Despite 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”).
Read MoreThe 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.”
Read MoreVIRGINIA, 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.
Read MoreNixon 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.
Read MoreNew 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.
Read MoreIn 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!)
Read MoreIn 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.
Read MoreWe’ve gathering some resources for NLG Chiropractice clients. Learn about updated medicare billing references and covered services and policies from the linked articles below.
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