Tag Archives: CMS

CMS Publishes Monumental Changes and Updates to the Physician Self-Referral (Stark) Law Regulations

On November 20, 2020, the Centers for Medicare and Medicaid Services (CMS) published its long-awaited and highly anticipated final rule updating regulations promulgated under the Physician Self-Referral or “Stark” law (the OIG simultaneously published updates to the Anti-Kickback Statute regulations). Among other things, CMS introduced new Stark exceptions for certain “value-based arrangements,” the donation of cybersecurity technology and services and limited remuneration to physicians; introduced new definitions and updated key terms, including “commercial reasonableness,” the “volume and value” standard and “fair market value”; and updated several existing exceptions, including …

Physician Self-Referral Law (Stark), Anti-Kickback Statute, and Beneficiary Inducement CMPs – HHS Releases Final Rules

On November 20, 2020, the Department of Health & Human Services (HHS) released heavily anticipated final rules revising the regulatory exceptions to the Physician Self-Referral Law (also known as the Stark Law), the Anti-Kickback Statute (AKS) safe harbors, and the Beneficiary Inducements Civil Monetary Penalties (CMP) regulations.  The changes to the regulations go into effect on January 19, 2021 (except for one change to the Physician Self-Referral Law that becomes effective January 1, 2022). In a separate rule also released November 20th, HHS removed safe harbor protection for rebates involving …

CMS Finalizes 2021 End-Stage Renal Disease Prospective Payment System Rule Expanding Payments for In-Home Dialysis Equipment and Supplies

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.…

The benefit of COVID-19 waivers to Stark Law, anti-kickback statute

Excerpt of a contributed article published in Medical Economics on November 3, 2020.

These waivers could lead to lasting flexibilities for physicians — if a few bad apples don’t spoil the bunch

On October 19, 2020, the Administrator of the Centers for Medicare & Medicaid Services (CMS) highlighted recent actions taken by the federal government to criminally charge, and revoke billing privileges of, health care providers nationwide for alleged involvement in fraudulent schemes. The recent crackdown resulted from coordination between the Department of Justice (DOJ), the Office of Inspector General …

CMS Announces New Telehealth Services Covered by Medicare and Provides States with Medicaid and CHIP Telehealth Expansion Assistance

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.…

CMS Extends Timeline for Finalizing Changes to Physician Self-Referral (Stark) Law Regulations to August 2021

On August 24, 2020, the Centers for Medicare & Medicaid Services (CMS) announced an “extension of the timeline” for publication of a final rule addressing changes to the Physician Self-Referral Law (or Stark Law) regulations.  In its announcement, CMS set a new deadline of August 31, 2021 for publication of a final rule.…

CMS Releases Guidance on the Allowance of Telehealth Encounters in eCQMs

On July 2, 2020, the Centers for Medicare and Medicaid Services (CMS) released guidance documents on the allowance of telehealth encounters for the Eligible Professional and Eligible Clinician electronic clinical quality measures (eCQMs) used in CMS quality reporting programs for the 2020 and 2021 performance periods. The guidance applies to eCQMs used in the:

  • Quality Payment Program: The Merit-based Incentive Payment System (MIPS) and Advanced Alternative Payment Models (Advanced APMs)
  • APM: Comprehensive Primary Care Plus (CPC+)
  • APM: Primary Care First (PCF)
  • Medicaid Promoting Interoperability Program for Eligible Professionals

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

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 …

CMS Proposes IPPS and LTCH PPS Payment and Policy Changes for FY 2021

On May 11, 2020, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule to update Medicare payment policies for hospitals under the Inpatient Prospective Payment System (IPPS) and the Long-Term Care Hospital (LTCH) Prospective Payment System (PPS) for FY 2021 (the “Rule”).  IPPS and LTCH PPS proposed rules are released on a fiscal year cycle to define payment and policies for inpatient hospitals, long-term care hospitals, inpatient rehabilitation facilities, inpatient psychiatric facilities, skilled nursing facilities, and hospices. CMS also released a fact sheet highlighting certain major provisions …

CMS Releases Additional Blanket Waivers in Response to COVID-19 Pandemic

On May 11, 2020 the Centers for Medicare and Medicaid Services (CMS) announced additional blanket waivers for hospitals and other facilities in response to the COVID-19 pandemic. According to CMS, the new waivers “provide the flexibilities needed to take care of patients during the COVID-19 public health emergency.” The blanket waivers have a retroactive effective date of March 1, 2020 and do not require a waiver request or notice to CMS to apply.…

CMS Interim Rule Makes Sweeping Changes in Response to COVID-19 Public Health Emergency

On May 8, 2020, the Centers for Medicare & Medicaid Services (CMS) published an interim final rule with comment period (the “Interim Rule”) in the Federal Register, setting forth additional regulatory waivers and other changes to healthcare regulations and policies in response to the COVID-19 public health emergency (PHE). At a high level, the Interim Rule encompasses topics including expansion of telehealth, support for and expansion of COVID-19 testing, allowing certain licensed professionals to practice at the top of their licenses, Medicare payments for teaching hospitals, changes to the Medicare …

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 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 …

CMS Issues Explanatory Guidance of Blanket Physician Self-Referral (Stark) Law Waivers for COVID-19 in Response to Industry Feedback

Amidst the cavalcade of regulatory and policy changes from federal and state governments intended to help health care providers confront the COVID-19 pandemic, on April 21, 2020 the Centers for Medicare & Medicaid Services (CMS) published “Explanatory Guidance” (Guidance) of the applicability of the blanket waivers of the federal Physician Self-Referral Law (PSR Law) CMS previously issued on March 30, 2020. See our analysis of the PSR Law blanket waivers here.…

CMS Issues New Interim Final Rule With Sweeping Regulatory Changes in Response to the COVID-19 Pandemic

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 Aid, Relief, and Economic Security Act, or CARES Act” states CMS in its press release. Spanning 279 pages, the Rule makes sweeping changes for the full spectrum of health care providers. On a high …

CMS Announces Merit-Based Incentive Payment for Clinicians Participating in COVID-19 Clinical Trial

On April 21, 2020, the Centers for Medicare & Medicaid Services (CMS) announced that clinicians participating in the Quality Payment Program (QPP) can earn credit in the Merit-based Incentive payment system (MIPS) by attesting to a new COVID-19 Clinical Trials improvement activity based on participation in a clinical trial and reporting information. Clinicians who may earn this MIPS credit include physicians, physician assistants, nurse practitioners and others. MIPS is one of two options for clinicians to participate in Medicare’s QPP, and requires clinicians to report certain quality, cost and other …

CMS Issues Phase-In Recommendations for Non-COVID Non-Emergent Care

On April 19, 2020, the Centers for Medicare & Medicaid Services (CMS) issued recommendations for Re-opening Facilities to Provide Non-emergent Non-COVID-19 Healthcare: Phase I. The recommendations apply to areas with a low, or relatively low and stable incidence of COVID-19, in states or regions that have passed Phase I gating criteria that were previously announced by the Administration on April 16, 2020. Initially, the recommendations apply to non-emergent care that is currently on hold, such as chronic disease care, surgery and other procedures, and, eventually, preventive care. CMS is …

CMS Updates and Revises COVID-19 FAQs on Medicare FFS Billing

On April 9 and 10, 2020, the Centers for Medicare and Medicaid Services (CMS) updated and revised their COVID-19 Frequently Asked Questions (FAQs) on Medicare Fee-for-Service (FFS) Billing. The updates were intended to bring the FAQs up to date in light of new section 1135 waivers, provisions from the Coronavirus Aid, Relief, and Economic Security (CARES) Act and the interim final rule for Medicare and Medicaid Programs; Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency. The extensive new FAQs are marked in the document as “New: …

CMS Updates Blanket Waivers to Help Expand Health Care Workforce

On April 9, 2020 the Centers for Medicare and Medicaid Services (CMS) updated blanket waivers issued previously in response to the COVID-19 public health emergency. According to CMS, the new waivers “focus on reducing supervision and certification requirements so that practitioners can be hired quickly and perform work to the fullest extent of their licenses.” The blanket waivers have a retroactive effective date of March 1, 2020 and do not require a waiver request or notice to CMS to apply.…

CMS Issues Blanket Waivers of Physician Self Referral (Stark) Law Penalties to Support COVID-19 Response Efforts

On March 30th, the Centers for Medicare and Medicaid Services (CMS) issued blanket waivers (Blanket Waivers) of sanctions under the federal physician self-referral law (Stark Law) to relax regulatory requirements related to health care providers’ response to the COVID-19 pandemic. The Blanket Waivers were issued under the Department of Health and Human Services Secretary’s authority in Section 1135 of the Social Security Act to ensure that (i) sufficient health care items and services are available to federal health care program beneficiaries, and (ii)  health care providers are reimbursed for providing …

CMS grants Massachusetts Section 1135 Waiver, DPH issues Guidance regarding Determination of Need and Nurse Staffing Requirements, and MassHealth Issues Provider and Pharmacy Guidance

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.…

CMS Announces Targeted Plan for Healthcare Facility Inspections in Light of COVID-19

On March 23, 2020, the Centers for Medicare & Medicaid Services (CMS) announced that, effective immediately, it is temporarily postponing routine facility inspection and focusing on infection control and situations involving Immediate Jeopardy (where patient safety is placed in imminent danger). CMS is rolling out a new focused survey and inspection process to assess whether facilities are prepared for COVID-19, and has published a fact sheet describing the initiative. This will apply to inspections of all Medicare and Medicaid certified provider and supplier types across the country, such as long …

Federal Government Significantly Expands Telehealth Reimbursement During COVID-19 Public Health Emergency

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 …

Massachusetts COVID-19 Guidance for Health Care Providers, Payors and Laboratories on Issues Including Telehealth, Elective Procedures, COVID-19 Testing, and Provider Licensure

Massachusetts executive agencies have been issuing an array of further guidance to the healthcare provider community regarding COVID-19.  All orders and guidance are available at https://www.mass.gov/2019coronavirus. Review of this website and CDC websites for periodic updates is strongly encouraged, as the situation is fluid and continually evolving. …

HHS Finalizes Joint Rules on Electronic Health Record Interoperability and Access

On March 9, 2020, the Department of Health and Human Services (HHS) announced final rules seeking to give patients more access to, and control of, their health data. The final rules were issued by the Office of the National Coordinator for Health Information Technology (ONC) and Centers for Medicare and Medicaid Services (CMS). The ONC rule is available here and the CMS rule here. Both rules implement interoperability and patient access provisions from the 21st Century Cures Act and the Trump administration’s MyHealthEData initiative.…

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