Trending: Call for Papers Volume 4 | Issue 4: International Journal of Advanced Legal Research [ISSN: 2582-7340]



In the rapidly evolving landscape of global healthcare, access to quality medical services is a fundamental right that every citizen should enjoy. Recognizing this imperative, governments worldwide have been striving to create robust frameworks that ensure affordable and comprehensive health insurance coverage for their citizens. With its burgeoning population and diverse healthcare needs, India stands at the forefront of this challenge. In 2016, the Government of India introduced the India Health Insurance Regulations, a landmark policy framework designed to revolutionize the nation’s healthcare sector.

The introduction of the India Health Insurance Regulations in 2016 marked a significant milestone in the country’s efforts to provide accessible and affordable healthcare to its citizens. With a population exceeding 1.3 billion, India faces unique challenges in healthcare delivery, ranging from urban-rural disparities to socioeconomic variations. The regulations were crafted with a dual purpose: to enhance the reach of health insurance services and to ensure the quality and transparency of these services. Understanding the multifaceted nature of health insurance, the regulations encompass many provisions addressing issues such as coverage expansion, standardization of policies, and protection of consumer rights.

This research paper delves deep into the intricacies of the India Health Insurance Regulations, 2016, aiming to provide a comprehensive analysis of its provisions, impact, and challenges. By critically examining the critical facets of this regulatory framework, this study seeks to unravel the successes and shortcomings of the policy, shedding light on its actual influence on the Indian healthcare landscape.

In the following pages, we will explore the historical context of health insurance in India, tracing its evolution and examining the pivotal moments that led to the formulation of the 2016 regulations. Through an in-depth overview, we will dissect the core provisions of the regulations, elucidating their intended objectives and practical implications. Additionally, this paper will scrutinize the challenges faced in implementing these regulations, offering critical insights into the gaps in the system. Furthermore, a comparative analysis will be undertaken, juxtaposing the Indian regulations against the USA to draw valuable lessons and inspiration for future policy improvements.

As we embark on this analytical journey, we endeavour to provide a nuanced understanding of the India Health Insurance Regulations, 2016. By doing so, we hope to contribute meaningfully to the discourse surrounding healthcare policy-making in India and, by extension, provide insights that can resonate with other nations grappling with similar challenges.

Historical Context of Health Insurance in India

Evolution of Health Insurance Policies

The concept of health insurance in India traces its origins back to the early 20th century when select companies introduced the first health insurance policies to cover industrial workers.[1] However, after independence in 1947, the Indian government recognized the need for comprehensive healthcare initiatives. The Bhore Committee Report of 1946, a pivotal document in India’s public health history, emphasized the importance of health insurance to make healthcare services accessible to all, particularly to the economically vulnerable sections of society.[2] Various health insurance schemes were launched in the subsequent decades, primarily targeting government employees and organized sector workers. These initiatives aimed to provide primary health coverage but needed to expand their outreach and coverage scope. The 1980s witnessed a shift with the establishment of public sector insurance companies like Oriental Insurance, New India Assurance, and United India Insurance, which significantly expanded health insurance services to a broader audience.

Key Milestones and Developments

The liberalization of the Indian economy in the early 1990s ushered in a new era for the health insurance sector. Private insurance companies entered the market, bringing innovation and competition. The year 2000 was a watershed moment with the launch of the Central Government Health Scheme (CGHS), a comprehensive health insurance program for government employees and pensioners. Around the same time, the RashtriyaSwasthya Bima Yojana (RSBY) was introduced in 2008, specifically targeting families below the poverty line and providing cashless health insurance coverage for hospitalization expenses.

The launch of the Ayushman Bharat Pradhan Mantri Jan Arogya Yojana (PM-JAY) in 2018 marked a significant milestone in India’s healthcare landscape. PM-JAY, also known as Ayushman Bharat or the National Health Protection Scheme, is one of the world’s largest publicly-funded health insurance schemes.[3] It aims to provide health coverage to over 100 million families, making it a monumental step towards universal health coverage in India.

Additionally, the Insurance Regulatory and Development Authority of India (IRDAI) has been instrumental in shaping the health insurance sector.[4] It introduced regulations to standardize health insurance policies, ensuring transparency and simplifying the terms and conditions for policyholders. These regulatory interventions have been pivotal in enhancing consumer confidence and promoting the uptake of health insurance policies nationwide.

Overview of Indian Health Insurance Regulations, 2016

The India Health Insurance Regulations 2016 represent a watershed moment in the country’s healthcare sector. Enacted to standardize and regulate health insurance policies, these regulations were designed to address the complexities and challenges of India’s rapidly expanding health insurance industry. The primary objective was to ensure that health insurance products offered to the public are fair, transparent, and beneficial, providing a safeguard for consumers while promoting the growth and stability of the insurance market.

The Insurance Regulatory and Development Authority of India (Health Insurance) Regulations, 2016 govern health insurance policies in India. The regulations ensure fairness, transparency, and standardized practices within the industry. Here are the key points outlined in the regulations:

Sections Content
Section 2  – Definitions for various terms, including “Health Services Agreement,” “Ayush Treatment,” “Cashless facility,” “Health insurance business,” and more, are provided. – Certain terms not defined in these regulations are interpreted as per the Insurance Act 1938 or Insurance Regulatory and Development Authority Act 1999.
Section 3  – “Health insurance products” can be offered by registered general and standalone health insurance companies. – Various types of policies, including individual health products, group policies, group personal accident policies, “travel cover, and personal accident cover, can be offered for different terms.”
Section 4  – Health insurance products and any modifications must be approved by the Authority based on specified guidelines before being marketed.
Section 5  – Withdrawal of a health insurance product is subject to guidelines specified by the Authority.
Section 6  – Health insurance products “must be reviewed by the Appointed Actuary at least once a year.” – Insurers must seek approval for any variations in assumptions regarding loss or combined ratios.
Section 7  – Group insurance policies require a minimum of 20 members, but micro-group insurance policies may have a minimum of 5 members. – Insurers must issue a Certificate of Insurance detailing benefits, premiums, and claims procedures.  
Section 8  – Insurers must have a “Health Insurance Underwriting Policy” approved by the company’s board. – Policy acceptance or denial is based on the approved underwriting policy.
Section 9  – Every insurer must have a proposal form capturing necessary information for underwriting. – Information collected must not be shared with third parties except as per statutory laws or regulatory instructions.
Section 10  – Premiums are based on completed age for individual policies. – Premiums remain unchanged for group and travel insurance products. – Premium rates generally remain fixed for at least three years.
Section 11  – Health insurance products can be tailored for specific age, gender, treatment locations, or geographies. – Insurers must provide clear product information on their websites, including prospectuses, policy wordings, and premium rates.
Section 12  – Health insurance policies must allow entry up to 65 years unless specified otherwise. – Renewal cannot be denied based on age if the policy is maintained without a break.
Section 13  – Health insurance policies are renewable except in cases of fraud, moral hazard, or misrepresentation. – A mechanism allows condoning a renewal delay of up to 30 days without deeming it a break in policy.
Section 14  – Individual health insurance policies have a “free look period of at least 15 days” for policy review. – If no claims are made during this period, “the insured is entitled to a refund of the premium paid.”
Section 15  – Pre-insurance medical examination costs may be borne partly by the insurer, especially for products with a term of one year or less.
Section 16  – Cumulative bonuses accrued under health insurance policies shall be explicitly stated and may be reduced if a claim is made.
Section 17  – Policyholders can migrate to alternative policies at the end of the specified exit age or at renewal, with suitable credits for previous policy years.
Section 18  – Insurers may provide coverage for AYUSH treatment if undergone in government-recognized or accredited institutions. – Insurers can promote wellness services but not products or services of third parties.
Section 19  – Standard definitions for phrases and terms used in health insurance policies are defined by the Authority.
Section 20  – Nomenclature and procedures for critical illness cover are defined by the Authority.
Section 21  – Insurers can offer optional cover for generally excluded items, disclosed transparently in policies and websites.
Section 22  – Premiums for senior citizens must be fair and transparent, and a separate channel must be established to address their claims and grievances.
Section 23  – Insurers must settle claims independently of payments received under other similar policies. – Policyholders can choose which insurer settles their claims for policies covering the same risk.
Section 24  – Loadings on renewal premiums must be based on objective criteria and disclosed upfront. – Fresh underwriting is not allowed during renewal unless there’s a change in the sum insured offered.
Section 25  – Benefit-based policies must not exceed the upper limit prescribed, and insurers may cancel cover beyond this limit.
Section 26  – Regulations for policyholder protection are applicable to health insurance policies. – Policyholders must be provided with a Customer Information Sheet, and efficient claims processing systems must be established.
Section 27  – Claims, including rejections, must be settled within thirty days of receiving the last necessary document. – Insurers should not ask for documents beyond policy terms and conditions unless fraud is suspected.
Section 28  – Policy documents must include disclosures specific to the regulations, claims submission procedures, sub-limits, penal interest provision, and TPA details.
Section 29  – Insurers must disclose TPA details on their website, update it regularly, and provide information on cashless services offered. These regulations ensure standardized practices, fair treatment for policyholders, and transparent communication between insurers and insured individuals in the health insurance sector in India.

Section 30: This provision outlines the administration of health insurance policies and cashless facilities offered to policyholders:

  1. Cashless Facility: Insurers must offer cashless facilities or reimbursement for medical treatments at specified establishments or any medical establishment, subject to the policy terms.
  2. Network Providers: Cashless facilities are available at establishments with agreements with the insurer (Network Providers). Reimbursement is allowed at any licensed or registered medical establishment.
  3. Health Plus Life-Combi Products: The administration of Health Plus life-combi products must comply with Schedule II of the Regulation.
  4. Pre-Authorization: Except in emergencies, cashless facilities may require pre-authorization issued by the insurer or appointed TPA (Third Party Administrator). Standard forms provided by the Authority are used for this purpose.
  5. Identification Card: Insurers must issue an identification card to the insured within 15 days of policy issuance, either through a TPA or directly. The card carries policyholder details and the insurer’s logo. Smart Cards with technological improvements are encouraged.
  6. Continuation of Cashless Facility: If a policyholder has a pre-authorization for treatment in a hospital being removed from the Network Provider list, insurers must continue cashless benefits until the claim is settled.
  7. Arrangements Between Insurers: Insurers can share Network Providers and transactional data through arrangements with other insurance companies beyond their service areas.

Tripartite Agreement (TPA)

Sections 31 to 36 of the act talk about the Tripartite Agreement. The Parties under the Tripartite Agreement are:

  1. Insurance Company (Insurer): The insurer provides health insurance coverage to the policyholder. In the context of the Tripartite Agreement, the insurer agrees to pay the medical expenses directly to the healthcare provider (hospital or network provider) when the insured avails services covered under the insurance policy. The insurer establishes a network of healthcare providers with agreements for cashless facilities.
  2. Insured (Policyholder): The insured is the person who holds the health insurance policy. When the insured requires medical treatment at a network hospital, they do not have to pay the hospital directly (up to the limit covered by the policy). Instead, the insurer settles the bill with the hospital directly, making the process convenient and cashless for the policyholder.
  3. Healthcare Provider (Hospital or Network Provider): The healthcare provider, usually a hospital, agrees to provide medical services to the insured without requiring immediate payment. The provider sends the medical bills to the insurer for reimbursement or directly coordinates with the insurer for payment, per the Tripartite Agreement’s terms. The hospital benefits by having a guaranteed payment from the insurer and attracting more patients due to the cashless facility.

Section 31. Tripartite Agreement

  1. Insurance companies can offer cashless services if provided by network providers under agreements with the insurer or agreements involving health service providers, TPAs, and the insurer.
  2. Insurers must have written agreements with network providers directly or through TPAs. These agreements cover tariffs, fraud prevention, continuity of services, claim denial responsibilities, and inspection rights. The Authority might prescribe standard clauses.
  3. Insurers must maintain agreements with an adequate number of public and private providers, preserving them for ten years.
  4. The Authority may set standards for network providers, and insurers and TPAs must comply.
  5. Insurers must issue specific claim guidelines to TPAs detailing payments and benefits.

Section 32. Payments and Claims Settlement

  1. Insurers will directly pay network providers and policyholders through integrated banking systems. Payments through checks or demand drafts are allowed upon request.

Section 33. Engagement of TPAs

  1. Insurers need a written agreement with TPAs specifying claims handling guidelines and capacity requirements.
  2. TPAs cannot reject claims, make direct payments to policyholders or network providers, or provide services not in line with the agreement.
  3. Insurers are responsible for prompt service to policyholders. Denials must be communicated with reasons and grievance redressal procedures.
  4. Insurers can engage multiple TPAs.

Section 34. Change of TPAs

  1. Policyholders must be informed 30 days before changing TPAs, with new TPA contact details provided immediately.
  2. Insurers must seamlessly transfer data from the previous TPA, ensuring no inconvenience to policyholders.

Section 35. Data and Related Issues

  1. TPAs and insurers must establish seamless electronic data transfer for claims. Claim settlement files must be handed over to insurers within 15 days.
  2. Authority may issue guidelines on data-related matters.

Section 36. Fraud Mitigation Systems

Insurers and TPAs must implement fraud identification, monitoring, and mitigation systems in line with Authority guidelines.

These provisions outline the requirements for insurers, TPAs, and network providers, ensuring seamless services, data management, and fraud prevention in health insurance policies.

Comparative Analysis with U.S. Affordable Care Act, 2010

The Affordable Care Act (ACA), known as Obamacare, is a groundbreaking healthcare reform law enacted in March 2010 in the United States. Its primary goal was to enhance healthcare accessibility, quality, and affordability for millions of Americans. The ACA significantly changed the U.S. healthcare system, influencing insurance coverage, consumer protections, and healthcare delivery. Here is an in-depth explanation of the ACA and its key provisions:

Individual Mandate and Health Insurance Exchanges

The ACA introduced the individual mandate, requiring most Americans to have health insurance coverage or face a penalty during tax filing. Health Insurance Marketplaces, also called Exchanges, were established to facilitate compliance. These platforms allowed individuals and families to compare and purchase health insurance plans, promoting transparency and competition among insurance providers.

Expansion of Medicaid

The ACA aimed to expand Medicaid, a joint federal and state program providing health coverage to low-income individuals. Before the ACA, Medicaid eligibility criteria varied significantly across states, leaving many low-income adults without coverage. The ACA expanded Medicaid eligibility, ensuring more low-income adults gained access to essential healthcare services. However, a Supreme Court ruling made Medicaid expansion optional for states, leading to varying implementation nationwide.

Pre-Existing Conditions and Essential Health Benefits

A significant achievement of the ACA was the elimination of pre-existing condition exclusions. Previously, insurance companies could deny coverage or charge high premiums based on pre-existing health conditions. The ACA prohibited these practices, guaranteeing coverage for individuals with pre-existing conditions. Additionally, the ACA defined essential health benefits that all insurance plans were required to cover, enhancing the comprehensiveness of insurance coverage.

Subsidies and Tax Credits

The ACA introduced premium subsidies and tax credits to make health insurance more affordable for low- and middle-income individuals. These financial assistance programs helped eligible individuals and families pay for insurance premiums, with subsidies calculated based on income and household size.

Insurance Reforms and Consumer Protections

The ACA implemented various insurance reforms and consumer protections, including guaranteed issues and community ratings. Guaranteed issues ensured that insurers had to offer coverage to all applicants, regardless of their health status. Community rating prevented insurers from charging different premiums based on health status or gender. Additionally, the ACA placed limits on annual and lifetime benefit caps, ensuring comprehensive coverage for policyholders.

Young Adults’ Coverage

The ACA allowed young adults to remain on their parent’s health insurance plans until age 26, providing a safety net for those transitioning into the workforce or pursuing higher education. This provision significantly reduced the number of uninsured young adults in the U.S.

Employer Mandate

The ACA included an employer mandate for larger businesses. Employers with 50 or more full-time employees were required to offer health insurance coverage to their employees or face penalties. This provision aimed to ensure that a significant portion of the population received coverage through their employers.

Accountable Care Organizations and Payment Reforms

The ACA introduced initiatives to enhance healthcare quality and efficiency, including establishing Accountable Care Organizations (ACOs). ACOs are networks of healthcare providers delivering coordinated, high-quality care. The ACA also encouraged payment reforms such as bundled payments and value-based purchasing, incentivizing providers to deliver cost-effective, high-quality care.

Public Awareness and Prevention

The ACA allocated resources to raise public awareness about health insurance options and preventive care services. It funded programs to educate Americans about the importance of health insurance coverage and promote preventive measures, reducing the prevalence of chronic diseases. The ACA aimed to improve public health outcomes and reduce long-term healthcare costs by emphasizing prevention.

Challenges and Repeal Efforts

Despite its significant impact, the ACA faced political challenges and opposition. Critics argued against the individual mandate, leading to a legal challenge that reached the Supreme Court. In 2012, the Supreme Court upheld the mandate’s constitutionality as a tax, allowing the ACA to proceed. In 2017, the individual mandate penalty was effectively eliminated, raising concerns about the stability of the insurance market.

The Affordable Care Act marked a transformative effort to reshape the U.S. healthcare system. By expanding Medicaid, implementing insurance reforms, providing subsidies, and emphasizing preventive care, the ACA aimed to enhance healthcare access, reduce disparities, and improve public health. Its influence on healthcare accessibility, public health outcomes, and the lives of millions underscores its significance as a pivotal piece of American healthcare legislation.

Challenges and Criticisms

The Health Insurance Regulations of 2016 in India, while aiming to create a more standardized and consumer-friendly environment, faced several challenges and criticisms during implementation. These issues encompassed various aspects, from the complexities of implementation to specific provisions within the regulations.

One of the primary challenges faced during the implementation of the Health Insurance Regulations 2016 was the need for more awareness and understanding among consumers. Many policyholders and even some insurance providers needed to be fully aware of the standardized terms and conditions, leading to misunderstandings and disputes. Additionally, the transition for insurance companies, particularly regarding policy documentation and claims processing, posed significant operational challenges. Adapting existing systems and training staff to comply with the new regulations required substantial investments of time and resources.

Several specific provisions within the regulations faced criticisms and controversies. One central point of contention was the standardized list of exclusions and waiting periods. Critics argued that specific essential treatments were still excluded, limiting the effectiveness of policies. Moreover, the waiting periods, although standardized, were considered lengthy for critical treatments, causing dissatisfaction among policyholders, especially those requiring immediate medical interventions.

The method of premium calculation also came under scrutiny. While the regulations aimed to make premiums fair and transparent, concerns about the scientific models used were raised. Critics contended that the premiums did not always accurately reflect individual policyholders’ actual risk factors, leading to pricing and affordability disparities. This raised questions about the fairness of the entire pricing structure.

The limited focus on preventive healthcare was another significant point of criticism. Although the regulations encouraged insurance companies to promote preventive healthcare, critics argued that the incentives were often insufficient. There was a predominant emphasis on curative aspects, with limited encouragement for policies that actively promoted and rewarded policyholders for adopting healthier lifestyles. This gap meant a missed opportunity to address the root causes of many health issues.

Analysis of Regulatory Gaps and Areas Needing Improvement

Addressing the challenges and criticisms required a holistic analysis of regulatory gaps and improvement areas. Consumer education emerged as a pivotal factor. Comprehensive educational campaigns were essential to mitigate the need for more awareness. These campaigns could target policyholders and healthcare providers, ensuring that all stakeholders were well-informed about the regulations, their rights, and the procedures for claims processing. Investing in consumer education would empower individuals to make informed decisions, reducing disputes arising from misunderstandings.

Streamlining claims processing systems was imperative. Implementing digital technologies, such as blockchain and artificial intelligence, could enhance the efficiency and transparency of claims processing. Additionally, regular training and capacity building for insurance company staff and healthcare providers could minimize delays and errors in claims settlements.

Revisiting the standardized list of exclusions and waiting periods was crucial. A comprehensive review involving healthcare experts, insurance professionals, and consumer advocates could identify areas where the regulations fell short. Ensuring that essential treatments were covered without excessively long waiting periods would align the regulations more closely with the population’s healthcare needs.

Enhancing incentives for preventive healthcare was vital. Insurance companies could collaborate with healthcare providers and wellness organizations to design innovative programs that encourage healthy behaviours. This could include discounts on gym memberships, subsidized health check-ups, and rewards for maintaining specific health metrics. By promoting preventive healthcare in meaningful ways, the regulations could significantly contribute to improving public health outcomes.

In conclusion, while the Health Insurance Regulations of 2016 were a commendable step toward creating a standardized and consumer-friendly health insurance environment, addressing the identified challenges and criticisms was crucial. The regulatory framework could be refined by focusing on consumer education, streamlining claims processing, revisiting policy exclusions and waiting periods, and enhancing incentives for preventive healthcare. These improvements were essential for the effectiveness of the regulations and the overall well-being of the citizens relying on health insurance for their medical needs.


In the ever-evolving landscape of healthcare, the India Health Insurance Regulations of 2016 stand as a pivotal milestone in India’s journey toward a more equitable and accessible healthcare system. Through a comprehensive analysis, this research paper has delved deep into the intricacies of these regulations, shedding light on their objectives, provisions, challenges, and areas for improvement.

The Health Insurance Regulations 2016 represented a significant stride toward standardization, consumer protection, and transparency in the Indian health insurance sector. By introducing provisions for standardizing policies, regulating premiums, ensuring lifelong renewability, and encouraging portability, the regulations aimed to create a fairer environment for policyholders. These measures were essential steps toward universal healthcare coverage, ensuring that a broader population could avail of health insurance benefits.

However, as with any transformative policy, challenges and criticisms emerged. The complexities of implementation, criticisms related to exclusions and waiting periods, and the limited focus on preventive healthcare were areas that required attention. Addressing these challenges necessitates continuous efforts from regulatory bodies, insurance providers, and other stakeholders involved in the healthcare ecosystem.

Furthermore, this research paper provided a comparative analysis of the USA’s Affordable Care Act, highlighting each country’s contextual differences and unique approaches. While India’s regulations focused on standardization and consumer protection, the Affordable Care Act in the USA implemented a broader set of reforms, including the expansion of Medicaid and the introduction of state-based health insurance marketplaces.

In conclusion, the Health Insurance Regulations of 2016 in India have set the stage for a more inclusive and transparent health insurance sector. However, this is not the end but a crucial step in an ongoing journey toward comprehensive healthcare reform. Future endeavours must focus on refining the existing regulations, bridging gaps in implementation, enhancing consumer education, and embracing technological advancements to create a seamless, efficient, and affordable healthcare experience for every citizen. As India moves forward, the lessons learned from these regulations must serve as a foundation for further policy innovations, ensuring that the vision of accessible and high-quality healthcare for all becomes an enduring reality.

[1]Joseph Schumpeter, “Origins and Evolution of Employment-Based Health Benefits“, The NCBI, <https://www.ncbi.nlm.nih.gov/books/NBK235989/> as accessed on 15thSeptember, 2023.

[2]Jivraj Narayan Mehta, “Medical Services in India.” Journal of the Royal Society of Arts, vol. 113, no. 5112, 1965, pp. 995–1019. jstor, <http://www.jstor.org/stable/41369568.> as accessed on 15thSeptember 2023.

[3]Ayushman Bharat –Pradhan Mantri Jan AarogyaYojana (AB-PMJAY)”, THE Press Information Bureau – Government of India, <https://pib.gov.in/Pressreleaseshare.aspx> as accessed on 15thSeptember, 2023.

[4]“Insurance Regulatory & Development Authority“, The Department of Financial Services | Ministry of Finance<https://financialservices.gov.in/insurance-divisions/Insurance-Regulatory-&-Development-Authority> as accessed on 15thSeptember 2023.