The No Surprises Act and Good Faith Estimates

November 15, 2021 Effective January 1, 2022, health care providers and facilities will be required to provide a Good Faith Estimate of expected charges for all items and services upon request or scheduling. Items or services include everything provided or assessed in connection with the provision of health care: all encounters, procedures, medical tests, prescription drugs, durable medical equipment and …

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OSHA Interim Final Rule: COVID-19 Vaccination and Testing ETS

November 5, 2021 On November 5, 2021, the Occupational Safety and Health Administration (“OSHA”) published an Emergency Temporary Standard on Vaccination and Testing (“Vaccination and Testing ETS”) requiring employers with at least one hundred employees to develop, implement and enforce a mandatory COVID-19 vaccination policy, or adopt a policy requiring employees to elect either to get vaccinated or to undergo …

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CMS Interim Final Rule: Mandatory COVID-19 Vaccination for Health Care Staff

November 5, 2021 The Centers for Medicare & Medicaid Services (“CMS”) issued an Interim Final Rule, effective November 5, 2021, requiring Medicare and Medicaid-certified providers and suppliers (“Facilities”) to implement mandatory COVID-19 vaccination for all eligible staff. The Interim Final Rule applies to the following Facilities: Ambulatory Surgical Centers; Hospices; Psychiatric residential treatment facilities (PRTFs); Programs of All-Inclusive Care for …

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The No Surprises Act and Surprise Billing Regulations

October 19, 2021 The No Surprises Act was signed into law on December 27, 2020 as part of the Consolidated Appropriations Act, 2021. The Act and associated regulations outline new requirements and processes for health care providers, health care facilities, and health care plans when submitting certain out-of-network plans. Effective January 1, 2022, certain billing practices related to surprise medical …

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The Stark Law: Changes for Group Practice Compensation

September 27, 2021 On December 2, 2020, the Centers for Medicare & Medicaid Services (“CMS”) published the Final Rule, “Modernizing and Clarifying the Physician Self-Referral Regulations” that included several revisions and updates for group practices under the Stark Law. CMS delayed the effectiveness of the changes related to group practices until January 1, 2022 to ensure physician practices have the …

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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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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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