CCLA Board Meeting



CCLA Board MeetingThursday, February 19, 201510:00 am – 2:00 pmMeeting MinutesEmbassy Suites LAX North9801 Airport BlvdCALL TO ORDERMeeting called to order by Julie Ramage, at 10:01 AM PSTMEETING ATTENDEESAttendeeCompanyAttendeeCompanyAmy McNealBioceptKen NealLabCorpBill Gardner?Kim LerouxCM DiagnosticsBonnie FisherXifinKristen BlanchetteDWTBrittany RambinoAltheaDxKristi FoyCCLACheryl StokesPhysician's Automated LaboratoryLaurie HowardLabCorpChristine VernuskyQuestLee HilborneQuestCurtis JohnsonSpectraLinacel Cadden Cedars-Sinai David GeeDWTLiza VismnosLotus LaboratoriesDeon ChenPrometheusLorri Dean-YoakumLabCorpHeather HoldbergPacToxMarlk OldroydFoundation Medicine Inc.Jack JiAriosa DiagnosticsMelissa WoodGenomic HealthJean Amos WilsonAltheaDxMichael ArnoldCCLAJeff LanzolattaPacToxRam VairavanPersonalizeDx LabsJenna TaylorAccurate Courier Services, Inc.Rana OstradrahimiPacToxJoan KegerizeGMBIRobert FootlikCedars-Sinai Joanne IkedaSpectraSukhee NeeABC LabsJon Nakamoto QuestVickie AumentProovebioJoyce HulenPhysician's Automated LaboratoryWalt WilliamsGenoptix, Inc. Julie RamagePfizerWendy MorrayPrometheusAPPROVAL OF MEETING MINUTESJanuary Meeting MinutesMotion to approve, motion carried. Minutes approved as submitted. HOT TOPICS FOR DISCUSSIONCCLA LCD Lawsuit Update– Kristi FoyGovernment filed motion to dismiss in July 2014 by raising jurisdictional issuesOn February 2nd, 2014 Patric Hooper presented oral arguments in regards to the motion to dismiss.Anticipated that the judge will issue written decision in the next 60 days.It is not unusual for the judge to side with the government especially on jurisdictional issues.After receiving the written decision, there will be time to decide on the next action.New Legislative Session: State Budget, New Legislation, Etc – Kristi FoyBob Footlik is retiring in a couple more months and CCLA recognized him with a plaque for his many years of dedication as the CCLA legislative committee ernor introduced budget in January. Budget is carefully balanced.The state has eliminated $20 billion in structural deficitsThe increase in Medi-Cal population is a big hit on the budget. Last open enrollment period was recently completed. We have seen about a 50% increase in Medi-Cal enrollment. Governor is against restoration of previous budget cuts. The Governor does not want to restore the cuts since he feels the budget is now carefully balanced. It is anticipated the budget will be passed on time (Mid June) and will be in place by new fiscal year – July 1st, 2015.By the end of 2015, there will be 12 million Californians on Medi-Cal. Will cost $98B/year. 72% of beneficiaries are in Medi-Cal Managed Care. They are trying to move the remaining 28% currently on Fee For Service Medi-Cal to Medi-Cal Managed Care.The Governor is cautious on the budget because the Federal government is currently paying 100% of the cost until 2020 then it will be reduced to 90%. The difference will then be the state’s responsibility.Medi-Cal program will continue to expand.This is the start of the 2 year Legislative Sesion.Bill introduction deadline is February 27, 2015.The bills have been very slow to come in this year.People are either introducing less bills or procrastinating.The new term limits allow a member to stay in the Assembly or Senate for 12 years so it seems to have taken away the sense of urgency by the member. Legislative Status Report details all the bills that CCLA is tracking. There are currently 10 bills on the report.By the March meeting, we will know the landscape of all the bills introduced.In regards to new legislation, CCLA will be sponsoring a bill. It realtes to Laboratory Personnel. CCLA should have a bill number by the March meeting.Quest Diagnostics is thinking about a bill regarding in-office Phlebotomy Services. This was previously distributed to the CCLA membership. Bill has not been formally introduced so there is no bill number. CCLA cannot take a position on the bill until CCLA reviews the official language of the LA will revisit this topic at the next meeting if the Quest legislation has been introduced. There is a moratorium in place that will not allow Medi-Cal provider numbers to be issued to clinical laboratories. There are 16 exceptions to the moratorium. There was a hearing on the moratorium yesterday. The moratorium has been in place since 2001. It has been renewed every 6 months. The purpose of the moratorium was to reduce fraud. During that time, a number of bills were introduced to prevent fraud. Motion was made by Joyce Hulen to have CCLA support the repeal of the moratorium on the issuance of Medi-Cal provider numbers to clinical laboratories. Lorri Dean-Yoakum seconded the motion. All in favor. Passed.Key Legislative Committees – Kristi FoyThis was previously distributed to the membership.Encouraged laboratories to invite legislative members to tour their laboratory.There are new legislative members that will be in office for the next 12 LA Lab PAC Update – Kristi FoyAccount balance is $38KDonation was recently made to the fund by Spectra.This fund allows the CCLA office to attend fundraisers (typically costs $1K-$2K/person to attend an event)Medi-Cal: Update on the DHCS New Rate Methodology Project – Kristi FoyThe department announced that they plan on moving forward with the program as is.A request has been put out for 2014 data. CCLA contacted the department and requested an extension. The department granted the extension to March 27th (an additional 30 days)The 2014 data will be analyzed using the same methodology previously used. Goal is to have new rates effective by July 1st, 2015.Palmetto GBA Requirement for “MolDx Panel Registration” – Michael ArnoldDr. Oakes and Dr. Jeter attended the Medicare Contractor Advisory Committee last month in San Diego.This has been delayed until July 1, 2015. Dr. Jeter will be rewriting the proposal but it is unknown how she will do this.Noridian LCD re Pharmacogenetic testing DL 35478 – Bonnie FisherNoridian and Palmetto GBA agreed that they did not have access to many of the studies attached to the comments/documentation submitted in response to the draft CYP LCD. They were unable to review many of the studies that supported the comments. PGx testing is not going to be addressed with blanket coverage or non-coverage but instead will be handled by coverage with limitations. Now would be a good time to come forward with redetermination requests in order to expand the indications currently covered under the CYP LCD. A group has been put together to specifically address which indications should be included in the redetermination requests. The redetermination requests are going to be addressing both the LCD for CYP2C19, CYP2D6, and CYP2C9 in addition to the latest Palmetto J11 noncoverage draft for Factor II, Factor V and MTHFR. The goal for the group is to submit these redetermination requests by the 1st week of March.Issue of Mobile Phlebotomy – David GeeThis issue has been coming up. The 1997 legislative counsel opinion is the basis upon which the subcommittee put together data to inform the CCLA group of the risks of mobile phlebotomy.A certified phlebotomist needs to be a physician, nurse, employee of a clinical laboratory. There have been questions raised if you can contract someone to perform the phlebotomy service. The counsel opinion advised that a roving phlebotomist is not ok. David Gee contacted Bea O’Keefe but she indicated they will no longer share their opinion. There are some things (Q&A and PowerPoint) posted on Lab Field Services website regarding phlebotomy services. Their Q&A and PowerPoint cause uncertainty that they are unwilling to LA may need to make a formal request from Lab Field Services since this is an area where there is a lot of confusion.Kristen Blanchette has a revised Matrix for distribution. Document is available as a LA will revisit this topic at the next meeting. Electronic version will be distributed for review. Revisions will be discussed at the next CCLA meeting.Cytotechnologist Scope of Practice Bill Proposal – CCLA Position – Michael ArnoldThe California Society of Pathologists will be sponsoring the bill dealing with cytotechnologists.They want to expand the scope of practice from Cytology to LA will review and determine a position on this bill once it has been introduced.Department of Insurance – David GeeThere is a Department of Insurance regulation regarding out of network billingPatients receive significant bills they were not expecting because the hospital sent this out or the testing was sent to an out of network laboratory.The focus of this regulation is on the referring entity. The obligation required by the regulation is that the referring entity would need to disclose to the patient that the ancillary provider(s) are out of network and the extent of the financial liability.David Gee will send the information to the CCLA office for distribution.BUSINESS REPORTSTreasurer’s Report- Ken NealCCLA bank account balance is $285,378.34$670.00 in outstanding checksApproximately $150,000 received in membership dues since January 2014Approximately $9,000 received in annual conference feesSignificant amount is funded by the annual conferenceMembership Update – Kristi FoyOnly 7 labs have not renewed yet. There has been great success with CCLA renewal.There are 7 new members to CCLACardioDxGuardant Health, Inc.PersonalizeDx LabsAmerican International BiotechnologyLCMS Solutions, Inc.Lotus LaboratoriesWebsite is now available, can pay for the meetings online by credit card (Visa, MC and American Express)If you have any feedback on the website, contact the CCLA office.Password for members is “LABCCLA”. This will give you access to the member section.Industry Developments – DiscussionNone discussedAnnual Conference – November 4th – 6th, 2015 – Kristi FoyThe website has the information for registration and to make hotel reservations. Vendors also have the ability to register online.Discounted registration offered if conference fees are paid by October 22nd.Hotel will block rooms until October 20th Westin South Coast Plaza, November 4th-6th, 2015Contract has been signed Room rates are $189/nightRates honored three days prior and following conference datesFor planning purposes, facilities are booking 1-2 years in advance. Reviewing locations for 2016. Westin – Long BeachWestin – San DiegoWestin – South Coast PlazaCLINICAL LABORATORY TECHNOLOGY ADVISORY COMMITTEE (CLTAC) – Lorri Dean-YoakumQuarterly Meeting will be in MarchCALIFORNIA COALITION OF CLINICAL LABORATORY PROFESSIONS – Lorri Dean-YoakumQuarterly Meeting will be in MarchMEDICARE CONTRACTOR ADVISORY COMMITTEE –Ken Neal & Jean Amos-Wilson It was suggested an advisory group be formed where the members are not hired or paid by Medicare.There were 3 MolDx tests being presented for limited coverageAll were supported by a practicing physicianThe tests are all proprietary testsMEDI-CAL CONTRACTOR ADVISORY COMMITTEE – Kristi Foy No reportNext meeting scheduled for April 22nd, 2015ADJOURNMENTMeeting was adjourned at 12:11 PM PSTRespectfully Submitted, Kim Leroux ................
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