Emily J. Cook

Emily J. Cook

McDermott Will & Emery

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Program Integrity Changes to the Medicare Provider Enrollment Process

On March 1, 2016, the U.S. Department of Health and Human Services Centers for Medicare & Medicaid Services (CMS) published a proposed rule (Proposed Rule) entitled “Medicare, Medicaid, and Children’s Health Insurance...more

3/11/2016 - Affordable Care Act Billing CHIP CMS DMEPOS Enrollment Healthcare Medicare Overpayment Provider Payments

MedPAC Votes to Recommend Changes to 340B Drug Payment Under Medicare Part B

For most of the past year, the Medicare Payment Advisory Commission (MedPAC) has been examining Medicare Part B payments to hospitals that participate in the 340B drug purchasing discount program in an effort to better align...more

1/28/2016 - Drug Pricing Hospitals Medicare Part B MedPAC Prescription Drugs Section 340B

CMS Finalizes Prior Authorization Program for Certain DMEPOS Items

On December 30, 2015, the Centers for Medicare & Medicaid Services (CMS) published its final rule establishing a prior authorization program for certain durable medical equipment, prosthetics, orthotics and supplies (DMEPOS)...more

1/8/2016 - CMS DMEPOS Durable Medical Equipment Final Rules Medicare Prior Authorization Provider Payments

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

CMS Finalizes Controversial Changes to "2-Midnight Rule" for Inpatient Stays

On October 30, 2015, the Centers for Medicare & Medicaid Services (CMS) released its final rule updating the Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System for...more

11/10/2015 - Ambulatory Surgery Centers CMS Final Rules Hospitals OPPS Physicians Two-Midnight Rule

Congress Take Step Toward Site-Neutral Medicare Payments in Bipartisan Budget Act of 2015

On October 28, 2015, the U.S. House of Representatives approved legislation that, if enacted, would, among other things, substantially alter how and how much Medicare pays for outpatient services furnished by hospitals. The...more

10/30/2015 - Ambulatory Surgery Centers CMS Debt Ceiling Federal Budget Generic Drugs Health Care Providers Healthcare Hospitals HRSA Medicaid Medicare Medicare Part B OPPS Pending Legislation Physician Fee Schedule Physicians Prescription Drugs Rebates Section 340B Sequestration

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

CMS Addresses Current Position on Supervision and Practitioner Qualifications Under ‘Incident-To’ Billing Rules

Among the proposed changes to Medicare regulatory requirements related to billing and coverage of physician services set forth in the 2016 Medicare Physician Fee Schedule Proposed Rule (the Proposed Rule), the Centers for...more

7/21/2015 - CMS Health Care Providers Medicaid Medicare Nurse Practitioners OIG Physician Fee Schedule Physicians Proposed Regulation Stark Law Supervision

CMS Proposal Broadens Medicare Inpatient Reimbursement Eligibility Under the “2-Midnight Rule"

On July 1, 2015, the Centers for Medicare & Medicaid Services (CMS) released proposed updates to the Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System for Calendar Year...more

7/8/2015 - Ambulatory Surgery Centers CMS Health Care Providers Hospitals Inpatient Billing Medicaid Medicare Medicare Administrative Contractors (MAC) Medicare Part A OPPS Physicians Proposed Regulation Recovery Audit Contractors (RACs) Two-Midnight Rule

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

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 (IPPS) 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 - 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

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 Inpatient Prospective Payment System (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 - 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

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

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