Publications by Todd A. Nova

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DSCSA Update – FDA Extends Deadline for Connected Trading Partners to Meet Requirements

[10/18/24]

HHS Cannot Exclude § 1115 Waiver Days from Medicare DSH Formula

[08/22/24]

U.S. Supreme Court Issues Ruling Rejecting Challenge to Mifepristone Access

[06/18/24]

HHS Publishes Its Final 340B ADR Regulation

[04/18/24]

Federal Court of Appeals Panel Issues Ruling in Litigation Challenging FDA Approval of Mifepristone

[08/31/23]

CMS Releases Repayment Proposal for 340B Payment Cuts

[07/07/23]

DEA & SAMHSA Issue Temporary Rule Extending COVID-19 Telemedicine Flexibilities for Controlled Substances Prescribing Beyond the Termination of COVID-19 PHE

[05/09/23]

DEA Proposes New Rules that Would Permanently Allow for Telemedicine Controlled Substance Prescriptions

[02/27/23]

FDA Expands Access to Mifepristone: Next Steps for Providers and Retail Pharmacies

[02/07/23]

"Top Ten Issues in Health Law 2023." AHLA Health Law Connections, January 2023.

FDA Issues Prescription Drug Importation Guidance: Recommendations for Certain Importers of Canadian Drugs

[07/29/22]

Supreme Court Overturns 340B Payment Reductions

[06/15/22]

FTC Launches Inquiry into Pharmacy Benefit Managers: Is This Time Different?

[06/15/22]

FDA Proposes National Licensing Standards for Wholesale Drug Distributors and Third‑Party Logistics Providers

[05/11/22]

PREP Act Liability Coverage Extended to Pharmacists and Interns for Flu Vaccination

[02/04/22]

DEA Soliciting Input for Development of Telepharmacy Practice Regulations

[12/23/21]

FDA Revises Health System Compounding Guidance, Implementing a More Practical Approach

[10/14/21]

PREP Act Eligibility Expanded for Pharmacists, Pharmacy Technicians and Interns Administering COVID-19 Therapeutics

[10/01/21]

HHS’s New Practice Guidelines Reduce Certain Barriers to Buprenorphine Prescribing

[05/19/21]

HHS Advisory Opinion: Drug Manufacturers Must Offer 340B Program Discounts to Contract Pharmacies

[02/25/21]

OIG Finalizes Controversial Rule Updating AKS Discount Safe Harbor Applicable to Prescription Drug Rebates

[12/21/20]

New CMS Most Favored Nation Drug Pricing Rule Could Negatively Impact the Bottom Lines of Hospitals, Physician Practices

[12/04/20]

"340B Program in the Crosshairs: What the Next Few Months May Bring." AHLA, November 2020.

New DEA Pharmacist’s Manual: Top Five Changes Pharmacies Need to Know

[11/11/20]

D.C. Circuit Upholds 340B Drug Reimbursement Cuts: Is This the End of the Road?

[08/07/20]

Potential Compliance Program Effects of Proposed DEA Theft Reporting Rule

[08/05/20]

Assessing the Impact of the New Drug Pricing Executive Orders

[07/31/20]

Eligible Outpatient Facilities of 340B Hospitals Can Now Bypass Registration Delays

[06/05/20]

Hospitals Fear Pandemic May Threaten Their Eligibility to Participate in the 340B Drug Program

[05/29/20]

PREP Act Immunity for Pharmacists Ordering COVID-19 Tests: New HHS OGC Advisory Opinion Addresses Conflicting State Laws

[05/21/20]

Attention 340B Hospitals: CMS Cost Data Survey Due May 15 Raises Important Compliance Questions

[05/01/20]

FDA Issues Sterile Compounding Pharmacy PPE Guidance

[04/17/20]

A COVID-19 340B Update: OPA Updates Its GPO Prohibition Guidance and Other Outstanding 340B Program Issues

[03/25/20]

USP Publishes Guidance on Conserving PPE in Sterile Compounding and Compounding Hand-Sanitizer During COVID-19 Pandemic

[03/23/20]

COVID-19 Testing Update: Legal Considerations for Drive-Through Collection Sites, Diagnostic Testing Sites and Diagnostic Test Development

[03/20/20]

Informational Bulletin from CMS Addresses Best Practices to Avoid 340B Duplicate Discounts

[01/17/20]

Attention Nonresident Alaska Pharmacies, Distributors and 3PLs: State Implements New Nonresident Licensing Classifications and Prescription Requirements for Controlled Substances

[11/01/19]

Homeopathic Products Manufacturers Beware – FDA Steps Up Plans for New Enforcement Regime

[10/25/19]

What’s in YOUR Cannabidiol Product Claim? FDA and FTC Want to Know

[10/24/19]

Proposed CMS Hospital Survey Could Support CMS’s Efforts to Reduce 340B Drug Reimbursement

[10/07/19]

CMS Continues 340B Payment Cuts in 2020 OPPS Proposed Rule Yet Acknowledges Potential for Future Reversal

[08/02/19]

D.C. Court Decides Medicare 340B Program Payment Reduction Lawsuit Remedy: Spoiler Alert – The End Is Not Here

[05/08/19]

"Securing the safety net: Current compliance issues in Federally Qualified Health Centers." CT Magazine, May 2019.

340B Moving Forward: Legislative and Executive Branch 340B Priorities for 2019-2020

[04/19/19]

The 340B Crystal Ball: New Clarity on 340B Prices and the Program’s Future

[04/05/19]

Discount Disruption: PBM Rebate Protection May Be Removed, New Safe Harbors Combat Increasing Drug Costs

[02/01/19]

Impact Analysis: Federal Court Blocks 2018 Cuts to 340B Drug Discount Program Payments

[01/11/19]

Judge Rejects 2018 Cut to Medicare 340B Payments

CMS Proposes to Require Manufacturers to Disclose Drug Prices in TV Ads

[11/21/18]

FDA Issues New Draft MOU for 503A Compounders Governing Cross-Border Dispensing and Comments Related to CGMP Compliance for Outsourcing Facilities

[11/02/18]

Newly Enacted Opioid Law: How Does It Impact Providers?

[10/26/18]

CMS Allows Medicare Advantage Plans to Implement Step Therapy for Part B Drugs – Will It Really Lower Drug Costs or Simply Increase Administrative Burdens?

[09/19/18]

340B Program OPPS Payment Reductions and Legislative Limitation Proposals: What’s Smoke and What’s Fire?

[07/27/18]

Wisconsin Court Analyzes Relationship Between 340B and Wisconsin Medicaid Requirements in Important Overpayment Case

[07/13/18]

CMS Announces New Opioid Safety Measures for Part D Plan Sponsors: What Is Really Going On?

[05/23/18]

The Wave of PBM and Insurer Integration Continues as Cigna and Express Scripts Announce a Merger of Their Own

[03/16/18]

Medicare 340B Payment Cuts Go Live as of January 1. What’s Next?

[01/05/18]

Federal Judge Denies Hospitals’ Motion to Enjoin Imminent 340B Program Payment Cuts

[12/30/17]

Medicare’s 340B Payment Cut: What Does It Mean for All Hospitals?

[11/08/17]

340B in 2017 and Beyond: What Covered Entities and Contract Pharmacies Need to Know

[08/11/17]

Prescriber Enrollment Requirements for Part D Prescriptions: Enforcement to Begin in Early 2017

[04/19/17]

340B “Mega-Guidance” Withdrawn – Next Steps Unclear

[02/01/17]

Pharmacy Lawsuit Challenges Government Investigation After Relying on Purported Prior Telephone Assurance from Regulators

[01/25/17]

Pharmacy Fraud and Abuse: Operationalizing the New OIG Final Rule in an Integrated Care Environment

[01/04/17]

Efforts to Enhance Prescription Drug Pricing Transparency Gaining Traction: Implications for Pharmacy Stakeholders

[11/30/16]

New Wisconsin Pain Clinic Certification Requirement Enacted

[09/01/16]

7th Circuit Rules “Usual and Customary Pricing” Can Include Discount Programs

[05/31/16]

HRSA Delays Release of New 340B Guidance and Rules, Including the Omnibus Guidance

[05/24/16]

Prescription Drug Compounding Practices for Hospitals, Pharmacies and Outsourcing Facilities – New FDA Draft Guidance Released

[04/20/16]

FDA Again Delays Drug Product Tracing Obligations for Dispensers (Including Pharmacies and Physician Offices) to March 1, 2016

[11/02/15]

340B Program Omnibus Guidance: A Deeper Dive

[09/03/15]

Breaking: HRSA Releases Preliminary Version of Proposed 340B Omnibus Guidance

[08/27/15]

FDA Delays Enforcement of Dispensers’ Drug Product Tracing Obligations Until November 1, 2015

[07/01/15]

HRSA Proposes New 340B Regulations Including Civil Monetary Penalties for Charges Above the 340B Ceiling Price

[06/19/15]

340B Program House Subcommittee Testimony: Overview and Insights

[03/30/15]

DEA Final Rule Reschedules Hydrocodone Combination Products from Schedule III to Schedule II

[10/10/14]

Implications of the U.S. District Court Opinion Vacating the 340B Program’s “Orphan Drug” Final Rule and Regulations

[05/29/14]

CMS Issues Final Rule Establishing Medicare FQHC Prospective Payment System

[05/16/14]

President Signs Compounding Pharmacy Bill – First Related FDA Guidance Published

[12/01/13]

The Drug Quality and Security Act: Implications of the Proposed New Law for Compounding Pharmacies and the Pharmaceutical Supply Chain

[11/26/13]

CMS Issues Proposed Rule Establishing Medicare FQHC Prospective Payment System

[09/30/13]

HRSA Issues 340B Program Orphan Drug Final Rule and Regulations

[07/24/13]

HRSA Extends 340B GPO Exclusion Guidance Compliance Deadline from April 7, 2013 to August 7, 2013

[04/08/13]

CMS Proposes Changes Affecting Rural Health Care Providers

[02/19/13]

Allina Health DSH Case Implications: DSH Payments and 340B Eligibility

[02/14/13]

Opportunities for Pharmacies and Long-Term Care Facilities in the new DEA Proposed Rule for Controlled Substance Disposal, but what about Hospitals?

[12/28/12]

Proposed Drug Shortage Bill Threatens 340B Drug Discounts for Injectables

[12/13/12]

CMS Publishes CY 2013 Home Health Prospective Payment System Final Rule

[12/13/12]

HRSA Releases 340B Program Audit Guidance

[06/21/12]

Rural Health Clinic Medicare Deeming Authority Approved

[03/27/12]

340B Update: HRSA Issues Program Notice Addressing Ongoing 340B Program Audits

[03/09/12]

Possible Rural Health Clinic Deeming Authority on the Horizon – Comments Requested

[11/08/11]

Proposed Rule: Revised TRICARE Inpatient Payment Methodology for Sole Community Hospitals

[07/22/11]