AUGUST 2007

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URGENT UPDATE!
Effective September 17 - the NPI/Legacy ID Combinations Must Match
 

By NHIC, Corp.

CMS recently announced that contractors should begin editing and rejecting claims that do not match on the NPI crosswalk file. This essentially means that any solo incorporated physician (who also needed both a type I and type II NPI number) should have re-enrolled in the Medicare program using the 8551 form.   READ MORE...



UROLOGY ANCILLARY REVENUE
CMS Proposed Regulations - An Update and Additional Guidance
By Greg L. Smith
Healthcare attorney practicing with Womble Carlyle Sandridge & Rice, PLLC


As reported last month, on July 2nd the Center for Medicare and Medicaid Services (CMS) issued the Medicare Physician Fee Schedule (MPFS) Proposed Rules that, if finalized, could materially negatively affect many urology ancillary revenue opportunities.  In this letter we will provide additional clarification of the MPFS proposed rules, as well as guidance to assist you in submitting comments to CMS before the August 31, 2007 deadline...  READ MORE..





CUA Annual Meeting and Lunch
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During the Western Section AUA 83rd Annual Meeting
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QUESTION & ANSWER

Jeffrey Kaufman, M.D.

Should I send additional information, from another date of service, which was not requested, that supported the use for Mitocycin C rather than BCG, the lower cost drug? Are non participating physicians receiving repayment requests?  Are retired physicians receiving repayment requests?
READ MORE... 





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Effective September 17 - the NPI/Legacy ID Combinations Must Match
By NHIC, CORP.

Members:

CMS recently announced that contractors should begin editing and rejecting claims that do not match on the NPI crosswalk file. This essentially means that any solo incorporated physician (who also needed both a type I and type II NPI number) should have re-enrolled in the Medicare program using the 8551 form.  If they haven't they wouldn't know that a problem loomed since they are currently still being paid on the basis of their legacy (old fashioned) identifier.  However, what this warning means is that if they don't submit the 8551, when NHIC ceases to accept the old identifier, they won't be in the system and won't be paid.  If they delay submitting until they see the problem, they may still be paid but it will delay payments quite a long time causing considerable hardship.

See full text of letter from NHIC below.


Dr. Jeffrey Kaufman.




Since October 2, 2006, providers have been encouraged to submit both the NPI and Medicare legacy identifier (PIN) on their claims.  During this timeframe providers were not penalized for invalid NPI/legacy ID combinations.

Effective September 17, 2007, NHIC, Inc. will begin editing the NPI/legacy ID combinations for validity against the NPI crosswalk file. Where a match cannot be located on the crosswalk, claims will be rejected or returned to the provider.
 

When the claim is returned, a provider should first verify that the correct NPI was submitted.  If correct, you will need to verify that your legacy identifier (PIN) number corresponds with the information on file with the National Plan and Provider Enumeration System (NPPES). NPPES data may be checked on line at  https://nppes.cms.hhs.gov.

If your NPPES information is correct and you have included and matched ALL Medicare legacy identifiers with a corresponding NPI in NPPES, but you are experiencing provider identifier problems with your claims that contain an NPI, you may need to submit a Medicare enrollment application (i.e., the CMS-855).  Please contact Customer Service at 877-527-6613 if  you need more information.    


More information and education on the NPI may be found at the CMS NPI page, http://www.cms.hhs.gov/NationalProvIdentStand on the CMS website. Also, providers can apply for an NPI online at https://nppes.cms.hhs.gov.

If your claims are processing properly with the NPI / Legacy cross-walk, we urge you to send a small batch of 3-10 claims with the NPI number only to validate that the cross-walk of the legacy number, formerly Provider Identification (PIN) or Provider Transaction Access Number (PTAN), with the NPI is correct.  This approach will be helpful in detecting any NPI problems for the provider without effecting cash flow.


Thank you for your assistance in getting the word out about this change.

NHIC, Corp.
1055 West 7th Street, Suite 500
Los Angeles, CA  90017
  



UROLOGY ANCILLARY REVENUE
CMS Proposed Regulations - An Update and Additional Guidance
Click for Guideline Letter

As reported last month, on July 2nd the Center for Medicare and Medicaid Services (CMS) issued the Medicare Physician Fee Schedule (MPFS) Proposed Rules that, if finalized, could materially negatively affect many urology ancillary revenue opportunities.  In this letter we will provide additional clarification of the MPFS proposed rules, as well as guidance to assist you in submitting comments to CMS before the August 31, 2007 deadline.  Through your comments to CMS, you can make a difference in preserving the quality of patient care provided by the urological community, while also protecting urologists' ability to participate in ancillary revenue opportunities.


A.
     Proposed Regulation Stark Law Changes

The new MPFS proposed rules, if finalized, would make sweeping changes to the Federal Stark law.  The Stark Statute prohibits a physician from making referrals to an entity, with which the physician or his immediate family has a financial interest, for the furnishing of specified designated health services (DHS) under Medicare, unless an exception applies.  Targeted financial interests include compensation arrangements and ownership arrangements.  The new MPFS proposed rule suggests changes to the Stark Statute and its regulatory exceptions that could limit many urology ancillary revenue opportunities.

1.      Services Furnished Under Arrangements.  The Medicare statute permits providers, such as hospitals, to furnish services to beneficiaries "under arrangements" with third party vendors.  Lithotripsy and bph laser services are commonly provided by urologist-owned vendors that contract under arrangements with hospitals.  Historically, CMS interpreted "entity" under the Stark Statute to only mean the entity billing for the service in an under arrangement contract, which would be the hospital.  The Stark financial interest in such circumstance would be a compensation arrangement between the hospital and physician owned vendor, and most urologist-owned lithotripsy and bph vendors have historically relied on the Stark indirect compensation arrangement to comply with the Stark law.  The new MPFS rule proposes to change the Stark definition of entity to mean not only the hospital that bills for the services, but also the person or entity that either provides the DHS (e.g., the urologist vendor) or "causes a claim to be presented" for the DHS.

If the contracting urologist lithotripsy or bph vendor is interpreted to be the entity "performing" the DHS service or "causing" the claim for DHS to be presented, then the urologists' ownership interest in the contracting vendor could require a Stark ownership exception.  As there is no applicable Stark ownership exception under such circumstances, the proposed rule could be interpreted to prohibit the physician-owned entity from contracting under arrangements with hospitals for DHS services.  However, this is not a foregone conclusion.  What does "causes a claim to be presented" mean under the new proposed rule?  Urologist vendors have little influence on causing Medicare claims to be presented by a contracting hospital.  Further clarification is required.  Also, lithotripsy and bph laser services are DHS only if billed by a hospital.  Consequently, if the Stark "entity" is the urologist-owned vendor, it could be argued that the urologist vendor is performing non-DHS lithotripsy and bph services, and not DHS hospital inpatient or outpatient hospital services.  Again, further clarification is required.  In the American Lithotripsy Society vs. Thompson case, the court held that lithotripsy is not a DHS.  Consequently, a further argument exists that a urologist-owned lithotripsy vendor cannot be deemed to be performing a DHS service that requires a Stark ownership exception.  There is also legislative history that supports that Congress intended that under arrangements contracts only require a Stark compensation exception, and not an ownership exception, which raises questions whether CMS has the authority to issue regulations contrary to congressional intent.

2.      Unit of Service (Per-Click) Payments.  Most service arrangements between urologist vendors and hospitals provide for payment for services on a per procedure basis.  Current Stark regulations for space and equipment leases (and personal services) allow payment on a per procedure basis.  Under the new proposed regulations, the Stark equipment lease and space rental exceptions would be modified to prohibit per unit of service rental charges.  Consequently, an individual urologist would no longer be allowed to lease a bph laser or lithotripter to a hospital for a per procedure fee.  It should be noted, however, that the new proposed rule does not contemplate adding a similar prohibition to the personal services exception or indirect compensation arrangements exception.  The latter exception is relied upon by most urologist vendors in their leases of equipment to hospitals.  There is danger, however, that the new regulations could be modified to apply to indirect compensation arrangements.  CMS has also hinted that it may modify the indirect compensation arrangement definition in the anticipated Stark III regulations.  It is likely that the future Stark III regulations will collapse together individual physicians with their group practices in any revised indirect compensation arrangement definition, which would trigger the use of the direct equipment rental Stark exception, and the corresponding per procedure rent prohibition under the proposed MPFS regulation.  It is uncertain whether the impending Stark III regulations would also collapse together joint ventures with their physician owners.  Any attempt by CMS to prohibit per procedure payments, however,  will be subject to serious challenge on the basis that it is contrary to clear congressional intent, as expressed in the Stark legislative history, to permit per procedure payments under the Stark exceptions.

3.      Restriction on Percentage Fee Payments.  Several important Stark exceptions require that compensation be "set in advance;" e.g., personal service arrangements, fair market value compensation, and the office and equipment lease exceptions.  Historically, CMS interpreted the "set is advance" requirement to permit percentage fee payments.  In the proposed MPFS rule, CMS would change the "set in advance" definition to prohibit percentage based fees, except for professional services.  The proposed regulations would prohibit an individual urologist from directly leasing equipment to a hospital in exchange for a percentage fee.  It is notable, however, that the Stark indirect compensation arrangement exception does not have a "set in advance" requirement, so the proposed percentage fee prohibition would not appear to apply to urology practices or typical urologist joint venture equipment lease arrangements with hospitals.  As discussed previously, there is a danger that the new proposed regulations may be modified to extend the percentage fee prohibition to physician practice and joint venture equipment lease arrangements.  The anticipated Stark III regulations could also negatively modify the indirect compensation arrangement exception.

4.      In-Office Ancillary Services Exception.  The Stark Statute in-office ancillary services exception allows a physician to furnish and benefit from many ancillary services that are DHS, as long as the services are provided in the physician's office and certain other requirements are met.  Specifically, urologists rely on this exception to provide path lab, CT imaging and IGRT/IMRT within their individual group practices.  In its commentary to the proposed MPFS rules, CMS expresses concern that the in-office ancillary services exception is being used to allow physicians to benefit financially from referrals that are not closely related to a physician's professional practice.  CMS expresses particular concern with growing reliance on the exception to allow in-office path labs and use of expensive imaging equipment in physicians' offices.  Without proposing new regulations, CMS solicits comments on whether changes are needed to the in-office ancillary services exception to stop perceived program abuse.  CMS specifically requests comments on (i) whether certain services not fully integrated into a practice should be excluded from the exception, (ii) whether changes should be made to the exception to limit where the ancillary services can be performed, and (iii) whether non‑specialists (e.g., urologists) should be allowed to use the exception for specialty services (e.g., anatomical pathology, external beam radiation and CT imaging) involving equipment owned by the non‑specialist (e.g., path lab equipment, IGRT/IMRT and CT).  CMS has hinted that the anticipated Stark III regulations may modify the in-office ancillary services exception to at least shut down off-site anatomical path labs.  In drafting the Stark law, Congress specifically excluded certain DHS from the exception (e.g., durable medical equipment), which raises questions whether CMS has the independent authority to exclude any other DHS services not contemplated for exclusion by Congress.  

5.      "Stand in the Shoes".  In the MPFS commentary, CMS solicits comments, without issuing a rule, on providing additional restrictions on "indirect" relationships involving multiple DHS entities.  Specifically, CMS proposes that where a DHS entity (e.g., a hospital) owns or controls another entity (e.g., an ambulatory surgery center) to which a physician refers Medicare patients for DHS, the controlling and controlled DHS entities would be collapsed together so that the referring physician would be deemed to have a compensation arrangement with the controlling entity.  This is a complicated provision and it has many applications, but in the context of urology ventures, it will most likely have the greatest impact on urologist-owned bph laser and lithotripsy vendors contracting with ambulatory surgery centers (ASC) owned or controlled by hospitals.  Bph laser and lithotripsy services only trigger the Stark Statute when they are provided at hospitals, so traditionally those services don't have to comply with a Stark exception when provided at an ASC.  Under the CMS proposal, however, a hospital-owned or controlled ASC would be collapsed into the hospital, and a urologist-owned bph laser or lithotripsy vendor contracting with the ASC would have to comply with Stark.  Note that under other regulations published by CMS, it is anticipated that Medicare will reimburse lithotripsy services performed at ASCs beginning in 2008.

B.     Proposed Reassignment/Purchased Diagnostic Test Rules

Under the existing Medicare purchased diagnostic test rule, if a physician bills the technical component of a diagnostic test performed by an outside supplier, the physician is required to bill Medicare the lower of the Medicare reimbursement for the technical service, or the amount charged to the practice by the outside supplier for the technical service.  This old rule essentially prohibits a physician from profiting from the purchase of the technical component of a diagnostic test performed by an outside supplier.  The new MPFS proposed rules expands this concept to the professional component of diagnostic tests as well.  Consequently, under the new proposed rule if a urology practice owns and operates imaging or lab equipment in its office, and globally bills Medicare for both the technical and professional components of the related service, the practice cannot make any profit on the professional component of the service, unless the professional performing the services is a full-time employee of the urology practice.  Therefore, if the party providing the professional component (e.g., pathologist or radiologist) is a part-time employee or independent contractor, or full–time independent contractor, then either the entire Medicare professional component must be paid to such party by the urology practice, or the global fee professional component billed to Medicare must be reduced to reflect the amount actually paid to such professional.  The proposed rules also prohibit a urology practice from offsetting against the professional fee paid to the outside physician (e.g., pathologist or radiologist) any billing and collection administrative expenses, or other overhead costs.

It should be stressed that the July 2nd MPFS rules are proposed only and do not change the current laws under which urologists provide ancillary services.

C.     Guidance on Submitting Your Comment Letter to CMS

The deadline for submitting your written comments to CMS regarding the proposed MPFS rule is 5:00 p.m. August 31.  It is very important that CMS hears from you, and from as many other individual urologists as possible, regarding the unfairness of the proposed rules, and the negative impact they would have on patient access to the most innovative medical technologies.

1.      Guidance in Submitting Written Comments.  In Sections A and B of this Update, we highlight the most material provisions of the proposed rules that could negatively impact ancillary urology revenue opportunities, and those provisions should be the focus of your comments.  CMS gives little to no weight to mass prepared form letters, so it is important that you prepare your own individual comments that reflect your personal circumstances and concerns.  Given the complexity of the proposed regulations, we appreciate that preparing an individual comment letter can be a daunting task.  If you would like additional assistance in preparing your comment letter, please contact us at [add organization e-mail address here], and we will e-mail you a guideline with bullet points relating to each material proposed regulation provision for you to consider incorporating into your own letter.  Although there are strong legal arguments that certain proposed provisions shouldn't apply to many ancillary urology revenue opportunities, comments must direct CMS to clarify the proposed regulations to ensure contracting hospitals will accept such arguments.  

2.      U.S. Mail Written Comments.  Written responses must be received by CMS by 5:00 p.m. August 31, 2007.  If you plan to submit your comments by regular U.S. mail, then you should post them (one original and two copies) no later than August 27, 2007 to the address below:

                                      Center for Medicare and Medicaid Services

                                      Department of Health and Human Services

                                      Attention:  CMS-1385-P

                                      P.O. Box 8018

                                      Baltimore, MD 21244-8018


3.
      Overnight Mail Written Comments.  If you are going to overnight mail your written comments, they should be posted (one original and two copies) no later than August 30, 2007 to the address below:

                                      Center for Medicare and Medicaid Services

                                      Department of Health and Human Services

                                      Attention:  CMS-1385-P

                                      Mail Stop C4-26-05

                                      7500 Security Boulevard

                                      Baltimore, MD 21244-1850


4.      Electronic Mailed Comments.  You may submit electronic mail comments before 5:00 p.m. August 31, 2007 by clicking on the following web link http://www.cms.hhs.gov/eRulemaking.  Once on the website, click on the link "Submit electronic comments on CMS regulations with an open comment period" and follow the instructions.  Emailed attached comments may be in WordPerfect, Microsoft Word or Excel formats.

We encourage you to timely submit your comments to CMS in order to protect your patients access to high quality urology services, and preserve your opportunity to participate in urology ancillary revenue opportunities.   


This Update on the new proposed regulations was prepared and submitted by Greg L. Smith, a healthcare attorney practicing with Womble Carlyle Sandridge & Rice, PLLC, and specializing in urology-based ancillary revenue opportunities.  Greg can be reached at gsmith@wcsr.com and 336-721-3665.



Question & Answer: Lupron    
Jeffrey Kaufman, M.D., F.A.C.S.

QUESTION

Dear Dr. Kaufman:

Thank you for your tremendous efforts in dealing with the Lupron repayment crises.

PRG Schultz has now embarked in other endeavors and have requested records with Mitomycin C instillations.

They have not requested the documentation supporting the use of Mitomycin C instillation, only the code for Mitoymycin C.  Of course, they made it difficult to identify the patient, by not including their name, but only stating their Medicare number and the date of service.

Should I send additional information, from another date of service, which was not requested, that supported the use for Mitocycin C rather than BCG, the lower cost drug?  There was no charge for an EM service on the date of instillation, only the charge for instillation and Mitomycin C. The documentation is for 40 mg versus 20 mg. 

I thank you again for your great efforts in dealing with Lupron.  It appears that PRG Shultz may go after all drug treatments for the lowest cost payment, which should create a greater uproar for medical specialties that administer parenteral medications.

After reading through all the communications, PRG Schultz expects to collect their monies from direct re-payments from doctors or from withholds from future Medicare Payments.  Are non participating physicians receiving repayment requests?  Are retired physicians receiving repayment requests?  If they are, will PRG Schultz use a collection agency to collect money due from those physician categories?

ANSWER

Several issues are pertinent here.  First, be sure the claim date in question falls within the 4 year scope allowed to them (determined by the date the claim was paid).  Second, I have already complained to CMS and PPAC that the letters are vague and do not include enough information to allow you to know what to submit, especially if they don't make it clear what particular aspect of your care is being investigated.  This holds (obviously) when they don't include the patient name but only refer to the claim by their internal code.  We have already gone round with them on this and they are SUPPOSED to refer to the patient by name and the claim by date.  Next, in most cases where records are requested, they are doing a "complex" review to confirm that the care was delivered, was reasonable and necessary, was billed and paid for correctly and that all policies were adhered to.  I would submit all related documents that support the indication (such as pathology reports, consults, previous records showing that this particular treatment is necessary (such as previous failure to respond to BCG or something about their situation that specifically warrants mitomicin, etc) even if it is not specifically requested or pertains to another date of service.  Remember, these charts are reviewed by nursing, not doctors and they may have no idea about proper treatments beyond what they read in some printed policy.  If appropriate and necessary, include a separate letter translating any abbreviations you use, explaining the background on this case (such as why you chose mitomicin) and why this disease warranted treatment in the first place.  Finally, if there is a specific policy on an issue for which records are requested, try to respond directly to what you suspect they are questioning to head off trouble prophylactically.  HOWEVER, realize that the general policy that raised questions about LHRH agonists specifically relates to Least Costly Alternative  (not least costly drug).  There is no policy that suggests mitomycin and BCG are alternatives.  They are different drugs used in different situations.  While the LCA policy is based on the concept that Medicare is only charged with paying for reasonable and necessary treatment (and they don't consider more expensive alternatives either), they crux of any argument over LCA is whether the agents compared are truly alternatives.  You can't argue that radical cystectomy and intravesical instillations are reasonable alternatives even though both treat bladder cancer. Similarly, BCG and mitomycin are used differently, have different side effects and therapeutic outcomes.  If you had any reason at all for your choice of mitomycin (and I assume you had some basis for choosing it regardless whether some nurse agrees with your clinical judgement), you have the right and responsibility to treat as your training and experience indicate.  They cannot deny you payment for mitomycin based on the LCA policy.  If they try, let me know and I will help you draft an appeal and take the decision to the highest levels since it exceeds their authoritity to apply policies.  I would have to research the BCG policy but I am fairly certain no one could interpret these two drugs as alternatives in the was we have considered the term previously.  The RAC would be breaking entirely new ground here and would be challenged. 


If I am correct that they simply can't review this case under the least costly alternative policy umbrella, then they must be searching to confirm that the drug was administered consistent with policy (proper indication, doctor in attendance, dose in chart confirms what was billed, medical literature supports use, chart fully documents what was done,etc.).  Review your records carefully before sending them and include a letter of explanation or support or justification if necessary and include all data you think a nurse would need to understand what you did, why you did it and to believe you did it correctly and deserve to be paid.

Next issue was that the RAC doesn't collect money if the appeal is won. And, the carrier NHIC doesn't withhold money during the time an appeal is considered althought, if you lose the appeal, you will owe interest from the time the money was first due. However, this is all dependent on the fact that they feel money was paid incorrectly and demand recoupment, a decision I would hope doesn't occur. I hope that answers your questins. Please follow up and let me know how this turns out. Contact me for any other questions.


Jeffrey Kaufman, M.D.
CUA



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