ONC seeks comment on Trusted Exchange Framework aimed at facilitating greater interoperability of health information

On January 5, 2018, the Department of Health and Human Services’ Office of the National Coordinator for Health Information Technology (ONC) released a draft Trusted Exchange Framework and Common Agreement (TEFCA), outlining a common set of principles for trusted exchange of health data and interoperability between health information networks (HINs) and proposing a Common Agreement aimed at operationalizing the principles for data exchange in an effort to drive interoperability. ONC released the draft framework in compliance with provisions of the 21st Century Cures Act, which was enacted in December 2016.

The draft framework is part of an effort “to scale interoperability nationwide by providing a single ‘on-ramp’ to allow all types of healthcare stakeholders to join any health information network they choose and be able to participate in nationwide exchange, regardless of what health IT developer they use, health information exchange or network they contract with, or where the patients’ records are located.”

Comments on the draft framework are due to ONC by February 20, 2018. ONC will post comments on its website. ONC will consider comments on the draft framework as it develops a final TEFCA product, which will be posted on the ONC website and published in the Federal Register.

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Open enrollment period for ACA Exchanges begins under President Trump for first time amid ongoing debate over cost-sharing reduction subsidies, ACA waivers

The open enrollment period for coverage for 2018 through the health insurance Exchanges created under the Affordable Care Act (ACA) begins today, Wednesday, November 1, 2017. This is the fifth open enrollment period since the Exchanges opened in 2014 and the first open enrollment period of President Trump’s Administration. The open enrollment period for the 39 states using the HealthCare.gov platform for plan year 2018 will close December 15, 2017; the open enrollment period in previous years ran through January 31 of the plan year. A number of states running their own Exchanges for plan year 2018 will have longer open enrollment periods than states using the HealthCare.gov platform.

This year’s open enrollment period begins after nine months of debate in Congress over various proposals to repeal and replace select provisions of the ACA, President Trump’s October 12, 2017, decision to stop reimbursing health plans for cost-sharing reduction (CSR) subsidies without congressional authorization, and a number of other regulatory decisions reflecting the Trump Administration’s position on the ACA.

Highlights of the current status of select issues related to the ACA Exchanges are provided below.

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HRSA Withdraws 340B “Mega-Reg”

HRSA Withdraws 340B Mega-Reg

On November 13, 2014, the Department of Health and Human Services (HHS) announced that it is withdrawing the highly-anticipated and comprehensive 340B drug pricing program (340B program) regulation (also known as the “mega-reg”) and will replace it with program guidance issued early next year through the Health Resources and Services Administration (HRSA). The “mega-reg” was designed to address key topics not fully defined in the original legislation. It was drafted earlier this year and given to the White House Office of Management and Budget in April; however, it stagnated amidst controversy and legal proceedings surrounding the HRSA-proposed orphan drug policy issued in 2013. The withdrawal of the “mega-reg” now leaves more questions than answers for covered entities as we enter into what will likely be a formative year for the 340B program.

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