On November 2, 2020, the Centers for Medicare & Medicaid Services (CMS) finalized its 2021 End-Stage Renal Disease Prospective Payment System Rule. Among other things, the final rule expands Medicare payments for in-home dialysis equipment and supplies as part of an effort to encourage in-home care for populations vulnerable to COVID-19. We previously wrote about the proposed rule here.
Continue Reading CMS Finalizes 2021 End-Stage Renal Disease Prospective Payment System Rule Expanding Payments for In-Home Dialysis Equipment and Supplies

On October 14, 2020, the Centers for Medicare & Medicaid Services (CMS) expanded the list of telehealth services covered by Medicare during the COVID-19 Public Health Emergency. CMS also announced it would be providing additional support to state Medicaid and Children’s Health Insurance Program (CHIP) agencies in delivering telehealth services. CMS added the telehealth services using, for the first time, an expedited process that does not involve rulemaking which had been established by CMS in May 2020.
Continue Reading CMS Announces New Telehealth Services Covered by Medicare and Provides States with Medicaid and CHIP Telehealth Expansion Assistance

On July 6, 2020, the Centers for Medicare and Medicaid Services (CMS) proposed its calendar year 2021 End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) rule. ESRD PPS rules are promulgated on an annual basis, providing updates to payment policies and rates for renal dialysis services furnished to beneficiaries. The 2021 proposed rule also proposes to update the acute kidney injury (AKI) dialysis payment rate for renal dialysis services furnished by ESRD facilities to individuals with AKI, and proposes changes to the ESRD Quality Incentive Program. In addition to the annual technical updates, the 2021 rule proposes, at a high level:

  • Changes to the eligibility criteria and determination process for the transitional add-on payment adjustment for new and innovative equipment and supplies (TPNIES), and defining “new” to be within three years, beginning on the date of the FDA marketing authorization;
  • Expansion of the TPNIES to include new and innovative capital-related assets that are home dialysis machines, used in the home for a single patient;
  • Updates to the outlier policy and outlier services fixed-dollar loss amounts as well as the Medicare allowable payment amounts;
  • An addition to the ESRD PPS base rate to include calcimimetics in the ESRD PPS bundled payment;
  • A change to the low-volume payment adjustment eligibility criteria and attestation requirement to account for the COVID-19 public health emergency; and
  • An update to the ESRD PPS wage index to adopt the new Office of Management and Budget (OMB) delineations with a transition period.


Continue Reading CMS Proposes 2021 End-Stage Renal Disease Prospective Payment System Rule

On April 30, 2020, the Centers for Medicare & Medicaid Services (CMS) issued an interim final rule with comment period published in the Federal Register on May 8, 2020 (the April 30 Interim Rule) building on previous regulatory waivers and other revisions to regulations issued March 31, 2020 in an interim final rule (March 31 Interim Rule) in response to the COVID-19 public health emergency (PHE). Among other changes, the April 30 Interim Rule further broadens access to patient care provided via telehealth and other communication technology-based services and increases reimbursement for some of these services. Highlights of these changes and pertinent background are provided below.
Continue Reading CMS Broadens Telehealth Access Across the Board, Including Audio-Only Telephone Services

On April 30, 2020, the Centers for Medicare & Medicaid Services (CMS) issued an interim final rule with comment period (the “Rule”) which sets forth additional regulatory waivers and other changes to healthcare regulations in response to the COVID-19 pandemic. “Today’s actions are informed by requests from healthcare providers as well as by the Coronavirus

In this article, we highlight additional updates issued by state and federal government authorities for the health care community in Massachusetts related to COVID-19. This post addresses the Section 1135 waivers granted by the Centers for Medicare and Medicaid Services (CMS) related to MassHealth and CHIP, Massachusetts Department of Public Health (DPH) orders and guidance regarding Determination of Need and nurse staffing ratios, and MassHealth guidance for providers and pharmacies.
Continue Reading CMS grants Massachusetts Section 1135 Waiver, DPH issues Guidance regarding Determination of Need and Nurse Staffing Requirements, and MassHealth Issues Provider and Pharmacy Guidance

On March 17, the Trump Administration announced expanded reimbursement for clinicians providing telehealth services for Medicare beneficiaries during the COVID-19 Public Health Emergency. The Centers for Medicare and Medicaid Services (CMS) published an announcement, a fact sheet and Frequently Asked Questions.  To further facilitate telehealth services, the Office for Civil Rights (OCR) issued a notification describing certain technologies that would be permitted to be used for telehealth without being subject to penalties under the Health Insurance Portability and Accountability Act regulations (HIPAA). In addition, the Office of Inspector General (OIG) announced it will allow healthcare providers to reduce or waive cost-sharing for telehealth visits.
Continue Reading Federal Government Significantly Expands Telehealth Reimbursement During COVID-19 Public Health Emergency

Following the President’s proclamation on March 13 that the COVID-19 outbreak constitutes a national emergency, Secretary of the Department of Health and Human Services (HHS) Alex Azar issued a Waiver or Modification of Requirements Under Section 1135 of the Social Security Act (full text available here) that waives or modifies certain health care laws and regulations in connection with the COVID-19 pandemic.  This “1135 Waiver” applies nationwide and took effect on March 15 at 6:00 p.m., but its applicability is retroactive to March 1, 2020.  The 1135 Waiver applies for a period of 60 days (subject to extension by the Secretary for successive 60-day periods) or for the duration of the COVID-19 national emergency (if earlier), except the waiver of the HIPAA Privacy Rule described below applies for only 72 hours following a hospital’s implementation of its disaster protocol.
Continue Reading HHS Issues Section 1135 Waiver, and CMS Issues Blanket Waivers of Health Care Laws, in Response to Coronavirus (COVID-19) Emergency

On December 12, 2019, the Centers for Medicare and Medicaid Services (CMS) announced that it will automatically reprocess claims which had been reimbursed at a reduced rate in 2019 under the site-neutral payment policy and pay hospitals monies that were withheld due to the policy.

In November 2018, CMS promulgated a Final Outpatient Prospective Payment System (OPPS) Rule and implemented its site-neutral payment policy, which cut Medicare reimbursement rates for outpatient hospital services provided at certain off-campus, provider-based departments (PBDs) to the lower Physician Fee Schedule (PFS) rate for the clinic visit services – a 60 percent reduction from the OPPS reimbursement rate for the same service. CMS planned to phase in application of this payment reduction over two years. The American Hospital Association, Association of American Medical Colleges, and nearly 40 hospitals challenged the policy, arguing that the Medicare Act did not allow CMS to cut the rates. CMS believed it could develop a method to set payment rates for a particular service that is causing “an unnecessary increase in cost and volume without regard to budget neutrality.”
Continue Reading CMS to Repay Hospitals Millions After Court Finds Reduction in Rates Improper

On November 15, 2019, the Department of Justice (DOJ) announced it had reached a settlement with Sutter Health (Sutter) and Sacramento Cardiovascular Surgeons Medical Group Inc. (Sac Cardio) to resolve alleged violations of the Physician Self-Referral Law (PSR Law), commonly known as the Stark Law. Sutter is a California-based health services provider; Sac Cardio is a Sacramento-based practice group of three cardiovascular surgeons. The total settlement in excess of $46 million includes $30.5 million from Sutter to resolve allegations of an improper financial relationship specific to compensation arrangements with Sac Cardio. Sac Cardio has agreed to pay $506,000 to resolve allegations of duplicative billing associated with one of these compensation arrangements. Separately, the settlement includes another $15,117,516 from Sutter to resolve self-disclosed conduct principally concerning the PSR Law.
Continue Reading DOJ Announces Physician Self-Referral (Stark) Law Settlement in Excess of $46 Million with California Health System and Surgical Group