Key Takeaway: As healthcare takes center stage in the 115th Congress, the House Republican Study Committee released their plan to repeal and replace the Affordable Care Act (ACA) last week.
Why It Matters: Among top priorities for both the incoming President and Republican Congress leadership is to repeal and replace the Affordable Care Act.
Many repeal and replace proposals have been floating around Congress since the passage of the ACA, including that from House Speaker Paul Ryan, who unveiled the “Better Way” proposal in 2016.
On January 4, 2017, the House Republican Study Committee, led by Mark Walker (R-NC) released the American Health Reform Act (AHRA) would fully repeal the ACA. The RSC plan varies from the plan released by Speaker Paul Ryan (R-WI), the so-called “Better Way” proposal uses tax credits while the AHRA would convert tax deductions into an above-the-line standard deduction for health insurance. Individuals with qualifying plans will receive a $7,500 deduction while families would receive a $20,500 deduction under AHRA.
There is currently no timeline for the replacement portion of the legislation.
Cyber & HIPAA Update
FDA News
Key Takeaway: FDA announced final cybersecurity guidance for manufacturers.
Why it Matters: Around this time last year the FDA released draft guidance detailing the steps they expect (but do not mandate) manufacturers should take in securing medical devices. CHIME and AEHIS responded by submitting comments. The FDA released the final guidance on December 28th, 2016. The guidance in many cases remains similar to the draft guidance, however, they do appear to place a stronger emphasis on patient safety and calling for manufacturers to adhere to stipulations for “uncontrolled risks”, that is, risks that pose significant issues to patient safety. The FDA however, rejected the notion that privacy issues can be a contributing factor to patient safety for the purposes of this guidance. They also added a new section focusing on ISAOs. CHIME has put together a chart detailing what FDA expects of manufacturers when it comes to securing devices which you can find here.
Bipartisan House Internet of Things (IoT) Working Group
Key Takeaway: The bipartisan House Internet of Things (IoT) Working Group released a year-end paper that included coverage of how healthcare is impacted by the rapid shift to IoT.
Why It Matters: Congress held a number of hearings and roundtables in 2016 outlining the challenges and opportunities posed by the IoT, including a hearing held by the House Committee on Energy and Commerce for which CHIME submitted comments.
The Working Group was led by Representatives Bob Latta (R-OH) and Peter Welch (D-VT), formed with the intention of educating members of Congress about the many opportunity and challenges posed by the internet of things. The working group held a healthcare-focused roundtable that included conversation on interoperability challenges that are impeding improved patient care. The roundtable also featured concerns about privacy and security, and the complexity of data security in IoT world. The working group’s paper notes that among the recommendations discussed at the healthcare roundtable was that the industry should seek to limit vulnerabilities by developing software and devices with security in-mind rather than solely based on functionality.
FTC News
Key Takeaway: The Federal Trade Commission (FTC) takes action involving medical devices.
Why it Matters: U.S.-based global healthcare company Abbott Laboratories has agreed to divest two medical device businesses to settle FTC charges that its proposed $25 billion acquisition of St. Jude Medical, Inc. would likely be anticompetitive. The FTC’s complaint alleges that without a remedy, the proposed acquisition would harm competition in the U.S. markets for vascular closure devices, which are used to close holes in arteries from the insertion of catheters, and for “steerable” sheaths, which are used to guide catheters for treating heart arrhythmias. FTC asserts their action preserves competition in U.S. markets for medical devices used in cardiac and vascular The Commission vote to issue the complaint and accept the proposed consent order for public comment was 3-0. The FTC will publish the consent agreement package in the Federal Register shortly. The agreement will be subject to public comment for 30 days, beginning today and continuing through January 26, 2017, after which the Commission will decide whether to make the proposed consent order final. Comments can be filed electronically or in paper form by following the instructions in the “Supplementary Information” section of the Federal Register notice.
OCR News
Key Takeaway: The Office for Civil Rights (OCR) issues new fact sheet on permitted disclosures involving public health.
Why it Matters: OCR in conjunction with the Office of the National Coordinator for Health Information Technology (ONC) have released a new Fact Sheet that explains how the HIPAA Rules permit disclosures of Protected Health Information (PHI) to support public health activities conducted by public health agencies, as authorized by state or federal law. It also gives a few helpful examples of sharing PHI in support of other important public health policies.
MIPS Update
Key Takeaway: CMS announces details on a Clinical Practice Improvement Activity (CPIA).
Why it Matters: The Centers for Medicare & Medicaid Services (CMS) is conducting a Clinical Practice Improvement Activities (CPIA) Study, as outlined in the MACRA final rule. Applications for this study will be accepted from January 1 - 31, 2017. Clinicians and groups who are eligible for the Merit-based Incentive Payment System (MIPS) that participate successfully in the study will receive full credit for the Improvement Activities performance category. Study participants will have to meet the following requirements between January and December 2017: Complete at least three survey questionnaires throughout the course of the study, participate in at least three focus groups, and submit at least three clinician quality performance measures to CMS. For more information and to apply to participate in the study, please visit the CMS website. Completed applications should be submitted to [email protected] by January 31.
Meaningful Use Update
Key Takeaway: The CMS attestation portal is now open!
Why it Matters: The EHR Incentive Programs attestation system will be open from January 3 - February 28, 2017. Providers must attest by the attestation deadline to avoid a penalty in 2018. CMS has released two attestation worksheets for eligible professionals and eligible hospitals and critical access hospitals. Providers can log their meaningful use measures for each objective in the worksheet and use it as a reference when attesting for the 2016 Medicare EHR Incentive Program in CMS’ Registration and Attestation System.
Interoperability Update
Key Takeaway: Busy, busy the government has been over the holidays releasing several new items.
Why it Matters: Here is a summary of what was released over the holidays
The ONC Health IT Playbook: The most prominent change is the inclusion of ONC’s workforce webinars which you can view under the Transformation Support Section. The tool serves as a one-stop shop for folks looking for a variety of health IT resources.
The Shared Nationwide Interoperability Roadmap: A Year in Review. This interactive presentation highlights the work ONC accomplished in the past year to support the goals and objectives of the Roadmap.
The 2017 Interoperability Standards Advisory (ISA). The ISA updates the draft version released in August 2016 and is a coordinated catalog of standards and implementation specifications that are available for use by the health IT industry to meet interoperability needs.
