Karilynn Bayus

Karilynn Bayus

Saul Ewing LLP

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Latest Publications


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


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


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

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 Announces Implementation of Fingerprint Background Checks for Owners of “High Risk” Providers and Suppliers

Certain owners of home health agencies and durable medical equipment, prosthetics, orthotics, and supplies (“DMEPOS”) companies seeking to enroll in the Medicare program will now be subject to a new fingerprint-based...more


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

Hospital Executive Indicted for Allegedly Lying about Meaningful Use of Electronic Health Records

A hospital executive was recently indicted for allegedly submitting a false attestation regarding a hospital’s “meaningful use” of electronic health records (“EHR”) technology through the Medicare EHR incentive program. This...more

3/27/2014 - CMS Compliance Criminal Prosecution EHR Healthcare HHS 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

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 Maintains Position on "Carve Outs" of Federal Health Program Beneficiaries Implicating the Anti-Kickback Statute

A recent OIG Advisory Opinion concludes that a proposed arrangement, in which a commercial laboratory would contract with medical practices to assist them in developing their own clinical laboratories, necessarily implicates...more

6/25/2013 - Anti-Kickback Statute Carve Out Provisions Healthcare OIG

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