eRx Hardship Exemption Requests Extension

On November 1st CMS extended the time period for eligible professionals to request a hardship exemption under the e-Prescribing Incentive Program.  Those eligible professionals that have made at least 10 electronic prescriptions (eRx) between January 1, 2012-June 30, 2012 (for certain CPT codes) will not be subject to the Medicare penalties, and those that have prescribed 25 in 2012 will receive an incentive payment under the program (unless they are receiving the Medicare EHR Incentive Program incentives).  However, there are some eligible professionals that due to “hardships” cannot participate in this program, and CMS acknowledges should not be penalized.  Current hardship exemption categories include:

1.  The inability to e-prescribe due to local, State or Federal law or regulation.

2.  Providers that prescribe fewer than 100 prescriptions between January 1st and June 30, 2012.

3.  Providers practicing in a rural area without sufficient high speed internet access.

4.  Providers practicing in an area without sufficient available pharmacies for eRx.

To apply for a hardship exemption click here.  CMS has added the following two new hardship exemption request categories:

5.  Eligible professionals who achieve meaningful use during certain eRx timeframes. For the 2013 eRx payment adjustment, this will include any eligible professional who achieved meaningful use during January 1, 2011 through June 30, 2012 and has attested to this by January 31, 2013.

6.  Eligible professionals who demonstrate intent to participate in the EHR Incentive Program and adoption of Certified EHR Technology by registering for the EHR Incentive Program by January 31, 2013.  Please note: EHR Incentive Program participants must provide their entire EHR Certification Number  in the CMS EHR Certification ID field during registration to receive this hardship.

For these last two hardship exemption categories, eligible professionals do not have to apply through the Communications Support Page.  But instead must register and attest for the EHR Incentive Program by January 1, 2013.

If you have questions regarding the eRx program please contact Elana Zana.

OIG Opines Favorably on Hospital Emergency Department Call Coverage Arrangement

On October 23, 2012, the Office of Inspector General (“OIG”) issued a favorable response to a hospital’s request regarding its payment of per diem fees to various physician specialties in exchange for emergency department call coverage and related services.  Based on the facts as certified by the hospital-requestor, the OIG concluded that, although the arrangement could violate the federal anti-kickback statute if the parties intended the arrangement to induce or reward referrals of federal health care program business, it would not impose administrative sanctions.  While only the requestor may rely on this advisory opinion, it represents the third time the OIG issued a favorable Advisory Opinion regarding hospital pay for call arrangements.  The OIG similarly reached favorable conclusions in Advisory Opinion No. 07-10 and Advisory Opinion No. 09-05.

In the Opinion, the requestor is a tax-exempt hospital that operates a full time emergency department.  Under the arrangement, the hospital pays per diem fees to physicians to provide call coverage.  The physicians on call are required to be available and respond to calls from the ED within 30 minutes and must provide follow up care, regardless of a patient’s ability to pay.  The Hospital certified to the OIG that 19% of its patients seen in its ED receive uncompensated care, that it offers the arrangement to all specialists on its medical staff who are required to participate in call coverage, that it sets an annual allocation per specialty based on various “burden” factors, that it experienced shortages in the availability of physicians to take call, and that it monitors ongoing performance under the program.  Based on an independent consultant’s review of the per diem rates, the requestor certified to the OIG that the rates are consistent with fair market value and do not take into account the volume or value of referrals or other business generated between the parties.

The OIG concluded that the arrangement fails to qualify for the safe harbor under the federal anti-kickback statute for personal services and management contracts because aggregate compensation is not set in advance (See Safe Harbor, 42 C.F.R. 1001.952(d))    In addition, the arrangement failed to precisely specify a schedule of part-time service intervals.  Because the arrangement does not fit squarely within the safe harbor, the OIG analyzed the totality of the facts and circumstances to determine if the arrangement presents minimal fraud and abuse risk.

Just as it did in the previous Advisory Opinions, the OIG applied the following general “rule of thumb”:

“The general rule of thumb is that any remuneration flowing between hospitals and physicians should be at fair market value for actual and necessary items furnished or services rendered based upon an arm’s-length transaction and should not take into account, directly or indirectly, the value or volume of any past or future referrals or other business generated between the parties.”  70 Fed. Reg. 4858, 4866 (Jan. 31, 2005).

While the OIG generally recognized that hospitals may properly structure pay for call arrangements within the general “rule of thumb,” it also generally identified the same problematic compensation structures that it listed in previous opinions:  (1)  Arbitrary “lost income” compensation, (2) payment for no identifiable service, (3) aggregate on call payments disproprotionately high compared to regular practice income, and (4) payment for services for which the physician already receives separate reimbursement from payors or patients.

The OIG concluded that, overall, the arrangement presents a low risk of fraud and abuse for the following reasons:

  1. The requestor certified that, based on an independent valuation, the per diem rates are fair market value and the hospital meaningfully contemplated call burden to set rates;
  2. Uniform administration of per diem payments without regard to referrals or volume of business generated;
  3. Physicians required to provide actual and necessary services for which they are not otherwise compensated;
  4. The arrangement is offered on a consistent basis to all specialists who are required to take call; and
  5. Costs are not passed on to federal health programs.

The OIG was ultimately convinced that this arrangement contains sufficient safeguards to reduce the risk that the per diem fees are intended to generate referrals of Federal health care business.

For more information about ED call coverage or the Anti-Kickback and Stark rules in general please contact Adam Snyder.

Supervision Levels for Certain Hospital Outpatient Therapeutic Services

On September 24, 2012, CMS published its preliminary decisions regarding recommendations of the Hospital Outpatient Payment Panel (“Panel”) on supervision levels for certain hospital outpatient therapeutic services.  CMS’s review of the Panel’s recommendations stems from a process CMS created in the final Hospital Outpatient Prospective Payment System Rules for Calendar Year 2012 (“CY2012 OPPS Rule”) in which CMS charged the Panel with recommending to CMS the appropriate level of supervision (i.e., general, direct, or personal supervision) for individual hospital outpatient therapeutic services.  CMS directed the Panel to recommend supervision levels for particular services that will “ensure an appropriate level of quality and safety for delivery of a given services.”

In its first efforts since this process was put in place, the Panel recommended that CMS change the supervision level currently required for 28 hospital outpatient therapeutic services.  Of those, CMS accepted the Panel’s recommendation to change the requirements for 15 services from direct supervision to general supervision because those services do not typically require the immediate availability of the supervising physician (or other permitted non-physician practitioners).  CMS declined to accept the Panel’s recommendation to change the supervision level for the other 13 services, choosing to maintain their current requirement of direct supervision because the service either involves assessment by a physician, or there is a significant potential for patient complications or reactions which would require the supervising physician/non-physician practitioner to be immediately available.  CMS’s preliminary decisions and the specific services considered can be found here.

Pursuant to the process CMS established in the CY2012 Final Rule, CMS’s preliminary decisions are subject to a 30-day public review and comment period.  The deadline for submitting comments on these services is October 24, 2012.  After considering any additional comments, CMS will post its final decisions on the services which will be effective on January 1, 2013.  To ensure compliance with the supervision levels required for reimbursement, hospitals should review CMS’s preliminary decisions on the Panel’s recommendation, and then take note of CMS’ final decisions when those are published.

OIG Releases 2013 Work Plan – Important Topics for Both Hospitals and Physicians

Fall must be here because the FY 2013 OIG Work Plan is out.  Providers of all shapes and sizes should at least browse the table of contents to see whether any of the  OIG’s topics for FY 2013 touch important aspects of their businesses and practices.  Among the many topics, some highlights include:

 

  • Analyze the “savings” of expanding the hospital three day payment window to 14 days;
  • Review Medicare payments for hospital discharges that should have been billed as transfers;
  • Review payment for canceled hospital surgical procedures;
  • Review effect on costs of hospital acquisition of ASCs;
  • Review payments for outpatient physical therapy services provided by independent therapists;
  • Review appropriateness of payments for sleep study services and the high utilization of sleep testing procedures;
  • Review coding of anesthesia services (personally performed versus medical direction of up to four concurrent procedures);
  • Review the payment for practice expenses of imaging services;
  • Review the medical necessity of high cost diagnostic imaging tests;
  • Review physician billing for “incident-to” services; and
  • Review physician coding of place of service.

 

Also of note, OIG states that it expects to publish a revised Provider Self-Disclosure Protocol some time in FY 2013.

If you have questions about any of these topics or the OIG Work Plan in general please contact Don Black.

 

Comparison of Stage 1 vs Stage 2 Meaningful Use

Sifting through the hundreds of pages of new rules can be overwhelming.  Luckily, CMS has provided comparison charts to help navigate the meaningful use changes coming our way with Stage 2.  Along with the new rules, CMS clarified that the earliest Stage 2 meaningful use is effective is fiscal year 2014 for hospitals and calendar year 2014 for eligible professionals (more on 2014 to come in future posts).

Click on the links below to see the comparison charts:

Stage 2 Meaningful Use – Eligible Professionals: 17 core objectives, 3 of 6 menu objectives, 9 of 64 clinical quality measures.

Stage 2 Meaningful Use – Hospitals & CAHs: 16 core objectives, 3 of 6 menu objectives, 16 of 29 clinical quality measures.

For more information about meaningful use and the EHR Incentive Programs please contact Elana Zana.

ICD-10 Compliance Delayed

In response to public encouragement, HHS announced earlier this week that it will delay requirements for ICD-10 compliance from October 1, 2013 to October 1, 2014.  The reconsideration of the compliance date was, according to the final rule,  a result of  “(1) the industry transition to Version 5010 did not proceed as effectively as expected; (2) providers expressed concern that other statutory initiatives are stretching their resources; and (3) surveys and polls indicated a lack of readiness for the ICD-10 transition.”  To view the final rule announcing the compliance delay click here.

Stage 2 Meaningful Use Final Rules Announced

After much delay and anticipation, the Stage 2 Meaningful Use Final Rules were announced late last week.  Though the primary focus of the new rules were to update (and increase) the meaningful use objectives and measures for the Medicare and Medicaid EHR Incentive Program, significant additional components regarding the EHR Incentive Program were also included.  To read the 672 pages of the Final Rule click here.  CMS has also posted a fact sheet which provides a good high level summary of some of the main topics of the Final Rule.  In addition to the Meaningful Use final rules, the Office of the National Coordinator has released its new standards governing certified EHR technology and a fact sheet.  The National eHealth Collaborative hosted a helpful webinar with an overview of these new rules, which can be accessed here.

Stay tuned for further information and analysis of these new rules, including an update regarding 2014, batch reporting for groups, commencement of payment adjustments, Medicaid patient volume calculations, new meaningful use measures, and more.

For immediate assistance regarding these new rules or for information regarding Stage 1 Meaningful Use and the EHR Incentive Program generally please contact Elana Zana.

ACO: Understanding Beneficiary Assignments

In the final rule, CMS chose to adopt a preliminary prospective assignment methodology with final retrospective reconciliation.  Under this model, CMS will create a list of beneficiaries likely to receive care from the ACO based on primary care utilization during the most recent periods for which adequate dates are available, and provide a copy of the list to the ACO.  During the performance year, CMS will update the list periodically on a rolling basis to allow the ACO to adjust to likely changes in its assigned population.  At the end of each performance year, CMS will reconcile the list to reflect beneficiaries who actually meet the criteria for assignment to the ACO during the performance year.  Determination of shares savings or losses for the ACO will be based on this final, reconciled population.

CMS chose this approach because it believes that it will provide the ACO with adequate information to redesign care processes while also encouraging ACOs to standardize care for all Medicare FFS beneficiaries instead of a subset.  At the same time, CMS believes that the model will provide adequate incentives for each ACO to provide quality care to its beneficiary population.

CMS has also announced a Pioneer ACO Model which will test alternative savings and alignment.  The Pioneer ACO Model will provide CMS with the opportunity to gain experience and evaluate a more prospective hybrid model than the approach explained above.  CMS will study the Pioneer ACO Model and will consider its experiences in the next rulemaking.

Majority vs. Plurality Rule for Beneficiary Assignment

The Act requires that beneficiaries be assigned to “an ACO based on their utilization of primary care services” furnished by an ACO professional who is a physician, but it does not prescribe the methodology for such assignment.  For its methodology, CMS adopted a plurality of primary care services model, defined in terms of allowed charges, as follows:

CMS considered whether to assign beneficiaries to an ACO when they receive a plurality of their primary care services from an ACO, or to adopt a stricter standard under which a beneficiary will be assigned to an ACO only when he or she receives a majority of their primary care services from an ACO.  CMS chose a plurality methodology because it would result in a greater number of beneficiaries being assigned to an ACO, thus promoting statistical stability and a greater incentive for ACOs to redesign care processes.  Additionally, CMS voiced that the plurality methodology promotes ACO accountability for patients that might otherwise fall through the cracks because they would not meet a majority standard.

  • No Plurality Threshold:  CMS declined to set a threshold requirement on the plurality of primary care services methodology.  This will maximize the number of patients assigned to an ACO.
  • Simple Service Count vs. Accumulated Allowed Charges:  CMS could determine the plurality of services on the basis of a simple service count for each visit or on the basis of the accumulated allowed charges for services delivered.  The method of using a plurality of allowed charges would place greater weight on more complex primary care services in the assignment methodology, while a simple service method count would weigh all primary care encounters equally in determining assignment.  CMS chose to adopt the accumulated allowed charges method count, which put responsibility on the ACO providing the highest complexity and intensity of primary care services.  Additionally, this method results in the assignment of responsibility for containing costs to the provider who generates the most costs.

Assigning Patients to ACOs

A hotly contested area of the proposed ACO rules concerns the assignment of Medicare Fee-for-Service (“FFS”) beneficiaries to ACOs.  Once a Medicare beneficiary is assigned to an ACO, the ACO will then be held accountable “for the quality, cost and overall care” of that beneficiary.  The ACO may also qualify to receive a share of any savings that are realized in the care of these assigned beneficiaries due to appropriate efficiencies and quality improvements that the ACO may be able to implement.

As the final rule explains, assigning Medicare beneficiaries requires several elements:

  1. An operational definition of an ACO, as opposed to a formal definition of an ACO, so that ACOs can be efficiently identified, distinguished, and associated with the beneficiaries for whom they are providing services;
  2. A definition of primary care services for purposes of determining the appropriate assignment of beneficiaries;
  3. A determination concerning whether to assign beneficiaries to ACOs prospectively, at the beginning of a performance year on the basis of services rendered prior to the performance year, or retrospectively, on the basis of services actually rendered by the ACO during the performance year; and
  4. A determination concerning the proportion of primary care services that is necessary for a beneficiary to receive from an ACO in order to be assigned to that ACO, as compared to the proportion of primary care services from other ACOs or non-ACOs.

Recent CMS Guidance Allows Non-Medical Staff Practitioners To Order Hospital Outpatient Services

 

On February 17, 2011, the CMS Office of Clinical Standards and Quality/Survey & Certification Group issued letter memorandum S&C-12-17  regarding who may order hospital outpatient services (the “SCG Letter”).  The SCG Letter clarifies CMS’s interpretation of the Medicare Hospital Conditions of Participation (CoPs) for outpatient services set forth in 42 CFR 482.54.  The regulatory language of this CoP is silent on who may order outpatient services.

CMS issued the SCG Letter in response to industry concerns and confusion created by Transmittal 72 previously issued by CMS.  Transmittal 72 described CMS’s interpretation of the hospital CoPs related to ordering rehabilitation and respiratory care services, requiring these services to be ordered by practitioners who have hospital medical staff privileges. 

 CMS issued the SCG letter after receiving industry comments that Transmittal 72 was having the unintended effect of stating that all ordering practitioners had to hold medical staff privileges, even though CMS had intended the transmittal to expand the categories of practitioners who could order rehabilitation and respiratory services beyond just physicians.  The SCG Letter specifically rescinds those portions of Transmittal 72 which conflict with the letter.

The SCG letter clarified CMS’s interpretation of the hospital CoPs for outpatient services to be:  a practitioner who does not hold medical staff privileges at a hospital may order (or make referrals) for hospital outpatient services to the extent that the practitioner is permitted to do so under approved hospital policies for ordering outpatient services.  The SCG letter states that practitioners may order hospital outpatient services if the practitioners are: 

(1) responsible for the care of the patient;

(2) licensed in, or holds a license recognized in the jurisdiction where the practitioner sees the patient (which could be in a different state as the hospital to where the outpatient services are ordered or referred);

(3) acting within their scope of practice under state law; and

(4) authorized by the medical staff to order the outpatient services under a written hospital policy approved by the governing body. 

The SCG letter makes clear that ordering practitioners can include both practitioners who are on the hospital medical staff and who hold medical staff privileges that include ordering services, and other practitioners who are not on the hospital medical staff but who satisfy the hospital’s policies for ordering or referring patients for hospital outpatient services.  Hospital policies authorizing practitioners to order and refer patients for outpatient services should address how the hospital verifies that the referring practitioner is appropriately licensed and acting within his/her scope of practice.  The policies should also make clear whether the policies apply to all hospital outpatient services or whether there are specific services for which orders may only be accepted from practitioners with medical staff privileges.

Based on the SCG Letter, hospitals should adopt policies addressing who may order and refer hospital outpatient services.  The policies should include defining which outpatient services can be ordered by practitioners with hospital medical staff privileges, and which outpatient services can be ordered by practitioners who do not hold medical staff privileges.  Consistent with the requirements described in the SCG Letter, these policies must be approved by the hospital’s governing body.

If you have any questions about the SCG Letter or CMS hospital Conditions of Participation, please contact Lee Kuo.