U.S. Legislative/Regulatory News

1. CLMA, ASCLS and ASCP Join Together for Annual Legislative Symposium

The 2008 ASCLS/CLMA/ASCP Legislative Symposium was successfully held in Washington, D.C. on March 17-18. This year’s symposium marks the seventh consecutive year that CLMA has partnered with the American Society for Clinical Laboratory Science (ASCLS). The American Society for Clinical Pathology (ASCP) has been a cosponsor of the event for the past three years. Close to 140 attendees from all three organizations representing more than 40 states brought the laboratory community’s legislative agenda to Congress.

Each year day one of the Legislative Symposium provides guided education on the issues impacting clinical laboratories and how to successfully present them to lawmakers. Attendees learned about the current political climate through an update on the status of the Fiscal Year (FY) 2009 budget. Speakers presented an in depth review of the competitive bidding demonstration project for clinical laboratory services, and previewed draft legislation to modernize the clinical laboratory fee schedule (CLFS). ASCP provided an update on the status of the personnel shortage.

 Piper Su, Legislative Counsel for Senator Ken Salazar (CO), discussed the outlook for Medicare legislation in 2008 and efforts to repeal competitive bidding, and provided general thoughts on an alternative to modernize the CLFS. Senator Salazar serves on the Senate Finance Committee and sponsored the “Protecting Access to Clinical Laboratory Services Act of 2007(S 2099)” to repeal the competitive bidding demonstration project for clinical laboratory services.

 Kate Gross, Legislative Assistant to Representative Allyson Schwartz (PA), also discussed the outlook for Medicare legislation and efforts to repeal competitive bidding. Ms. Gross provided attendees with a staffer’s view of a constituent’s Hill visit as well. Representative Schwartz serves on the House Ways and Means committee and is a co-sponsor of the “Community Clinical Laboratory Fairness in Competition Act (HR 3453)” to repeal the competitive bidding demonstration project.

 Experienced attendees and those new to the symposium were equally well prepared as to what to expect and what to do when they arrived on Capitol Hill for appointments with their legislators on day two.

 The top two issues for this year’s symposium were once again competitive bidding for laboratory services and the personnel shortage.

Competitive Bidding:

The competitive bidding demonstration project for clinical laboratory Services is mandated by section 302 (e) of the “Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108-173)” and is to apply to laboratory tests paid under the Medicare Part B fee schedule performed by entities without a face-to-face encounter with patients. It excludes Pap tests and colorectal screening tests.

The objective of the demonstration is to determine if competitive bidding can be used to provide Medicare Part B clinical laboratory services at fees below the current fee schedule, while maintaining beneficiary access and quality of care.

There will be two demonstration sites, or Competitive Bid Areas (CBAs) based on Metropolitan Statistical Areas (MSAs), and the first demonstration site is already in progress. On October 16, 2007, he San Diego-Carlsbad-San Marcos, California MSA was announced as the first demonstration site and bids were accepted as of February 15, 2008. Bid Winners will be announced on April 11, 2008 and the demonstration will begin implementation on July 1, 2008.  ASCLS, CLMA and ASCP believe the demonstration is anti-competitive, will reduce the number of laboratory service providers, and must be stopped now.

Secondly, the President’s Fiscal Year (FY) 2009 budget proposal again includes a national competitive bidding program for laboratory services. ASCLS, CLMA and ASCP are concerned that the President’s proposal assumes budgetary savings (5 percent) from the implementation of competitive bidding before CMS can assess the demonstration to determine if savings are, in fact, realized or before it can be determined whether there are significant impacts to patients or providers that may result in greater overall costs to the Medicare program.

CLMA, ASCLS and ASCP Symposium attendees urged Congress to immediately support repeal of the competitive bidding demonstration project for laboratory services by co-sponsoring the “Protecting Access to Clinical Laboratory Services Act of 2007(S 2099)” and the “Community Clinical Laboratory Fairness in Competition Act (HR 3453).”

Personnel Shortage:

Clinical laboratories, like other allied health professions, continue to face a severe workforce shortage.

According to the Bureau of Labor Statistics (BLS), 15,000 new clinical laboratory professionals will be needed each year from 2004-2014, yet we are educating less than 5,000 per year. Also, the number of educational programs to train laboratory professionals and the number of graduates has declined over 30 percent over the last 10 years. Approximately 40 percent of the laboratory workforce is within 10 years of retirement.

In addition, the Title VII Allied Health Professions program provides the only federal funding to support training programs for clinical laboratory professionals. In 2005, Congress cut funding for allied health from $11.8 million to $4 million and eliminated special project grants under Title VII that fund medical technology training programs.

Title VII is also due for reauthorization. This provides the opportunity to include new provisions to help train laboratory professionals.

CLMA, ASCLS and ASCP support the “Allied Health Reinvestment Act (S 605) (AHRA).” The AHRA provides incentives for individuals to pursue allied health careers, including the laboratory profession. S 605 supports students interested in such careers and the institutions that train them. It assists with faculty development and provides for public service announcements to raise awareness about careers such as laboratory science.

Past legislation supported by the laboratory community like the “Medical Laboratory Personnel Shortage Act of 2005 (HR 1175),” which specifically addressed the workforce shortage for laboratory professionals, has not been successfully enacted. The AHRA combines the power of all the allied health professions, giving it a better chance of being enacted as opposed to legislation that focuses only on laboratory professionals. It also builds on the important contributions of the Title VII Allied Health Education Programs.

CLMA, ASCLS and ASCP symposium attendees urged Senators to support the AHRA and asked Representatives to sponsor a House version of the bill. They also urged lawmakers to restore funding to Title VII Allied Health Programs to FY 2005 levels. Finally they asked that Congress reauthorize the Title VII Allied Health Programs, including new provisions to help train laboratory professionals;

Modernizing the Clinical Laboratory Fee Schedule:

The current clinical laboratory fee schedule (CLFS) is outdated and irrational. It is based on 1984 data that does not reflect the current market place and updates have been frozen or limited for over 20 years. Clinical laboratories continue to be the target of cuts in reimbursement as Congress continues to look for health care savings. Also, the impending competitive bidding demonstration project, designed to extract such savings, will forever alter the laboratory service provider market in such a way that everyone in our industry may not survive.

CLMA and ASCLS believe the solution is to develop an alternative to the current broken payment system that will also counteract harmful policies like competitive bidding. We have are working towards a solution in which all factions of the clinical laboratory industry come together and determine a fair and rational method of payment, that is, one that is based on the current state of the industry, contains appropriate updates to keep pace with inflation, adequate payment for new technology and a level playing field for all laboratories.  Our goal is a fundamental solution that will benefit all types of laboratory providers.

CLMA and ASCLS have drafted the “Clinical Laboratory Fee Schedule Modernization Act of 2008” to put in place a process  that will result in the creation of a modernized clinical laboratory fee schedule.  The purpose of this legislation is to ensure patient access, involve relevant stakeholders, and create mechanisms for periodic updates while updating the fee schedule to reflect increased cost and enhanced technology.  This legislation requires the Secretary of Health and Human Services to convene a negotiated rulemaking committee that would seek consensus on a clinical laboratory fee schedule within two years.  If the negotiated rulemaking committee fails to reach consensus, Congress or the Secretary must enact a modernized fee schedule within a maximum of four years, three months.   The Medical Payment Advisory Commission ("MedPAC") would review the proposed updated fee schedule and provide its recommendations.

Representative Bart Stupak (MN) will introduce the bill on July 1, 2008. Legislative Symposium attendees asked Congress to repeal competitive bidding first and foremost. Attendees also stated that we are aware of Congress’ fiduciary responsibility towards Medicare and that we stand ready to help them meet that duty. We want to help CMS reconstruct the laboratory fee schedule so that we are fairly and appropriately reimbursed and to control costs for our services in the future. Our draft proposal for legislation to modernize the CLFS was presented as a way to accomplish these goals.

2008 advocacy materials regarding competitive bidding, the personnel shortage (S 605 AHRA), and a one-page summary of the CLMA/ASCLS draft legislation to modernize the CLFS are available in the Policy section at www.clma.org.  

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2. San Diego Laboratories Seek Preliminary Injunction
to Halt Competitive Bidding Demo

On March 17, 2008, Sharp HealthCare, Scripps Health, and Internist Laboratory of Oceanside filed for a preliminary injunction (PI) in Federal Court to again block the competitive bidding demonstration project for clinical laboratory services from going forward.

The three laboratories are plaintiffs in a lawsuit filed against U.S. Department of Health and Human Services (HHS) Secretary Michael Leavitt on January 29, 2008. The Clinical Laboratory Coalition (CLC), of which CLMA is an active member, fully supports the lawsuit.

The Centers for Medicare and Medicaid Services (CMS), as part of the Medicare Prescription Drug, Improvement and Modernization Act of 2003, chose the San Diego area as the first of two demonstration project sites to test competitive bidding for the procurement of clinical laboratory services.  The agency has already accepted bids on laboratory services and will select only a very limited number of laboratories to perform tests that will be reimbursed under Medicare Part B.  Those laboratories that don’t win the bid cannot bill for reimbursement of Medicare clinical laboratory services for the three-year duration of the project.  Rather than creating competition, it will result in fewer laboratories, less competition and the government in essence picking winners and losers.

Internist, Sharp HealthCare and Scripps Healthcare are fighting to be able to continue to serve San Diego residents.   These laboratories will either be forced to shut down all together or close laboratory outreach services if they aren’t selected as winning bidders.

On February 28, 2008, Sharp HealthCare, Scripps Health, and Internist Laboratory of Oceanside filed a response to the February 14, 2008 order denying a temporary restraining order (TRO) to block implementation of the competitive bidding demonstration project.

The court denied the TRO based on legal issues filed at the last minute by HHS. The government argued that stopping the demonstration project was premature, because no winners or losers had yet been chosen, thus laboratories in the San Diego area have yet to be harmed. They further questioned whether the federal court has jurisdiction, and argued that the court may in fact be precluded from reviewing the legality of the project due to purported jurisdictional and other technical legal impediments that are unique to the Medicare Program. The February 28^th filing by the plaintiffs disputed many of the government’s arguments. Requesting the PI is the next step in the legal process to halt the demonstration.

In the meantime, CMS is moving forward with the demonstration project in San Diego. Bids were due on February 15, 2008, CMS will announce bid winners on April 11, 2008, and implementation will commence on July 1, 2008.

 A hearing on the case for preliminary injunction (PI) has been scheduled for April 7, 2008.

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3. Competitive Bidding Action Alert Update:
Repeal Legislation Still Alive in 2008!

Support for repeal of competitive bidding among key lawmakers continues to grow, thanks to the phenomenal grassroots response from CLMA members.  CLMA sincerely thanks all members who have contacted Congress regarding competitive bidding.  Rest assured that these efforts are not in vain and repeal for competitive bidding is still alive for 2008!

Congress must revisit Medicare legislation mid-2008 when the six-month extensions included in the 2007 Medicare bill expire. This presents the opportunity to address provisions left out of the 2007 bill such as repeal of competitive bidding. Currently two repeal bills have been introduced; the “Protecting Access to Clinical Laboratory Services Act of 2007(S 2099)” and the “Community Clinical Laboratory Fairness in Competition Act (HR 3453).” Support for these bills moving forward is absolutely critical so that repeal of competitive bidding can be attached to the earliest possible legislative vehicle in 2008!

On October 2, 2007, CLMA launched a grassroots campaign to gain support for S 2099 and HR 3453, and CLMA members have more than answered the call to action. To date 1146 messages from 573 members have gone to the Senate, and 675 emails have gone to the House asking for co-sponsors for the repeal bills. We have reached 361 Senators and Congressmen combined so far!

These grassroots efforts continue to have an impact. In addition to Rep. Nydia Velazquez (NY), HR 3453 now has 36 co-sponsors. In addition to Senator Ken Salazar (CO), S 2099 now has 7 co-sponsors.  Representative Keith Ellison (MN) just joined as a co-sponsor on March 14, 2008.  

*To contact your Members of Congress, please use CLMA’s “one-click” advocacy software, CapWiz.  The links below will connect you to action alerts for both S 2099 and HR 3453. A template letter has been provided for each bill. You can customize the letter with your own story. Also, if your Member of Congress is already a co-sponsor of S 2099 or HR 3453, please customize the letter to thank them for their support. Your letter will automatically be emailed to your Members of Congress. The links below represent separate letters to your two Senators and to your Representative. Please click on each link separately in order to contact both the Senate and the House.

House Bill (HR 3453): http://capwiz.com/clma/issues/alert/?alertid=10372476
Senate Bill (S 2099): http://capwiz.com/clma/issues/alert/?alertid=10372386

Thank you for your support!

Links for Medicare Competitive Bidding Demonstration Project for Clinical Laboratory Services:
Frequently Asked Questions (FAQs):
http://www.cms.hhs.gov/DemoProjectsEvalRpts/downloads/MMA302b_Appendix_A.pdf  .
Final Bidders Package: http://www.cms.hhs.gov/DemoProjectsEvalRpts/downloads/MMA302b_Final_Bidder.pdf

Project Web Page: http://www.cms.hhs.gov/DemoProjectsEvalRpts/MD/itemdetail.asp?filterType=
dual,%20data&filterValue=Upcoming%20Demonstrations&filterByDID=
2&sortByDID=3&sortOrder=ascending&itemID=CMS1198949&intNumPerPage=10%20

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4. CMS Announces Implementation of New
ABN Form: Laboratories Need to Prepare Now!

As of March 3, 2008, CMS has replaced both the General Use Advanced Beneficiary Notice (ABN) (CMS-R-131-G) and the Laboratory ABN (CMS-R-131-L) with a new “Advanced Beneficiary Notice of Noncoverage (ABN) (CMS-R-131).” The new form and instructions are posted on the Beneficiary Notice Initiative (BNI) web page at www.cms.hhs.gov\bni.

The ABN is required as written notice to inform Medicare beneficiaries of their liability regarding non-covered services as outlined in Section 1879 of the Social Security Act (SSA). As required by the Paperwork Reduction Act (PRA) of 1995, the ABN is subject to public comment and re-approval every three years. CMS published a revised ABN form with 60-day comment period in the February 23, 2007 Federal Register, and a notice for additional 30-day comment in the May 25, 2007 Federal Register. The changes reflected in the new ABN form are based on suggestions made during each of these comment periods.

 Previously there were two approved versions of the form, the General Use ABN-G (CMS-R-131-G), and a version specifically for laboratory tests; ABN-L (CMS-R-131-L).The new version of the ABN combines the ABN-G and the ABN-L into a single notice, with an identical OMB number.  Although combined, the new notice does permit pre-printing of the laboratory-specific reasons for noncoverage of previously included on the ABN-L: 1) “Medicare does not pay for these tests for your condition”2) “Medicare does not pay for these tests as often as this (denied as too frequent)”3) Medicare does not pay for experimental or research use tests. According to the new instructions, CMS will provide alternate versions of the ABN, including one that illustrates the laboratory-specific use of the notice.

 Features of the new ABN include:

• A revised official title, the “Advance Beneficiary Notice of Noncoverage (ABN),” in order to more clearly convey the purpose of the notice;
• Replaces both the existing ABN-G and ABN-L;
• A mandatory field for cost estimates of the items/services at issue;
• May also be used for voluntary notifications, in place of the Notice of Exclusion from Medicare Benefits (NEMB) and;
• A new beneficiary option, under which an individual may choose to receive an item/service and pay for it out-of-pocket, rather than submit a claim to Medicare.

• Assign a person to be responsible to ensure the transition occurs smoothly.
• Read all of the documents CMS has provided so far and start making decisions about how your lab will handle the optional components of the form and implement any new instructions.  The earlier you do this the better because most of the remainder of these suggestions are dependent on these decisions. 
• If you are using a computer program or system to generate your ABN, contact the person or vendor representative for that system and make certain they are aware of the changes to the form and instructions so they can begin working on revising their system to accommodate the new form and the processes and requirements connected to it.  Instruct them to build as much flexibility as possible into the new system.
• Figure out how you are going to deal with the estimated cost not only for when your employees are the notifiers, but also when a physician is using the form on your behalf.
• Review your existing ABN policies and procedures and start revising them to meet the new requirements of the new form and instructions.
• If your laboratory is in a hospital or part of a health system, communicate with the other components of your system to make certain that all parties are coordinating their ABN transition efforts.  Remember, ABNs are used in many other area of healthcare beside labs.
• Plan to train all the affected employees.
• Revise your compliance program and compliance training to accommodate the changes you make to ABN policies and processes.
• If you included the old form as a part of your requisition, or had hard copies of the old forms printed and distributed, plan to remove and replace your requisitions or old forms by September 1, 2008
• If you plan to pre-print the form and provide hard copies to your blood drawing stations and customers, initiate that process as soon after you make the form decisions mentioned above, as possible. 
• Communicate with your customers about the new form and your specific policies and process changes.
• Monitor the CMS BNI website and watch for program transmittals for information about the new form and instructions.

*Additional content provided by Chris Young, CLMA Regulatory Consultant, Laboratory Management Support Services (LMSS), Phoenix, AZ.

          
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On March 18, 2008, CMS announced that National Government Services (NGS) has been awarded a contract of up to five years to serve as the Part A/Part B Medicare Administrative Contractor (A/B MAC) for Jurisdiction 13 (J13). J13 includes Connecticut and New York. NGS is based in Indianapolis, Indiana.

Section 911 of the “Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108-173) requires the Secretary of Health and Human Services (HHS) to implement Medicare Contracting reform by 2011.

This reform is intended to standardize contracting principles by introducing competition and performance incentives. Through open competition, A/B MACs will perform the functions of, and will replace current Fiscal Intermediaries and Carriers. The A/B MACs will be a provider’s primary point of contact and will receive, process, and pay all Medicare claims for both Part A and Part B. The full fee-for-service workload is scheduled to be transitioned over to the A/B MACs by October, 2009.

NGS will take over processing claims for two Fiscal Intermediaries (FIs) and four Carriers in Connecticut and New York. The A/B MAC contract is valued at $323 million over five years. It includes a base period and four one-year options that will provide NGS with the opportunity to earn award fees based on the ability to meet or exceed performance standards set by CMS. All MAC contracts will be recompleted every five years. NGS will immediately begin transition activities and will assume full responsibility for processing claims no later than November 2008.

NGS is the sixth A/B MAC contractor named by CMS to date.  Previous awards include the following:

• J3 (Arizona, Montana, North Dakota, South Dakota, Utah and Wyoming)- Noridian Administrative Services, LLC (NAS)
• J4 (Colorado, Oklahoma, New Mexico, and Texas)- Trailblazer Health Enterprises (Trailblazer)
• J5 (Iowa, Kansas, Missouri and Nebraska)- Wisconsin Physician Service Health Insurance Corporation (WPS)
• J12 (Delaware, Maryland, New Jersey, Pennsylvania, and the District of Columbia) - Highmark Medicare Services, Inc.
• J1 (California, Hawaii, Nevada, American Samoa, Guam and the Northern Mariana Islands) - Palmetto GBA

• J8 (Indiana, Michigan)
• J9 (Florida, Puerto Rico, U.S. Virgin Islands)
• J10 (Alabama, Georgia, Tennessee)
• J6 (Illinois, Minnesota, Wisconsin)
• J11 (North Carolina, South Carolina, Virginia, West Virginia)
• J14 (Maine, Massachusetts, New Hampshire, Rhode Island, Vermont)
• J15 (Kentucky, Ohio)

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ASSOCIATION NEWS

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7. Official Notification CLMA Annual Business Meeting

Official Notification

CLMA Annual Business Meeting 

JoAnne T. Milbourn,

CLMA President

March 27, 2008

To All Full Voting Members of CLMA:

As you are well aware, CLMA’s ThinkLab ’08, sponsored by Orchard Software, has been cancelled due to extensive damage that the Georgia World Congress Center sustained during the March 14, 2008 tornado.

While we are all devastated by the cancellation of our premier event, the business of CLMA must go on. One of the corporate events held during our conference is CLMA’s Annual Business Meeting.

According to CLMA Bylaws Article IV Section 1: “The Annual Meeting of the Members shall be held in conjunction with the Annual Conference.”  While this will not be possible in 2008, the CLMA Board of Directors has decided to hold the Annual Business Meeting via teleconference.

Further, Article IV Section 2 states “Notice of the Annual Meeting shall be given to each member at least thirty (30) days before the date of the meeting.”This correspondence, dated March 27, 2008, serves as Official Notification of the CLMA Annual Business Meeting to be held via audio conference on Monday, April 28, 2008 at 3:00 p.m. Eastern Time. So that a quorum may be established, below please find registration instructions for CLMA’s Annual Business Meeting.

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1. Click here to register. (there is no registration fee for this audio conference). Please enter the word REGISTRATION in the Subject Line and be sure to include your full name and CLMA ID Number within the body of the email. Registration is now open and will close at 12:00 noon Eastern Time, Thursday, April 24, 2008.
2. If you are a valid, full-voting CLMA member and have registered for the call, the dial-in number, Conference ID, and Agenda will be emailed to you before 5:00 p.m. Eastern Time on Thursday, April 24, 2008.
3. At 2:45 p.m. Eastern Time on Monday, April 28^th, dial into the call using the dial-in number and Conference ID provided. An operator will ask you for your membership ID Number, and, after validating it against the roster, will place you into the meeting.

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EDUCATION NEWS

• Last chance to register for AudioLab presentation: Strategies to Reach Quality, Services, and Financial Goals for Laboratories.
  Click here for registration details.
  
  
• First LIS AudioLab presentation: What are the Options for my Vintage LIS? to be held Wed, April 23. Click here for registration details.
  CLMA is extremely grateful to Antek HealthWare for their sponsorship of the LIS series. The pricing for the LIS series would not have been possible without their generous support.  

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