NEW FDA APPROVALS
On May 15, 2013, the FDA approved radium Ra 223 dichloride (Xofigo Injection, Bayer HealthCare Pharmaceuticals Inc.) for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease. Xofigo is an alpha-particle emitting radiotherapeutic drug which mimics calcium and forms complexes with hydroxyapatite at areas of increased bone turnover, such as bone metastases. More Information: http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm352393.htm
On May 14, 2013, the FDA approved erlotinib (Tarceva, Astellas Pharma Inc.) for the first-line treatment of metastatic non-small cell lung cancer (NSCLC) patients whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations. This indication for erlotinib is being approved concurrently with the cobas EGFR Mutation Test, a companion diagnostic test for patient selection. More Information: http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm352317.htm
CMS PUBLISHES NEW EHR FAQ
On 4/26/2013, CMS published the new EHR FAQ #8231, which clarifies the criteria for numerators that fall outside the EHR reporting period timeframe:
Q. While the denominator for measures used to calculate meaningful use in the Medicare and Medicaid Electronic Health Records (EHR) Incentive Programs is restricted to patients seen during the EHR reporting period, is the numerator also restricted to activity during the EHR reporting period or can actions for certain meaningful use measures be counted in the numerator if they took place after the EHR reporting period has ended?
A. The criteria for a numerator is not constrained to the EHR reporting period unless expressly stated in the numerator statement for a given meaningful use measure. The numerator for the following meaningful use measures should include only actions that take place within the EHR reporting period: Preventive Care (Patient Reminders) and Secure Electronic Messaging. For all other meaningful use measures, the actions may reasonably fall outside the EHR reporting period timeframe but must take place no later than the date of attestation in order for the patients to be counted in the numerator.
NEW EDITS FOR NEW PATIENT CODES
Medicare Recovery Auditors (RAs – previously known as RACs) have identified claims with new patient evaluation and management (E/M) services as having improper payments because the new patient services were billed for the same patient two or more times within three years by the same physician or physician group. This resulted in overpayments, as the E/M services should have been paid as established patient E/M services.
To address these improper payments, CMS announced in MLN Matters® Number: MM8165 that they will implement changes to the Common Working File (CWF) to prompt CMS contractors to establish edits that would prevent payment for two new patient CPTs within a three year period of time.
As stated in the Medicare Claims Processing Manual, (Chapter 12, Section 30.6.7), a new patient is one who has not received any professional services, i.e., E&M service or other face-to-face service such as a surgical procedure, from the physician or physician group practice (same physician specialty) within the previous three years. For example, if a professional component of a previous procedure is billed in a three-year period, e.g., a lab interpretation, and no E&M service or other face-to-face service with the patient is performed, then this patient remains a new patient for the initial visit.
CMS reports that the new patient CPT codes that will be checked in these edits include 99201-99205, 99218-99223, 99304-99306, 99324-99328, 99341-99345, 99381-99387, 99460-99461, 99468, 99471, 99475, 99477, G0245, G0402, and G0344.
The new edits will be implemented October 7, 2013. As always, the implementation of new edits may result in errors of application so please watch carefully to make sure the edits are being applied appropriately.
Medicare Denials and eRx Updates
CMS TO CORRECT 96361 EDIT
Transmittal 2636, Change Request 7501 dated January 16, 2013 provides a
list of add-on CPT codes and the primary service codes that they must be
performed in conjunction with. The Add-On Code edit
file released for April 1, 2013 listed CPT code 96360 (IV infusion, hydration;
initial 31 minutes to 1 hour) as the only primary code for add-on code 96361
(each additional hour of hydration). Because of this erroneous edit,
practices have been experiencing denials when billing hydration (96361) as a
secondary or subsequent service after a different initial service.
CMS is taking
steps to correct this edit error. In the Add-On Code Edits version for
July 1, 2013, CMS will be expanding this list so that the primary codes
will be listed as 96360, 96365, 96374, 96409, and 96413. In
the meantime, it is suggested that oncologists may choose
to delay submission of claims for CPT code 96361 to July 1, 2013 or
I will provide more
information on this issue as it becomes available.
eRx DEADLINE TO AVOID 2014 PAYMENT PENALTY
The 2013 eRx 6-month reporting period
(January 1, 2013 to June 30, 2013) is the final reporting period available to
you if you wish to avoid the 2014 eRx payment adjustment. If you do not
successfully report, a payment adjustment of 2% will be applied, and you will
receive only 98% of your Medicare Part B PFS amount for covered professional
services in 2014.
Avoiding the 2014 eRx Payment Adjustment
Individual EPs and eRx GPRO participants who were not successful electronic
prescribers in 2012 can avoid 2014 eRx payment adjustment by meeting specified
reporting requirements between January 1, 2013 and June 30, 2013. Below
are the 6-month reporting requirements:
Individual EPs –
10 eRx events via claims
eRx GPRO of 2-24
EPs – 75 eRx events via claims
eRx GPRO of 25-99
EPs – 625 eRx events via claims
eRx GPRO of 100+
EPs – 2,500 eRx events via claims
Exclusions and Hardships Exemptions
Exclusions from the 2014 eRx payment adjustment only apply to certain
individual EPs and group practices, and CMS will automatically exclude those
individual EPs and group practices who meet the criteria. More information on
exclusion criteria and hardship exception categories can be found on the Electronic
Prescribing (eRx) Incentive Program: 2014 Payment Adjustment Fact Sheet.
Resources from CMS
Program Payment Adjustment Information
Prescribing (eRx) Incentive Program: Updates for 2013.
Questions about eRx?
If you have questions regarding the eRx Incentive Program, eRx payment
adjustments, or need assistance submitting a hardship exemption request, please
contact the QualityNet Help Desk at 866-288-8912 (TTY 1-877-715-6222) or via firstname.lastname@example.org. The Help Desk is
available Monday through Friday from 7am-7pm CT.
NEW BILL INTRODUCED TO STOP ICD-10
October 1, 2014 is the scheduled implementation deadline for the transition from ICD-9 to the ICD-10 code set. On Wednesday, April 24, Representative Ted Poe (R-TX) introduced legislation in the U.S. House of Representatives that would stop the replacement of the ICD-9 code set with ICD-10 or any other code set. H.R. 1701, The Cutting Costly Codes Act, would prohibit the U.S. Department of Health and Human Services from implementing, administering or enforcing current regulations that require the new code set to take effect. The bill also calls for a federal study to identify ways to mitigate disruptions caused by any replacement of the ICD-9 code set.
In a letter of support to Poe, the AMA states that they remain deeply concerned about the timing of the ICD-10 transition during a time when physicians are devoting significant time and resources towards implementing EHRs and participating in numerous Medicare programs to avoid present and future penalties. The AMA states that “physicians are overwhelmed with the prospect of the tremendous administrative and financial burdens of transitioning to the ICD-10 diagnosis code set,” and that the timing could not be worse as physicians are also dealing with the 2% sequester cuts and the prospect of even more cuts from the flawed sustainable growth rate (SGR) formula.
Nevertheless, the AMA is urging physicians to continue to prepare for ICD-10 in order to avoid financial hardship if the October 1, 2014 deadline is not delayed. If the October 1, 2014 deadline is upheld providers not meeting the deadline in transitioning to ICD-10 will not receive payment for their services.
AMA ICD-10 Web page:
CMS ICD-10 Web page:
AAPC ICD-10 Implementation Web page:
ION COMMUNITY COUNTS MONTHLY WEBINARS
Are you an ION member? Join me on ION's
monthly webinar - On May 23, we will outline the steps involved in Developing
and Implementing a Billing Compliance Plan.
Medicare Reimbursement Updates
On April 9, Representative Renee Ellmers (R-N.C.) introduced the Cancer
Patient Protection Act of 2013. This bill seeks to reverse the sequester
cuts that are being applied to physician administered cancer care drugs.
Beginning on April 1, 2013, the 2% sequestration reduction on Medicare
physician payments is being applied to physician services and physician
administered drugs. The application of the 2% cut to the reimbursement rate for
cancer care drugs have forced some cancer clinics to stop treating Medicare
patients. Passage of legislation is necessary to stop the cuts to cancer care,
as CMS has stated that they do not have the authority to do so. Representative Ellmers'
bill also requires the retroactive restoration of payments on cancer care drugs
that were reduced by the sequestration cuts.
STOP THE CUTS TO
If you have not yet contacted your legislators, please take a moment to
do so today! Every voice counts, tell your legislators how the sequester cuts
threaten cancer care in the community setting. ION Solutions has made it very
easy to contact your legislators, all you have to do is go to their Community Counts website, review or edit the
letter provided, complete the privacy-protected registration form, then click
on the ENACT CHANGE button. Your letter will be sent directly to your senator
Ask your legislators to sign-on to the Dear colleague letter to HHS, this letter
asks CMS for information on their authority to reduce Medicare Part B drug
reimbursement and asks CMS to use any flexibility it has to protect patient access
to cancer care in the community cancer clinic by applying the sequester cut to
just the 6% service payment and not the fixed drug cost. The deadline to sign on is Tuesday,
April 16 so please reach out to your legislators!
ION Solutions' website www.ourcommunitycounts.org
also contains helpful advocacy resources such as a Physician Office Poster,
Sequestration Talking Points, Sequestration Background Action Calls, and a
Sequestration Patient Letter Template.
BILL TO REMOVE PROMPT PAY DISCOUNTS
H.R. 800 , introduced by Representative Ed Whitfield
(R-KY) on February 15, would exclude customary prompt pay discounts from
manufacturers to wholesalers from the average sales price (ASP) for drugs and
biologicals under Medicare. This bill continues to gain sponsors with 48
cosponsors to date.
ION COMMUNITY COUNTS
Are you an ION member? Join me on ION's monthly webinar - On May 23, we
will outline the steps involved in Developing
and Implementing a Billing Compliance Plan, On June 27, we will
discuss What You Need to
Know about ASCO's QOPI Program, and on July 25, the topic will be Advocate for Your Practice &
Patients: Opportunities to Participate in Medicare Policy Decisions.
2% Medicare Cuts Effective April 1
SEQUESTRATION CUTS & MEDICARE
On Friday, March 8 CMS published a listserv message regarding the pending sequestration cuts and their impact on Medicare Part A and Part B fee-for-service (FFS) payments. CMS reports that Medicare FFS claims with dates-of-service or dates-of-discharge on or after April 1, 2013, will incur a 2% reduction in Medicare payment. The 2% reduction in payment will also apply to claims for durable medical equipment (DME) and supplies, including claims under the DME Competitive Bidding Program when the date-of-service, or the start date for rental equipment or multi-day supplies, is on or after April 1, 2013.
CMS explains that the 2% claims payment adjustment will be applied to all claims after determining coinsurance, any applicable deductible, and any applicable Medicare Secondary Payment adjustments. Therefore, beneficiary payments for deductibles and coinsurance are not subject to the 2% payment reduction.
The sequestration cuts are part of the Budget Control Act of 2011, which requires mandatory across-the-board reductions in Federal spending. CMS states that they remain hopeful that Congress will take action to eliminate the mandatory payment reductions.
ACT NOW TO STOP THE CUTS TO CANCER CARE
If you haven’t already contacted your Legislators and their health staff and completed the COA sequestration survey please take a few minutes to do so today! COA worked with ASCO, AmerisourceBergen/ION and McKesson/US Oncology to create one common message and talking points that you may use to send to your Legislators health staff.
COA has made it extremely easy to take action on this issue by posting talking points, contact information for your Senator’s and Representative’s health aides as well as a template letter that you can customize for your patients explaining the sequester cuts and the effect they will have on your practice.
Access all of these resources on the COA Website at: www.communityoncology.org/site/blog/detail/2013/03/08/fight-sequester-cuts-to-cancer-care.html The survey link is: https://www.surveymonkey.com/s/MedicareSequestration
Finally, please take a few minutes to complete COA’s sequestration survey by close of the day on Monday, March 11, 2013. This is a very brief 8-question survey and your participation will provide valuable input that will be useful in the effort to stop the sequester cuts to cancer care.
NEULASTA RAC AUDITS
HealthDataInsights (HDI), the Recovery Audit Contractor (RAC) for Region D (AK, AZ, CA, HI, IA, ID, KS, MO, MT, ND, NE, NV, OR, SD, UT, WA, and WY) has been auditing payments for pegfilgrastim (Neulasta) and requesting repayment if this medication was administered on the same day as chemotherapy for claims dating back to 2009.
Several state societies including WA, OR, ID, AZ, CA, UT and AK have been working with Noridian, CMS and ASCO to try to get these audits stopped. Last week, the WA state society was informed that the RAC audits on same day Neulasta have been halted. We are awaiting the publication of an article on the administration of Neulasta on the same day as chemotherapy, and will provide that information as soon as it is available. Nevertheless, it is very important that you continue to respond promptly to all RAC requests you receive and to appeal recoupments when appropriate. I will provide updates on this issue as they are received.
CDC ISSUES WARNS AGAINST USING SDVs FOR MULTIPLE PATIENTS
CDC ISSUES WARNS AGAINST USING SDVs FOR MULTIPLE PATIENTS
On July 13, the Centers for Disease Control (CDC) released a report detailing recent instances of improper reuse of single-dose vials (SDVs) for more than one patient that resulted in two outbreaks of invasive staphylococcus aureus infection.
In the report, the CDC states, “Proper use of SDVs in clinical settings consists of 1) withdrawing contents into a new sterile syringe in an aseptic manner, 2) promptly using the contents for a single patient during a single procedure, and 3) disposing of the vial and any remaining contents. To prevent unsafe practices and patient harm, CDC recently issued a communication clarifying recommended practices for safe use of SDVs (1). The safest option remains dedicating SDVs to individual patients. When individually packaged and appropriately sized SDVs are unavailable, qualified health-care personnel may repackage medication from a previously unopened SDV into multiple single-use vehicles (e.g., vials or syringes). However, this procedure should only be performed using a laminar-flow hood in accordance with standards in U.S. Pharmacopeia General Chapter 797 (Pharmaceutical Compounding — Sterile Preparations). Strict adherence to U.S. Pharmacopeia 797 standards is critical and might have helped prevent recent outbreaks associated with unsafe practices.”
The CDC website contains resources on injection safety including an injection safety checklist and a toolkit featuring a narrated PowerPoint presentation that can be incorporated into employee training in the medical office.
OPLINC’S BEST PRACTICES REVIEW NEWSLETTER NOW AVAILABLE AS AN iBOOK
The Oplinc Best Practices Review Newsletter, sponsored by Lilly Oncology is now available to download as an iBook on your iPad. To download to your iPad go to www.Oplinc.com, click on the “View Latest Best Practices Review” link. To sign up for the complimentary Best Practices Review newsletter Click Here.
Are you an Oncology Supply customer? If so, watch your drug shipments for the print copy of the Best Practices Review newsletter.