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Foley & Lardner Health Care Law Today - Health
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Telehealth Providers: HHS Issues HIPAA Best Practices | Foley & Lardner LLP
Recognizing the evolving landscape of care delivery and growth of telehealth, the U.S. Department of Health and Human Services published a resource guide aimed at assisting telehealth providers in explaining the privacy and security risks to patients that engage in telehealth.
CMS Expands Access to Behavioral Health Services; Physician Fee Schedule Expands Billing Providers and Flexibilities | Foley & Lardner LLP
On November 2, 2023, the Centers for Medicare and Medicaid Services issued its 2024 Physician Fee Schedule final rule for calendar year 2024 that will, in part, implement some of the most important changes to improve access to behavioral health care in Medicare’s history.
Top 5 Rules for Medicare 2024 Remote Patient Monitoring and Remote Therapeutic Monitoring: What Companies Need to Know | Foley & Lardner LLP
On November 2, 2023, the Centers for Medicare & Medicaid Services (CMS) finalized new policies related to remote physiologic monitoring (RPM) and remote therapeutic monitoring (RTM) services reimbursed under the Medicare program.
Massachusetts: Proceed With Caution - New Vaccination Criteria for Hospitals and Other Licensed Health Facilities | Foley & Lardner LLP
Following public hearings and at least 78 public comments, at the end of October, hospitals and other facilities licensed by the Massachusetts Department of Public Health (DPH) will have new flexibility to require both flu and COVID-19 vaccinations for personnel, with attendant potential pitfalls to navigate.
HHS OIG: New “General Compliance Program Guidance” Provides Voluntary Steps Towards Increased Effectiveness | Foley & Lardner LLP
In connection with the November 2023 Health Care Compliance Association’s (HCCA) Healthcare Enforcement Compliance Conference, and with acknowledgment by the Chief Counsel to the Inspector General, Rob DeConti, of the long partnership between the Office of Inspector General (OIG) and the HCCA, the OIG issued its new “General Compliance Program Guidance” (GCPG) on November 6, 2023.
New Biden EO on AI Oversight, Development, and Use: Implications for the Health Care Industry | Foley & Lardner LLP
On Monday, October 30, President Biden signed an executive order (EO) aimed at overhauling the governance and oversight of artificial intelligence (AI) and technological infrastructure, including setting standards for AI used in the health care industry.
FDA: New Draft Guidance on Communication of Unapproved Uses of Approved or Cleared Medical Products | Foley & Lardner LLP
On October 23, the FDA issued draft guidance, Communication from Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products on its website.
FDA’s New Enforcement Policy: A Win for Remote Patient Monitoring and Remote Therapeutic Monitoring Manufacturers | Foley & Lardner LLP
On October 19, 2023, the U.S. Food and Drug Administration issued Guidance for Industry and FDA Staff titled Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring.
HLTH 2023 Conference: Key Investing Takeaways | Foley & Lardner LLP
A panel discussion moderated by Sofia Guerra of Bessemer Venture Partners aptly titled “The Great Leveling Out” provided some clear insights into how investors view the current state of play in digital health markets. Laura Veroneau, Managing Director of Optum Ventures, Andrew Adams, Managing Director of Oak HC/FT and Nick Richtt, Managing Director of JPMorgan, covered the topic from early stage to mature private equity (PE) financed to public strategic buyers.
Episode 29: Let’s Talk Compliance: How Compliance Issues Affect Health Care Transactions | Foley & Lardner LLP
In this episode, partner Jana Kolarik of Foley’s Health Care Practice Group interviews partner Roger Strode of Foley’s Health Care and Transactional Practice Groups and Michael Ramey, managing principal of PYA's Strategic and Transaction Solutions on how compliance issues impact the health care transaction process.
ORI Proposes New Rulemaking for Research Misconduct Regulations | Foley & Lardner LLP
On October 5, 2023, the Office of Research Integrity of the Department of Health and Human Services issued a notice of proposed rulemaking to update the Public Health Service Policies on Research Misconduct, which set forth the requirements for addressing research misconduct in PHS-funded research.
FDA Laboratory Developed Test Oversight: What Stakeholders Need to Know About Proposed Overhaul | Foley & Lardner LLP
After years of enforcement discretion, the U.S. Food and Drug Administration (FDA) published a proposed rule on October 3, 2023 under which the agency articulated its intent to increase regulatory oversight of laboratory developed tests.
The No Surprises Act: The Departments Proposed Another Increase to IDR Fee, Will it Stick? | Foley & Lardner LLP
On September 26, 2023, the Departments of Health & Human Services (HHS), Labor, and the Treasury (collectively, the Departments) jointly proposed rules updating the administrative fee and Certified Independent Dispute Resolution entity fee ranges for the Federal IDR Process under the No Surprises Act.
CMS Proposes New All-Payor, Total-Cost-of-Care Model (AHEAD Model), Funding Opportunity for States | Foley & Lardner LLP
On September 5, 2023, the Centers for Medicare & Medicaid Services (CMS) announced a new all-payor, total-cost-of-care model that is designed to tackle growing health care costs, boost population health functions, and reduce disparities in health outcomes.
DEA Extends Telemedicine Flexibilities for Prescribing of Controlled Medications: Second Time is the Charm | Foley & Lardner LLP
On October 6, 2023, the Drug Enforcement Administration released a second temporary rule extending the COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications.
DTC Promotional Labeling and Advertisements: Quantitative Efficacy Wins Over FDA in Final Guidance on Presenting Risk Information | Foley & Lardner LLP
In June 2023, the U.S. Food and Drug Administration published final guidance on presenting risk and efficacy information for direct-to-consumer promotional labeling and advertisements for prescription drug and biologic products for humans and drug products for animals.
Clinical Trials: Consent Process Clarified in New FDA Final Guidance | Foley & Lardner LLP
The U.S. Food & Drug Administration (FDA) issued final guidance (Final Guidance) regarding informed consent titled “Informed Consent: Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors” on August 15, 2023.
Decentralized Clinical Trials: Sponsor Responsibilities | Foley & Lardner LLP
In the third edition of our blog series on decentralized clinical trials (DCTs), we address U.S. Food and Drug Administration’s (FDA) expectations of Sponsors with respect to DTCs as articulated in the recently released draft guidance.
Episode 28: Let’s Talk Compliance: Medicare Advantage Compliance Enforcement Underway | Foley & Lardner LLP
In this episode, partner Jana Kolarik of Foley’s Health Care Practice Group interviews partner Michael Tuteur of Foley’s Government Enforcement & Defense Investigations Practice Group and Valerie Rock, Principal of PYA on Medicare Advantage compliance and enforcement trends and why this is a hot topic in the health care industry.
Podcast Episode 107: Sheridan Organ, Summer Associate | Foley & Lardner LLP
This episode of The Path & The Practice features a conversation with Sheridan Organ a summer associate in Foley’s Boston office. Sheridan discusses growing up in Winnetka, Illinois, attending McGill University and Boston University School of Law.
Remote Patient Monitoring (RPM) and Remote Therapeutic Monitoring (RTM): A Deep Dive into Proposed Medicare Changes | Foley & Lardner LLP
On July 13, the Centers for Medicare & Medicaid Services released its annual Proposed Rule updating the Medicare Physician Fee Schedule for calendar year 2024, which includes various proposed changes related to the provision of remote physiologic monitoring and remote therapeutic monitoring services.
Gender Affirming Care in Florida: Current Rules of the Road | Foley & Lardner LLP
On May 4, 2023, the Florida Senate passed SB 254 by a sweeping vote of 83 to 23. This law, which imposes restrictions on gender-affirming care in Florida, took effect immediately upon Governor Ron DeSantis signing on May 17, 2023.
Software as a Medical Device (SaMD): Health Care Regulatory Considerations | Foley & Lardner LLP
Sophisticated clinical software systems employed in specific health care services have graduated from being interfaces, operating systems, and subordinate tools that support physical medical devices and have matured to the point that they themselves are now classified as medical devices and referred to as Software as a Medical Device (SaMD).
The No Surprises Act: A District Court’s Decision Results in Federal IDR Outage | Foley & Lardner LLP
Although the No Surprises Act was signed into law almost three years ago and has been in effect for the past year and a half, there have been numerous delays in implementation and execution due to the complexity of elements of the rules.
DEA: Potential New Telemedicine Special Registration for Controlled Substances Prescribing to be Discussed in Special Listening Sessions | Foley & Lardner LLP
At long last, the Drug Enforcement Administration has signaled its consideration of a separate Special Registration for telemedicine prescribing for patients without requiring an in-person examination.
Regulatory Alert: DEA’s New Controlled Substance Theft or Loss Rule Includes a New Deadline and May Require to Corporate Compliance Systems | Foley & Lardner LLP
On July 24, 2023, a new final rule from the Drug Enforcement Administration became effective, with important consequences for companies and individuals registered to manufacture, distribute, or dispense controlled substances.
Episode 27: Subsidy Arrangements Between Hospitals and Physician Practices: What You Should Know | Foley & Lardner LLP
In this episode, partner Jana Kolarik of Foley’s Health Care Practice Group, and Angie Caldwell, Consulting Principal and Tampa’s Office Managing Principal of PYA, discuss subsidy arrangements between hospitals, health care systems, and physician practices.
CMS Proposes Remedy for 340B-Acquired Drug Payment Policy for CY 2018-2022 | Foley & Lardner LLP
Along with its calendar year 2024 Medicare Outpatient Prospective Payment System proposed rule, the Centers for Medicare & Medicaid Services have also published the long-awaited proposal to remediate the violations that arose from Medicare’s rate cuts for 340B drugs dispensed by 340B hospitals from January 1, 2018 through September 27, 2022.
HRSA Uninsured Program Covid-19 Services: OIG Audit Finds HRSA Paid for Claims that did not Comply with Federal Requirements | Foley & Lardner LLP
On July 13, 2023 the Office of Audit Services of the Department of Health & Human Services Office of Inspector General released the long-awaited audit of the Health Resources and Services Administration Uninsured Program.
IP Toolbox Is Crucial In AI-Powered Drug Discovery | Foley & Lardner LLP
This article provides an overview of IP considerations for entities engaging in drug discovery, the benefits and challenges of leveraging AI/ML technology for this purpose, and how to handle breakthroughs that result from collaborations between companies in this space.
Complex Healthcare Litigation Toolkit: The Use of Plaintiff Fact Sheets and Summary Jury Trials | Foley & Lardner LLP
On May 15 and 30, 2023, the Northern District of California conducted two “summary jury trials in a pharmaceutical lawsuit brought by patients who claimed that taking the U.S. Food and Drug Administration (FDA)-approved HIV/AIDS medication developed and manufactured by defendant Gilead Sciences Inc. resulted in kidney and bone damages.