A great deal of buzz surrounds the "Clinical Establishment Act"  but will the Clinical Establishments Act help regulate medicine? Here is what it entails.

The recent death of a young girl due to dengue, and then the huge bill of nearly Rs. 16 lakh submitted by a reputed corporate hospital has kicked up a storm about medical expenses and overcharging by hospitals. Parties are sticking to their side of the narrative; while doctors claim that their bill comprises only 3% of the charges, activists note that this is a classic case of corporate hospitals overcharging hapless customers. 

 In the wake of this episode, the Union Health Ministry has urged all the states and union territories to adopt and implement the Clinical Establishment Act. Read more about it here.

The Clinical Establishments (Registration and Regulation) Act, 2010 was promulgated by the Central Government to create a streamlined system for registration and regulation of all clinical facilities in India. It aimed to create a set of basic standards with which any clinical establishment could be regulated.

However, several proposals in the Act have been contentious, and it has been hard to get the Act to be implemented across India since it cannot be directly applied to all states automatically. The states have the choice of passing a resolution to adopt the bill or passing a similar bill. Barring states such as Arunachal Pradesh, Himachal Pradesh, Mizoram, and Sikkim, which have already passed similar legislation, the other states are facing some issues regarding implementation of the Act.

Basic provisions

The aim of the Act is to register all clinical establishments in India to make it easier to regulate them and implement standard practices. With the exception of military clinical setups, the Act applies to all public and private clinical establishments, including those under the ambit of AYUSH. All clinical setups are required to register. A clinical establishment can then be a hospital, maternity home, nursing home, dispensary, clinic, sanatorium or any other institution that offer services for diagnosis, care or treatment of patients. The Act advises the formation of a National Council to monitor implementation of the Act, which will then supervise state and UT councils, which finally will monitor district-level registration authorities.

For new establishments, a provisional registration will be available, which will be valid for 1 year and must be renewed. Hospitals can also apply for a permanent registration. The registration certificate must be prominently displayed in the hospital like most other certificates. To ensure that the information is publicly available, the Act aims to have an online database of registration accessible to the public.

For streamlining hospitals into categories, hospitals will be divided into four major categories:

Hospital Level 1-These are the primary healthcare services provided by qualified doctors. It includes services such as General Medicine, Pediatrics, First aid services, emergency patient care and Out-Patient Services, Obstetrics & Gynecology, Non-surgical and Minor Surgery and which cannot have more than 30 beds. The establishment will need to be under the supervision of qualified manpower with support by registered medical practitioners and support staff.

Hospital Level 2-This level of hospitals will include those providing services of Surgery and Anesthesia in addition to the services provided at level 1 through registered medical practitioner under the supervision and with the support of specialists. It will also have complementing services such as pharmacy, laboratory, diagnostic facility, etc. for enabling

Hospital Level 3-This level includes all the services provided at level 1 and 2 and Multi-specialty clinical care with a distinct department and an Intensive Care Unit. Tertiary healthcare services can be provided through specialists. It will also have other support systems required for these services like pharmacy, Laboratory, and Imaging facility.

Hospital Level 4 –This is the highest level of medical establishments, such institutions will be for institutions doubling up as teaching/ training institution and when the hospital has multiple super-specialties. It shall have other support systems required for these services. It shall also include the requirements of MCI/other registering bodies.

The hospitals are required to follow a particular template for display of the various rates related to OPD, investigation/diagnostics, emergencies, etc. which is detailed in the draft documents issued by the ministry.

Some contentious issues

One of the chapters details various offences and punishments for the same. For example, running a hospital without registration is penalized at ₹50,000 as the first offence. For an employee who knows he is working in an unregistered establishment, a fine of up to ₹25,000 may be levied. There is also a fine for obstructing investigations, withholding information or giving false information. In case of violation by corporate hospitals, the management of the corporate body will be held responsible, hence ensuring accountability even among the top rung hospitals.

The Act also speaks about maintaining detailed patient records, which might prove to be of critical importance to investigate cases such as the recent case ( where a young girl, seven years of age succumbed to dengue but was billed nearly Rs 16 lakh by the hospitals). Under the Act, clinical establishments should keep a record of the all the patients and disclose and display the type of services they give. Among another provision which is deemed to be contentious, the hospitals will need to provide a detailed rate list and display it at prominent points in the hospitals.

Some states have gone farther to introduce harsher penalties for private practitioners, a move that has drawn criticism from the fraternity.

The Act in Karnataka raised the fine for running an unregistered establishment from. Rs 10000 to Rs. 5,00,000. Similarly, it aimed to fine and even imprison doctors for non-maintenance of clinical records at 3 years imprisonment and a fine of Rs. 2,00,000.

Among other provisions, there would be a price cap on certain medical procedures. The measures were deemed to be draconian, and even unfairly targeting private medical practitioners while government medical establishments were not under the rules’ ambit.