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- 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
- The “Regulatory Sprint to Coordinated Care” – Overview and Links to Further Resources from Dorsey & Whitney
- 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
