COVID-19 Vaccination Mandates

September 13, 2021 On September 9, 2021, President Biden announced the COVID-19 Action Plan: “Path Out of the Pandemic.” The Plan includes COVID-19 vaccination mandates for the staff of certain healthcare facilities, all federal employees and contractors, and the employees of large private employers. Healthcare Facilities The Plan provides that the Centers for Medicare & Medicaid Services (CMS) mandate COVID-19 …

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New OSHA Requirements for Healthcare Employers

June 11, 2021 On June 10, 2021, the Occupational Safety and Health Administration (“OSHA”) announced a new emergency temporary standard (“ETS”) to protect healthcare workers from occupational exposure to COVID-19. The COVID-19 ETS applies to all settings where employees provide healthcare or healthcare support service, including hospitals, nursing homes, assisted living facilities, home healthcare facilities, and some ambulatory care facilities …

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21st Century Cures Act: Information Blocking Now In Effect

April 8, 2021 Pursuant to 45 C.F.R. § 171.103, “information blocking” is defined as a practice conducted by a provider that is not required by law but “is likely to interfere with, prevent, or materially discourage access, exchange, or use of electronic health information.” Currently, the definition of “electronic health information” or “EHI” is limited to the elements listed in …

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Cannabis

Issuance of USDA Final Rule on Hemp Production

Two years after the passage of the Agriculture Improvement Act of 2018 (“2018 Farm Bill”), the USDA has finally issued the Final Rule (FR) regulating hemp production of hemp in the US. This is a more favorable and modified version of the Interim Final Rule (IFR). Despite these improvements, undoubtedly, industry stakeholders maintain numerous concerns and are eyeing for improvements …

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Issuance of USDA Final Rule on Hemp Production

January 18, 2021 Two years after the passage of the Agriculture Improvement Act of 2018 (“2018 Farm Bill”), the USDA has finally issued the Final Rule (FR) regulating hemp production of hemp in the US. This is a more favorable and modified version of the Interim Final Rule (IFR). Despite these improvements, undoubtedly, industry stakeholders maintain numerous concerns and are …

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New value-based Stark exceptions and Anti-Kickback Safe Harbors

December 15, 2020 On December 2, 2020, the Centers for Medicare & Medicaid Services (“CMS”) and Office of Inspector General (the “OIG”) published final rules, formalizing significant changes to the Stark Law and the Anti-Kickback Statute.  Although the Stark Law and the Anti-Kickback Statute are distinct statutes with fundamental differences in their statutory structure, implementation, operation and penalties, the final …

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HealthCare

New value-based Stark exceptions and Anti-Kickback Safe Harbors

On December 2, 2020, the Centers for Medicare & Medicaid Services (“CMS”) and Office of Inspector General (the “OIG”) published final rules, formalizing significant changes to the Stark Law and the Anti-Kickback Statute.  Although the Stark Law and the Anti-Kickback Statute are distinct statutes with fundamental differences in their statutory structure, implementation, operation and penalties, the final rules demonstrate a coordinated effort between …

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CMS Releases CY 2021 Hospital OPPS and ASC Payment System Final Rule

December 7, 2020 On December 2, 2020, the Centers for Medicare & Medicaid Services (“CMS”) issued its annual Medicare Hospital Outpatient Prospective Payment System (“OPPS”) and Ambulatory Surgical Center (“ASC”) Payment System final rule.  Highlights of the CY 2021 OPPS/ASC Payment System final rule include, but are not limited to, commencement of the elimination the Inpatient Only (IPO) list to …

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CMS Releases CY 2021 Physician Fee Schedule Final Rule

December 2, 2020 On December 1, 2020, the Centers for Medicare & Medicaid Services (“CMS”) issued its annual Physician Fee Schedule (“PFS”) final rule.  The CY 2021 PFS final rule expands telehealth services available for rural areas, increases payment for E/M comparable visits, makes permanent several workforce flexibilities provided during the COVID-19 public health emergency (“PHE”) and includes updates on …

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Modifications to the Personal Services and Management Contracts Safe Harbor

December 2, 2020 In the recently released Anti-Kickback Statute final rule, the Office of the Inspector General (the “OIG”) finalized its proposed modifications to the personal services and management contracts safe harbor located at 42 C.F.R. § 1001.952(d) to be effective January 19, 2021.  The Anti-Kickback Statute final rule in PDF format can be found here.  Modifications to Existing Safe …

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Brief Overview of Stark Final Rule

November 21, 2020 On November 20, 2020, The Centers for Medicare & Medicaid Services (“CMS”) released the much anticipated Stark Law final rule.  This final rule modifies existing Stark exceptions and fundamental terminology and also creates new exceptions.  We are in the process of reviewing CMS’s responses to comments received by stakeholders.  In the interim and due to the expansive …

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Brief Overview of Anti-Kickback Statute Final Rule

November 21, 2020 On November 20, 2020, the U.S. Department of Health and Human Services Office of Inspector General (the “OIG”) released the much anticipated Anti-Kickback Statute final rule.  This final rule modifies existing Anti-Kickback safe harbors and also creates new safe harbors.  We are in the process of reviewing the OIG’s responses to comments received by stakeholders.  In the …

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New Stark and Anti-Kickback Final Rules Released

November 20, 2020 Just today, The Centers for Medicare & Medicaid Services (“CMS”) and the U.S. Department of Health and Human Services Office of Inspector General (the “OIG”) released the long awaited final Stark Law and Anti-Kickback Statute rules.  The Stark final rule is over 600 pages and contains new permanent exceptions for value-based arrangements as well as additional guidance …

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OIG Special Fraud Alert – Speaker Programs

November 18, 2020 On November 16, 2020, the Office of Inspector General (OIG) issued a Special Fraud Alert detailing Anti-Kickback Statute violation risks associated with the offer, payment, solicitation or receipt of remuneration relating to speaker programs by pharmaceutical or medical device companies. The OIG considers speaker programs to generally be company-sponsored events at which a health care professional makes …

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Cybercrime in the Healthcare Sector

November 13, 2020 Several government agencies have reported that cybercrime directed at hospitals, healthcare providers, and medical devices is increasing. Healthcare records are more valuable to hackers than other types of data, and cybercrime groups have increased their focus on the healthcare sector. Some of the more common ransomware attacks and data theft begin with an email that appears legitimate, …

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Bipartisan Bill Introduced to Provide Medicare Reimbursement for Home Health Agencies’ Delivery of Telehealth Services During Public Health Emergencies

October 28, 2020 On October 23, 2020, U.S. Senators Susan Collins (R-ME) and Ben Cardin (D-MD) introduced the Home Health Emergency Access to Telehealth Act (“HEAT Act”). Concurrently, Representatives Roger Marshall (R-KS), Terri Sewell (D-AL), Jodey Arrington (R-TX), and Mike Thompson (D-CA) introduced a companion bill in the House. The purpose of the bill is “[t]o provide payments for home health services …

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HHS Expands Provider Relief Fund Eligibility

October 23, 2020 The Department of Health & Human Services (“HHS”) announced on October 22, 2020 that it is expanding Provider Relief Fund eligibility for Phase 3 General Distribution funding to include providers across a wider range of provider-types regardless of whether such providers accept Medicare or Medicaid payments.  Phase 3 General Distribution funding, which was originally announced on October …

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Amended Repayment Terms for Payments Issued Under the Accelerated and Advance Payments Program

October 9, 2020 On October 8, 2020, the Centers for Medicare & Medicaid Services (“CMS”) announced amended repayment terms for payments issued under the Accelerated and Advance Payments (“AAP”) Program during the COVID-19 public health emergency.  Pursuant to the Continuing Appropriations Act, 2021 and Other Extensions Act, enacted on October 1, 2020, repayment will now begin one year from the …

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Texas Governor Abbott Issues Executive Order Allowing Certain Elective Surgeries and Procedures to Resume

September 21, 2020 On September 17, 2020, Texas Governor Abbott issued Executive Order GA-31, effective immediately, which alleviates certain COVID-19 restrictions related to elective surgeries and hospital capacity issued under previous Executive Orders.  Executive Order GA-31 reduces the percentage of hospital capacity that licensed Texas hospitals must reserve for the treatment of COVID-19 patients from 15%, as mandated in Executive …

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OSHA Guidance for Employers as Workers Continue Returning to the Office

September 17, 2020 As companies across the United States continue to reopen following COVID-19 shutdowns, prioritizing the health and safety of workplace employees will be paramount.  In our previous posts (which can be found here and here), we discussed the CDC’s guidance for healthcare professionals exposed to COVID-19 and CMS’s recommendations for re-starting clinically necessary care, respectively.  The U.S. Department …

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