Bruce D. Armon

Bruce D. Armon

Saul Ewing LLP

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Medicare Shared Saving Program Interim Final Rule Extended

On October 17, 2014, the Centers for Medicare and Medicaid Services (CMS) and the U.S. Department of Health and Human Services, Office of Inspector General (OIG) published in the Federal Register (79 FR 62356 et seq) a notice...more

10/22/2014 - CMS Healthcare HHS Medicare Medicare Shared Savings Program OIG

OIG Proposes New Safe Harbors Under Anti-Kickback Statute and Civil Monetary Penalty Regulations

In the Friday, October 3, 2014 issue of the Federal Register (79 F.R. 59717 et. seq), the Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) published a proposed rule (“Proposed Rule”) to...more

10/9/2014

Business Associate Agreement September 22 Deadline; Same Sex Marriage Guidance Released

There are two important updates with respect to the Health Insurance Portability and Accountability Act of 1996 (HIPAA). First, on September 17, 2014, the U.S. Department of Health and Human Services (HHS) issued guidance to...more

9/23/2014 - DOMA Employee Benefits Healthcare HHS HIPAA Marriage Same-Sex Marriage SCOTUS US v Windsor

Sunshine Act Implementation Proceeds; CMS Re-opens the Open Payments System

On August 15, 2014, the Centers for Medicare and Medicaid Services (CMS) re-opened the Open Payments system for physicians and teaching hospitals to register, review, and, if needed, dispute information gathered to date. CMS...more

8/25/2014 - CMS Hospitals Open Payments Physicians Sunshine Act

CMS Shuts Down Sunshine Act Online Verification Process

On August 7, 2014, the Centers for Medicare & Medicaid Services (CMS) announced that the Open Payments system is “temporarily” off-line. The CMS announcement did not state when the Open Payments system would be back on-line....more

8/15/2014 - Affordable Care Act CMS Healthcare Medical Devices Open Payments Pharmaceutical Sunshine Act

FDA Releases Draft Guidance To Help Determine Substantial Equivalence for a Device that Has Different Technological...

In a new Draft Guidance entitled, Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications [510(k)] with Different Technological Characteristics, (the “Draft Guidance”) released on...more

8/6/2014 - Draft Guidance FDA Medical Devices Notice Requirements Premarket Approval Applications Risk Assessment Technology

CMS Proposes Elimination of CME Exception to Sunshine Act Reporting

The Centers for Medicare and Medicaid Services (“CMS”) issued a proposed rule that includes a plan to eliminate the continuing medical education (“CME”) exclusion to the reporting requirements under the federal Physician...more

7/10/2014 - CME CMS Healthcare Medicaid Medicare Sunshine Act

HHS Reports to Congress highlight HIPAA Compliance and Breach Activities

On June 11, 2014, the U.S. Department of Health and Human Services (HHS) Office of Civil Rights (OCR) issued two reports to Congress summarizing activities in calendar years 2011 and 2012. The Annual Report to Congress on...more

6/24/2014 - HHS HIPAA HITECH Information Reports OCR PHI Popular

CMS Proposes Change to 2014 “Meaningful Use” Rules

In the May 23, 2014 issue of the Federal Register (79 FR 29732), the Centers for Medicare & Medicaid Services (“CMS”) published a proposed rule (the “Proposed Rule”) that would change the so-called meaningful use stage...more

5/30/2014 - CEHRT CMS Data Protection EHR Healthcare Hospitals PHI

State Medical Board Association Adopts Telemedicine Guidelines

On April 26, 2014, the Federation of State Medical Boards (FSMB) House of Delegates adopted The Model Policy on the Appropriate Use of Telemedicine Technologies (FSMB Telemedicine Policy). FSMB is a national organization of...more

5/9/2014 - American Telemedicine Association FSMB Healthcare Patient Privacy Rights Telemedicine

CMS Releases 2012 Physician Medicare Data: Five Takeaways

On April 9, 2014, the Centers for Medicare and Medicaid Services (“CMS”) released the Medicare Provider Utilization and Payment Data: Physician and Other Supplier Public Use File (the “Data File”). The Data File contains...more

4/15/2014 - American Medical Association CMS Disclosure Fee Disclosure Fee-for-Service Medicaid Medicare Sunshine Act Transparency

New Resource Available to Providers for HIPAA Security Rule Compliance

On March 28, 2014, the U.S. Department of Health and Human Services (“HHS”) announced the release of a security risk assessment (“SRA”) tool to assist small- to mid-sized providers in conducting risk assessments of their...more

4/3/2014 - Data Protection HHS HIPAA PHI

FDA Seeks Comments for Revised Draft Guidance Regarding the Distribution of Publications Discussing Off-Label Uses of...

The Food and Drug Administration (FDA) released a draft guidance that revises its 2009 guidance on Good Reprint Practices. The draft guidance reflects FDA’s current thoughts on this important topic that impacts drug and...more

3/18/2014 - FDA Medical Devices Off-Label Use Prescription Drugs

Registration and Data Submission Begin Pursuant to the Sunshine Act

The Centers for Medicare & Medicaid Services (“CMS”) recently released guidance on its website describing a two-phase process for applicable manufacturers and group purchasing organizations (“GPOs”) to register and submit...more

2/28/2014 - CMS Data Collection GPOs Healthcare Healthcare Reform Sunshine Act

Extension of and Modification to Regulatory Protections for Donated EHR

In the December 27, 2013 edition of the Federal Register, the Office of Inspector General (“OIG”) and Centers for Medicare and Medicaid Services (“CMS”), both within the U.S. Department of Health and Human Services (“HHS”),...more

1/7/2014 - CMS Cybersecurity Data Protection EHR Healthcare HHS OIG PHI

Medical practice agrees to payment due to HIPAA data breach

One day after Christmas, the U.S. Department of Health and Human Services (HHS) Office of Civil Rights (OCR) announced that a Massachusetts-based dermatology practice (Practice) agreed to a $150,000 payment and entered into a...more

12/31/2013 - Breach Notification Rule Data Breach Data Protection Electronic Medical Records HHS HIPAA HITECH OCR Physicians

OIG Releases Five-Year Strategic Plan – Providers Need To Keep Compliance Focus

The federal government invests significant resources in combating health care fraud and abuse. The U.S. Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) recently released its Strategic Plan...more

11/26/2013 - Compliance Enforcement Healthcare HHS OIG

HIPAA compliance deadline approaching: Five steps to ensure you are ready

The September 23, 2013 deadline for covered entities, business associates and their subcontractors to comply with new HIPAA rules is fast approaching....more

8/5/2013 - Compliance Contractors Covered Entities Deadlines HIPAA Privacy Policy Subcontractors

HIPAA security violations result in $1.7 million settlement

On July 8, 2013, WellPoint, Inc., a managed care company (“WellPoint”), agreed to pay a $1.7 million fine to settle a self-reported breach of HIPAA, a key federal health privacy law, that led to the unauthorized disclosure of...more

7/17/2013 - Breach of Duty Data Breach Electronic Medical Records HHS HIPAA OCR Settlement Unauthorized Disclosure WellPoint

OIG Publishes Audit of Outpatient Therapy Services Seeking Return of $3.1 Million in Reimbursements

In June 2013, the Department of Health and Human Services, Office of Investigator General (OIG) published a review of its audit of an outpatient therapy services provider. The OIG concluded that the outpatient therapy...more

7/2/2013 - Fraud Health Insurance Healthcare HHS Insurance Fraud Medicare OIG Spectrum

U.S. District Court Decision Court Treats Physician Loans as W-2 Income Rather Than Bona Fide Debt

A recent federal court decision illustrates how “loan” arrangements between physicians and their employers, if not properly structured, may be treated as the payment of taxable compensation and the employers may be hit with...more

6/5/2013 - Loans Payroll Taxes Penalties Physician Recruitment Agreement Physicians W-2 Withholding Tax

White Collar Watch - April 2013

In This Issue: - Third Circuit Panel Liberalizes “Protected Activity” Immunity for Employees Claiming Whistleblower Status - Doing Time: A Requirement for White Collar Crime? - Casting a Smaller Net:...more

4/23/2013 - CMS Continuing Medical Education Financial Conduct Authority Fraud GPOs Protected Activity Publicly-Traded Companies Sarbanes-Oxley Settlement Shareholders Sunshine Act Transparency Whistleblower Protection Policies Whistleblowers White Collar Crimes

Highlighting Transparency Through The Federal Sunshine Act Regulations

The final regulations implementing the Physician Payments Sunshine Act take effect April 9, 2013. Pharmaceutical manufacturers, group purchasing organizations, academic medical centers and physicians need to be ready to...more

4/9/2013 - Affordable Care Act CMS Compliance Final Rules Healthcare Pharmaceutical Physicians Sunshine Act

OIG Places Fraud and Abuse Spotlight on Physician-Owned Entities

Physician-owned distributorships continue to attract federal scrutiny. A new OIG Alert highlights health care transactions that make these distributorships vulnerable to enforcement activity. ...more

3/28/2013 - Anti-Kickback Statute Fraud HHS Medical Devices OIG Physician-Owned Distributors Physicians Sunshine Act

OIG Provides Direction and CMS Seeks Direction Relating to Electronic Activities in the Health Care Delivery System

The OIG recently posted an Advisory Opinion which concluded that a hospital's proposal to provide free access to an electronic interface between the hospital and area physicians for laboratory and diagnostic services was not...more

1/7/2013 - Anti-Kickback Statute CMS Electronic Medical Records Electronics Hospitals OIG Physicians Remuneration

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