CMS has finalized the adoption of multiple CPT codes in the CY 2019 PFS that create more opportunities for providers and digital health companies to collaborate on chronic care management business models in the fee-for-service market.

Virtual Check-Ins

CMS finalized the creation of a new code to reimburse providers for brief “check-in” services conducted using communications technology by creating HCPCS code G2012, defined as “[b]rief communication technology-based service, e.g. virtual check-in.” Continue Reading Digital Health Updates in the 2019 Physician Fee Schedule (PFS) Rule

CMS has issued its 2019 Physician Fee Schedule Proposed Rule, containing highly anticipated new reimbursement policies for telehealth, remote monitoring, and other uses of digital tools, as well as updates to health IT requirements in the Quality Payment Program, with a stronger focus on patient access to health information. Comments are due September 10 at 5pm.

Continue Reading New CMS Incentives for Remote Patient Monitoring and Patient Access

Next week, on June 21, 2018, attorneys from Crowell & Moring will hold a bootcamp entitled “Early Stage Investing in Health Technology.” Crowell & Moring attorneys will present on topics of interest to entrepreneurs, investors, and early stage health technology companies. Attendees will have the opportunity to learn about a range of matters including formation of a start-up, protection of intellectual property, FDA and product safety requirements, and how to commercialize a product through government and commercial reimbursement. Specifically, the bootcamp will feature the following presentations:

  • Building an Investible Health Tech Company;
  • IP Basics for Health Tech;
  • Navigating The Existing Regulatory and Product Safety Landscape In A New Digital World;
  • Healthcare Reimbursement:  Commercialization Strategies and Approaches; and
  • Adding Value: Managed Care Contracting Issues.

The bootcamp is a co-sponsored event with the Inova Center for Personalized Health (“ICPH”). Following the bootcamp, there will be a networking reception and panel presentation on the State of Heathcare Investing. For more information, contact a participant listed below or your regular Crowell & Moring contact.

Crowell & Moring Participants:

A. Xavier Baker

Troy A. Barsky

Lex Eley

Michael H. Jacobs

Lisa A. Adelson

Rebecca Baden Chaney

Joe Records

Roma Sharma

Maya Uppaluru

Chalana N. Williams

Danielle Winston

 

On March 6, 2018 at the Healthcare Information and Management Systems Society (HIMSS) 2018 conference, Centers for Medicare & Medicaid Services (CMS) Administrator Seema Verma announced a new initiative furthering the current Administration’s focus on value-based care and increasing patient access to healthcare data. The initiative — called MyHealthEData — will be led by the White House Office of American Innovation, in collaboration with the Department of Health and Human Services (HHS), CMS, the Office of the National Coordinator for Health Information Technology (ONC), the National Institutes of Health (NIH), and the Department of Veterans Affairs (VA). (CMS press release here.) Continue Reading Liberating Data to Transform Value-Based Care: MyHealthEData, Blue Button 2.0, and Price Transparency

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

The Department of Health and Human Services, Office of the Inspector General (OIG), modified its Work Plan to announce that the agency will be conducting a nationwide audit of hospitals that participated in the Medicare Electronic Health Records (EHR) Incentive Program (also known as the Meaningful Use Program).  The OIG review is focusing on hospitals that received Medicare EHR incentive payments between January 1, 2011 and December 31, 2016.

The OIG’s modification to its Work Plan follows last month’s report that CMS improperly paid an estimated $729 million in Medicare EHR incentives. In our prior client alert, we flagged these findings as a potential area for significant overpayment recovery actions and noted that such actions could pose risks for incentive payment recipients. Read our entire client alert on the OIG’s nationwide audit on hospitals that participated in the EHR Incentive Program Here.

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.

The Office of the Inspector General of the Department of Health and Human Services (OIG) last week replaced a 20-year old policy statement, and issued guidance on the criteria the agency will use to evaluate whether to exclude certain individuals and entities from billing or “participation in” Federal health programs under its permissive exclusion authority. The new guidelines supersede and replace the OIG’s December 24, 1997 policy statement and set forth “non-binding” criteria that the OIG may consider in exercising this authority under circumstances involving fraud, kickbacks and other prohibited conduct. The newly-memorialized policy is yet another effort by the agency to encourage healthcare providers to implement robust compliance mechanisms that can timely identify and voluntarily self-disclose to the government any unlawful conduct.

Under Sections 1128(b)(1)-(b)(15) of the Social Security Act (the “Act”), the Secretary, by delegation to the OIG, has discretion to exclude individuals and entities based on a number of grounds. This so-called “permissive exclusion” authority grants significant discretion to the OIG.  The new policy provides guidelines for permissive exclusions that are based on Section 1128(b)(7) of the Act, which permits the OIG to exclude persons from participation in any Federal health care program if the OIG determines that the individual or the entity has engages in fraud, kickbacks and other prohibited activities.

Continue Reading OIG Updates Policy on Permissive Exclusions Based On Fraud and Kickbacks

This month, the Centers for Medicare & Medicaid Services (CMS) announced the beginning of the second application cycle for its Next Generation ACO Model (Next Gen Model).  We discussed the goals of the Next Gen Model and how it compares to the Medicare Shared Savings Program and Pioneer ACO models in this post from last year.

The Next Gen Model, along with other value-based payment initiatives being run by CMS, advances the goals of the Affordable Care Act by moving providers away from fee-for-service reimbursement models. Since CMS began implementing its ACO-based initiatives in 2012, over 477 ACOs nationwide have partnered with the agency to test the theory that coordinated care provide higher quality at a lower cost for beneficiaries.

Twenty-one ACOs are currently participating in the Next Gen Model – more than the 15-20 CMS anticipated accepting. Like last year, the Centers for Medicare & Medicaid Innovation (“CMMI”) is holding a series of Open Door Forums to explain key aspects of the Next Gen Model on the following dates:

ACOs (including MSSP participants and Pioneer ACOs) have until May 2, 2015 to submit a Letter of Intent (LOI) using CMS’s designated portal.  Applicants must electronically complete the narrative portion of the Next Gen Model application by May 25, 2016 and submit their participating provider lists and geographic service areas no later than June 3, 2016.

This will be the final year for ACOs to participate in the Next Gen Model. It is hard to predict what will happen to the Medicare payment reforms tested in the Next Gen Model and other ACA-related programs as the United States enters into a new administration after the 2016 elections, but CMS is currently staying the course to reduce health care costs while improving quality.

On January 28, 2016, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule that would change the methodology used to evaluate and adjust the performance of Medicare Shared Savings Program (MSSP) Accountable Care Organizations (ACOs). The proposed rule is intended to improve long-term incentives for ACOs and create a path for long-term sustainability.

ACO performance is currently measured using a multi-step process that evaluates an ACO’s effectiveness in lowering expenditures for a group of assigned beneficiaries against a benchmark established based on an ACO’s historical costs. At the beginning of the ACO’s three-year agreement period, CMS sets an average per capita historical benchmark. CMS adjusts the historical benchmark on an annual basis based on projected growth in national per capita expenditures for Medicare Parts A and B services under the fee-for-service (FFS) program.

Continue Reading CMS Proposes New ACO Performance Measures