Congress Votes to Legalize Low-THC Cannabis (Hemp)

On December 12, 2018, Congress passed the 2018 Farm Bill (The “Agriculture Improvement Act of 2018” or the “Bill”), which includes provisions that exempt Cannabis plants with lower than 0.3% THC content (also called “Hemp”) from the Controlled Substances Act (CSA). Once signed into law, the Farm Bill effectively legalizes the production, commercialization, and interstate shipment and sale of hemp and hemp-derived products like cannabidiol or “CBD”. Each state (including Indian Tribes and U.S. Territories) will eventually be able to regulate hemp production like any other agricultural commodity, as long as the U.S. Department of Agriculture (USDA) approves its plan to monitor and regulate the plant’s production.

Corporate Healthcare LawRebecca GwiltDecember 13, 2018CBD, 2018 Farm Bill, CBD company, CBD wellness, hemp

How to Get Paid for Remote Interprofessional Consultation between Physicians

Beginning January 1, 2019, physicians and other Qualified Healthcare Providers (“QHCPs”) eligible to independently bill for E/M services can obtain standalone reimbursement for Interprofessional Internet Consultations using CPT Codes 99446-99449, 99451, and 99452.

CMS introduces CPT Codes 99453, 99454, and 99457 to reimburse for Chronic Care Remote Patient Monitoring

The final 2019 Medicare Physician Fee Schedule (the “Rule”), released on November 1st, creates three new codes in the category of Chronic Care Remote Physiologic Monitoring (“CCRPM”) for (1) initial set-up and patient education, (2) initial device supply, and (3) monitoring data and interacting with patients or caregivers.

Should I Self-Disclose a Stark or AntiKickback Violation?

On September 27, 2018, the Department of Justice (“DOJ”) for the first time announced its own “road map” guiding voluntary self-disclosures and cooperation with government investigations of fraud and abuse in the healthcare industry. By encouraging self-disclosure, the government is incentivizing healthcare entities to come forward early with reports of violations in the hope of negotiating reasonable settlements, avoiding exclusion from Federal healthcare programs, and reducing the severe civil and criminal penalties that would otherwise be imposed for such violations.

When Do I Need a Healthcare Attorney? Responding to an Investigation by the Virginia Department of Health Professions

“Do I really need a healthcare attorney? The Board is simply asking me to answer some questions and provide some documentation. Of course, a Board complaint is a big deal, but this part seems harmless/easy enough. I will just respond and tell them what happened, right?” The reality is that an effective response is not as straightforward as it may seem. Hiring a healthcare attorney to assist in the preparation of your response to a complaint investigation can improve your chances of resolving the complaint at the investigation stage, incidentally saving you money in the long run.

Evolution of Cannabis Law and Regulations in Virginia

On September 25, 2018, the Virginia Board of Pharmacy met in closed session for more than five hours before awarding five conditional permits to five separate companies who will likely become the first Pharmaceutical Processors of Medical Cannabis in Virginia. Following this exciting announcement, these conditional license permittees will undergo background checks and, upon satisfactory results, will begin the arduous process of creating Virginia’s first vertically integrated Medical Cannabis cultivation, manufacturing and retail facilities. The state’s program started in earnest in 2015, and due to the advocacy of Virginia patients, caregivers, legislators, and healthcare providers, expanded to its current state in just three short years.

Practice Agreement Requirements for Virginia Nurse Practitioners

In Virginia (and in many other states), NPs who do not have an autonomous practice must practice under the direct supervision of a physician as part of a patient care team, pursuant to what is called a “Practice Agreement,” or, “Collaborative Practice Agreement.” A Practice Agreement is an agreement between an NP and the NP’s supervising physician that describes the relationship between the parties, including the procedures to be followed and acts to be performed by the NP in the course of providing care to patients.

Virginia Cannabis Industry Association Kicks Off at Legalize Virginia Festival in Norfolk

In anticipation of the forthcoming issuance of Virginia’s first pharmaceutical processor licenses, the Virginia Cannabis Industry Association (VCIA) will host a launch event at O’Connor Brewing Co,’s Legalize Virginia Festival, Tuesday, September 18. VCIA’s mission is to represent Virginia medical cannabis business owners and industry stakeholders to advance legislation and bring the highest quality, safest, and most compliant medical cannabis products to consumers in the Commonwealth.

The New California Privacy Law: Why healthcare tech companies in every state need to pay attention!

Many digital health technology companies have customers from multiple, or even all, states accessing their software and services. If these health tech companies have California customers, then starting in January 2020, they may need to abide by the California Consumer Privacy Act.

Top Seven Tips to Prepare for a Healthcare Security Compliance Audit

By building compliance processes into your internal structure, audits can be completed faster and can bring to light information that is beneficial for both your customers and employees. Here are seven tips to prepare for a healthcare compliance audit.

Virginia Medical Cannabis Update

Virginia’s medical cannabis program is moving forward, with a notice of proposed regulations and a new physician registration form. However, the Board of Pharmacy, whose ad hoc committee is currently evaluating pharmaceutical processor applications, has signaled that it will not be announcing the conditional permit recipients at its August 14th meeting, as was previously expected. The 53 applicants to the Board may be looking at a delay of weeks or months.

In the meantime, physicians can begin to prepare for increased demand from Virginians for medical cannabis certifications by registering with the Board of Pharmacy using its new application form. Also, industry stakeholders have until August 22nd to comment on the proposed regulations to replace the emergency regulations adopted by the Board earlier this summer.

How Can My Startup Get the IRS and State Department of Taxation to Help Pay for My R&D?

Act Fast – State deadline is July 1st!

Tax credits are a great way to increase cash flow for your business, and it may come as a surprise to many that millions of dollars go unclaimed each year.

If you’re a high growth start-up or early stage business engaging in research and development (R&D), you’re likely leaving State and Federal money on the table. Continue reading to see if you qualify for tax credits to help you propel your business.

Can Nurse Practitioners Run Their Own Practices in Virginia?

In April 2018, Governor Ralph Northam signed House Bill 793, which will allow Virginia nurse practitioners (NPs) with the equivalent of five years of full-time practice with a collaborating physician to be certified to practice independently. What does this mean for NPs in Virginia? Practically speaking, if a nurse practitioner meets the qualifications and makes the appropriate filings with the Board of Nursing, he or she can open up an independent practice to provide care in their community. This change aligns Virginia law with more than twenty other states across the country in adopting full practice authority and is expected to expand access to affordable primary care to thousands of Virginians.

Do I really need a Healthcare Lawyer?

Healthcare has now surpassed nuclear power and financial services as the most highly regulated industry in the U.S. - and for good reason. The health, safety, and privacy of individual patients and the public at large is at stake.

For better or for worse, there exists a complex web of local, state, and federal laws and regulations that govern the businesses of healthcare providers and healthcare companies - from patient safety and privacy protections, to corporate transactions and contractual relationships. Navigating this complicated landscape requires a deep understanding of the risks and opportunities inherent in the healthcare industry—namely, it requires an experienced healthcare attorney.

Nixon Law Group Launches Medical Cannabis Practice

Nixon Law Group’s Cannabis attorneys assist clients with licensing for growing/cultivation, processing/extraction and dispensing; intellectual property; real estate and equipment leases, and business/corporate transactions.

What do I need to know about GDPR?

Beginning on May 25, 2018, HIPAA won’t be the only healthcare data security standard with which U.S. companies have to comply. Medical practices, digital healthcare companies, and vendors (e.g., electronic health records companies, medical billing companies, and cloud services companies) that do business in the healthcare sector and collect data from European citizens will be required to comply with the new EU General Data Protection Regulation (the “GDPR”). A recent Reuters article called the implementation of these regulations “the biggest overhaul of online privacy since the birth of the internet.”

Privacy, Corporate Healthcare LawKatherine Bain, Esq.April 24, 2018HIPAA, GDPR

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.

Corporate Healthcare LawRebecca GwiltMarch 7, 2018Cannabis, medical marijuana, THC, CBD

Government Shutdown Averted, Telemedicine Coverage Expanded

The Bipartisan Budget Act of 2018 contains important changes to federal law related to reimbursement for and use of telemedicine, signaling Congress's continuing confidence in telemedicine's potential to improve care and reduce costs.

Telehealth, Corporate Healthcare LawCarrie NixonFebruary 20, 2018telehealth, telemedicine, reim, ACO, MSSP, Reimbursement

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.

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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Nixon Gwilt Law216 Apple Blossom Court, Suite 200Vienna, VA 22181

Nixon Gwilt Law
216 Apple Blossom Court, Suite 200
Vienna, VA 22181