Ober, Kaler, Grimes & Shriver, A Professional Corporation  
Ober|Kaler Health Law Alert - Summer 2007




In this Issue

From the Chair

Guide to Terms

Welcome

Ober|Kaler in Print

OIG
Advisory Opinion on Sale of Ownership Interests Raises Questions

E-prescribing and Electronic Health Records Protection

Physician Investments in Medical Device Industry

OIG Advisory Opinions

CMS
New Enrollment Regulations: Protect Your Current Medicare Participation

PHARMA
Behind the Scenes: Drug Company Patent Infringement Settlements

Hospitals
FY 2007 Wage Index and the Occupational Mix Adjustment

Medical Education Under Medicare: Confusion over Didactic Time

DME
Final DMEPOS Quality Standards

Self-Referral
CMS Plan Focuses on Physician Ownership in Specialty Hospitals e

FCA
OIG Guidelines for Evaluating State False Claims Acts

Rule 9(b) Does Not Require Pleading of Specific Claims

Business
Heed Insurance Coverage in Constructing and Renovating Health Care Facilities

Physician Focus
Planning to Charge a Yearly "Overhead" Fee? Proceed with Caution

 



Health Law Group

Sanford V. Teplitzky, Co-Chair

S. Craig Holden, Co-chair

Alan J. Arville

Melinda B. Antalek

William E. Berlin

Christi J. Braun

Kristin C. Cilento

Marc K. Cohen

Thomas W. Coons

John J. Eller

Joshua J. Freemire

Leslie Demaree Goldsmith

Lindsay E. Greenwood

Carel T. Hedlund

Leonard C. Homer

Thomas K. Hyatt

Julie E. Kass

Paul W. Kim

John F. Lessner

William T. Mathias

Robert E. Mazer

Carol M. McCarthy, Ph.D.

John J. Miles

Christine M. Morse

Patrick K. O'Hare

A. Thomas Pedroni, Jr.

Martha Purcell Rogers

Laurence B. Russell

Donna J. Senft

Ray M. Shepard

Steven R. Smith

Howard L. Sollins

E. John Steren

Chiarra-May Stratton

Emily H. Wein

James B. Wieland

Editorial Assistant:
Michele Vicente, Paralegal

 

From the Chair

Sandy Teplitzky, Chair of Ober|Kaler's Health Law GroupAs we work our way through the “summer doldrums,” we find that there are still many new developments relating to the area of health law. The most recent, and perhaps most significant, relates to the issuance by CMS, on July 12th, of the proposed 2008 Physician Fee Schedule. This document included a significant number of proposed changes and issues for consideration relating to the Stark physician self-referral law. Some of the most notable proposed changes relate to the Medicare reassignment and purchased diagnostic test rules, the in-office ancillary services exception to Stark, unit-of-service (per-click) payments in space and equipment leases, the Stark “set in advance” rules, Medicare rules relating to services furnished “under arrangements,” alternative methods for satisfying Stark exceptions, and the period of disallowance for noncompliant financial relationships.

In a number of areas, CMS has proposed specific changes. In others, they have simply requested comments and suggestions to assist in the development of proposed regulations to be published in the future. The publication also included a number of changes with respect to Independent Diagnostic Testing Facilities, Medicare Part B drug payment, as well as ESRD- and CORF-related issues.

The final changes to the Physician Fee Schedule and a number of the proposed Stark changes should be published later this year, in October or November, with an effective date of January 1, 2008. Additionally, as we wait for the temperature and humidity to drop, we also anticipate the publication of the Phase III Stark regulations in the near future (and probably before this issue of the Health Law Alert is published). Thus, you can expect a detailed discussion of the two documents in the next issue of the Health Law Alert.

This issue contains a number of extremely important developments, including the new Medicare enrollment regulations, a discussion of the issue of education under Medicare, the 2007 wage index and occupational mix adjustment, and the CMS strategic and implementing plan addressing physician ownership in specialty hospitals. We also present discussions of a large number of the OIG advisory opinions issued since our last Health Law Alert.

On the “what have you done for us lately” front, I want to announce a number of new publications. First, by the time you receive this Health Law Alert, you probably will have received at least one issue of our Payment Matters, a new e-mail initiative to bring you reimbursement-related developments as they occur. This publication will not replace the Health Law Alert, which will remain our vehicle for bringing you in-depth analysis on new developments and what they may mean to you and your organization.

Further, the Ober|Kaler Corporate Law Practice Group has begun to send out a number of client mailings of interest to both our health care and non-health care clients. The latest mailing in this area summarizes the Securities & Exchange Commission’s new guidance governing management’s report on internal control over financial reporting. This publication also discusses the Public Company Accounting Oversight Board’s new Accounting Standard No. 5, which addresses outside auditors’ audits of internal control. If you have not received either of these publications, and wish to do so, please contact our Marketing Department at marketing@ober.com.

On the personnel front, I am extremely pleased to announce that Tom Pedroni has recently joined our Health Law Practice Group. Tom brings nearly two decades of health care experience to Ober|Kaler with a practice area that includes health care institutions, physicians and dentists, health information technology, insurance, risk management, and alternative risk financing. We are certain that Tom will bring added value and insight to our health care clients.

It is with mixed emotions that I inform you that Leon Rodriguez recently left Ober|Kaler to become the County Attorney for Montgomery County, Maryland. This move is a wonderful opportunity for Leon as he continues to pursue his goal of public service and we wish him the best of success.

I also want to acknowledge Mary Ellen Chambers for her years of service to Ober|Kaler and specifically, to our Health Law Alert. Together with Michele Vicente (who thankfully is still with us and without whom we could not function), Mary Ellen was responsible for ensuring the timeliness and quality of our Health Law Alert. We wish Mary Ellen success as she takes on new challenges.

Finally, it is with great pride that I inform you that a publication entitled “Guide to the Leading US Lawyers - Best of the Best USA 2007” recently announced its list of the 31 most accomplished health care lawyers in the country. Ober|Kaler was honored to have six attorneys included in the list: Len Homer, Craig Holden, Tom Hyatt, Jeff Miles, Tom Coons, and myself. The list was chosen by in-house counsel and other health care lawyers and names many of our friends and colleagues from other firms for whom we have great respect. We are pleased at this recognition of our efforts to serve our clients.

Thanks again to all of you who have written or called with suggested topics for our Health Law Alert. Our goal is to be as responsive and helpful to our clients and friends as possible and thus, hearing from you in this regard is extremely helpful to us.

I hope that you enjoy the remainder of the summer. It appears that there will be much for us to discuss in the next issue of the Health Law Alert.

Copyright© 2007, Ober, Kaler, Grimes & Shriver