority to utilize

its income and enhance its capacity to ¢xpand and to improve the quality of its services, it



hereby authorize to retain and utilize
from various fees and surcharges without

ees percent (100%) of its income generated

tting the same to the Bureau of Treasury.

In no case shall the retained income be used for the payment of salaries and other

personnel benefits. The retained incom}
depositary bank recommended by the DO)

shall be deposited in an authorized government
H, the DBM, and the Department of Finance.

SEC. 19. Appropriations. ~ The curfent appropriations of the DOH under the General

Appropriations Act (GAA) shall be used

‘to carry out the initial implementation of this Act.

Thereafter, such sums as may be necessary for the continued implementation of this Act shall

be included in the succeeding GAA.

SEC. 20. Mandatory Review. — Con,
at least once every’five (5) years and
objective of overseeing the implementat
and the utilization of income of the B

ss shall undertake a mandatory review of this Act
often as it may deem necessary, with the primary
mn of this Act and reviewing the accomplishments

SEC. 21. Implementing Rules and Regulations. - The Secretary of Health, upon the

recommendation of the Bureau, FDA,
consultation with recognized health facil}

PNRI, and other concemed agencies and after
ties, associations, patients’ organizations and other

civil society organizations, shall issue the rules and regulations implementing the provisions

of this Act within ninety (90) days from it

SEC. 22. Separability Clause. ~ I
unconstitutional or invalid, other provis
in full force and effect.

effectivity.

any part or provision of this Act shall be held

ions hereof which are not affected shall continue to be

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SEC. 23. Repealing Clause. — Republic Act No. 4226, otherwise known as the “Hospital

Licensure Act” is hereby repealed.
regulations and other issuances or parts

sidential decrees, executive orders, rules and
f, which are inconsistent with the provisions of

this Act are hereby repealed, amended or modified accordingly.

SEC. 24. Effectivity. — This Act shall take effect fifteen (15) days after its publication in
the Official Gazette or in any newspaper of general circulation.
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Approved,