HHS Proposes New Safe Harbors Under the Anti-Kickback Statute and The Stark Law
HHS Proposes New Safe Harbors Under the Anti-Kickback Statute and The Stark Law

In a pair of proposed rules released by the Department of Health and Human Services (DHHS), Office of Inspector General (OIG) and the Centers for Medicare and Medicaid Services (CMS), the DHHS is looking to increase the utilization of value-based arrangements to drive health outcomes and ease the regulatory burdens associated with patient care coordination.  The proposed rules seek to change or add certain safe harbors or exceptions to the Anti-Kickback Statute (AKS), Physician Self-Referral prohibition (Stark Law), and the Civil Monetary Penalties (CMP) laws. 

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Corporate Healthcare LawTommy MillerHHS, Stark Law, CMP, OIG, dhhs, CMS, Anti-Kickback, proposed rule, Safe Harbor, AKS Safe Harbor
An overview of General Data Protection Regulation (GDPR), HIPAA, and what you need to do next
An overview of General Data Protection Regulation (GDPR), HIPAA, and what you need to do next

General Data Protection Regulation (GDPR) preparedness should be a priority and we will review the steps you need to take to make sure you’re in compliance. Though the GDPR comes from the European Union, businesses everywhere should apply GDPR principles in practice.

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PrivacyCarrie NixonHIPAA, GDPR, Healthcare compliance, data privacy, Patient Health Information, Patient Generated Health Data
CMS’ New Coding Policy Will Speed up Reimbursement for New Drugs and Devices
CMS’ New Coding Policy Will Speed up Reimbursement for New Drugs and Devices

When developing new medical device and drug products, it is important to understand how the product will be adopted and paid for in the marketplace. The development of new drugs and devices involves countless hours researching, testing, modifying, iterating, and testing some more… In larger companies, whole teams of people also dedicate the same effort into developing a market access plan—meaning careful planning for manufacturing, distribution, and insurance contracting.  This strategic planning can be overlooked in start-up biotech companies operating on limited resources and which are squarely focused on innovating new technologies.

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Care Management ServicesTommy MillerLife Sciences and Biotech, CMS, Reimbursement, medical device, pharmaceutical
FDA: Abbreviated, Special and Traditional 510(k) Clearance Applications
FDA: Abbreviated, Special and Traditional 510(k) Clearance Applications

The FDA has just issued four final guidance documents related to the 510(k) clearance applications for medical devices.  The Guidance documents can be found here, and they describe the FDA’s current thinking on special 510(k) clearance programs such as the Abbreviated application and the newly established “Special 510(k)” program. 

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FDATommy MillerFDA, FDA Regulations, Life Sciences and Biotech
Virginia Cannabis Industry Association (VCIA) to Host Legislative Update and 2020 Session Preview
Virginia Cannabis Industry Association (VCIA) to Host Legislative Update and 2020 Session Preview

The Virginia Cannabis Industry Association (VCIA) will host a series of regional legislative forums over the next several weeks.  Discussions will include an update about the Virginia cannabis industry and how outcomes of the November elections of all 140 seats of the Virginia General Assembly may affect the opportunities and challenges of this nascent industry. 

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Corporate Healthcare LawRebecca Gwiltcannabusiness, cannabusiness lawyer, cannabis association, Cannabis, Medical cannabis, legal marijuana, legal cannabis, CBD company, CBD, CBD wellness
Breakthrough Devices: CMS Removes Hurdles and Increases Payments for New Technology Add-On Payments Under the IPPS Final Rule
Breakthrough Devices: CMS Removes Hurdles and Increases Payments for New Technology Add-On Payments Under the IPPS Final Rule

Hospitals and medical device manufacturers will both benefit from the Centers for Medicare and Medicaid Services’ (CMS) finalization of the 2020 Inpatient Prospective Payment System (IPPS) Final Rule (“Final Rule”) scheduled to be published on August 16, 2019.  In an effort to increase Medicare beneficiaries’ access to innovative medical technologies, CMS has finalized certain changes to the “new technology add-on payment” “(NTAP) application and payment processes under the Final Rule. This change is likely to encourage hospital adoption of new technologies, which is intended to spur innovation and additional investment in these technologies.

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Care Management Services, Digital Therapeutics/SaMDTommy Millermedical device, FDA Regulations, FDA, CMS, Health IT, health tech, Life Sciences and Biotech, Healthcare innovation
UPDATE: VDACS Food Safety Program Releases CBD Manufacturing Requirements for Virginia Industrial Hemp Processors
UPDATE: VDACS Food Safety Program Releases CBD Manufacturing Requirements for Virginia Industrial Hemp Processors

Following its July 15th letter to Virginia Industrial Hemp Processors (“Processors”) notifying them of Governor Ralph Northam’s recent directive regarding the manufacture of CBD in Virginia, the VDACS Food Safety Program (the “FSP”) sent a letter to Processors on Friday, July 26th setting forth guidelines for Processors to follow when manufacturing cannabidiol (“CBD”) products intended for human consumption (the “Food Safety Letter”).

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Corporate Healthcare Law, FDAKaitlyn O'Connorcannabusiness, Cannabis, FDA, FDA Regulations
The Most Exciting Technologies Being Used in Patient Recovery
The Most Exciting Technologies Being Used in Patient Recovery

Seemingly every industry is being shaken up by a wide variety of emerging technologies, and physical therapy is no different. The field is seeing a number of important developments that change how practitioners approach both diagnosing and treating patients. 

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Remote Monitoring, Virtual RealityRae Steinbachphysical therapy, patient recovery, apps, integrative medicine, digital medicine, digital health, Remote Patient Monitoring, mobile medical applications, health tech
Proposed 2020 Medicare Physician Fee Schedule offers new reimbursement for Remote Patient Monitoring
Proposed 2020 Medicare Physician Fee Schedule offers new reimbursement for Remote Patient Monitoring

On July 29, 2019, the Center for Medicare and Medicaid Services (“CMS”) released its proposed rule for the 2020 Medicare Physician Fee Schedule (the “2020 MPFS”).

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Remote Monitoring, Medicare Physician Fee ScheduleCarrie NixonRemote Monitoring, Remote Patient Monitoring, Medicare, 2020 Medicare Physician Fee Schedule, physician practice, Physicians, Reimbursement, Coronavirus
VDACS Okays Manufacture of CBD Products Intended for Human Consumption
VDACS Okays Manufacture of CBD Products Intended for Human Consumption

The Virginia Department of Agriculture and Consumer Services (“VDACS”) Commissioner Jewel Bronaugh sent a letter (the “July Letter”) to all Virginia-registered Industrial Hemp Processors (“Processors”) on July 15, 2019 notifying the Processors that Governor Northam’s office has directed VDACS to “treat hemp-derived extracts intended for human consumption as approved food additives and to place qualifying Registered Industrial Hemp Processors under food safety inspection so that inspected and approved processors may manufacture a hemp-derived extract for human consumption.”

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Corporate Healthcare Law, FDAKaitlyn O'ConnorMedical cannabis, medical marijuana, CBD wellness, CBD, FDA
Nixon Law Group, a Leading Health Law Firm, Welcomes Thomas E. Miller, Esq.
Nixon Law Group, a Leading Health Law Firm, Welcomes Thomas E. Miller, Esq.

VIRGINIA, July 15, 2019/Nixon Law Group, PLLC – Nixon Law Group, a leading health law firm representing innovative healthcare providers and health technology companies, announced today that Thomas “Tommy” E. Miller, Esq. has joined the firm as Senior Counsel. Mr. Miller will be based in Nixon Law Group’s Richmond office and is licensed in Virginia and Maryland, with licensure in Washington, DC pending.

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Firm NewsCarrie Nixonhealthcare attorney, Richmond healthcare attorney, Richmond attorney
Nixon Law Group joins the ACO Exhibit Hall
Nixon Law Group joins the ACO Exhibit Hall

Nixon Law Group is pleased to be the only legal services provider in the ACO Exhibit Hall! This virtual exhibit hall was created to serve physicians and provider entities participating in (or desiring to participate in) Accountable Care Organizations, including the Medicare Shared Savings Program models, NextGen ACOs, commercial shared savings arrangements, and other value-based reimbursement models.

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Firm NewsCarrie NixonACO, Medicare ACO, Medicare Shared Savings Program
Mining and Sharing Healthcare Data: What you need to know
Mining and Sharing Healthcare Data: What you need to know

New technologies in healthcare means new risk to the security and privacy of patient health data. Though most healthcare companies and providers are aware of the need for internal data security, many may not be in compliance when sharing information with third parties. As providers and vendors find new and innovative ways to work together, the need for data sharing will only increase. It is critically important that all parties know when and how protected health information (PHI) is shared, and when patient authorization is required to do so.

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Telehealth, PrivacyCarrie NixonTelehealth, telemedicine, digital medicine, HIPAA, privacy, privacy and security, Healthcare compliance
OCR Shifts Focus to HIPAA Compliance Enforcement
OCR Shifts Focus to HIPAA Compliance Enforcement

In October, The Health and Human Services Office for Civil Rights (OCR) shared that future health-care privacy and security audits will shift from an educational focus to an enforcement focus. Previously, OCR performed these audits to educate providers on patient privacy and HIPAA. But now, the priority is enforcement. Instead of relying on complaints and breach notifications, the OCR will be more proactive in identifying problem providers. It’s important for all healthcare provider entities to have a HIPAA compliance plan actively in use. (We can help!)

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PrivacyRebecca GwiltHIPAA, Healthcare compliance
New CMS Innovation Models: Primary Care First and Direct Contracting
New CMS Innovation Models: Primary Care First and Direct Contracting

In April, the U.S. Department of Health and Human Services (HHS) and the Centers for Medicare and Medicaid Services (CMS) announced a new set of payment models meant to allow primary care providers deliver better care at a lower cost to their patients by removing unneccessary administrative and adjust payouts from procedures to outcomes.

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Care Management ServicesCarrie NixonHealthcare innovation, CMS, Medicare, medicaid, regulations
Reimbursement and Practical Considerations for House Call Practices
Reimbursement and Practical Considerations for House Call Practices

Are you thinking about starting a new house call practice? There will be things you need to prepare for (and budget for), so Nixon Law Group compiled this information. Note that major concerns include whether commercial clients can reimburse, what kinds of safety needs there are, and Medicare requirements for a “practice location.” Read more below and feel free to contact us with questions!

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Rebecca Gwiltcpt codes, house call practice, medical practice, Healthcare compliance