On August 12, HRSA published a formal proposed rule regarding a 340B Drug Pricing Program administrative dispute resolution (ADR) process. HRSA’s use of the administrative rulemaking process is a rare occasion given its...more
8/30/2016
/ Arbitration ,
Comment Period ,
Covered Entities ,
Dispute Resolution ,
Drug Pricing ,
Healthcare ,
HRSA ,
Manufacturers ,
Pharmaceutical Industry ,
Prescription Drugs ,
Section 340B
On Wednesday, the United States District Court for the District of Columbia issued its highly anticipated opinion regarding the 340B orphan drug litigation. The Court ruled in favor of PhRMA, a trade association that...more
10/20/2015
/ Biopharmaceutical ,
Covered Entities ,
GPOs ,
Health Care Providers ,
Healthcare ,
Hospitals ,
HRSA ,
Orphan Drugs ,
Pharmaceutical Industry ,
PHRMA ,
Prescription Drugs ,
Rural Health Care Providers ,
Section 340B ,
Summary Judgment
As noted in our previous client alert, the Health Resources and Services Administration (“HRSA”) released its highly anticipated proposed 340B Drug Pricing Program Omnibus Guidance (“Guidance”). The Guidance offers updated...more
9/17/2015
/ AIDS ,
Covered Entities ,
Fee-for-Service ,
GPOs ,
Healthcare ,
HRSA ,
Managed Care Contracts ,
Medicare ,
Pharmaceutical Industry ,
Prescription Drugs ,
Section 340B
The Health Resources and Services Administration (“HRSA”) released an advanced copy of its long-awaited proposed 340B Omnibus Guidance (“Guidance”) today. The document can be found here. Polsinelli is currently reviewing the...more
On July 16, 2015, the Federal Register published Centers for Medicare and Medicaid Services' (CMS) proposed rule to reform the requirements for Long Term Care Facilities participating in Medicare and Medicaid. CMS will be...more
On July 16, 2015, the Federal Register published Centers for Medicare and Medicaid Services’ (CMS) proposed rule to reform the requirements for Long Term Care Facilities participating in Medicare and Medicaid. CMS will be...more
8/3/2015
/ Arbitration ,
Arbitration Agreements ,
Centers for Medicare & Medicaid Services (CMS) ,
Compliance ,
Department of Health and Human Services (HHS) ,
Ethics ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
Long Term Care Facilities ,
Long-Term Care ,
Medicaid ,
Medicare ,
Quality Assurance Programs
On July 13, 2015, CMS issued a proposed rule to reform the requirements for long term care facilities participating in Medicare and Medicaid. The 400-page proposed rule recommends the biggest overhaul to nursing home...more
The House Energy & Commerce Health Subcommittee on Health hearing entitled, “Examining the 340B Drug Pricing Program”, originally scheduled for Thursday, March 5th has been RESCHEDULED for March 24, 2015 at 10:00 a.m. EST. ...more
Thursday, March 5th at 10:00 a.m. EST, the House Energy & Commerce Health Subcommittee on Health will hold a hearing entitled, “Examining the 340B Drug Pricing Program.” The purpose of the hearing is to review the...more
Currently, Medicare patients that wish to receive palliative hospice care have a tough choice to make—forgo any curative treatment or incur all hospice care costs. This could change, however, with the recent launch of CMS's...more