David Ivill

David Ivill

McDermott Will & Emery

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OIG Reports on, Proposes Alternatives to Medicare Part B Reimbursement for 340B Drugs

In November 2015, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) published a report (the Report) on the subject of Medicare Part B (Part B) payments made for covered outpatient drugs...more

12/7/2015 - Covered Entities Drug Pricing HRSA Medicare Part B OIG Section 340B

Federal Court Rejects HHS Interpretation of 340B Program’s Orphan Drug Rule

On October 14, 2015, the United States District Court for the District of Columbia (the Court) issued a decision in Pharmaceutical Research and Manufacturers of America v. United States Department of Health and Human...more

10/21/2015 - Affordable Care Act FDA HHS Hospitals HRSA Judicial Review Omnibus Guidance Orphan Drugs Pharmaceutical Industry PHRMA Section 340B

HHS Releases Long-Awaited 340B Proposed Guidance

In August 27, 2015, the U.S. Department of Health and Human Services (HHS) released the long-awaited and much-anticipated proposed 340B Drug Pricing Program (340B Program) Omnibus Guidance (Proposed Guidance). The Proposed...more

9/1/2015 - Comment Period Covered Entities Draft Guidance Drug Pricing DSH Adjustments GPOs Health Care Providers Healthcare Healthcare Facilities HHS Hospitals MCOs Medicaid Medicare Pharmaceutical Industry Pharmacies Prescription Drugs Recordkeeping Requirements Recovery Audit Contractors (RACs) Section 340B

Proposed Rules Released Covering 340B Ceiling Prices and Manufacturer Penalties

On June 16, 2015, the U.S. Department of Health and Human Resources (HHS) and the Health Resources and Services Administration (HRSA) issued a notice of proposed rulemaking (Notice) related to the 340B Drug Pricing Program...more

6/17/2015 - Civil Monetary Penalty Covered Entities Drug Pricing HHS HRSA Pharmaceutical Industry Prescription Drugs Section 340B

House Subcommittee Circulates Proposed Legislation Providing Insight on the Future of the 340B Drug Pricing Program

The 340B Federal Drug Pricing Program (the 340B Program) requires pharmaceutical manufacturers to offer drugs at discounted prices to eligible hospitals, clinics and other entities for use in the outpatient setting. The 340B...more

5/27/2015 - Drug Pricing HHS HRSA Orphan Drugs Pharmaceutical Industry Prescription Drugs Proposed Legislation Section 340B

340B ‘Mega-Guidance’ Arrives at OMB

On May 6, 2015, the Health Resources and Services Administration (HRSA) submitted guidance on the 340B Federal Drug Pricing Program (340B Program) to the federal Office of Management and Budget (OMB) for review. ...more

5/8/2015 - Healthcare HRSA OMB Prescription Drug Coverage Prescription Drugs Section 340B

New Challenge to 340B Rule Regarding Orphan Drugs

On October 9, 2014, Pharmaceutical Research and Manufacturers of America (PhRMA) filed a complaint (the October 9 Complaint) against the U.S. Department of Health and Human Services (HHS), the Health Resources and Services...more

10/14/2014 - Affordable Care Act HHS Hospitals HRSA Orphan Drugs Pharmaceutical Industry PHRMA Rulemaking Process Section 340B

340B Federal Drug Pricing Program September Update: Self-Disclosures

As part of its ongoing series of monthly 340B Federal Drug Pricing Program (340B Program) integrity updates, the Health Resources and Services Administration (HRSA) Office of Pharmacy Affairs (OPA) released an update on...more

9/16/2014 - FDA HRSA Pharmaceutical Industry Prescription Drugs Section 340B

340B Registration Changes: Re-enrollment of Currently Participating Facilities and Eligibility Based on Amended Cost Reports

In April 2013, the federal Office of Pharmacy Affairs (OPA) released guidance instructing hospitals participating in the 340B Drug Pricing Program (340B Program) to register new outpatient facilities by service, rather than...more

6/24/2014 - Orphan Drugs Pharmaceutical Industry Prescription Drugs Section 340B

Federal Court Vacates 340B Rule Regarding Orphan Drugs

On May 23, 2014, the U.S. District Court for the District of Columbia issued a Memorandum Opinion in Pharmaceutical Research and Manufacturers of America v. United States Department of Health and Human Services, et al. At...more

6/2/2014 - Affordable Care Act Covered Entities HHS Hospitals Orphan Drugs Pharmaceutical Industry Section 340B

Two Recent 340B Developments: New Hospital Registration Guidance and Proposed Rules Under Review at OMB

Earlier this week, the much-anticipated 340B Drug Pricing Program (340B Program) proposed rule arrived at the Office of Management and Budget for review. Publication of this proposed rule is expected in June and will likely...more

4/11/2014 - Healthcare Hospitals OMB Prescription Drugs Section 340B

OIG Reports on Contract Pharmacy Arrangements in the 340B Program

On February 4, 2014, the U.S. Department of Health and Human Services, Office of the Inspector General (OIG) issued a memorandum report regarding contract pharmacy arrangements in the 340B Program. In its report, OIG found...more

2/12/2014 - Healthcare HHS Medicaid OIG Pharmacies Section 340B

HRSA Finalizes 340B Program Orphan Drug Exclusion Rules

On July 23, 2013, the U.S. Department of Health and Human Services Health Resources and Services Administration (HRSA) issued a long-anticipated Final Rule regarding the 340B Drug Pricing Program (340B Program) orphan drug...more

7/24/2013 - Exclusions FDA Final Rules GPOs Healthcare HHS HRSA Prescription Drugs Section 340B

340B Program GPO Prohibition Compliance Extension

Hospitals subject to the 340B Drug Pricing Program (340B Program) Group Purchasing Organization (GPO) prohibition now have an additional four months, until August 7, 2013, to comply with 340B Program guidance issued February...more

4/9/2013 - Compliance Extensions GPOs Pricing Requirements Section 340B

340B Drug Pricing Program Notices on Group Purchasing Organizations and Medicaid Exclusion File

Following the recent release of new Program Notices regarding the Group Purchase Organization (GPO) prohibition and Medicaid Exclusion File, 340B participating entities should review their 340B program policies and procedures...more

3/28/2013 - GPOs Healthcare Medicaid Pharmaceutical Industry Prescription Drugs Section 340B

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