Emily J. Cook

Emily J. Cook

McDermott Will & Emery

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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 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 - 340B FDA HRSA Pharmaceutical Prescription Drugs

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 - 340B Orphan Drugs Pharmaceutical Prescription Drugs

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 - 340B Affordable Care Act Covered Entities HHS Hospitals Orphan Drugs Pharmaceutical

CMS Proposal to Implement New Metropolitan Areas Would Affect Medicare Payments for Most Hospitals

The Centers for Medicare & Medicaid Services (CMS) recently issued the federal Fiscal Year 2015 Medicare Inpatient Prospective Payment System Proposed Rule, which contains a proposal to implement new metropolitan areas...more

5/7/2014 - CMS Healthcare Hospitals Inpatient Prospective Payment System Medicare OMB

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 - 340B Healthcare Hospitals OMB Prescription Drugs

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 - 340B Healthcare HHS Medicaid OIG Pharmacies

CMS Again Delays Implementation of Controversial “2 Midnights Rule"

Hospitals gearing up for implementation of the “2 Midnights Rule” have more time to prepare—or consider joining efforts to modify or rescind the rule—now that CMS has delayed implementation for a third time....more

2/4/2014 - CMS Healthcare IPPS Medicaid Medicare

Federal Office of Rural Health Policy Releases Updated List of Rural Counties and Census Tracts

The federal Office of Rural Health Policy (ORHP) recently released its updated list of counties and census tracts that are designated as “rural” based on 2010 U.S. Census data and the Rural Urban Commuting Area Code (RUCA)...more

1/8/2014 - Healthcare Rural Development Rural Health Care Program Rural Health Care Providers

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 - 340B Exclusions FDA Final Rules GPOs Healthcare HHS HRSA Prescription Drugs

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 - 340B Compliance Extensions GPOs Pricing Requirements

New Metropolitan Areas Could Affect Medicare Payment, Regulations

The U.S. Office of Management and Budget recently announced new Metropolitan Areas based on revised standards and 2010 census data. If adopted by Medicare, which they typically are, these changes would affect many aspects of...more

3/28/2013 - Census CMS Fraud Healthcare Medicare OMB Provider Payments

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 - 340B GPOs Healthcare Medicaid Pharmaceutical Prescription Drugs

CMS Issues Second Set of Proposed Rule in Response to Executive Order 13563

The proposed rule, issued on February 7, 2013, would make reforms to existing Medicare regulations applicable to hospitals, ambulatory surgical centers, intermediate care facilities for individuals who are intellectually...more

2/21/2013 - Ambulatory Surgery Centers Clinical Laboratories CMS Critical Access Hospitals Hospitals Long Term Care Facilities Medicaid Medicare Organ Transplant Centers Rural Health Care Providers

Overview of 2013 Final Rule on DME Written Order and Face-to-Face Encounter Requirements

In the 2013 Medicare Physician Fee Schedule final rule, the Centers for Medicare & Medicaid Services significantly expands the list of durable medical equipment (DME) items that will require a face-to-face encounter and...more

11/14/2012

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