PHILIPPINES

DEPARTMENT OF HEALTH
DEPARTMENT OF TRADE AND INDUSTRY

JOINT ADMINISTRATIVE ORDER

No. 2020 - _pPpol

SUBJECT : Guidelines for the Implementation of Executive Order No. 118 on

Regulation of Prices for COVID-19 Reverse Transcription-
Polymerase Chain Reaction (RT-PCR) Testing and Test Kits

I. RATIONALE

Department of Health (DOH) Department Memorandum 2020-0439

Interim Guidelines on Prevention, Detection, Isolation, or the Omnibus
Treatment, and Reintegration Strategies
for COVID-19 has been issued to ensure risk-based,
targeted testing. The demand for testing has
grown to include essential travelers, overseas F ilipinos and
workers, and other individuals
beyond the priority population for testing.

To date, the country has significantly increased its

laboratory testing capacity with the
operation of 168 licensed COVID-19 laboratories in all its
17 regions. Through these
a
laboratories, total of 5,388,872 tests have been
conducted as of November 19, 2020. The private
sector, hospitals, and diagnostic facilities, in particular, have
improvement in our laboratory testing capacity. significantly contributed to this
They have played a vital role in the realization
of the whole-of-system, whole-of-
government, and whole-of-society response to the COVID-19
pandemic. However, there is a need to ensure the
protection of Filipinos from undue financial
risks when availing of these essential health
services.
Section 4-r of Republic Act No. 11494 the
or “Bayanihan to Recover As One Act” grants
the President temporary authority to enforce
measures to protect the people from hoarding,
profiteering, injurious speculations, manipulation of
prices in restraint of trade or other
pernicious practices affecting supply, distribution
and movement of medicine and medical
supplies whether imported or locally produced
or manufactured.
Further, RA 10623 or the amendment to the
“Price Act”, provides that the President,
upon recommendation of an implementing
agency, may impose a price ceiling on any basic
necessity or prime commodity, including drugs
as may be further determined and classified
the DOH as basic or prime by
commodity, during the existence or effects of
emergency. a calamity or

Based from the foregoing, Executive Order

mandates the Department of Health (EO) No. 118 dated 04 November 2020
(DOH), in coordination with the Department of Trade
Industry (DTI), to determine, formulate and and
implement a price range for COVID-19
conducted by hospitals, laboratories, and other testing
health establishments and facilities
test Kits used in the conduct of sajd including the
tests, subject to existing rules, and regulations.
 II. OBJECTIVES

This DOH-DTI Joint Administrative Order (JAO) sets the guidelines for the
implementation of EO No. 118, to wit:
A. Establish the processes and parameters in imposing the price
range for COVID-19
diagnostic testing and test kits that will foster transparency, accountability, and
fairness to all stakeholders;
B. Determine mechanisms for the review of the price
range, implementation, and
monitoring of compliance; and
C. Identify the roles and responsibilities of the different DOH offices and the
DTI
involved in the price regulation of COVID-19 testing and test kits.

III. SCOPE AND COVERAGE

This JAO shall apply to all private and public hospitals, laboratories, and other health
facilities and establishments, and all other public and private entities involved
.

This JAO covers the price range for plate-based RT-PCR testing
using the top-down
approach. As such, supplemental guidelines on per item costing and price
other testing modalities such as cartridge-based RT-PCR tests, and range of test kits and
antigen tests, among others,
shall be issued separately.

IV. DEFINITION OF TERMS

A. Health Care Providers (HCP) refers

to (1) health facilities, which
may be publicly
or privately owned; (ii) health care professional, who may be a doctor of medicine,
nurse, midwife, dentist, or other allied professional or practitioner duly licensed to
practice in the Philippines; and (iii) pharmacies or drug outlets, laboratories, and
diagnostic clinics (RA 11223 or the Universal Health Care Law).
B. Licensed COVID-19 Testing Laboratory refers to
a health facility that has
complied to the standards and requirements set by RITM and HFSRB/CHD-RLED
and has obtained a license to operate (LTO) as a COVID-19
testing laboratory (40
2020-0014)
C. Mandated Price Range refers to the
range of prices determined by the DOH, in
coordination with the DTI, to be just and reasonable based
on the established
processes and parameters;
D. Testing refers to the COVID-19 testing procedures,
including all charges related to
basic testing services, conducted in hospitals, laboratories, and other
testing facilities
licensed by the DOH to conduct COVID-19 testing, as such, the
term refers to
SERVICES being rendered by such facilities.
E. Test Kits refers to any FDA-registered kits used for the
diagnosis, screening, and
surveillance of COVID-19. As used in this, test kits shall refer to real time
reverse
transcriptase polymerase chain reaction (rRT-PCR) test kits and other
testing
modalities, as may be determined by the DOH.
F. Public Sector or Entities refer to agencies, instrumentalities
of the government,
including Government-Owned or Controlled Corporations, whether stock
or non-
stock, and local government units.
G. Private Sector or Entities refer to all those not otherwise covered
by the definition
of the Public Sector above. These would also include facilities that
are under a
public-private partnership agreement.

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 GUIDING PRINCIPLES
A. Rational price reduction shall be the goal in setting the price
range for the goods and
services covered by EO No. 118.
B. Balance of equity, access, and consumer’s choice shall guide the
setting of fair price
ranges. The price range must be just, equitable, and sensitive to all stakeholders.
. Setting fair price ranges shall follow an evidence-based, information-driven, and a
consultative process promotive of quality, efficiency, effectiveness, and innovation
in the delivery of the identified goods and service.
Prices shall be made transparent to the public through readily available and accessible
platforms upholding the value of informed choice.

VIL. GENERAL GUIDELINES

A. The DOH, with the DTI, shall set the price of COVID-19 testing and test kits
range
to ensure quality of service, affordability, and availability to patients and
consumers.
This shall capitalize on the costing exercises performed by PhilHealth in
determining
the amount of PhilHealth COVID-19 Testing Packages.
A set of price range of COVID-19 testing per modality for public and
private sector
and entities shall be imposed to consider their varying costing frameworks, and
other
pertinent factors that affect pricing,
The DOH and DTI shall ensure transparency, accountability, and
.
good governance
in the process of determining the price
range through the conduct of public
consultations involving various stakeholders such as academic institutions,
patient
advocacy organizations, consumer groups, HCPs, and other relevant industries.
The mandated price range shall be published using different available
venues, such
as the official agency website, other social media platforms, and
newspapers of
general circulation. The cost of publication shall be for the account of and at the
expense of the DOH.
For their costs to be considered, all HCPs, licensed COVID-19
testing laboratories,
manufacturers, wholesalers, distributors and retailers upon the request of the DOH
the DTT shall submit any and all pertinent data on the prices of different or
testing and
test kits.
The costs associated with a faster turnaround time and other
premium services such
as but not limited to home or community swabbing, shall be within the
mandated
price range for testing.

VII. SPECIFIC GUIDELINES

A. Determination of Mandated Price Range
1. To enable the DOH and DTI to determine the mandated price range for COVID-
19 testing and test kits, they shall gather data and information
on prices of testing
and test kits through local and international publicly available
databases, and
third party research firms; and manufacturers, distributors,
wholesalers, and
consumers (such as patients and HCPs).
2. Inthe interim, a top-down approach shall be used to determine
the price range for
COVID-19 testing.
a. Data on retail prices and other relevant information shall be
gathered
through a survey. Selection process of survey respondents shall ensure
adequate representation from both public and private laboratories across
all regions.
b. Data analysis shall determine the minimum,
median, and maximum retail
prices of testing conducted by the licensed COVID-19 laboratories.

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 ¢. In setting the price range, the median to the 75th percentile price shall
serve as the price range, median price being the reference price, and the
75th percentile price as the price cap.
d. Different price ranges for public and private licensed COVID-19
laboratories shall be implemented to account for the differences in the
costing frameworks.
3. Corresponding issuances on the mandated price
range per testing modality and
test kits shall be issued.
4. In order to ensure responsiveness to the needs of stakeholders, the DOH and
DTI
shall further solicit inputs from patients, HCPs, and consumers
price range of testing and test kits, as far as practicable.
in determining the
5. The DOH-Pharmaceutical Division (PD), DOH-Health
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Facilities Services and

Regulatory Bureau (HFSRB), DTI-Consumer Policy and Advocacy Bureau
(CPAB), and DTI-Board of Investments (BOI) shall conduct price evaluations
and provide technical advice and support to the Secretary of Health
(SOH) and
Secretary of Trade and Industry (STI) on whether or not to subject a specific
diagnostic test modality for the price regulation. Based thereon, the DOH shall
issue within 15 days from the effectivity of the JAO the price
range for testing
and test kits.

B. Implementation
1. No HCP or licensed COVID-19 testing facilities shall charge
patients for
COVID-19 testing at a price exceeding the mandated price
range for COVID-19
testing issued by the DOH.
2. As provided under EO 118, compliance with the
price range set by the DOH and
DTI shall form part of the standards for the licensing of hospitals,
laboratories,
and other facilities as DOH licensed establishments for COVID-19
3. HCPs or licensed COVID-19
testing.
testing facilities, at their own discretion, may charge
patients for COVID-19 testing at a price below the reference price, provided that
quality of service shall still be maintained.

C. Publication and Posting of Price List

1. The DOH through the CHDs shall
release an electronic version of the list of
prevailing prices to be distributed in all hospitals, laboratories, and other health
facilities licensed by the DOH to conduct COVID-19 testing.
2. All COVID-19 testing facilities are required to
post a clear copy of the price list
in conspicuous areas within their premises. It shall be made available
to the
consumers and regularly updated as the situation may warrant.
3. The standard DOH-developed
Information, Education, and Communication
(IEC) material shall be part of the licensing and inspection checklist for HFSRB.

D. Monitoring, Evaluation, and Enforcement

1. The mandated price
range for COVID-19 testing and test kits shall be subject to
review every month by the DOH through the PD, HFSRB,
RITM, and
PhilHealth, together with the DTI.
2. Complaints on overcharging of COVID-19
testing facilities shall be filed with
HFSRB Complaints Unit, while complaints on overpricing of test kits shall be
coursed through the Fair Trade Enforcement Bureau.
3. The HFSRB, PhilHealth, with the assistance of DTI shall
conduct random on-site
monitoring for compliance to this JAO. Notice of violations shall be issued to the
erring individual or institution, which shall then be referred to the DTI
Adjudication Division.
 4. Upon the authority of the DOH, the DTI-FTEB shall proceed with adjudication
process, as applicable, and file the necessary criminal charges with the Regional
Trial Court (RTC).
The preceding provision does not preclude HFSRB from initiating criminal
charges.
Sanctions and penalties for non-compliance are detailed in Section IX of this
JAO.

VIII. ROLES AND RESPONSIBILITIES

A. Department of Health shall:
1. Set and disseminate the price
range for conducting COVID-19 testing and test
kits;
2. Review and update the price range as necessary;
3. Coordinate with the DTT on all matters concerning review and implementation of
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this JAO; and

4. Provide the DTI monitoring team with service vehicles and
personal protective
equipment.

. DOH Health Facilities and Services Regulatory Bureau shall:

1.Provide technical assistance in the costing, determination, and review of
price
range for testing and test kits;
2. Monitor the cost of COVID-19 testing by HCPs and licensed
COVID-19 testing
facilities;
3. Investigate alleged violations by HCPs and
licensed COVID-19 testing
laboratories on price range set by the DOH and DTI, in accordance with
appropriate laws;
Impose appropriate sanctions to hospitals and other HCPs for non-compliance
with any of the provisions of this JAO; and
Conduct random on-site monitoring for COVID-19 laboratories,
hospitals and
other HCPs

- Research Institute for Tropical Medicine shall:

1. Provide technical assistance in the costing, determination, and review
of price
range for testing and test kits;
2. Continue the issuance of validation
reports to aid the laboratories in the choice of
test kits to be used based on the clear specifications for the indicators of
quality
in a test kit; and
Continue assessment of laboratories on their COVID-19
testing compliant to key
performance indicators and other quality related issues.

. DOH Pharmaceutical Division shall:

1. Provide technical assistance in the
costing, determination, and review of price
range for testing and test kits; and
2. Convene stakeholders and conduct public consultations
as necessary.

Health Promotion Bureau and Communications Management Unit shall:

1. Propose and develop
a communication plan on the dissemination of information
related to the imposition of the price range;
2. Publish the price range in the official DOH website and other social
media
platforms; and |

3. Develop a standard IEC material for the price

range of COVID-19 test kits and
Frequently Asked Questions (FAQs) which shall be used by all drug outlets.
 F. DOH Legal Service shall:
1. Assist HFSRB in investigating alleged violations
by HCPs and licensed COVID-
19 testing laboratories; and
2. Provide legal assistance on all matters related to the implementation of
this Order.
G. DOH Centers for Health Development Regulations, Licensing and Enforcement
Division and Ministry of Health - BARMM Regulation, Licensing and
Enforcement Cluster shall:
1. Monitor the compliance of all COVID-19
testing laboratories to the
implementation of the mandated price range; and
2. Submit violators of the mandated y price
range to the HFSRB for investigation.
H. Food and Drug Administration shall:
1. Ensure the quality of COVID-19 test kits available
in the market;
2. Monitor compliance of manufacturers, importer, trader,
distributors, wholesalers
and retailers; |

3. Collect information regarding the prices of the

COVID-19 test kits upon
registration; and
4. Continuously update DOH and DTI of the FDA registered COVID-19
diagnostic
test kits. |

I. Philippine Health Insurance Corporation shall:

1. Ensure the payment of valid claims within
sixty (60) days from submission of
claims with complete documentary requirements;
2. Monitor the cost of COVID-19 testing by HCPs and licensed COVID-19
testing
facilities;
3. Incorporate the mandated price
range set by the DOH, in coordination with DTI,
in revising/determining the cost of their benefit package for COVID-19
testing;
4. Take appropriate measures against hospitals and other HCPs for
failure to comply
with the mandated price range, and any other provisions of this
JAO; and
5. Conduct random on-site monitoring for
hospitals and other HCPs.

J. Department of Trade and Industry shall:

1. Assist the DOH in obtaining price and supply related data and information from
manufacturers, importers, distributors, and retailers, and analyses thereof:
2. Assist in the evaluation and determination of the mandated
price range for
conducting COVID-19 testing and test kits;
3. Assist in the conduct of price
monitoring of COVID-19 test and test Kits,
document the same and provide copy thereof to the DOH; and
4. Assist mn the adjudication of consumer complaints
directly filed with DTI
Consumer Care and endorsed by DOH.

K. HCPs and Licensed COVID-19 Testing Laboratories shall:

1. Provide test kits and COVID-19
testing services at rates within the set price
ranges;
2. Cease charging for any and all additional costs associated with
COVID-19 testing
services; and
3. Provide routine documentation and data
as requested by the DOH, DTI, and any
associated agencies.

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 IX. SANCTIONS AND PENALTIES

A. Non-Compliance to the Mandated Price Range for COVID-19 Test Kits

Pursuant to RA No. 7581, as amended, imprisonment for a period of not less than one
(1) year nor more than ten (10) years or a fine of not less than Five thousand
pesos (P5,000) nor
more than One million pesos (P1,000,000), or both, at the discretion of the court.

B.Non-compliance to the Mandated Price Range for COVID-19 Testing

A fact finding team shall be organized by the HFSRB upon receipt of complaint regarding
violation of the price range set in this guideline. After diligent and thorough evaluation of the
gathered evidences, any HCPs, licensed COVID-19 testing laboratory, or any other entity, if
found to have indeed violated provisions of the AO, shall be penalized and sanctioned as follows:
First Violation 15-day suspension of LTO as a COVID-19 testing
laboratory and an administrative fine of twenty thousand
pesos (PhP 20,000.00)
Second Violation 30-day suspension of LTO as a COVID-19 testing
laboratory and an administrative fine of thirty thousand
pesos (PhP 30,000.00)
Third Violation Revocation of LTO as a COVID-19 testing laboratory.
The HCP, licensed COVID-19 testing laboratory or any other entity can only
reapply for
a new LTO one year after its revocation. Any HCP, licensed COVID-19 testing
laboratory or
any other entity aggrieved by the decision of the HFSRB can file an appeal to the Secretary of
Health (SOH) upon receipt of the complaint resolution. HFSRB shall endorse all
pertinent
documents relating to the complaint to the Office of the Secretary of Health. The decision of the
SOH shall be final and executory.

Non-compliance with this JAO by any PhilHealth-accredited Health Care Providers and
licensed COVID-19 testing facilities or laboratories shall give rise to administrative
liability
under RA No. 7875, as amended by RA 1 1223, for violation of pertinent law and DOH rules
and
regulations, and breach of performance commitment.

X. REPEALING CLAUSE
All orders, rules, regulations, and other related issuances inconsistent with
or contrary to
this JAO are hereby repealed, amended, or modified accordingly.

XI. SEPARABILITY CLAUSE

It for any reason, any portion of this JAO shall be declared unconstitutional and/or
rendered invalid by any court of law or any competent authority, parts or provisions
not affected
shall remain in full force and effect.

XII. EFFECTIVITY DATE

This JAO shall be effective immediately upon publication in a
newspaper of general
circulation and upon filing with the Office of the National Administrative
Register (ONAR) of
the University of the Philippines Law Center of three (3) certified copies of
be valid until throughout the duration of the state of public health
this Order, and shall
emergency.
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Z} NOV
Done this day of 2020.

Department of Health Department of Trade and Industry

FRANCISCO TZDUQUE III, MD, MSc RAMON M({ LOPEZ

Secretary of Health - — Secretary of Trade and Industry