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MACRA’s Advancement of EHR Interoperability and Telehealth

This is the fourth and final post in our series on the Medicare Access and CHIP Reauthorization Act (MACRA). Pub.L. No. 114-10.  In this post, we’ll be looking at other important provisions contained in MACRA, including the extension of CHIP funding through fiscal year 2017 and the advancement of interoperability in electronic health record (EHR) systems.

Section 106(a): Medicare Opt-Out and Private Contracts

Since 1998, Medicare has permitted physicians and certain other providers to enter into private contracts with Medicare beneficiaries under Part B and to bill for services without being limited by the upper payment limits established by Medicare. When providers make this “opt-out” decision, they also must agree to decline any reimbursement from Medicare for all Medicare beneficiaries for two years, except in cases of emergency or urgent care provided to a Medicare beneficiary with whom the provider does not have a private contract. MACRA allows private contracts between providers and Medicare beneficiaries to be automatically extended unless the provider furnishes the beneficiary with notice that the contract will not be extended 30 days prior to the expiration of the contract. Additionally, MACRA requires the Department of Health and Human Services (HHS) to make publicly available information regarding opt-out physicians. The information about opt-out physicians will include the number and specialties of opt-out physicians, as well as the proportion of opt-out providers billing for emergency or urgent care. HHS must post this information on its website and update it on an annual basis.

Section 106(b): EHR Interoperability

The Health Information Technology for Economic and Clinical Health Act of 2009 authorized Medicare and Medicaid to provide incentive payments to eligible hospitals and physicians who attest to “meaningfully using” certified EHR technology.  Although the ostensible purpose of the Meaningful Use Program was to encourage physicians and hospitals to adopt EHR technology, the program also was used to drive a variety of quality delivery changes for these providers. While the incentives have accomplished the limited goal of expanding the use of EHR, the benefits have been limited due to ongoing problems with interoperability among EHR systems. (“Interoperability” refers to the capability of EHR systems to be able to use the information exchanged among systems based on common standards.)  MACRA requires HHS to establish metrics by July 1, 2016, for measuring how hospitals and providers progress in moving toward the goal of widespread interoperability of EHR systems. HHS will have to submit a report to Congress if this goal has not been met by December 31, 2018.  In this report, HHS would be required to make recommendations for achieving this goal, such as adjusting payments and de-certifying certain EHR technology. MACRA also requires the Meaningful Use Program to require attestations by eligible hospitals and physicians that they have “not knowingly and willfully taken action (such as to disable functionality) to limit or restrict the compatibility or interoperability of the certified EHR technology.”  This is a standard in the Stark Law EHR exception and Anti-Kickback EHR safe harbor.  Finally, HHS is also required to submit a report to Congress (within one year from the date of enactment of MACRA) on methods to aid providers in comparing and selecting certified EHR technology.

Section 106(c): Telehealth

Medicare currently reimburses physicians for certain services provided at certain sites through live video conferencing for eligible Medicare beneficiaries. 42 U.S.C. § 1395m(m). MACRA requires the Government Accountability Office (GAO) to draft two reports to be submitted to Congress within two years of MACRA’s enactment; the first report will pertain to the Medicare telehealth program, and the second will focus on remote patient monitoring technology and services.  The first report on the Medicare telehealth program will evaluate circumstances that help or inhibit the use of telehealth under Medicare and the possible effects of an expansion of telehealth on payment and delivery systems under Medicare and Medicaid.  The second report will examine incentives for adopting patient monitoring technology and services by private health insurance, as well as barriers for adopting this technology by Medicare. This report will also look at which patients and circumstances may receive the greatest benefit from this technology.   Many health care practitioners believe that the time for government studies of telehealth has long passed and legislative action is needed now to expand beneficiary access, particularly in rural areas.

Title III (Sections 301 to 305): CHIP Reauthorization

Federal funding for the State Children’s Health Insurance Program (CHIP) was provided through fiscal year 2015 under the Affordable Care Act. CHIP provides health benefits to uninsured children up to age 19 whose families have incomes too high to qualify for Medicaid. Similar to Medicaid, the federal government provides funding to states for the program but allows flexibility in how each state structures the program. MACRA extends federal CHIP funding for two years by appropriating $19.30 billion for the program for fiscal year 2016 and $20.40 billion for fiscal year 2017. In fiscal year 2017, the funding will be structured as it is for fiscal year 2015, where funding is broken into semiannual appropriations of $2.85 billion and a one-time appropriation of $14.70 billion. MACRA also extends certain provisions related to CHIP funding through fiscal year 2017 (unless otherwise noted below), including:

  • The qualifying state option, which allows states that significantly expanded Medicaid eligibility to children before the enactment of CHIP in 1997 to use their CHIP funding to pay for the difference between Medicaid and CHIP matching rates;

  • The Child Enrollment Contingency Fund, which provides states with payments beyond their CHIP allotment if CHIP enrollment exceeds a state-specific target amount;

  • “Express Lane” eligibility (ELE), which allows states to rely on a finding from certain agencies for ELE determinations (through September 30, 2017);

  • Outreach and enrollment grants; and

  • The childhood obesity demonstration project and the pediatric quality measures program.

With the extension of ELE determinations, MACRA also requires HHS’s Office of the Inspector General to submit a report to the House Energy and Commerce Committee and the Senate Finance Committee regarding the number of individuals enrolled through ELE, whether these individuals meet Medicaid and CHIP eligibility requirements, and the difference in federal and state expenditures for those who meet the Medicaid and CHIP eligibility requirements and those who do not.

Section 511: Application of the Common Rule to Clinical Data Registries

The Physician Quality Reporting System (PQRS) is a reporting program established by the Centers for Medicare and Medicaid Services (CMS), which provides incentive payments and negative payment adjustments to encourage eligible professionals (EPs) to report certain quality data to CMS. In 2012, the American Taxpayer Relief Act required HHS to consider EPs who participate in a “qualified clinical data registry” as satisfying the PQRS reporting requirements for 2014 and beyond. HHS also has regulations regarding the protection of human subjects in federally-funded research projects, known as the “Common Rule.”  45 C.F.R. 46, Subpart A. The Common Rule is implicated when human subjects are physically involved in research, such as in a clinical trial, or when their identifiable health information is used for research purposes.  Qualified clinical data registries are intended to support health care quality improvement initiatives; however these initiatives can be difficult to distinguish from research activities, intended to create “generalizable knowledge” and thus implicating the Common Rule.  MACRA requires HHS to promulgate a clarifying or modifying rule regarding whether the Common Rule applies to activities involve clinical data registries.

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About this Author

Dianne Borque, Health Care, licensure, risk management, attorney, Mintz
Of Counsel

Dianne advises a variety of health care clients on a broad range of issues, including licensure, regulatory, contractual, and risk management matters, and patient care. As former in-house counsel to an academic medical center, a large part of her practice involves counseling researchers and research sponsors in matters related to FDA and OHRP regulated clinical research, including patient consent, access to and use of tissue and associated patient information, and the Institutional Review Board process. In addition, Dianne currently serves as a Vice Chair of AHLA's...

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Thomas Crane, Health Care Attorney, Mintz Levin, Anti-Kickback Lawyer, FLSA,Health Care Compliance, Fraud & Abuse, and Regulatory Counseling Medicare, Medicaid & Commercial Coverage & Reimbursement Health Care Enforcement & Investigations White Collar Defense & Government Investigations

Tom is nationally recognized for his work defending health care clients against anti-kickback, Stark Law, false claims, and whistleblower allegations. His work includes litigation, internal investigations, corporate integrity agreements, and self-disclosures. Tom also counsels clients on the legal, practical, and fraud and abuse implications of business arrangements and sales and marketing practices. Additionally, Tom has worked with several academic medical center clients in restructuring arrangements among medical school, teaching hospital, and faculty physicians. Tom gained national recognition for his work on the anti-kickback statute during his tenure at the HHS Office of Inspector General, where he prosecuted the Hanlester Network case and was the principal author of the 1991 safe harbor regulations. He is an elected Fellow of the American Health Lawyers Association.

Tom is nationally recognized for his experience with fraud and abuse. Practicing in Boston and Washington, DC, he advises national and local clients on structuring complex strategic affiliation arrangements and transactions to comply with the applicable fraud and abuse laws as well as the variety of other regulatory requirements to meet today’s health reform challenges. His work in defending clients against anti-kickback, Stark Law, false claims, and whistleblower allegations includes litigation, internal investigations, self-disclosures, and negotiating settlements and Corporate Integrity Agreements (CIAs).

He has appeared before numerous US attorneys’ offices, the FBI, and the Office of Inspector General (OIG) and Centers for Medicare & Medicaid Services (CMS) around the country and in Washington. In addition, he has served as an expert witness and consulting expert in health care fraud cases.

In addition to his fraud and abuse defense work, Tom advises clients on the legal, practical, and fraud and abuse implications of business arrangements and sales and marketing practices. This part of his practice focuses on Medicare and Medicaid fraud and abuse compliance and reimbursement issues and related laws, including the federal Physician Payments Sunshine Act, ‘meaningful use’ of EHR technology, under arrangement and provider-based rules, and OIG issues.

Tom has implemented and audited comprehensive corporate compliance programs for clients in various health care sectors.

His clients have included hospital systems and executives, medical device and pharmaceutical manufacturers, pharmacies and pharmacy benefit management companies, physicians and groups, renal dialysis providers, supply companies, home care providers as well as national and state trade groups.

He became nationally known for his work on the anti-kickback statute during his tenure at the Office of Inspector General at the Department of Health and Human Services in Washington, DC. In particular, Tom gained recognition as a prosecutor in the Hanlester Network joint venture case and as the principal author of the 1991 safe harbor regulations.

Ellen L. Janos, Health care attorney, mintz levin law firm,Digital Health PBMs & Pharmacies Hospitals & Health Systems Post-Acute & Long-Term Care Retail & Urgent Care Physician Organizations

Ellen utilizes her in-depth knowledge of health care regulation to assist clients with government audits and investigations, M&A and financing transactions, and corporate compliance activities. She also provides strategic advice to traditional health care providers, investors, and start-ups on telehealth initiatives as well as the traditional practice of medicine across multiple states. Ellen often comments on developments in telehealth, HIPAA, and the corporate practice of medicine. As an assistant attorney general for the Commonwealth of Massachusetts, Ellen represented state...