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Healthcare regulations must factor in complex structure of private sector

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Health is a public good; hence the regulation is not only about enforcement but also but timely intervention by the concerned to ensure fair play and justice for both the healthcare provider and the patient

Representative image.

As per NSO (75th round), private sector accounts for 55 percent of patient care, public sector 42 percent, and 3 percent patents are treated in medical charitable trusts. Given this, for the private sector to be trustworthy partners in healthcare delivery, regulatory framework, and its mindful implication is imperative.

Recent news reports show that investigations by the Competition Commission of India (CCI) have found that some super-speciality hospitals of well-known chains that operate in the Delhi-National Capital Region abused their positions of dominance by charging “unfair and excessive prices” for renting rooms, medicines, medical tests, medical devices, and consumables.

The COVID-19 pandemic also highlighted the requirement for regulation with widespread complaints of over-charging, unnecessary procedures, issues in quality, denial of admission without advance, opaqueness in treatment protocols, and so on. At the same time, one must acknowledge that without the participation of private hospitals, India’s fight against COVID-19 was not possible. During the testing times, many states requisitioned beds in private hospitals, centrally allocated them at fixed charges, and the private hospitals willingly co-operated.

The Clinical Establishment Act 2010 and the Clinical Establishment Rules (2012) — which provide for registration and regulation of all clinical establishments in India with a view to prescribe the minimum standards of facilities and services provided by them — have been adopted by 11 states, and came into force in most union territories except Delhi. This is because states are free to enact their own Act.

The Indian Medical Association (IMA) has not been supportive of this Act. They object to the Act requiring private hospitals and clinics to provide standard facilities, and yet charge minimum fees. The law also requires hospitals and clinics to stabilise patients, who are in a critical condition; this may not be possible for small establishments not having specialists, they argue. It is true that healthcare establishments have to comply with multiple regulatory requirements.

The Report on the Working Group on Clinical Establishments, Professional Services Regulation and Accreditation of Health Care Infrastructure for the 11th Five-Year Plan highlights this issue while stating that, health regulation in India encompasses a variety of actors, and issues. These include promulgation of legislation for health facilities and services, disease control and medical care, human power (education, licensing, and professional responsibility), ethics and patients’ rights, pharmaceuticals and medical devices, radiation protection, poisons and hazardous substances, occupational health and accident prevention, elderly, disabled, and rehabilitation family, women and child health, mental health, smoking/tobacco control, social security and health insurance, environmental protection, nutrition and food safety, health information and statistics and custody, civil and human rights to enumerate a few. The Consumer Protection Act also covers healthcare services.

Private healthcare entities are not a homogenous lot. Ranging from super-specialty chains of hospitals, you have nursing homes, single-specialty hospitals of varying sizes, urgent care clinics, birth centres, hospice homes, ambulatory surgical facilities, rehabilitation centers, radiology and imaging centers, et al. The book ‘Perils in Practice: The Prevention of Violence Against Healthcare Professionals aptly points out another complexity: While doctors are held to ethical standards, hospitals and corporate health institutions are accountable to industry regulations. Regulatory arrangements, therefore, have to keep in mind the diversity and complexity of healthcare service delivery.

As the first step to transparency and accountability, hospitals can post on their websites, or on association websites, outcomes (for example, average duration of length-of-stay, readmission, and mortality rate), and patient feedback on quality, safety, and cost of care. This will help build confidence, and also dispel any doubts about patient care.

Health is a public good; hence the regulation is not only about enforcement but also but timely intervention by the concerned to ensure fair play and justice on both sides. Since health is a state subject, states will need to take the initiative with all stakeholders on board. An independent regulator with enabling single-window clearances for different forms of healthcare establishments is perhaps the practical way forward. Appointing a healthcare ombudsman by states could also help. The ombudsman could act as an arbitrator enabling fair play for all stakeholders.

With the government encouraging initiatives like ‘Heal in India’ and ‘Heal by India’, a well-laid out, implementable, facilitatory, regulatory framework with the underlying principle of acknowledging health as a public good is a must.

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