Centers for Medicare and Medicaid Services ("CMS")

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On January 13, 2021, Brad Smith, the current (and fourth) director of the Center for Medicare and Medicaid Innovation (the “Center”), published an article[1] in the New England Journal of Medicine in which he evaluates the Center’s performance over its decade-long history against the Center’s stated goals – to decrease health care spending and improve health care quality.  Smith describes an underwhelming showing from the Center and puts forward several key lessons from the Center’s past performance as a way to inform and improve future performance.…
Continue Reading Evaluation of Innovation Center Models

Over the last year, we have seen volatility in the healthcare industry overall, and Medicare Advantage (“MA”) and Medicare Part D plans (together, “Plans”) have not been immune. Particularly because of their risk adjustment payment models, and metrics by which they are measured, it was unclear how the Centers for Medicare and Medicaid Services (“CMS”) would respond.…
Continue Reading CMS to the Rescue for MA and Part D Plans – Rate Announcement Includes Significant Increase in Plan Payments for 2022

As part of the “CY 2021 Medicare Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment System Final Rule” (the “Final Rule”) published on December 2, 2020, the Centers for Medicare and Medicaid Services (“CMS”) finalized policies designed to overhaul the methodology used to calculate the Overall Hospital Quality Star Rating effective 2021.…
Continue Reading New Criteria Established for the Overall Hospital Quality Star Rating

On December 3, 2020, Centers for Medicare & Medicaid Services (“CMS”) announced key details concerning a new value-based reimbursement and patient care model – the Geographic Direct Contracting Model (the “Model” or “Geo”). Geo is a geographic-based approach to value-based Medicare reimbursement and patient care that focuses on improving health outcomes and decreasing the cost of care across an entire geographic region. Direct contracting entities (“DCEs”) participating in the Model will be taking responsibility for the total cost of care of Medicare fee-for-service beneficiaries in their region.  Accountable care organizations (ACOs), health systems, health care provider groups, health plans, and other potential applicants will be permitted to participate in the Model as DCEs.  The Model intends to encourage care coordination across a physical, geographic area and to deliver care that considers a region’s particular local needs.[1]…
Continue Reading CMS Announces New Geographic Direct Contracting Model: Letters of Interest Due by December 21, 2020

The Physician Payment Sunshine Act (the “Sunshine Act”) – a federal law first adopted as Section 6002 of the Patient Protection and Affordable Care Act of 2010 (“PPACA”) – requires the Centers for Medicare and Medicaid Services (“CMS”) to collect and display information reported by applicable manufacturers and group purchasing organizations about the payments and other transfers of value these organizations have made to physicians and teaching hospitals. Currently, CMS fulfills its Sunshine Act obligations to collect and report data to the public through the “Open Payments” program.…
Continue Reading On Your Mark, Get Set, Go: Life Science Companies Face A Challenging Year For Compliance With New Open Payment Program Data Collection And Reporting Requirements

As highlighted in a May 2020 Milbank Memorial Fund white paper titled, “How Payment Reform Could Enable Primary Care to Respond to COVID-19,” the COVID-19 public health emergency has driven transformation in the provision of primary care services across the country.  Whether it’s the use of telehealth technology to facilitate “virtual visits” or the development of new treatment protocols to identify and treat patients who need behavioral health support to manage the emotional challenges endemic to the public health emergency, changes in primary care delivery have drawn increased attention to the need for concomitant changes in the way primary care is financed.…
Continue Reading Primary Care First: CMS’s New Value-Based Approach to Primary Care

On September 14, 2020, the Centers for Medicare & Medicaid Services (“CMS”) issued the Advance Notice of Methodological Changes for Calendar Year (CY) 2022 for Medicare Advantage (MA) Capitation Rates and Part C and Part D Payment Policies – Part I, CMS-HCC Risk Adjustment Model (the “Advance Notice”).  CMS is issuing the Advance Notice in two parts: Part I includes key information about the Medicare Advantage CMS-Hierarchical Condition Categories (“HCC”) risk adjustment model and the use of encounter data for CY2022.  Part II, which will include other changes to the CY2022 payment methodologies, will be issued later this Fall.   CMS will announce the CY2022 MA capitation rates and final payment policies no later than Monday, April 5, 2021.…
Continue Reading CMS Issues the 2022 Medicare Advantage Advance Notice Part I – Risk Adjustment

Earlier this month, the U.S. Department of Health and Human Services Office of the Inspector General (the “OIG”) released a report highlighting concerns about the extent to which Medicare Advantage Organizations (“MAOs”) are using health risk assessments (“HRAs”) to improve care and health outcomes under the Medicare Advantage Program (“MA”), as intended, and about the sufficiency of oversight by the Centers for Medicare & Medicaid Services (“CMS”).…
Continue Reading HHS OIG Issues Report Critical of Medicare Advantage Risk Adjustment Practices

As we discussed in our April 27, 2020 blog post, nursing homes have become the focus of significant attention during the COVID-19 crisis.  In many respects, the attention is well deserved:

  1. Nursing homes traditionally serve seniors who often struggle with chronic health conditions. As a result, nursing home residents are particularly vulnerable to coronavirus infection due to both their age and health status;
  2. Nursing homes residents are highly interactive with each other. The close proximity of nursing home rooms/beds and the personal relationships often formed among nursing home residents make social distancing hard to maintain;
  3. In order to relieve pressure on hospitals that need to reserve their beds for the most acute COVID-19 patients, nursing homes are under significant pressure to accept COVID-19 patients who have been discharged from hospitals because they no longer require an acute level of care but still may be symptomatic and require isolation and treatment; and
  4. Most importantly, the above three factors and others have turned many nursing homes across the country into hot spots for coronavirus infection and, in some cases, COVID-19 fatalities. Overwhelming data as to the dangers found in nursing homes is highlighted in the blog article referenced above.

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Continue Reading Nursing Home Liability Waivers and Nursing Home Investigations and Enforcement: A Delicate Balance During the COVID-19 Pandemic

As the COVID-19 emergency continues to heavily impact the U.S. and its health care system, CMS has issued additional flexibilities for providers and payors seeking to respond to the pandemic.  These new flexibilities are described both in revisions to CMS’ blanket waivers and in a new Interim Final Rule with comment period, both issued on April 30.  Many of these flexibilities are responsive to questions and requests submitted to CMS over the past few weeks, providers’ experiences with developing and implementing pandemic response plans, and the regulatory obstacles they have encountered.  While these new flexibilities will not eliminate all of the regulatory challenges currently facing providers responding to COVID-19, and providers must be careful to continue to track the scope of CMS’ flexibilities, they will be very helpful to many providers in their ongoing COVID-19 response efforts.  In particular, and among other things, CMS’ new guidance expands flexibility for telehealth services, provides additional support for COVID-19 testing, relaxes additional regulatory requirements applicable to certain payors, provides other key regulatory flexibilities, and offers guidance to MSSP ACOs on payment calculations for periods affected by the public health emergency.…
Continue Reading CMS Updates Waivers, Provides More Flexibility for Providers Responding to COVID-19

On April 21, 2020, the Centers for Medicare and Medicaid Services (“CMS”) released “Explanatory Guidance” related to the March 30, 2020 Blanket Waivers of Section 1877(g) of the Social Security Act (information about those waivers available in our previous blog post here), applicable during the COVID-19 public health emergency (“PHE”). The Explanatory Guidance clarifies the scope and application of the Blanket Waivers to certain financial relationships and responds to some of the issues raised by stakeholders since the release of the Blanket Waivers. The Explanatory Guidance offers some new insight, which providers should consider in structuring any arrangements that rely on the Blanket Waivers, but leaves many key questions and challenges unaddressed. …
Continue Reading Even in a Crisis, Stark Law Compliance Demands Attention: CMS Issues Explanatory Guidance on Stark Law Blanket Waivers