CLIENT ALERT: FDA Pilot Program Seeking Software Developers

CLIENT ALERT: FDA Pilot Program Seeking Software Developers

The U.S. Food and Drug Administration is currently accepting requests from medical software developers to participate in a precertification pilot program that is scheduled to begin September 1, 2017.  The program is aimed at developing precertification criteria for software companies that would allow approved companies to engage in a streamlined premarket review process for certain digital health products.  The FDA will accept up to nine participants for the pilot program, which the Agency says will include both large, established software developers and small startup companies.

The MACRA 2018 Proposed Rule: What does it mean for you?

The MACRA 2018 Proposed Rule: What does it mean for you?

Last week, CMS issued a Proposed Rule suggesting changes for Year 2 of the Quality Payment Program ("QPP"), established under the Medicare Access and CHIP Reauthorization Act of 2015. The changes are aimed at reducing administrative and financial burdens of the QPP on physician practices, particularly small independent practices and practices serving rural communities. Per CMS, the Proposed Rule "continues the slow ramp-up of the Quality Payment Program by establishing special policies for Program Year 2 aimed at encouraging successful participation in the program while reducing burden, reducing the number of clinicians required to participate, and preparing clinicians for the CY 2019 performance period."

Stuck in the Middle Again: Protected Workplace Recordings Must Coexist with Patient Privacy

Stuck in the Middle Again: Protected Workplace Recordings Must Coexist with Patient Privacy

Healthcare providers are highly sensitive to the risks introduced by recordings in the workplace—not the least of which are potential violations of federal and state laws regarding the privacy of their patients and residents.  We have often advised our healthcare clients to enact restrictions on recordings that could introduce unnecessary risk, but a National Labor Relations Board (NLRB) decision, recently upheld by the U.S. Court of Appeals for the Second Circuit, indicates that those same restrictions on recordings might, in and of themselves, introduce compliance risk.  In its decision, the NLRB had to determine whether no-recording policies maintained by employer Whole Foods were overly broad by prohibiting all recordings by Whole Foods employees without prior management approval.  The NLRB’s position seems clear: Policies reasonably read as prohibiting all employee workplace recordings violate the National Labor Relations Act.

Business Associates of Business Associates - Partners Pointer

Business Associates of Business Associates - Partners Pointer

Caitlin Riccobono, Esq., Counsel at Nixon Law Group, develops these routine “Partners Pointers” for the Virginia-based healthcare organization Partners in Healthcare.

Topic: Business Associates of Business Associates

I was asked to address two main questions regarding a Business Associate that is a subcontractor of another Business Associate (we will call this a “Sub-BA”).  First, to what extent is a Sub-BA permitted access to PHI?  Second, what are the Sub-BA’s obligations with respect to safeguarding PHI?

CLIENT ALERT: Remedial Measures for eClinicalWorks Customers Under the  Corporate Integrity Agreement

CLIENT ALERT: Remedial Measures for eClinicalWorks Customers Under the Corporate Integrity Agreement

On May 31, 2017, the U.S. Department of Justice announced that electronic health records (EHR) vendor eClinicalWorks (ECW), along with certain individual officers and employees, have agreed to pay a total of $155 million to settle a lawsuit under the False Claims Act (FCA). In its Complaint-in- Intervention, the government alleged ECW falsified compliance with certification requirements for EHR under the Meaningful Use program. The programming shortcuts ECW allegedly took in developing its software, along with inadequate post-market support and patches, could expose providers to increased risk of errors and jeopardize patient care. If you or your practice uses the eClinicalWorks software, you should be aware of ECW’s obligations and your rights under the Corporate Integrity Agreement (CIA).

Nixon Law Group, a leading boutique healthcare law firm, welcomes Caitlin Riccobono, Esq.

Nixon Law Group, a leading boutique healthcare law firm, welcomes Caitlin Riccobono, Esq.

VIRGINIA, June 5, 2017/Nixon Law Group, PLLC/- Nixon Law Group, a Virginia-based boutique law firm representing clients in the healthcare industry exclusively, begins Summer 2017 by welcoming Caitlin Riccobono, Esq. as Counsel with the firm. Cait will be based in Nixon Law Group’s Richmond office. Prior to beginning her career as a healthcare lawyer, Cait spent five years in skilled nursing/long-term care facilities as a social worker. 

Physician Employment Contracts: The Compensation Package

Physician Employment Contracts: The Compensation Package

Before signing an employment contract, it is crucial to understand the details of your compensation package.  Often, things are not as straightforward as they may appear, and small details may make a big difference to your take-home bottom line and your lifestyle. Before you sign on the dotted line, consider both the cash and non-cash components and evaluate what is most important to you. 

Is Telemedicine Right for My Healthcare Practice?

Is Telemedicine Right for My Healthcare Practice?

Before you dismiss telemedicine as an unnecessary complication and investment for your business, consider the changes in technology, customer preference, trend toward value-based care, and aging population.

For many businesses, telemedicine is a way to increase patient care options, raise the quality of care, increase reimbursements, and grow business.

Interested? Then let’s take a look at why telemedicine might be right for your practice. 

Five New Safe Harbors to the Fraud and Abuse Statutes: What do they mean for healthcare providers?

Five New Safe Harbors to the Fraud and Abuse Statutes: What do they mean for healthcare providers?

Five new safe harbors have been added to the Anti-Kickback Statute (AKS) in the final rule, issued on December 17, 2016 by the Health and Human Services Office of the Inspector General (OIG). In addition, existing safe harbors have been revised to grant further protections to providers from criminal prosecution and civil damages. What these changes mean for providers: The trend in healthcare is to move from volume-based care to value-based care. 

MACRA for Physicians, Part Three

MACRA for Physicians, Part Three

In Part Three of the MACRA series, you’ll learn about Advanced Alternative Payment Models (APMs) and the requirements for participating in this track, along with how doing so will affect your Medicare payments for 2017 and beyond.