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Articles by Anjali Downs
OIG Issues Guidance, Request for Information on DTC Programs
Last week, the OIG posted two important issuances on Direct to Consumer drug programs, including TrumpRx – a Special Advisory Bulletin and a Request for Information (RFI). These issuances follow the announcement of Most Favored Nation Direct to Consumer pricing last May in White House Executive Order 14297, “Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients” (May 12, 2025).
HHS OIG's 13 New FAQs Shed Light on Post-Public Health Emergency Enforcement
On March 22, 2023, the U.S. Department of Health and Human Services’ Office of Inspector General (“OIG”) updated its Frequently Asked Questions (“FAQs”), drafting 13 FAQs aimed at easing the transition from COVID-era flexibilities to the end of the Public Health Emergency (“PHE”) on May 11, 2023.
Podcast: CMS and OIG Final Rules for Innovating Your Value-Based Payment Program – Diagnosing Health Care
Legal Disclaimer You are responsible for reading, understanding and agreeing to the National Law Review's (NLR’s) and the National Law Forum LLC's Terms of Use and Privacy Policy before using the National Law Review website. The National Law Review is a free to use, no-log in database of legal and business articles. The content and links on www.NatLawReview.com are intended for general information purposes only.
Building Compliance Programs for AI Tools | JD Supra
Artificial Intelligence (“AI”) applications are powerful tools that already have been deployed by companies to improve business performance across the health care, manufacturing, retail, and banking industries, among many others. From largescale AI initiatives to smaller AI vendors, AI tools quickly are becoming a mainstream fixture in many industries and will likely infiltrate many more in the near future.
Building Compliance Programs for AI Tools
Legal Disclaimer You are responsible for reading, understanding and agreeing to the National Law Review's (NLR’s) and the National Law Forum LLC's Terms of Use and Privacy Policy before using the National Law Review website. The National Law Review is a free to use, no-log in database of legal and business articles. The content and links on www.NatLawReview.com are intended for general information purposes only.
Stark Law Updates Aimed at Advancing the Transition to Value-Based Care: CMS Issues a Final Rule Creating New Exceptions for Value-Based Arrangements | JD Supra
On December 2, 2020, the Centers for Medicare & Medicaid Services (“CMS”) and the Office of Inspector General (“OIG”) of the Department of Health and Human Services (“HHS”) published in the Federal Register companion final rules that present significant changes to the regulatory framework of the federal physician self-referral law (commonly referred to as the “Stark Law”), the federal health care program’s Anti-Kickback Statute (“AKS”) and the federal civil monetary penalties (“CMP”) law.[1]...
OIG Issues a Final Rule Designed to Advance the Transition to Value-Based Care and Modernize the Regulatory Framework | JD Supra
On December 2, 2020, the Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) and the Centers for Medicare & Medicaid Services (“CMS”) published in the Federal Register long-awaited, companion final rules to revise the Anti-Kickback Statute, the civil monetary penalties (“CMP”) law, and the federal physician self-referral law (commonly referred to as the “Stark Law”) to address obstacles to coordinated care.[1] The new rules are the culmination of the agencies’...
HHS’s Efforts to Reduce Prescription Drug Prices and Transition to Value-Based Care – Part 1: CMS and OIG Issue a Series of Final Rules | JD Supra
In a completely unexpected move, on November 20, 2020, the Centers for Medicare & Medicaid Services (“CMS”) and the Department of Health and Human Services (“HHS”) Office of the Inspector General (“OIG”) published advance copies of a collection of four rules focusing on two themes: (i) reducing prescription drug prices and (ii) advancing the transition to value-based care and modernizing the regulatory framework.
Justice Ginsberg’s Multi-Generational Impact
Legal Disclaimer You are responsible for reading, understanding and agreeing to the National Law Review's (NLR’s) and the National Law Forum LLC's Terms of Use and Privacy Policy before using the National Law Review website. The National Law Review is a free to use, no-log in database of legal and business articles. The content and links on www.NatLawReview.com are intended for general information purposes only.
INSIGHT: Fake Cures and Test Kits-Scammers Target Health Care
The Department of Justice is prioritizing the prevention of fraud during the coronavirus pandemic, and health care is a particularly fertile ground for scams. There will always be unscrupulous individuals and organizations, even in health care, that seek illegitimate gains during a crisis. Below are recent fraud-fighting efforts by the DOJ and a look at what to expect in the health-care industry as this pandemic continues.
INSIGHT: Fake Cures and Test Kits-Scammers Target Health Care
The Department of Justice is prioritizing the prevention of fraud during the coronavirus pandemic, and health care is a particularly fertile ground for scams. There will always be unscrupulous individuals and organizations, even in health care, that seek illegitimate gains during a crisis. Below are recent fraud-fighting efforts by the DOJ and a look at what to expect in the health-care industry as this pandemic continues.
Secretary Azar Urges Governors to Take Action to Lift Restrictions to Extend the Capacity of the Health Care Workforce | JD Supra
Updated: May 25, 2018: JD Supra is a legal publishing service that connects experts and their content with broader audiences of professionals, journalists and associations.
INSIGHTS: Waived Medicare Telehealth Copayments Leave Unanswered Questions
Medicare beneficiaries reportedly are among the most vulnerable to the Covid-19 virus. However, the federal fraud and abuse laws designed to protect Medicare beneficiaries actually can make it more difficult for them to get the care they need during this crisis by preventing well-intentioned providers, practitioners, and suppliers from waiving cost-sharing obligations that may impede beneficiaries’ access to care.
INSIGHTS: Waived Medicare Telehealth Copayments Leave Unanswered Questions
Medicare beneficiaries reportedly are among the most vulnerable to the Covid-19 virus. However, the federal fraud and abuse laws designed to protect Medicare beneficiaries actually can make it more difficult for them to get the care they need during this crisis by preventing well-intentioned providers, practitioners, and suppliers from waiving cost-sharing obligations that may impede beneficiaries’ access to care.
Secretary Azar Urges Governors to Take Action to Lift Restrictions to Extend the Capacity of the Health Care Workforce
You are responsible for reading, understanding and agreeing to the National Law Review's (NLR’s) and the National Law Forum LLC's Terms of Use and Privacy Policy before using the National Law Review website. The National Law Review is a free to use, no-log in database of legal and business articles. The content and links on www.NatLawReview.com are intended for general information purposes only.
Secretary Azar Urges Governors to Take Action to Lift Restrictions to Extend the Capacity of the Health Care Workforce
In response to the growing concerns of the capacity of the health care workforce as a result of the COVID-19 pandemic, on March 24, 2020 the Secretary of Health and Human Services, Alex Azar, issued a letter and associated Guidance to all Governors urging them to take immediate action.
INSIGHT: Key Medicare Telehealth, HIPAA Changes During Coronavirus Pandemic
The Trump administration recently made telehealth services available to Medicare patients in an effort to limit the spread of the coronavirus. On March 6, President Trump signed into law the Coronavirus Preparedness and Response Supplemental Appropriations Act. Embedded in this act is the Telehealth Services During Certain Emergency Periods Act, which loosened regulatory restrictions on telehealth to enable patients to obtain necessary medical services without having to leave their homes.
INSIGHT: Health-Care Coverage and Reimbursement Amid Coronavirus
An unprecedented amount of federal, state, and local laws, regulations, orders, and the like have been promulgated as the U.S. struggles to deal with the Covid-19 crisis. Whether and to what extent state and local officials are able to coordinate with Congress and federal policymakers on key issues will be an important determinant of how the health-care system is able to respond to Covid-19.
INSIGHT: Health-Care Coverage and Reimbursement Amid Coronavirus
An unprecedented amount of federal, state, and local laws, regulations, orders, and the like have been promulgated as the U.S. struggles to deal with the Covid-19 crisis. Whether and to what extent state and local officials are able to coordinate with Congress and federal policymakers on key issues will be an important determinant of how the health-care system is able to respond to Covid-19.
INSIGHT: Health-Care Transactions Will Pick Back Up After Virus
Merger and acquisition activity in the health-care industry has been growing leaps and bounds ever since the passage of the Affordable Care Act in 2010 with its mandate for reducing cost, increasing quality of care and resulting value-based reimbursement. The effect, over the last several years, has been increasing consolidation in major sectors of the industry.
INSIGHT: Health-Care Transactions Will Pick Back Up After Virus
Merger and acquisition activity in the health-care industry has been growing leaps and bounds ever since the passage of the Affordable Care Act in 2010 with its mandate for reducing cost, increasing quality of care and resulting value-based reimbursement. The effect, over the last several years, has been increasing consolidation in major sectors of the industry.
INSIGHT: Managing Health-Care Workers During Coronavirus
Health-care employers face unique concerns about protecting their workers and themselves during the new coronavirus pandemic, including refusals to work, concerns over employee fevers, and wages for sick employees. Employers also must stay in compliance with regulations and maintain good communication with employees during this unprecedented time. How Do We Manage Refusals to Work? Employees who believe their workplace is safe are less likely to refuse to report to work.
INSIGHT: Managing Health-Care Workers During Coronavirus
Health-care employers face unique concerns about protecting their workers and themselves during the new coronavirus pandemic, including refusals to work, concerns over employee fevers, and wages for sick employees. Employers also must stay in compliance with regulations and maintain good communication with employees during this unprecedented time. How Do We Manage Refusals to Work? Employees who believe their workplace is safe are less likely to refuse to report to work.
HHS’s Regulatory Sprint to Coordinated Care – Part 3: CMS Proposes Expansive Set of Changes to Stark Regulations | JD Supra
[co-authors: Brian HedgemanandBailey Wendzel - Law Clerks] This Client Alert serves as the third in a three-part series in which we describe and analyze the rules proposed by the Department of Health and Human Services (“HHS”) Centers for Medicare & Medicaid Services (“CMS”) as part of its “Regulatory Sprint to Coordinated Care.” On October 17, 2019, the HHS Office of Inspector General (“OIG”) and CMS published in the Federal Register companion proposed rules that present significant changes...
HHS’s Regulatory Sprint to Coordinated Care – Part 2: OIG Issues Long-Awaited Proposed Rules | JD Supra
[co-authors: Alexis Boaz and Brian Hedgeman - Law Clerks] This Client Alert serves as the second in a three-part series in which we describe and analyze the rules proposed by the Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) as part of its “Regulatory Sprint to Coordinated Care.” On October 17, 2019, OIG and the Centers for Medicare & Medicaid Services (“CMS”) published in the Federal Register companion proposed rules that present significant changes to...
HHS’s Regulatory Sprint to Coordinated Care – Part 1: CMS and OIG Issue Long-Awaited Proposed Rules | JD Supra
Updated: May 25, 2018: JD Supra is a legal publishing service that connects experts and their content with broader audiences of professionals, journalists and associations.
Arrangements, Exceptions and Modifications- OIG and CMS Challenge the Status Quo | JD Supra
Updated: May 25, 2018: JD Supra is a legal publishing service that connects experts and their content with broader audiences of professionals, journalists and associations.
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