Eric Zimmerman

Eric Zimmerman

McDermott Will & Emery

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

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 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

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

The American Taxpayer Relief Act of 2012 and Anticipated Medicare and Medicaid Payment Reforms

On January 1, 2013, the U.S. Congress approved the American Taxpayer Relief Act of 2012 (the Act), concluding a protracted debate on how to prevent the United States from falling over the proverbial “fiscal cliff.” President...more

1/9/2013 - American Taxpayer Relief Act Fiscal Cliff Income Taxes Medicaid Medicare

Reimbursement Issues Facing Molecular Pathology Services in Calendar Year 2013 and Beyond

The Centers for Medicare & Medicaid Services recently issued final regulations and a final payment guidance that address reimbursement for laboratories furnishing molecular pathology services. While the publications answer...more

11/15/2012

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