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New 340B Dispute Resolution Process: Will It Level the Playing Field?

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

MedPAC Report Recommends Reduction in Medicare Part B Payments to 340B Hospitals

On March 15, 2016, the Medicare Payment Advisory Commission (MedPAC) released its latest report to Congress that included 340B Implications for Medicare Part B Drugs along with a quick fact sheet regarding the report. Key...more

Orphan Drug Ruling Disrupts the 340B Program

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

Summary of Key 340B Omnibus Guidance Proposals

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

Breaking News: Proposed 340B Omnibus Guidance Released

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

Impending Deadline: CMS Issues Proposed Rule Reform for Long Term Care Facilities – Part 4 of 4

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

Impending Deadline: CMS Issues Proposed Rule Reform for Long Term Care Facilities – Part 3 of 4

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

CMS Issues Proposed Rule Reform for Long Term Care Facilities - Part 1 of 4

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

Special Update: OPA Sends 340B Program Omnibus Guidelines to Office of Management and Budget

On Wednesday, May 6, the Health Resources and Services Administration, Office of Pharmacy Affairs (“OPA”) forwarded a draft copy of its 340B Program Omnibus Guidelines (“Guidelines”) to the Office of Management and Budget for...more

RESCHEDULED: 340B in the Spotlight: Congress Offers Webcast of Upcoming Hearing Regarding the 340B Drug Pricing Program

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

340B in the Spotlight This Thursday: Congress Offers Webcast of Upcoming Hearing Regarding the 340B Drug Pricing Program

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

340B State of Affairs – Study Reveals Benefits to Vulnerable, Chronically Ill Patients

The 340B provider community received welcome news from a recent study published by Health Affairs, which published a long-awaited report analyzing 12 months of outpatient prescription data to identify trends in 340B contract...more

Breaking 340B News: HRSA Withdrew its Much-Anticipated 340B Mega-Reg

On Thursday, HRSA formally withdrew its much-anticipated 340B Mega-Reg from the rulemaking process, effectively abandoning its effort to overhaul existing 340B program guidance through new regulations. Commander Krista...more

11/18/2014  /  HRSA , Rulemaking Process , Section 340B

Recent 340B Orphan Drug Decision May Have Widespread Implications

In This Issue: - Orphan Drug Rule Background - PhRMA Sues to Block the Orphan Drug Rule - District Court Says HHS Overstepped Its Authority and Invalidates Orphan Drug Rule - Implications on the...more

Don't Be Left On The Sidelines: CMS Is Seeking Applications For A New Hospice Demonstration Program

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

Proceed With Caution: Contracts Between Senior Communities And Placement Agencies May Not Violate The Anti-Kickback Statute

In This Issue: - Background of the Arrangement - The OIG’s Analysis: How the Senior Communities Reduced Their Risk - What Providers Should Know - Excerpt from Background of the Arrangement: The...more

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