Bruce D. Armon

Bruce D. Armon

Saul Ewing LLP

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Massachusetts Hospital Agrees to Six-Figure Payment Related to HIPAA Compliance Allegations

St. Elizabeth’s Medical Center (SEMC), a tertiary care hospital based in Brighton, Mass., agreed to pay $218,400 to address deficiencies in its HIPAA compliance activities. The SEMC settlement continues a pattern of...more

7/15/2015 - Compliance Corrective Actions Covered Entities Data Breach Electronic Medical Records HHS HIPAA Laptop Computers OCR

Supreme Court Affirms Exchange Subsidies; Health Care Reform Continues

On June 25, 2015, the United States Supreme Court (the "Court"), in the high-profile decision of King v. Burwell, upheld the availability of tax credits under the Affordable Care Act ("ACA") for individuals purchasing health...more

6/29/2015 - Affordable Care Act DHS Health Insurance Health Insurance Exchanges Healthcare Reform King v Burwell Public Health Insurance Marketplace SCOTUS State Health Insurance Exchanges Subsidies Tax Credits

Physician Directorships the Focus of New Fraud Alert

On June 9, 2015, the Department of Health and Human Services Office of Inspector General (OIG) published a one-page fraud alert entitled, "Physician Compensation Arrangements May Result in Significant Liability." This is the...more

6/12/2015 - Fraud Alerts Healthcare OIG Physician Compensation Arrangements Physicians

Legislation Proposed In New Jersey to Alert Patients to Out-of-Network Costs

On May 14, 2015, four New Jersey legislators introduced the Out-of-Network Consumer Protection, Transparency, Cost Containment and Accountability Act (the "Legislation"). If enacted, the Legislation would increase health care...more

5/22/2015 - Health Care Providers Health Insurance Healthcare Healthcare Facilities New Legislation Out of Network Provider

ONC-HIT Releases Updated Guide for Privacy and Security of Electronic Health Information

The Office of the National Coordinator for Health Information Technology (ONC-HIT) released version 2.0 of its Guide to Privacy and Security of Electronic Health Information (the Guide). While the Guide clearly states that it...more

5/7/2015 - EHR Guidance Update Health Care Providers Healthcare ONC Security and Privacy Controls

Colorado Compounding Pharmacy Enters Six-Figure Settlement Agreement to Settle Alleged HIPAA Privacy Rule Violations

On April 27, 2015, the U.S. Department of Health and Human Services (HHS) announced that Cornell Prescription Pharmacy (CPP), a single-location pharmacy in the Denver, Colo. metropolitan area, agreed to settle alleged HIPAA...more

4/30/2015 - Document Destruction Drug Compounding HHS HIPAA Pharmacies PHI Settlement Settlement Agreements

President Signs Into Law Changes to Medicare Physician Reimbursement Formula

On April 16, 2015, President Obama signed into law the Medicare Access and CHIP Reauthorization Act of 2015 ("the Act"). The national headlines about the Act’s passage focused on the repeal of the sustainable growth rate...more

4/24/2015 - CHIP Healthcare Hospitals Medicare New Legislation Physician Medicare Reimbursements Physician SGR Formula Physicians

HHS Announces Next Generation ACO Model of Payment

On Tuesday, March 10, 2015, the U.S. Department of Health and Human Services ("HHS") announced the introduction of the Next Generation Accountable Care Organization ("ACO") Model of payment and care delivery. ACOs...more

3/12/2015 - ACOs CMS Fee-for-Service Healthcare HHS Medicare Shared Savings Program Shared Savings Program

HHS Announces Timeline for Accelerated Transition to Value-Based Payments in Medicare Program

On January 26, 2015, the U.S. Department of Health and Human Services ("HHS") announced the launch of the Better Care. Smarter Spending. Healthier People: Why it Matters initiative. According to HHS, this is the first time...more

2/2/2015

CMS Issues Additional Sunshine Act Guidance With Respect to Payments to Speakers at Continuing Medical Education Events

In a final rule published in the Federal Register on November 13, 2014, the Centers for Medicare and Medicaid Services (CMS) eliminated the federal Sunshine Act reporting exclusion for payments to physicians at continuing...more

12/23/2014 - CMS Continuing Medical Education Final Rules Healthcare Physicians Professional Conferences Sunshine Act

$150,000 HIPAA Settlement Following Breach of Unsecured PHI Due To Malware

The U.S. Department of Health and Human Services (HHS) Office of Civil Rights (OCR) announced on December 8, 2014 that a community behavioral health organization agreed to pay $150,000 and adopt a corrective action plan to...more

12/16/2014 - Healthcare Facilities HIPAA Malware OCR PHI Popular Settlement

New Jersey Physicians—Final Opportunity to Register a Surgical Practice

In early November 2014, the New Jersey Department of Health (DOH) sent a letter to every physician licensed by the New Jersey Board of Medical Examiners (BME) regarding New Jersey’s statutory requirement that every surgical...more

11/11/2014 - Codey Law Department of Health Hospitals Physicians Registration

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

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