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OSHA Issues COVID-19 Workplace Safety Rule for Healthcare Employers Considerations for Health Care Employers under Iowa’s Vaccine Passport Law and Recent CDC, CMS and EEOC Guidelines OIG Advisory Opinion No. 21-02 Provides Helpful Insights into Risk Mitigation Factors Regarding Health System-, Physician-, and Management Company-Owned Ambulatory Surgery Centers Coronavirus Lawsuits More Than Double In 2021; Those Against Healthcare Providers Steadily Increase Stark Regulatory Changes Effective January 1, 2022 Require Modifying Certain Group Practice Compensation Methodologies The “Regulatory Sprint to Coordinated Care” – Overview and Links to Further Resources from Dorsey & Whitney Granny Cams Are Likely Here to Stay: Taking Steps to Address the Inevitable Nursing Facilities and CMPs: The Latest Fight Borrowers and Banks Beware: The New Year Brings the Nation’s First False Claims Act Settlement for Paycheck Protection Program Fraud White Papers: Understanding the Final Rules to Revise the Stark Law, Anti-Kickback Statute and Beneficiary Inducement Civil Monetary Penalty Regulations Is Data the Next Frontier in ERISA Litigation? Coronavirus Lawsuits Against Healthcare Providers are on the Rise The Regulatory Sprint Catches up to HIPAA: New Proposed HIPAA Rules OIG Skeptical of Medical Device and Pharmaceutical Speaker Programs Much-Anticipated Final Rules to Revise Stark Law, Anti-Kickback Statute, Beneficiary Inducement CMP Regulations Released under “Regulatory Sprint to Coordinated Care” 2020’s a Bust, but HIPAA Enforcement Is on a Roll! Finalized Rule to Remove Disincentives to Living Organ Donation CMS Issues Interim Final Rule to Enforce COVID-19 Reporting Requirements DOJ Demonstrates Continued Focus on Opioid Crisis with $600 Million Criminal and Civil Settlement Against Indivior Solutions, Indivior Inc., and Indivior plc Is Your Compliance Program More than a Paper Program? DOJ Issues Revised Guidance for Evaluating Corporate Compliance Programs Top Three Current Revenue Stream Considerations for Tax-Exempt Organizations Providing Elder Care New Opportunities for Hiring Foreign Physicians in Shortage Areas False Claims Act Exposure for Beneficiaries of the Public Health and Social Services Emergency Relief Fund: Mitigating Risks of Ambiguous Terms & Conditions CMS Expands Emergency Declaration Blanket Waivers for Health Care Providers CMS Provides Additional COVID-19 EMTALA Guidance for Hospitals CMS Issues Explanatory Guidance on Stark Law Blanket Waivers The “War” Between Out-of-Network Providers and Insurers Spreads Into COVID-19 Territory The Paycheck Protection Program and Health Care Enhancement Act: Summary of “Phase 3.5” COVID-19 Stimulus Package HHS Announces Additional Allocations of CARES Act Provider Relief Fund Privacy of Substance Use Disorder Records and The CARES Act: Steps Toward Harmonizing Part 2 Privacy Laws with HIPAA Untimely Dispensing Allegations Against Pharmacies Stricken in Opioid Litigation HHS Releases Notices of $30 Billion to Healthcare Providers and Suppliers OIG Initiatives to Ease Provider Burdens Related to COVID-19 Medicare Payment Rules Changed to Allow Broad Use of Remote Communications Technology New CMS COVID-19 Blanket Waivers for Health Care Providers Stark Law Blanket Waivers Related to “COVID-19 Purposes” Announced What All Employers Should Know About Disaster Relief Funds to help with COVID-19 Accelerated and Advance Payments: Financial Relief for Medicare Participating Providers & Suppliers – A COVID-Prompted CMS Announcement CARES Act Summary of Provisions that Support America’s Health Care System COVID-19 and Provider Enrollment: CMS issues FAQs About the Broad 1135 Waiver CMS Announces Enforcement Discretion for Physician Payments Sunshine Act Reporting by Applicable Drug and Device Manufacturers FFCRA Employment Benefit Exclusions for Health Care Providers and Emergency Responders HIPAA and COVID-19 Updates: The Office for Civil Rights Provides Additional Guidance on Permitted Disclosures to First Responders FCC Narrows the TCPA’s Emergency Purpose Exception Amid Pandemic While Greenlighting Certain Emergency Messages by Hospitals, Health Care Providers, and Government Supreme Court holds “actual knowledge” in ERISA statute means “what it says” CMS Announces Relief for Participants in Quality Reporting Programs in Response to COVID-19 COVID-19 and EMTALA: Ongoing Requirements and New Waivers Clinical Trials During the COVID-19 Pandemic Protecting Patients and Providers in Unprecedented Times COVID-19 and Cross-State Clinician Licensure: Federal and State Regulations, Revisited, and What To Do About Them Controlled Substance Prescribing Exceptions During Public Health Emergencies Medicare Telehealth Payment Expanded to Help Address the COVID-19 Public Health Emergency New HIPAA Waivers for Health Care Providers During the COVID-19 Emergency Coronavirus Resource Center Public Health Emergencies and the HIPAA Privacy Rule First EKRA Enforcement Announced Triggering the Public Disclosure Bar: It’s in the Details Justice Department Touts FY2019 False Claims Act Statistics as Evidence of Administration’s “High Priority” Against Fraud, but the Numbers Show Less of a Priority on Qui Tams Don’t Get Bitten by Your COBRA Notices OIG’s Latest Congressional Report Sees Continued Emphasis on Fraud and Abuse Enforcement 2020 CPI-U and DHS Code List Updates Posted on CMS Website New Proposal to Remove Disincentives to Living Organ Donation Naughty or Nice: Feds Hand Out More Than Lumps of Coal When it Comes to Healthcare Fraud Escobar in Action: Physician-owners’ fraud claims against hospital defeated in Fifth Circuit appeal for lack of materiality New Disclosure Requirements to be Phased-In to CMS Enrollment and Revalidation Process CMS Finalizes Changes to the Stark Advisory Opinion Regulations; 2020 DHS Code List and CPI-U Updates Hospital Price Transparency Rule Finalized; Health Plan Transparency Rule Proposed Settlement Reached in the First Federal Opioids Trial California Attorney General Issues Draft Regulations for CCPA Drug Companies Preview Trial Defenses for Bellwether Opioid Trial A Massive Number of New Health Law Regulatory Proposals as Part of the “Regulatory Sprint to Coordinated Care”: Proposed Changes to the Stark Law, Anti-Kickback Statute, Beneficiary Inducement CMP, Privacy Laws Governing Substance Use Disorder Records, and the Stark Law Advisory Opinion Process Reimbursement for Remote Patient Monitoring Services in 2019 CCPA Compliance Screening and Assessment Tools–Now Available Breathing Room? California Legislature Passes Two Major Amendments to California Consumer Privacy Act (CCPA) CCPA Requires “Reasonable Security”: but You Can’t have Reasonable Security Without Proper Vulnerability Management Proposed Drug Rebate and PBM Service Fee Regulations Abandoned by Administration The Eliminating Kickbacks in Recovery Act of 2018 (EKRA): A New Federal Kickback Law Applicable to All Payors Q&A: Financial Restructuring and Healthcare Providers Court Invalidates Final Rule Requiring Advertisements to List Drug Prices Finding that CMS Exceeded Its Statutory Authority Minnesota Enacts New Assisted Living Facility Law DOJ Issues Consolidated Guidance for False Claims Act Cooperation Credit At Long Last, CMS Issues Proposed Guidance on Hospital Co-Locations CMS’s New “Primary Cares Initiative” Places Primary Care at the Center of the Shift to Value-Based Care Federal Government’s Charges against 60 Medical Personnel for Illegal Prescribing and Distributing of Opioids Demonstrates Continued Focus on Compliance throughout Supply-Chain CMS Continues Expansion of Supplemental Benefits in Medicare Advantage Plans CMS “Actively Working” on Stark Law Reforms to be Issued Later this Year; “Regulatory Sprint to Coordinated Care” Continues New Transportation Model Creates Value-Based Care Payment Opportunities for Ambulance Providers and Suppliers DOJ Levels False Claims Act at Pharmacies to Combat Opioid Crisis Drug Rebates Threatened Under Proposed Anti-kickback Rule Getting Ready for Open Payments For FY2018, Justice Department Touts Nearly $3 Billion in False Claims Act Recoveries, Mostly From Qui Tams and Alleged Healthcare Frauds Changes to Medicare Advantage Risk Adjustment Model Proposed to Phase-In Beginning 2020 “Pathways to Success” – CMS Finalizes Overhaul of National ACO Program FDA Testing New Approaches for Review of Digital Health Device Applications CMS Announces Strategy to Reduce Health IT and EHR Burden CMS Finalizes Site-Neutral Payments for Hospital Outpatient Clinics; Legal Battle with Hospitals Looms CMS Proposed Rule to Require Drug Pricing Transparency President Trump Signs Federal “Gag Order” Pharmacy Bills Healthcare Message Exempt under the TCPA’s Implementing Regulations OIG Seeks Public Input on Anti-Kickback Statute and Beneficiary Inducements CMP as part of the “Regulatory Sprint to Coordinated Care” The California Consumer Privacy Act of 2018—Increased Consumer Privacy Protections and Significant Business Compliance Burdens Calls for Modernizing the Stark Law Continue; CMS Seeks Public Input on Stark Law Reforms FDA Issues Guidance on Drug and Device Manufacturer Communications: Part II – Medical Product Communications that are Consistent with the FDA-Required Labeling FDA Issues Guidance on Drug and Device Manufacturer Communications: Part I – Health Care Economic Information and Unapproved Products/Use Communications with Payors CMS Announces Rural Health Strategy CMS Expands Health Related Supplemental Benefits in Medicare Advantage Plans President Trump Gives Speech on Prescription Drug Prices and Releases Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs Iowa Legislature Sends Bill Imposing Additional Requirements for Prescription Monitoring Program Reporting to Governor for Signature FDA Chief and HHS Secretary Cite Prescription Drug Prices as Top Priorities for Agencies; President Trump Scheduled to Speak on Issue on May 11, 2018. HIMMS, Chronic Care Management, and the Top 5 Overlooked Items Advance Refunding Bond Legislation of Interest to Non-Profit Hospitals and Senior Living Organizations Significant Changes in Healthcare Laws Enacted Through the Bipartisan Budget Act of 2018: Stark, Civil and Criminal Penalties, Telehealth, ACOs and More Third Circuit: False Claims Act Liability Premised on an Anti-Kickback Statute Violation Requires Proof that at Least One Federal Claim Resulted from an Improper Referral or Recommendation How HHS’s New Division in the Office for Civil Rights Will Enforce Rights of Conscience and Religious Freedom Stark Law Reform a Focus of Recent Regulatory and Legislative Initiatives; 2018 DHS Code List and CPI-U Updates Cap-Subject H-1B Visa Petitions to be filed on April 2, 2018 Two Recent Justice Department Memoranda May Have Significant Consequences for Pending and Future False Claims Act Enforcement The Latest State Law Addressing the Opioid Crisis: New Regulations Prohibit New Jersey Prescribers Accepting Payments from Drug Manufacturers Applying Escobar’s Materiality Standard, Florida Federal Court Reverses $350 Million False Claims Act Verdict against a Nursing Home Operator OIG Issues Favorable Advisory Opinion Addressing Gainsharing CMP Arrangement HIPAA As a Basis for FCA Liability? One Court Says Yes FDA Commissioner Announces Plans to Streamline Approval Process for Headline-Grabbing Products VA Proposed Rule Would Expand Telemedicine and Override State Licensure Barriers CMS To Expand Use of TPE Audits Nationwide by End of 2017 OIG issues Advisory Opinion on a Retail Pharmacy’s Paid Membership Program Which Includes Federal Health Care Program Beneficiaries State Scrutiny of Payments to Providers Growing in Response to Opioid Crisis Consultant found guilty of illegal kickbacks by “referring” doctors’ patients to another medical provider in exchange for remuneration Creation of Health Care Fraud Unit in Chicago and Recent “Takedown” Shows Continued Emphasis on Health Care Fraud Enforcement Opioid Epidemic Declared a National Emergency; Proposed Law Calls for Mandatory E-Prescribing of Controlled Substances to Curb Drug Abuse CMS’s 2018 Medicare Physician Fee Schedule Proposed Rule Would Slash Non-Excepted Provider-Based Department Payments Medicare Proposes Continued Relief for Critical Access and Rural Hospitals Through 2-Year Moratorium on Direct Supervision Requirements New Medicare Proposals that Reduce Payment to Hospitals for 340B Drugs in 2018 Genesis Healthcare Settlement with Federal Government New York Times Obtains Copy of Draft Executive Order on Drug Prices; FDA Blogs that it is Working to Lift Barriers to Generic Drug Competition CMS continues to tinker with new physician Quality Payment Program created by MACRA Cybersecurity Task Force Issues Report on Improving Cybersecurity in the Health Care Industry Expected Executive Order to take on High Drug Prices; Senate Committee Hears Recommendations on Drug Supply Chain from Experts EHR Vendors Beware: eClinicalWorks Settles with DOJ for $155 Million New legislation eases the way for telehealth providers in TX and signals increasing national alignment FDA Requests Painkiller Removed From the Market CMS Issues New SRDP Forms How Effective Is Your Compliance Program? New OIG and DOJ Guidance for Measuring the Effectiveness of Your Corporate Compliance Program CMS Gives Clinical Labs Reporting Deadline Extension DOJ Issues New, Practical Guidance on Effective Corporate Compliance Programs CMS Proposes Affordable Care Act Exchange, Individual, and Small Group Insurance Market Changes OIG Announces Drug Pricing and Reimbursement Web Portfolio One In – Two Out and Healthcare Regulation Virtual Care Realities: Launching a Telehealth Initiative – Key Questions a Provider Should Address to Ensure Impact The Affordable Care Act in the Trump Administration OIG Interprets and Incorporates Statutory Exceptions to CMP Law Medical Software and the 21st Century Cures Act OIG Creates New AKS Safe Harbors, Codifies Others OIG Releases 2017 Work Plan Stark Law Updates in 2017 Medicare Physician Fee Schedule Final Rule CMS Finalizes Payment Changes for Off-Campus Provider-Based Departments Transitioning from Volume to Value: Medicare’s New Physician Payment Program Omnicare Inc. Settles Kickback Allegations for $28 Million The Changing Landscape of the Fight Against Opioid and Heroin Addiction and the Availability of Naloxone CMS Overhauls Regulatory Requirements for Long-Term Care Facilities Former CEO of Health System Agrees to Pay $1 million to settle False Claims Act case with U.S. Department of Justice CMS FINALIZES RULE FOR EMERGENCY PREPAREDNESS REQUIREMENTS Eighth Circuit Determines that Compliance with Reasonable Interpretation of Government Regulation Sufficient to Avoid FCA Liability (Absent a Government Warning to the Contrary) CMS Issues Proposed Rule Addressing Off-Campus Outpatient Departments New OSHA Rule Effective Next Month – Are Your Drug-Testing Policies Placing You At Risk? How to Prepare for Theft of Company Information First Circuit Affirms Dismissal For CVS Caremark Under Public Disclosure Bar Implied Certification, Escobar, and the Impact on Healthcare Providers Sample ADA Notice for Wellness Programs Failure to Disclose Best Pricing: Pharmaceutical Companies Settle FCA Claims for $784 Million Health Care Discrimination Litigation Gets a New Set of Teeth under the ACA: 2015 Litigation Review and Preview of 2016 CMS Finalizes Rule Requiring Healthcare Providers to Return Overpayments Nashville Pharmacy Services, LLC Settles FCA Allegations IRS Notice 2016-4 — ACA Reporting Extension for Forms 1094 & 1095 Can My Website Subject My Business to Liability Under the Americans With Disabilities Act (ADA)? California Court Permits FCA Claim Involving Medicare “Referral and Regeneration” Scheme to Proceed Against Healthcare CEO Novartis Pharmaceuticals Settles $390MM FCA Allegations FDA Seems Ready to Weigh In on “Natural” Food Labeling The Impact of the Bipartisan Budget Act of 2015 on Off-Campus Hospital Outpatient Departments FDA Issues Three New Rules Under the Food Safety Modernization Act OIG Releases 2016 Work Plan CMS Proposes Significant Revisions to Stark Law ACA Reporting: defining the Employer (ScreenCast 01) Dialysis Provider Settles Whistleblower Lawsuit for $450 Million EHR ROI: Meaningful Use and Leveraging Your Electronic Health Record OIG Issues Practical Guidance for Health Care Governing Boards on Compliance Oversight
