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Health law and ethics update

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The abbreviated abbreviates

1. HMI & PMB charges

2. Medical devices & medicines

3. NHI

4. OHSC & CON

5. DSPs, and other med scheme cases

6. Global fees

7. HPCSA matters

8. Malpractice

HMI ….

“So, who is this Peter?” …

“and who are the Departments of Silly

Questions?”

Where we are in HMI… • Timelines:

– First set of hearings (Feb, March & May),

should be 6 sets

– Provision report of Aug 2016 postponed

• OECD/WHO Report (next slide): 30 August

round table

– Is used to make case for (further) price

regulation & in NHI White Paper

• PMB up-coding and charging more

• DSPs & co-payments

Reply by WHO “After careful review of all comments, we find no substantive

issues related to the data and analysis that alter the main

findings and conclusions of the WHO/OECD report, namely

that:

• Prices in South African private hospitals are high

relative to South Africa's income level, and on par with

the OECD average and much higher income

European countries (i.e., France, U.K, and Germany).

• Prices in South African private hospitals are increasing

above the rate of increase for other goods and

services in the South African economy

• Prices in South African private hospitals are

unaffordable for the vast majority of South Africans •

even higher income groups”

Bestmed, BHF and DoH

addressed this at HMI

Indications of possible

recommendations • Implementation of non-implemented provisions

of NHA (incl RPL, info on quality, etc.)

• Patient RIGHTS: – PMB info,

– info on quality and

– info on pricing

• Implementation of PMB Review

• Doctor employment by hospital

• Address technology… (“when last were you in Chicago?”)

• Role of brokers and administrators(?)

Medical devices & Medicines

The SAHPRA Project

• Acts 72 of 2008 and 14 of 2015

(amending the current Medicines Act)

• Regulations still outstanding

• MCC will become SAHPRA

• Device “establishments” (importers,

manufacturers, distributors) must apply

for licence BEFORE 1 March 2017

(under current Act)

Medical devices Will also be subject to:

• Section 18A: No bonus, rebate or incentive

scheme (unless declared acceptable - MoH)

• Section 18B: No sampling, unless for exhibition

or appraisal purposes (regs)

• Section 18C: Marketing Codes

• SO:

– Product placement in facilities? (capex, etc.)

– Free goods (e.g. glucometer free + strips sold)?

– Differential pricing and discounts? (e.g. implants,

sutures, etc.)

Developments in medicines

• SEP and a second SEP)

• IP:

– Bolar provision & parallel importation &

mandatory generic substitution

– Voluntary licensing

• IP - DTI – new framework

– Search and Examination of patents

– Different criteria for patentability

– Compulsory licensing

NHI White Paper: re-cap

Work Streams 1. NHI Fund: (Prof McIntyre)

2. NHI Benefits (Dr Yogan Pillay)

• Draw on PHC, HIV/TB, NCDs, EMS & hospital

packages – public sector

• Health technology assessment

3. Purchaser-provider split (Dr Anban Pillay)

• Providers: mix of public and private

• Independent multidisciplinary group practices

• Results-based purchasing & contracting

• Registration of facilities

• DRG’s and capitation

• Incentives for providers to contract

Work Streams 4. Medical schemes (Mr Vishal Brijlal)

• Unified information system

• Only complementary benefits (?) – MSA to change

• Tax subsidies towards NHI Fund (DTC)

5. Finalise NHI Policy Paper (Dr Thulare)

6. Strengthen District Health System (Mr

Morewane)

• Shift from hospital care to PHC

• DHM (District Health Management) Offices

• Consider demographics & epidemiology

• Coordination of services, referral system

And now?

• Davis Tax Committee asking for input on

NHI tax – hearings begin Nov

• White Paper to be finalised

• Various regs, e.g. on EMS have been

finalised, some laws still to go through

Parliament

• Consultation through Work Streams

• Financing Paper still outstanding (DTC?)

OHSC and the CON

OHSC – Office of Health

Standards Compliance

• http://www.ohsc.org.za

National Health Act, s36

You’d need a CON to —

• Establish (start a new “health establishment” (incl

pharmacies), occ health clinic, what equipment, staffing,

etc.),

• Construct (developers, builders)

• Modify (existing practice, etc.)

• Acquire (BUY! -buyers gets CON, not seller provides

CON to buyer)

• Renew (x number of years, whereas x ,20yrs)

a health establishment or health agency

The issuing or renewal may be made subject

to:

“compliance by the holder with national operational

norms and standards (OHSC) for health

establishments and health agencies, as the case

may be; and any condition regarding—

(i) the nature, type or quantum of services to be

provided by the health establishment or health agency;

(ii) human resources and diagnostic and therapeutic

equipment and the deployment of human resources or

the use of such equipment;

(iii) public private partnerships;

(iv) types of training to be provided …; and

(v) any criterion contemplated in subsection (3).”

DSPs

CMS v Genesis (SCA)

• What is it about?

– Scheme not paying for prostheses (not

available in state sector)

– Scheme saying its rules say state = DSP

and/or they only have to pay up to level of

state care

– Reversal of benefits already paid

SCA = Supreme Court of Appeal

Q: Can the scheme rules override the Act and regulations?

A: No, scheme cannot contract out of legal framework

Q: Can the scheme say it only pays up to the level available in

public sector?

A: No, it has to pay in full

Q: Can the scheme say the state is their DSP but not appoint

them?

A: No, you cannot oblige members to go to state and then

there is little or no cost to the scheme

Q: Can the scheme only appoint the state as their DSP?

A: No, as it would go against objective of the PMBs and the

law

Q: can scheme say they don’t pay for prostheses not available

in state?

A: No, if reasonable and part of treatment

CMS Appeals Board: Punative

Co-payments: ICPA v CMS • History:

– Schemes impose penalty co-payments when

members elect to use not network/DSP

providers (even where services, fees, etc. are

the same)

• Schemes of the opinion that if no penalty co-

payment, no incentive to use DSPs

• ICPA: CMS to have penalty co-payment

system declared Undesirable Business

Practice (Section 61) = ruling of Appeal

Board

SCA case:

Sechaba, Gen-health

• Schemes do NOT have a free choice to

now pay provider, then pay member

• At par 25:

– If it is owing to the provider, it must be paid

to the provider

– People become members exactly so that

scheme will pay up to benefits, only when

patient chose to pay provider themselves,

should scheme pay patient

Global fees

• Medical schemes going out on tender

• Hospitals incorporating professional

fees in their services

• Some models a hit with the HMI

• HPCSA rules:

– No fee sharing (rule 7)

– No subcontracting (rule 18)

– Possible exploitation (rule 22)

• Proposals for amendments to ethical

rules?

HPCSA

Findings

• Failure to perform to an adequate

standards to ensure an effective and

sufficient administration

• Failure to ensure appropriate operations

management

• Mismanagement, maladministration,

irregularities in professional conduct

inquiries

• Also structure of HPCSA with 12 Boards

is problematic

Latest from HPCSA Hearings

• Can your PROVE that: you have

obtained –

– informed consent and

– informed BILLING consent?

Malpractice

Some proposed solutions

MPS (2015) Challenging the cost of clinical negligence

elsabe@ekconsulting.co.za

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