Author Archive for Kimberly Hoy
Kimberly Anderwood Hoy is director of Medicare and compliance for HCPro, Inc.
As a hospital compliance officer, Kimberly regularly provided research and guidance on coding, billing, and reimbursement issues for a wide range of hospital services. She has a particular expertise in charge description master operation, development, and maintenance. She has experience conducting billing compliance audits and internal investigations. Kimberly also has had primary responsibility for HIPAA privacy regulation compliance, including risk assessment, program development, implementation of policies and procedures, and ongoing operations.
As In-House Legal Counsel, Kimberly had oversight of expense contracting and regulatory compliance, including federal and state laws and regulations. Kimberly regularly provided legal advice on such complex topics as consents, EMTALA, Stark, anti-kickback and anti-inducement laws, physician recruiting, and tax exemption regulations.
Kimberly has served as a speaker at compliance-related conferences in the areas of compliance program effectiveness and physician education. Kimberly is an active member of the American and California Bar Associations, the American Health Lawyers Association and the Health Care Compliance Association.
Kimberly earned her Juris Doctor degree from the University of Montana School of Law, where she received the Corpus Juris Secundum Award for Excellence in Contracts. She also holds a Bachelor of Arts degree in Philosophy from Yale University.
Signature for Laboratory Tests, Clarification in the MPFS Final Rule
This week, I would like to review a “clarification” regarding physician signatures on orders for clinical diagnostic testing that came out in the Final Rule for Payment Policies under the Physician Fee Schedule and Other Revisions to Part B for 2010. This blog is hospital-directed and we do not normally report on physician fee schedule issues, however, this “clarification” could affect hospital policies on obtaining signatures for the laboratory services they provide.
In the proposed rule published in August, CMS solicited comments on the issue of signatures on clinical diagnostic lab test orders, and a distinction they were drawing between test orders and lab requisitions. In the final rule, CMS reviewed their policy and the comments they received on that policy.
As part of their “clarification” in the proposed rule, CMS reviewed the history of Federal Register and manual guidance on the requirement for signatures on lab requisitions and orders. The issue was first discussed in the clinical lab negotiated rule making final rule on coverage and administrative policies, published November 23, 2001 in the Federal Register. In that rule, CMS indicated that lab tests must be ordered by a physician treating the patient, but that a signed requisition from the physician was not the only way to document that order. However, in the 2010 final rule “clarification” they also state that at the time of the 2001 publishing, they “implicitly left in place the existing requirements for a written order to be signed by the ordering physician”.
After the 2001 rule, in implementing manual sections in Transmittal AB-02-030 they reiterated the statement that a signature is not required on requisitions. They go on to say that another way of documenting the order for these services would be for the ordering physician to document the order in the patient’s medical records. The applicable regulations at 42 CFR 410.32 also do not require the entity submitting a claim for clinical laboratory service to maintain the physician’s order, but do allow for additional information to be requested. They also require that the billing entity be able to provide on audit “documentation of the order for the service billed (including information sufficient to enable CMS to identify and contact the ordering physician or nonphysician practitioner). ” (emphasis added)
These statements were incorporated into the paper-based Carriers Manual via Transmittal R1787B3 published in 2003. Highlighted in red text is the statement “NOTE: No signature is required on orders for clinical diagnostic tests paid on the basis of the physician fee schedule or for physician pathology services.” When CMS transitions to the internet-only manuals this section was inadvertently left out, however CMS added it back in Transmittal 94 to the Benefit Policy Manual in 2008. The new language in the Benefit Policy Manual states that it also applies to tests paid based on the clinical lab fee schedule.
The language in the manual seems clear regarding signatures on lab test orders, however, CMS points out in their clarification that the change in terminology from “requisition” in the 2001 rule to order in the manual was inadvertent. They continue to reiterate that they do not require a signature on a lab requisitions as they view them as administrative in nature, but a signature on a lab requisition could qualify as a physician order. They go on to point out, notwithstanding the clear manual text, that it is their longstanding policy that a written order for diagnostic tests must be signed by the ordering physician. They also cite the Conditions of Participation and Joint Commission standards as having signature requirements in their medical records standards.
This leaves us in the strange situation that the manual, through several transmittals and iterations, says no signature is required for lab orders. But we have a preamble discussion that says in effect ‘we didn’t really mean that’ and CMS stating their longstanding policy is to require signatures on lab orders which was suppose to be implicit in their statements about not requiring a signature on requisitions.
This led to many very good comments. Several of these CMS deferred to future rule making or indefinitely, simply stating they would consider the comment. Some responses were quite vague. For instance, a commenter asked if the requisition did not need to be signed and the documentation of the order could be maintain instead in the physician’s medical record, how was the lab suppose to verify its existence, especially in light of the urgency of testing degrading samples or the need to immediately perform tests. CMS’ response what simply that the regulation allows for the billing entity to request additional documentation from the physician without further explanation about when the entity should obtain this documentation, etc.
Due to the confusion raised by this issue, I would expect that it will be raised on the next hospital open door forum and will be the subject of more clarification in the near future. In the meantime, I encourage providers to review the discussion in the final rule. The discussion begins on page 939 of the display copy of the rule. Additionally, the provider may wish to inquire with their MAC as to specific standards the MAC may be applying and their rationale for their policies in light of the clarification.
On a personal note, for those of you wondering why you haven’t seen a note from me in a while, I was off having a baby. Zoey Mae was born August 4th and is doing well but still keeping her mom awake at nights. Her and I enjoy sitting up and reading all that interesting reading material CMS seems to like to putting out. Glad to be back!
More on condition code 44 and observation
We have received many questions on the articles we have published on the counting of hours of observation in cases where condition code 44 is used to convert an inpatient to an outpatient after UR review. A couple weeks ago I wrote about this issue following contact by a National Government Services representative, encouraging providers to contact their local MAC for more information.
I recently received some further clarification from National Government Services and wanted to update you. As you know, I’ve advised that hospitals should not be counting the time between the inpatient order and the change to outpatient status as observation – rather, I said, the observation time should begin with the change in status to outpatient when the observation order is written (assuming the appropriate level of care). NGS’ recent clarification, confirmed to me in an email exchange, is as follows:
As you are aware, the recent regulation changes resulted in many questions. We received confirmation from our CMS representative that indeed, a written order for observation status is required and that the inpatient stay can not be converted to observation time when CC 44 is applicable. If the physician (or UR committee in conjunction with the physician) deems the patient meets observation criteria after conversion to outpatient status, then observation time may be billed if the level of care is met. But observation time would begin when the order is written; and the previous (although incorrect) inpatient time could not be billed as observation. The services rendered while the patient was placed in inpatient status would be billed as outpatient services, but no observation time could be billed.
NGS is relying on their CMS central office contact for this clarification and not just their individual interpretation. Therefore, if any of you have received conflicting advice from your MAC, I would encourage you to provide them with this information and continue to use caution in billing any hours of observation without a proper order for observation services.
More on the OPPS proposed rule
Earlier this week, I discussed the physician supervision provisions of the CY2010 OPPS proposed rule.
Another section of interest to many providers will be the sections on the new cardiac rehab, intensive cardiac rehab and pulmonary rehab benefits. CMS discusses their implementation of these new benefits added to the Social Security Act by the MIPPA, effective January 1, 2010. Of particular interest is CMS implementation of the MIPPA provision that states that physician supervision for these programs is assumed when provided in a hospital.
Other significant proposals in the rule include a large proposed increase in the OPPS outlier threshold from $1800 to $2,225, the highest the fixed dollar threshold has been since its introduction.
Additionally, a significant portion of the rule was also devoted to payment methodologies for drugs, however, the end resultant proposal for most drugs remains at ASP + 4%. This includes ASP based payment for therapeutic radiopharmaceutical when the statutory cost based payment methodology expires in 2009. CMS did make the submission of ASP data for therapeutic radiopharmaceutical voluntary, and will base rates on CY2008 hospital mean cost data if ASP is not available.
Similarly, brachytherapy sources, which also were under a statutory cost based payment methodology for 2009, will be transitioned to CY2008 hospital mean cost data (the usual method for setting APC rates for other services). CMS is soliciting comments on several of their proposals and I would encourage pharmacy, radiology and chargemaster coordinators to review these proposals carefully and submit comments if they disagree with any of the proposals.
2010 OPPS proposed rule released
This was a busy week, but the biggest news was the somewhat early release of the OPPS proposed rule for 2010. While the rule is about the same number of pages as previous years, the substantive policy changes seem fewer than in the last couple of years.
For instance there were no new composite APCs introduced this year. Additional composite APCs, including cardiac resynchronization therapy, are being considered for future years. However, CMS indicated that in accordance with comments received in response to the previous composite APCs, they were going to study the effects of existing composites on payment and utilization before introducing additional composite APCs.
One of the more important proposals in the rule relates to physician supervision, a topic we have discussed several times. CMS discusses the recent “restatements” and “clarifications” made over the course of the last year and proposes regulatory changes in accordance with some of the comments they have received from many industry groups.
More on condition code 44 and observation
UPDATE: Please read our more recent article on this topic for updated information.
This is an especially light week of publications from CMS, so I thought I would update you a bit on an issue we have included in recent postings, which has resulted in a number of questions from readers. In two recent articles related to use of condition code 44, we indicated that, based on the written manuals, it appeared inappropriate to report the hours from the beginning of the stay as observation when converting the stay to outpatient.
Manual changes related to condition code 44
I’d like to turn my attention to the manual changes related to condition code 44, as promised. Overall, the changes were designed to incorporate discussion and FAQs that were previously published in MLN Matters Article SE0622. In this respect, the changes to the manual have very few surprises. Almost everything added came directly from SE0622 and nothing added was really anything new. With that said, however, I do think that hospital case managers and anyone involved in condition code 44 cases or billing for cases with changed status should review the changes carefully to be sure they are following all the guidance provided.
CMS replaces the term ’observation status’ with ’observation services’
In the July 2009 quarterly updates, CMS revised portions of both the Claims Processing Manual and Benefit Policy Manual related to observation. These changes were characterized as “editorial” in nature, removing certain terms CMS felt were confusing and revising some sections in accordance with that. Additionally, a new section entitled “Policy and Billing Instructions for Condition Code 44” was added to Chapter 1 of the Claims Processing Manual, along with other revisions to information on condition code 44.
New modifiers for outpatient never events; billing for hospital-acquired conditions
This week, CMS published the July Integrated Outpatient Code Editor (I/OCE). Although there were relatively few changes, CMS did introduce three new modifiers for use with the occurrence of three never events identified by the National Quality Forum (NQF) that were recently the subject of National Coverage Analyses by CMS. The new modifiers are: PA for surgical or invasive procedure on the wrong body part, PB for surgical or invasive procedure on the wrong patient, and PC for wrong surgery or invasive procedure on patient. The modifiers were added to the list of valid modifiers effective January 1, 2009.
Clarification of reference (non-patient) laboratory testing
CMS released Transmittal 1729 to the Claims Processing Manual this week, implementing provisions of the Medicare Improvements for Patients and Providers Act (MIPPA) regarding payment of reference laboratory tests performed at a Critical Access Hospital (CAH). Although directed at CAHs, this is a good opportunity to review the rules for reference lab billing for OPPS hospitals as well. This is a common area of confusion for hospitals because of the definition of non-patient in the context of reference lab services. See Claims Processing Manual, Chapter 16, Section 40.3, as revised by Transmittal 1729, and Benefit Policy Manual, Chapter 6, Section 70.5. [more]
Medically Unlikely Edits and ABNs
This was an especially light week for items from CMS for hospitals. This is, perhaps, because shortly we should see the FY2010 Inpatient Prospective Payment System Proposed Rule.
I did want to discuss a new FAQ on Medically Unlikely Edits (MUEs) that brings up some questions. The new FAQ focuses on Advanced Beneficiary Notices (ABNs), pointing out that a beneficiary can not be billed for units in excess of an MUE even if the provider issues an ABN to the beneficiary. CMS explains that an MUE denial is a coding denial, and that ABN provisions only apply to medical necessity denials. [more]
