CMS announced important changes to Medicare reimbursement for remote patient monitoring and telemedicine that can help accelerate adoption and use of these digital health tools. These changes are implemented through two rules released this week that will take effect January 1, 2018. Understanding these rules can help you incorporate these tools into clinical practice and can positively affect the business model for technology developers and innovators.

What are these new rules and do they affect me?

The 2018 Quality Payment Program Final Rule provides policy updates to the Quality Payment Program (QPP), which was established by the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) and will be entering its second year. MACRA offers two “tracks” for eligible clinicians to take as they move toward value-based care:

  • Participation in QPP and its scoring, or
  • Participation in an Advanced Alternative Payment Model (APM).

The majority of Medicare payments are still tied to fee-for-service, but HHS has set a goal of moving to 50 percent of Medicare payments for alternative payment models by 2018. For previous coverage of QPP proposals, visit our summary here.

The 2018 Physician Fee Schedule Final Rule addresses revised payment policies for the Medicare physician fee schedule. Any provisions in the PFS rule typically apply to fee-for-service type providers. Continue Reading New Reimbursement for Remote Patient Monitoring and Telemedicine

On November 2, 2016, the final rule with comment period (the “Final Rule”) implementing provisions of the Medicare Access and CHIP Reauthorization Act (MACRA) relating to the new Merit-Based Incentive Payment System (MIPS) and Alternative Payment Models (APMs) will be published in the Federal Register.  The Center for Medicare and Medicaid Services (CMS) also launched a new website with tools and updates to help MIPS-eligible clinicians learn and prepare for participation in MIPS and APMs.

As we describe in our client alert titled “CMS Releases Final Rules on MACRA Quality Payment Program Implementation for 2017-Onward,” the Final Rule makes several significant changes to the MIPS and APM tracks of the “Quality Payment Program” as they were proposed in the notice of proposed rulemaking.  We previously summarized the proposed rule in two previous alerts MACRA and MIPS: The Basics and Beyond and Medicare Quality Payment Program: Alternative Payment Models (APMs).  When compared to the proposed rule, the Final Rule increases flexibility for eligible clinicians or groups to participate in MIPS by creating several “choose-your-own-pace” options that would allow them to avoid negative payment adjustments.  The Final Rule also includes more value-based payment models that qualify as Advanced APMs.

Given the significant changes, the agency has published the Final Rule with a 60-day comment period for certain provisions that will end on December 19, 2016.

Barsky

Yesterday, our colleague Troy A. Barsky testified before the U.S. Senate Finance Committee led by Chairman Orrin Hatch (R-Utah) and provided recommendations for modernizing the Stark Law to regulate self-referrals without impeding the care coordination and value-based payment models promoted by health care reform legislation. Other witnesses before the Committee included Dr. Ronald A. Paulus, president and chief executive officer of Mission Health; and Peter Mancino, deputy general counsel of The Johns Hopkins Health System Corporation.

During his oral testimony, Barsky raised the following points and recommendations to the Senate Finance Committee:

  • That the Stark Law is affecting the health care industry because it has moved beyond the bounds of its original intent;
  • Because of the changing nature of the health care system, the Stark Law should be reformed to facilitate new alternative payment models; and
  • What Congress can do to reform the law while still protecting patients and the Medicare program, such as removing the compensation-based prohibitions in the Stark Law and granting the Centers of Medicare & Medicaid Services more authority to issue broad waivers for a wider variety of innovative health care and payment systems to limit the piecemeal waiver approach developing under the Affordable Care Act.

In addition, Barsky urged that reform of the Stark Law should focus on “[m]aking bright line rules that providers can follow and expanding CMS’s authority to provide guidance through advisory opinions will greatly assist provider.” Other options for reform also included implementing a lower penalty scheme for technical violations of the Stark Law, and lowering CMS’s heightened standard of “no program or patient abuse” for promulgating new regulatory exceptions to the general prohibition” against self-referrals.

The Committee members in attendance, representing both the Republican and Democratic Parties, largely responded positively to comments shared by all of the witnesses during the hearing and Chairman Hatch said that the Committee would move reform proposals forward in the remainder of the year.

Barsky’s full written testimony can be found here. His comments are also featured in Bloomberg BNA, Inside Health Policy, Law360, and MedTech Insight (subscriptions required).

On Tuesday July 12, 2016, the Senate Finance Committee (“Committee”) will hold a hearing on “Examining the Stark Law: Current Issues and Opportunities.” Crowell & Moring Partner Troy Barsky will be testifying before the Committee as a Stark Law subject matter authority.

In advance of this hearing, the Committee released last week the white paper “Why Stark, Why Now? Suggestions to Improve the Stark Law to Encourage Innovative Payment Models.”  Amid growing support for Stark law reform, the white paper deems the Stark law, as currently drafted, both an impediment to implementing health care reform, e.g., the Medicare Access and CHIP Reauthorization Act of 2015 (“MACRA”), and of limited value given shifts from fee-for-service to alternative payment models that reward quality health care rather than the volume of services.

The white paper focuses predominantly on modifications to the Stark law that would remove obstacles to implementing health care reform. After a roundtable held in December, 2015, that was co-moderated by Troy Barsky, the Committee had solicited and received a range of stakeholder comments that proposed various Stark law reform solutions: repeal the law in its entirety; repeal the compensation arrangement prohibitions; implement new exceptions and modify existing exceptions; implement new or expand existing waivers; and expand CMS’s regulatory authority pertaining to waivers, exceptions, and advisory opinions. These comments are catalogued and discussed throughout the white paper. The white paper also examined the need to distinguish between technical, e.g. documentation requirements, and substantive violations of the Stark law.  Commenters generally agreed that a separate set of sanctions should apply to technical violations and that such violations should not give rise to False Claims Act exposure.

Continue Reading In Advance of Senate Finance Committee Hearing on Stark Law Next Week, the Committee Releases Stark Law White Paper

Earlier this month, the Office of the National Coordinator for Health Information Technology (ONC) released a report to Congress on the feasibility of creating tools to help providers compare and select certified health IT products. As part of the Medicare Access and CHIP Reauthorization Act (MACRA), Congress required ONC to conduct a study to examine the feasibility of establishing mechanisms to assist providers in comparing and selecting certified EHR technology products. Congress suggested that ONC consider mechanisms like establishing a website of aggregated survey results that would allow meaningful EHR users to directly compare the functionality of certified health IT products. Congress also suggested compiling information from vendors of certified health IT products, and making that information publicly available in a standardized format.

In response to its Congressional directive, and drawing upon recommendations from the Certified Technology Comparison (CTC) Task Force, public input, and its own market analysis, ONC’s report focused on two subgroups of the health care community – providers and comparison tool developers – and identified specific problem areas in the comparison tool marketplace. Ultimately, the report proposed four mechanisms to improve the health IT comparison marketplace:

Continue Reading The Rise of the One-Stop Shop? ONC Outlines Four Mechanisms to Help Providers Compare Certified Health IT Products

Congress set its sights on achieving the widespread exchange of health information through interoperable-certified electronic health records (“EHR”) by declaring it a national objective in the Medicare Access and CHIP Reauthorization Act of 2015 (“MACRA”). To accomplish this goal, MACRA directs the Department of Health and Human Services (“HHS”) to establish metrics in consultation with the health information technology (“health IT”) community. The Office of the National Coordinator for Health IT (“ONC”), the division of HHS responsible for advancing connectivity and interoperability of health IT, has issued a request for information (“RFI”) seeking input on how to measure “interoperability.” Interoperability refers to the ability of systems to exchange and use electronic health information from other systems.

The RFI presents an opportunity for stakeholders and the public to weigh in on how policy makers understand interoperability. Congress and HHS likely will make both policy and funding decisions based on the goals and measurements that are established in response to feedback received through the RFI. Specifically, ONC seeks advice regarding the following:

  1. What populations and elements of information flow should HHS measure?
  2. How can HHS use current data sources and associated metrics to address the MACRA requirements?
  3. What other data sources and metrics should HHS consider to measure interoperability more broadly?

The public comment period closes on June 3, 2016. Take a look at the RFI here for more specific questions.

Last week, Democrats and Republicans from both chambers introduced the Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act (S. 2484, H.R. 4442), which would improve health care quality and realize cost savings by eliminating current restrictions on telehealth and remote patient monitoring. Click here to read our detailed analysis of the CONNECT for Health Act.