Eric Zimmerman

Eric Zimmerman

McDermott Will & Emery

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Latest Publications


340B Program Rules to Remain Unclear

As had been widely anticipated, late on January 30, 2017, the Department of Health and Human Services (HHS) withdrew the 340B Program “Mega-Guidance” that had been under review at the Office of Management and Budget (OMB)...more

2/3/2017 - HHS OMB Section 340B

21st Century Cures: Congress Approves Legislation Expanding Hospital Site-Neutral Payment Exceptions and Making Other Payments...

The 21st Century Cures Act encourages biomedical research investment and facilitates innovation review and approval processes, but also serves as a vehicle for a wide variety of other health-related measures, including...more

12/8/2016 - 21st Century Cures Initiative Healthcare Hospitals Long Term Care Facilities Medicare Off-Campus Departments Physical Therapists

Briefing Points for the Board: The Election and the 2017 Health Policy Agenda

It is vitally important for the health system board, as well as certain of its key committees, to receive an introductory briefing as soon as possible on the health policy implications of last week’s Presidential and...more

11/15/2016 - Affordable Care Act Alternative Payment Models (APM) Fee-for-Service Healthcare Reform Medicaid Expansion Medicare Presidential Elections Trump Administration

CMS Releases CY 2017 Final Rule Implementing Changes to Outpatient Prospective Payment System

The Centers for Medicare & Medicaid Services released the calendar year 2017 final rule implementing changes to the Medicare hospital Outpatient Prospective Payment System, or OPPS, including provisions implementing Section...more

11/3/2016 - Bipartisan Budget Act CMS Drug Pricing Final Rules Hospitals Medicare MPFS Off-Campus Departments Outpatient Prospective Payment System (OPPS) Section 340B

HHS Proposes Administrative Dispute Resolution Process for 340B-Related Claims

On August 12, 2016, the US Department of Health and Human Services (HHS) Health Resources and Services Administration issued a notice of proposed rulemaking that establishes an administrative dispute resolution process for...more

8/17/2016 - Administrative Proceedings Advanced Notice of Proposed Rulemaking (ANPRM) Affordable Care Act Covered Entities Dispute Resolution Government Claims HHS HRSA Manufacturers Prescription Drug Coverage Prescription Drugs Proposed Rules Section 340B Statute of Limitations

CMS Proposed Rule Implements Limitations on Medicare Payments for Off-Campus Outpatient Hospital Departments

In Depth - Background - On July 6, 2016, the Centers for Medicare & Medicaid Services (CMS) released the CY 2017 Outpatient Prospective Payment System (OPPS) Proposed Rule, which includes proposed regulations to...more

7/12/2016 - Ambulatory Surgery Centers Bipartisan Budget Act CMS Comment Period Hospitals Medicare MPFS Off-Campus Departments OIG OPPS Payment Systems Physician Fee Schedule Proposed Rules Section 340B

Managing the Transition to Transformation: The Strategic Implications of MACRA

In Depth - On April 27, the Centers for Medicare and Medicaid Services (CMS) unveiled the much-anticipated (and, for some, feared) proposal to implement the physician payment reforms required under the Medicare Access to...more

7/6/2016 - CMS Health Care Providers Hospitals Medicaid Medicare Medicare Access and CHIP Reauthorization (MACRA) Physician Payments

Congress Considers Broader Hospital Site-Neutral Payment Exceptions and Other Payments Changes

In Depth - The House Ways and Means Committee next week is expected to consider and approve the Helping Hospitals Improve Patient Care Act of 2016, legislation that would create broader exceptions under much maligned...more

5/23/2016 - Ambulatory Surgery Centers Bipartisan Budget CMS Hospitals Inpatient Prospective Payment System (IPPS) Meaningful Use Medicare OPPS Rural Health Care Providers Ways and Means Committee

CMS Finalizes Mandatory Bundled Payment Model for Lower Extremity Joint Replacements

On November 16, 2015, the Centers for Medicare & Medicaid Services (CMS) released final regulations implementing the Comprehensive Care for Joint Replacement Model, its five-year mandatory bundled payment program for hip and...more

11/24/2015 - Bundled Payments CCJR CMMI CMS Final Rules Hospitals Medicare Value-Based Payments

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

King v. Burwell Decision Upholds Subsidies in Federal Exchanges

On June 25, 2015, the Supreme Court of the United States ruled in King v. Burwell that the Affordable Care Act (ACA) requires premium tax credits to be made available in states that use a federal exchange. The case challenged...more

6/26/2015 - Affordable Care Act Chevron Deference Health Insurance Health Insurance Exchanges Individual Mandate IRS King v Burwell SCOTUS Subsidies Tax Credits

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

Anticipated Framework for Regulatory Oversight of Laboratory Developed Tests

Historically, the U.S. Food and Drug Administration (FDA) has exercised enforcement discretion with respect to most laboratory developed tests (LDTs) and has not required laboratories that furnish LDTs to comply with FDA’s...more

8/7/2014 - CLIA Clinical Laboratories FDA Laboratory Developed Tests

U.S. Appeals Courts Issue Conflicting Decisions on Whether ACA Permits Tax Subsidies of Health Care Coverage Purchased Through...

On July 22, 2014, three-judge panels of the U.S. Courts of Appeals for the District of Columbia and Fourth Circuits issued conflicting decisions regarding whether the Affordable Care Act (ACA) permits federal tax credits for...more

7/25/2014 - Affordable Care Act Halbig v Burwell Healthcare IRS King v Burwell Subsidies Tax Credits

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

Sweeping Changes to Medicare Payment for Clinical Laboratory Services

On March 31, 2014, the Senate gave final approval to the Protecting Access to Medicare Act of 2014 (the Act), which includes significant reforms to the way Medicare pays for clinical diagnostic laboratory services. The House...more

4/2/2014 - Clinical Laboratories Healthcare Healthcare Reform Medicare

Congress Approves Legislation Extending and Changing Medicare Programs

On March 31, 2014, the U.S. Senate approved comprehensive Medicare legislation reauthorizing and extending dozens of Medicare payment enhancements, but also making several substantive changes that will profoundly impact...more

4/2/2014 - Healthcare Healthcare Reform Medicare Shareholders

CMS Take Steps to Modernize Clinical Lab Policies

Through two recently issued regulations, the Centers for Medicare and Medicaid Services have announced their intention to reform and improve Medicare policies addressing clinical diagnostic laboratory services. These...more

2/12/2014 - Clinical Laboratories CMS Healthcare 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

CMS Announces Plans to Modernize and Update the Clinical Laboratory Fee Schedule

On November 27, 2013, Centers for Medicare & Medicaid Services posted the final 2014 Medicare physician fee schedule and, in it, announced plans to change how and how much Medicare pays for clinical diagnostic laboratory...more

12/17/2013 - Clinical Laboratories Diagnostic Tests Fees Health Care Providers Healthcare Healthcare Reform Laboratories Medicaid Medicare Physician Fee Schedule Physicians

Lawmakers Reach Deal to End Government Shutdown, Raise Debt Ceiling

While the focus over the past 16 days has been on the shuttered government and the prospect of the United States defaulting on its debt obligations, there are subtexts that are relevant to the health care industry. This On...more

10/18/2013 - Affordable Care Act CMS Debt Ceiling Federal Budget Government Shutdown Medical Device Tax Medicare Sequestration

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

Significant Proposed Changes for Federal Health Care Programs in President’s Fiscal Year 2014 Budget Plan

On April 10, 2013, President Obama released his budget proposal for fiscal year (FY) 2014 (the Budget). The President reiterated his long-standing goal of reducing the deficit by $4.3 trillion over 10 years and his...more

4/19/2013 - Bad Debt Barack Obama Biologics CMS Deficit Reduction Federal Budget Fraud and Abuse Generic Drugs Healthcare Hospitals Medicaid Medicare Medicare Advantage Medicare Part D Patient Self-Referral Pharmaceutical Industry Physician Payments

CMS Offers Partial Concession to Hospitals by Issuing Ruling, Proposed Rule on Part B Re-Billing

The U.S. Centers for Medicare & Medicaid Services (CMS) recently released both a “ruling” and a proposed rule intended to address growing concern among hospitals about billing Medicare Part B following a medical necessity...more

3/29/2013 - CMS Hospitals Medicare Medicare Part B

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