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Emerging Healthcare Laws – 21st Century Cures Act


The pace of healthcare landscape in the U.S. is rapidly changing with new researches and digital health innovations. On December 13, 2016, a new federal healthcare law was signed by President Obama called the 21st Century Cures Act, which has direct impact on healthcare IT, regulatory bodies like FDA/NIH/HSS, clinical researchers, healthcare providers, drug & medical device manufacturers, pharmacies, and others.

There is an ongoing speculation that few sections of the law are vague in details, thereby lacking clarity. However, several federal agencies like ONC, HHS, CMS and FDA are working on various initiatives set forth by the act to:

  • Promote & fund the acceleration of research into preventing and curing serious illnesses
  • Accelerate drug & medical device development and FDA approval process
  • Attempt to address opioid abuse crisis
  • Improve mental health service delivery
  • Adoption of electronic health records and nationwide interoperability
  • Support human service programs

Healthcare IT vendors, regulatory bodies and research institutes are closely analyzing various sections of the Cures Act to identify mandatory regulations, timelines and underlying business opportunities. To comply with the law, companies are required to either improve existing business processes, innovate new digital tools or unlock the potential areas which were never considered before. Let’s look at the implications of Cures Act on several healthcare sectors like drug manufacturers, insurers, providers and healthcare IT vendors.

Drug Approval

The FDA drug approval process for certain diseases like cancer takes nearly 10 years or more to bring the drug to market. Some of the key provisions of Cures Act talks about modernizing the clinical trials process to speed up FDA review and drug approval. With initiation of patient-focused drug development, FDA will consider and review additional sources of data collected as real-world evidence on patient’s drug usage and clinical outcomes. FDA and clinical trial programs must leverage innovative digital tools using big data, risk analytics and others to collect, track and analyze outcomes of data and generate drug/disease specific KPIs/KRIs.

Also, the act initiates Precision Medicine Initiative for a personalized approach to treat certain diseases rather than ‘one therapy fits all’.

Specialty drug management: Prescription insurance sponsors and PBMs will be able to select specialty drugs for coverage/reimbursements that are limited to FDA-approved indications. Other factors considered are reduced dosage warnings, clinical trials/expanded access, patient outcomes’ data, etc. Certain drugs may not necessarily have to meet the NDA requirements. The formulary committee should gather necessary information for such drugs from the results of clinical trials and related researches. Technologies such as big data, analytics and artificial intelligence prove useful to analyze data relevant to drugs & diseases, claims and medication adherence to arrive at accurate, formulary coverage decisions, without compromising on cost and quality.

Manage opioid crisis: Further, the Comprehensive Addiction and Recovery Act (CARA) signed in July 2016, requires PBMs to include prescription drug monitoring programs and expand access to opioid treatment program to deal with addiction and mental health issues.

Home healthcare & personal care services

To avoid fraud, waste and abuse of home healthcare services in Medicaid, agencies should implement EVV (Electronic Visit Verification) by January 1, 2019. The system should be capable of tracking caregiver visits, timeliness, authorizations, date of service, locations and other details. The act mandates the states to create a centralized database for caregivers to verify their identities. It’s important for hospitals and home healthcare agencies to use technology platforms for care coordination and patient engagement to collect real time data and report the data to hospitals for efficacy. In case of hospital readmissions of Medicare beneficiaries – adherence to the care & support plans, completing scheduled visits, total number of hours delivered, billing, and other related metrics are to be presented by the providers. These metrics determine cost of care for hospitals, subsequently depicting the profit margin.

Impact on digital health

Cures Act focuses more on the usage of EHR and interoperability of health data using APIs, FHIR and others. Also, it aims at bringing a standard Trusted Exchange framework to ensure secure data exchange among trusted entities at the federal level. To facilitate information sharing among healthcare entities, Cures Act includes penalties for information blocking. This requires companies to move away from less proprietary information storage and adopt higher standards for data storage and transmission.

Overall, the Cures Act is a game changer in today’s healthcare ecosystem across the U.S. It focuses on improving existing healthcare business models & leveraging new digital platforms to provide enhanced options, access and quality of healthcare services.



AUTHOR: Krupa TP
She works as a Senior Business Analyst in the US Healthcare and Insurance domain.