The 2020 Medicare Physician Fee Schedule (the “Final Rule”), released on November 1, 2019, finalized two new codes in a new category of reimbursement titled “Principal Care Management” (PCM) Services. The new codes will be effective as of January 1, 2020, and provide reimbursement for managing a patient’s care for a single high-risk disease or complex chronic condition.
Read MoreFor nearly two years, digital healthcare companies and data brokers from across the country have been preparing to comply with California’s newest data privacy law—the California Consumer Privacy Act of 2018 (CCPA). Companies are making determinations about the applicability of this law to their operations, developing inventories of the types of consumer information they collect, and implementing operational and procedural changes in order to comply with the requirements of the law’s requirements. For those companies whose operations are not subject to the CCPA law, some have determined that it may be a strategic advantage to voluntarily adhere to some of the CCPA’s requirements, as they are likely to be adopted by other states (and even the Federal Government) as privacy legislation continues to proliferate. If you are a digital healthcare company or healthcare data broker and you’ve not initiated these conversations within your company, now is the time.
Read MoreThe lines between health data and consumer data are increasingly blurred as more technology companies venture into healthcare analytics and data processing. Why does this matter? Because there are state and federal laws protecting healthcare data collected by a person’s insurance company or physician, but for-profit companies that may collect healthcare and other sensitive person data are often not subject to these laws. In addition, healthcare companies subject to state and federal healthcare privacy laws are increasingly leaning on third party technology companies to derive value or insight from the healthcare data they collect in ways that would surprise many consumers.
Read MoreIn this article on the proposed changes to the fraud and abuse regulations, we focus on OIG’s proposed Patient Engagement and Support safe harbor to AKS and CMP and discuss how this new safe harbor may affect care management services vendors such as Chronic Care Management (CCM), Remote Patient Monitoring (RPM), Transitional Care Management (TCM), and Behavioral Health Integration (BHI) services vendors.
Read MoreThe Centers for Medicare and Medicaid Services (CMS) released the Final Medicare Physician Fee Schedule for CY 2020 (the “2020 MPFS”) on November 1, 2019. The 2020 MPFS finalizes six new CPT codes for e-Visits, providing new opportunities for physician practices to be reimbursed for conducting digital health assessments and evaluations for their patients and for remote patient monitoring companies to add these capabilities to their platforms.
Read MoreThe Centers for Medicare and Medicaid Services (CMS) released the Final Medicare Physician Fee Schedule for CY 2020 (the “2020 MPFS”) on November 1, 2019, finalizing some important changes relating to Remote Patient Monitoring (RPM) services, but leaving many questions unanswered as of yet.
Read MoreIn this article, we focus on the proposed Care Coordination Arrangements safe harbor to the Anti-Kickback Statute and discuss how this new safe harbor may affect vendors of care management services such as Remote Patient Monitoring, Chronic Care Management services, Transitional Care Management services, and Behavioral Health Integration services.
Read MoreDespite division along party lines and industry pushback, the House of Representatives has passed legislation (H.R. 3), the “Lower Drug Costs Now Act”, which would require the Department of Health and Human Services (DHHS) to establish a “Fair Price Negotiation Program” responsible for negotiating Medicare payments for some of the most expensive drugs available to Medicare beneficiaries.
Read MoreIn 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.
Read MoreNixon Law Group, a leading health care law firm representing innovative healthcare providers and health technology companies, announced today that Faisal Khan, Esq. has joined the Firm as Senior Counsel. Mr. Khan will be based in Cleveland, Ohio, expanding Nixon Law Group's reach in the Midwest.
Read MoreGeneral 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.
Read MoreWhen 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.
Read MoreThe 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.
Read MoreOn Tuesday, the Federal Trade Commission (the “FTC”) released three warning letters to unnamed companies who were illegally advertising their CBD products.
Read MoreThe 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.
Read MoreHospitals 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.
Read MoreMaryland’s Secretary of Health adopted new regulations that lay out standards for the nonclinical practice of teletherapy by certified registered nurse practitioners/psychiatric mental health (CRNP/PMHs) and psychiatric mental health/advanced practice registered nurses (PMH/APRNs).
Read MoreFollowing 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”).
Read MoreSeemingly 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.
Read MoreOn 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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