Virginia Legalizes Cannabis for Medical Use
Virginia Legalizes Cannabis for Medical Use

On February 21, the Virginia House of Delegates voted 99-0 (1 abstention) to approve HB 1251, a bill that will dramatically expand the state’s medical cannabis laws. The bill was sent to Governor Ralph Northam for signature and – thanks to an emergency clause recommended by the Governor himself – will be effective immediately once he signs. With this bill, doctors will now be able to recommend the use of medical cannabis oil to patients with any diagnosed condition or disease that the doctor determines will benefit from such use.

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Corporate Healthcare LawRebecca GwiltCannabis, medical marijuana, THC, CBD
The 21st Century Cures Act and the Future of Healthcare
The 21st Century Cures Act and the Future of Healthcare

The Cures Act is aimed at modernizing and personalizing healthcare by encouraging innovation and streamlining the process for discovery, development, and delivery of new treatments and technologies to those suffering from illness. Importantly, the legislation provides for significant funding to advance these goals, to the tune of $4.8 billion to the National Institutes of Health ("NIH"), $500 million to the Food & Drug Administration ("FDA"), and $1 billion in grants to states for opioid abuse prevention and treatment. This article will provide an overview of key components of the Cures Act and highlight implications for the future of healthcare.

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Corporate Healthcare LawCarrie NixonCures Act, Future of Healthcare, Precision Medicine Initiative, 21st Century Cures Act, Cancer Moonshot, Patient Generated Health Data, FDA Regulations, Real World Evidence, National data sharing, interoperability
Join Nixon Law Group at MATRC 2018
Join Nixon Law Group at MATRC 2018

Join NLG Partner Rebecca E. Gwilt and telemedicine vendors, practitioners, and academicians from Virginia, Maryland, Delaware, Washington, D.C., Pennsylvania, New Jersey, West Virginia, North Carolina, and Kentucky at the Mid-Atlantic Telehealth Resource Center's (MATRC) 2018 Summit in Hershey, PA this April. Rebecca will be speaking alongside Brian Scarpelli with the Connected Health Initiative during the session: “Deconstructing Reimbursement for Chronic Disease Management”. (Monday April 16 from 2:30 PM - 3:45 PM)

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Rebecca Gwilttelemedicine, MATRC, Remote Patient Monitoring, RPM, CCM, Chronic Care Management
New Rule for Substance Abuse Records: Confidentiality and Disclosures
New Rule for Substance Abuse Records: Confidentiality and Disclosures

On January 2, 2018, the Substance Abuse and Mental Health Services Administration (“SAMHSA”) issued a Final Rule, amending 42 C.F.R Part 2 (“Part 2”), creating new changes to the federal rules governing confidentiality and disclosures of patient substance use disorder (“SUD”) records for the first time since 1987. Part 2 protects the confidentiality of SUD records, which are subset of protected health information (PHI). This means that these records are subject to HIPAA, but are also protected by Part 2, which contains additional (and more stringent) federal protections. These overlapping standards can make the storage and disclosure of patient records administratively burdensome for healthcare providers, patients and their families. It is also a challenge for technology companies that store, analyze, and transmit patient records on behalf of providers and patients.

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Privacy, Corporate Healthcare LawRebecca Gwiltsubstance abuse, PHI, 42 CFR Part 2, Part 2 Programs, mental health records, drug and alcohol, medical records, patient consent, SUD
What You Need to Know About the Revised Virginia Assisted Living Regulations: STAFFING (Part 1 of 2)
What You Need to Know About the Revised Virginia Assisted Living Regulations: STAFFING (Part 1 of 2)

The revised Virginia assisted living regulations go into effect February 1, 2018.  This is the latest summary in Nixon Law Group’s series highlighting key changes under the new regulations.  This summary is the first of two that will focus on some of the new staffing requirements, including qualifications, training, and records.

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Corporate Healthcare LawCait Riccobonoassisted living, post-acute, staffing, regulations, ALF, Virginia, personnel
How to get paid for Remote Patient Monitoring with CPT Code 99091
How to get paid for Remote Patient Monitoring with CPT Code 99091

Two Final Rules issued by CMS in November 2017 opened up entirely new avenues for reimbursement of Remote Patient Monitoring services in 2018, creating the potential for better patient outcomes and a boost to a medical practice's bottom line.

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Remote MonitoringCarrie NixonCPT Code 99091, Remote Patient Monitoring, Telehealth, Patient Generated Health Data, Reimbursement, Clinical Practice Improvement Activities, Advancing Care Information, Quality Payment Program, MACRA, MIPS, 2018 Medicare Physician Fee Schedule, Coronavirus
What You Need to Know About the Revised Virginia Assisted Living Regulations: Private Duty Personnel and Volunteers
What You Need to Know About the Revised Virginia Assisted Living Regulations: Private Duty Personnel and Volunteers

NLG continues its series of posts on certain key changes in the new Virginia assisted living regulations, scheduled to take effect February 1, 2018.  In this installment, we review new requirements for the use of private duty personnel and volunteers.  Keep reading THE LATEST from Nixon Law Group more information on the new ALF regulations and other healthcare happenings!

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Corporate Healthcare LawCait Riccobonoassisted living, post-acute, regulations, ALF, Virginia, personnel, volunteers
What You Need to Know About the Revised Virginia Assisted Living Regulations: Records & Reports
What You Need to Know About the Revised Virginia Assisted Living Regulations: Records & Reports

In this third installment of NLG posts summarizing the new Virginia assisted living regulations, we cover notable changes to requirements for Electronic Records and eSignatures, Incident Reporting, and Reports of Abuse, Neglect, or Exploitation.  These regulations are scheduled to take effect February 1, 2018, so keep checking back for THE LATEST from Nixon Law Group! 

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Corporate Healthcare LawCait Riccobonoassisted living, Virginia, regulations
What You Need to Know About the Revised Virginia Assisted Living Regulations: Infection Control
What You Need to Know About the Revised Virginia Assisted Living Regulations: Infection Control

This is the second NLG summary in our series on the revisions to Virginia’s Standards for Licensed Assisted Living Facilities, scheduled to take effect February 1, 2018.  The new regulations include changes to the timing for submitting incident reports, a new section addressing electronic records and electronic signatures, substantial revisions to requirements for infection control programs, and changes to the required content of the Disclosure Statement and admission agreements.  This summary focuses on changes to Infection Control regulations. 

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Corporate Healthcare LawCait RiccobonoVirginia, assisted living, regulations
CLIENT ALERT: Revisions to Virginia Assisted Living Regulations
CLIENT ALERT: Revisions to Virginia Assisted Living Regulations

Final regulations that comprehensively revise Virginia’s Standards for Licensed Assisted Living Facilities are scheduled to take effect February 1, 2018.  The new regulations include changes to the timing for submitting incident reports, a new section addressing electronic records and electronic signatures, substantial revisions to requirements for infection control programs, and changes to the required content of the Disclosure Statement and admission agreements.  This is the first in a series of summaries on key changes under the new assisted living regulations, so stay tuned! 

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Corporate Healthcare LawCait Riccobonoassisted living, regulations, compliance, policies and procedures
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.

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FDACait Riccobonomedical software, FDA, Health IT
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."

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Care Management Services, Corporate Healthcare LawCarrie NixonMACRA, MIPS, Physicians, Virtual Groups, CEHRT
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.

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Corporate Healthcare Law, PrivacyCait Riccobonophoto, video, policy, policies and procedures, taking pictures, record/recordings
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?

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PrivacyCait RiccobonoHIPAA, healthcare business
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).

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Fraud and AbuseCait RiccobonoAKS, EMR, Health IT, healthcare vendor, fraud and abuse