Friday Morning Panel: Text Q&A

Please find below answers to questions that were texted in but not answered during Friday’s general session. All of these answers are based solely on Medicare policies. Check with your state laws and/or accrediting body’s requirements which may be more restrictive. This material has been prepared for informational purposes only. None of this information is offered, nor shall be construed, as legal advice. Although ASCA makes every attempt to ensure this information is as accurate as possible, you should not act or rely upon information contained in these materials without specifically seeking professional legal advice.

If you have any follow up questions, please contact Kara Newbury at knewbury@ascassociation.org.

To review the Conditions for Coverage, click here.

The State Operations Manual: Appendix L (Interpretive Guidelines) can be found here.

Conditions for Coverage

1. What actually gives CMS the right to govern how Non-Medicare patients are cared for in the ASC? Unless your state requires Medicare certification for state licensure, you are not required to be Medicare-certified. However, those facilities that would like to be reimbursed for Medicare patients must meet the Conditions for Coverage, which state: “§416.30 Terms of agreement with CMS. (a) Compliance with coverage conditions. The ASC agrees to meet the conditions for coverage specified in subpart C of this part and to report promptly to CMS any failure to do so.”

Discharge

2. For those patients who do not have reliable transportation or are unable to secure transportation for surgery, are there any regulations preventing discharging patients to a taxi service? While there are not regulations specifically addressing sending a patient home in a cab, you should have a responsible adult along with the patient. The Conditions for Coverage state: §416.52(c) Standard: Discharge. The ASC must - (3) Ensure all patients are discharged in the company of a responsible adult, except those patients exempted by the attending physician.” The Interpretive Guidelines: §416.52(c)(3) indicate that “Unless the physician who is responsible for the patient’s care in the ASC has exempted the patient, the ASC may not discharge any patient who is not accompanied by a responsible adult who will go with the patient after discharge. ASCs would be well-advised to develop policies that address what criteria a physician should consider when deciding a patient does not need to be discharged in the company of a responsible adult. Exemptions must be specific to individual patients, not blanket exemptions to a whole class of patients.”

3. Final discharge follow up. Can the pre-printed order "discharge when stable" apply to overnight patients? In other words surgeon does not need to see patient the next day – correct? Please check your state regulations regarding overnight care in respect to a discharge process. They may be prescriptive on this issue. While it may not be prescriptive, it is standard of care for “rounds” to occur in the morning prior to discharging the patient.

Hospital Transfer Agreements

4. Could we get an update on new rules regarding transfer agreements with local hospitals? Do you need a transfer agreement with multiple hospitals, ie pediatrics? There was no change to the actual Condition for Coverage language which states §416.41(3) The ASC must— (i) Have a written transfer agreement with a hospital that meets the requirements of paragraph (b)(2) of this section; or (ii) Ensure that all physicians performing surgery in the ASC have admitting privileges at a hospital that meets the requirements of paragraph (b)(2) of this section. There was additional guidance regarding emergency transfers .

H&Ps

5. Is it acceptable for the surgeon to write a CPT on the diagnosis line on a short form H&P? No. The diagnosis must be written out.

6. Can you comment on H &P update necessity if H&P performed date of service - survey citations disparity on this item? If you do the H&P immediately prior to surgery, such as a patient coming in for a GI procedure after being referred by a primary care physician, then no, you would not need an update note. If, however, the H&P were performed in the morning and the surgery was not until the afternoon, an update should be done. The goal is not time prescribed but the purpose is to determine if anything has changed with that patient that may affect their surgical or anesthetic outcome and the process of informed consent.

7. For the H&P requirement update on day of surgery, is it permissible to use a stamp that says H&P updated and then have surgeon sign that stamped note? Yes, as long as it is within the 30 day timeframe. Just make sure you have a location for updates to be documented and ensure that the updates do not change the appropriateness of the patient to have surgery at the ASC or change the risks/benefits/alternatives that were given by the surgeon at the beginning of the informed consent process.

HIPAA

8. Do you see CMS doing more active surveying for HIPAA compliance - and potential sharing of information that might lead to audit? CMS has not publicly released any guidance to this point, and even if they were to do so, it would probably be a region by region determination. Surveyor guidance already states, “if broader violations of the Privacy Rule are suspected, the case may be referred to the Regional Office, which may in turn forward the information to the Office of Civil Rights.”

Infection Control

9. Do we have to have that antiquated sterilization consent form in the chart for vasectomy patients if they are not Medicare or Medicaid patients? Sterilization consents are State specific requirement so please check your state regulations.

Informed Consent/Patients’ Rights

10. Patient bill of rights can this be given in the pst process? We are not familiar with the phrase “pst process” – may be a typo. Advance notification of the Patient Rights, your facility Advance Directive policy and Ownership can be given to the patient at any point prior to the procedure.

11. Can an anesthesia consent be signed without speaking to anesthesia provided, the information on anesthesia is in the prep pamphlet that is given prior to procedure? The patient has not given an informed consent to the anesthesia provider until they meet with that provider and discuss the planned anesthesia and the risks/benefits/alternatives related with this administration. Certainly you can give this information to the patients prior to speaking with anesthesia. It may help them understand the process, but the anesthesia provider must still give this information to the patient so that the patient is truly giving an “informed” consent.

12. Do surgical consents need to have physician signature /date and time? Surgeon consents are typically completed in their offices. The ASC does not have responsibility for them and there are not any regulatory bodies that provide oversight. It would be beneficial for the surgeon(s) to discuss this with their malpractice carrier. In case you are referring to the Facility Consent, no, the surgeon does not need to sign that document.

13. Does the physician's informed consent need to be on the ASC's record? No, though you need a facility consent.

14. Is it required to have two consents? One for treatment at the facility and one for the procedure. No, but make sure your facility consent includes verbiage that the patient is saying they understand their procedure, and have been told about the risks, alternatives and benefits to the procedure.

15. How does the physician discussing informed consent come into play for GI patients? Typically that patient was sent directly for this procedure by their PCP and hasn't seen the physician performing the procedure in his office. The physician that performs the GI procedure needs to discuss the procedure, risks, benefits and alternatives and ensure the patient does not have any questions prior to the consent being signed. This should be done before the patient goes into the procedure room.

16. How long is the consent good? There is not a regulation regarding this unless your State has specified this. However, the consent is obtained when the risks/benefits/alternatives are given to the patient. If anything changes with the patient’s condition (new med, illness, etc.) prior to the procedure, then the risks/benefits/alternatives may have changed. To avoid any issues, it may be easiest to obtain this on the day of surgery, though that is a consultative comment only.

17. In regards to the electronic patient signature again. If a witness needs to be in place, how acceptable then are the new on-line pre-admission computer programs where patients complete a lot of paperwork at home? If you require a witness (some states specify this and a facility may require it to mitigate risk), then the patient needs to wait to sign this at the facility.

Surveys

18. We are deemed status Joint Commission (TJC). My last survey in 2013 TJC came then 2 weeks later we underwent deemed status survey also should I expect the same in 2016? Unfortunately we cannot know when your surveys may occur. While we have heard that CMS is sometimes surveying just weeks after accrediting bodies, there is no set guidance as to this.

Radiologic Services

19. If we have a contracted agreement with a local hospital, do we still need someone to oversee the radiology services? We do not own radiologic equipment and pay per use? While we did answer this question at the general session, here is the citation:

The Interpretive Guidelines §416.49(b)(1) state that: The scope and complexity of radiological services provided within the ASC, either directly or under arrangement, as an integral part of the ASC’s surgical services must be specified in writing and approved by the governing body. The ASC must also ensure that the provision of radiological services in the ASC complies with the hospital radiologic services requirements at § 482.26(b), (c)(2), and (d)(2), regardless of whether the service is provided directly by the ASC or under arrangement.

Payment Policy

20. Also, when you meet with CMS in Baltimore to address the ASC payable list can you please get amnio graft w/ Pterygium added for reimbursement in ASC. As mentioned during the general session, CMS is increasingly packaging codes, and moving toward payment for an episode of care instead of individual services or procedures. If you are referring to V2790, it is unfortunately no longer separately payable in any setting. ASCA will continue to raise concerns with CMS as to the payment for the primary code. If payment is not increased enough to cover ancillary codes that are often performed as part of the procedure, these policy changes will discourage physicians from performing these procedures in the ASC setting.

21. Is there any problem doing cases that are NOT on the approved CMS list. Such as spine total joints etc. utilizing private pay, LOP, commercial insurance? The Code of Federal Regulations, §416.2, defines an ASC as “any distinct entity that operates exclusively for the purpose of providing surgical services to patients not requiring hospitalization and in which the expected duration of services would not exceed 24 hours following an admission.”

Life Safety Code

22. If Life Safety Code changes, my understanding is that you don't have to change to the new code unless new construction. Is this correct? Follow up about LSC 2012 - What changes will existing centers have to undergo? As a reminder, CMS has proposed adoption of updated Life Safety Code (LSC) requirements. A fact sheet on the proposed rule can be found here.

In the proposed rule it states, “Buildings that have not received all pre-construction governmental approvals required by the jurisdiction(s) in which the building is to be built before the rule's effective date, or those buildings that begin construction after the effective date of this regulation, would be required to meet the New Occupancy chapters of the 2012 edition of the LSC. Buildings constructed before the effective date of this regulation would be required to meet the Existing Occupancy chapters of the 2012 edition of the LSC. Changes made to buildings would be required to comply with Chapter 43—Building Rehabilitation, which could require compliance with the New Occupancy chapters, depending on the changes being made. In instances where mandatory LSC references do not include existing chapters, existing occupancies must ensure buildings and equipment are in compliance with provisions previously adopted by CMS at the time they were constructed or installed.

ASCA will update members as soon as any changes are finalized.

Quality Reporting

23. Can you mention if you bill for anesthesia ie CRNA there are requirements report? I’m not exactly sure what this question is asking, but if this is in regards to the physician quality reporting system (PQRS), CRNAs are included in the 2015 PQRS List of Eligible Professionals.

Recovery Care Centers/Overnight Care

24. Recovery Care Centers- where do you foresee the advancement and allowability of RCCs within Medicare as an appropriate midlevel site. While many states are currently addressing this issue, CMS has not released any recent guidance. The Interpretive Guidelines currently state that, “Some States permit the operation of “recovery centers” that are neither Medicare-certified healthcare facilities nor licensed hospitals, but which provide post-operative care to non-Medicare ASC patients. If such recovery centers would be considered hospitals if they participated in the Medicare program, then it is doubtful that an ASC that transfers patients to such centers meets the Medicare definition of an ASC. However, surveyors are not expected to make determinations about the nature of such recovery centers. If a SA is concerned that a recovery center is providing hospital inpatient care, it should discuss this matter further with the CMS Regional Office.” As more states address this issue, it is probably something that CMS will need to further explore.

25. Any advice for a center that is interested in doing 23 hour stays? What is required of the center, what cases should be done as a 23 hr stay, required staffing, etc? What/who is the best resource for this topic? There was a great session on this topic at ASCA 2015. If you were unable to attend, you can purchase session recordings. There has also been discussion on this topic on the ASCA Connect boards; please feel free to network there with others who are currently doing or contemplating 23 hour stays. It is ultimately up to your individual facility, physicians and staff to determine which cases are appropriate for the ASC setting. Also make sure your state regulations allow overnight stays; states can be more restrictive than Medicare regulations.

26. For facilities that provide extended care services, should the facility just follow local health department rules regarding food services? What requirements are in place for patients with dietary restrictions? Check your state regulations to determine if there are specific regulations regarding food preparation and service in healthcare facilities. The Conditions for Coverage and Interpretive Guidelines do not specifically address dietary needs of patients in ASCs.

27. Is it possible to have an ASC also be approved/allowed to be "a recovery care" or an "extended recovery care" center? (A dual accreditation?) A Medicare-certified ASC is defined under §416.2 as “any distinct entity that operates exclusively for the purpose of providing surgical services to patients not requiring hospitalization and in which the expected duration of services would not exceed 24 hours following an admission.

Drug Compounding/Shortages

28. What do you think about the 503B outsourcing facilities and leveraging their ready to use medications?

There is a significant amount of potential with 503B outsourcing facilities. These facilities are intended to create a “gold standard” for facilities that compound medications (with or without prescriptions) as well as subject themselves to a higher level of scrutiny through increased FDA inspection and oversight. In turn, the certification as an outsourcing facility would be made publicly available and enable ASCs to identify the highest quality facilities quickly and easily.

However, the FDA has provided limited guidance on what can and cannot be compounded in these facilities, and they only recently clarified the definition of “compounding” to exclude the repackaging of drugs. As a result of this problem, only 62 companies have registered as outsourcing facilities. For a full list of 503B facilities, click here.

Regarding the leveraging of ready-to-use medications, the FDA has been actively promoting and encouraging facilities to register as 503Bs, but there is no widespread, consistent strategy in place for facilities to leverage their ready-to-use medications. ASCA will continue to monitor the situation and keep members apprised of any new developments.

29. Re: drug costs, what is ASCA doing to bring this issue to legislators’ attention?

ASCA has proactively discussed the drug shortage issue with key members of the US House of Representatives Energy and Commerce Committee and the Senate Health, Education, Labor, and Pensions (HELP) Committee. The association has also provided information on the impact of drug shortages to a number of congressional offices and highlighted the access/pricing issues as well, particularly around the current saline and lactated ringer shortages. Congress is aware of the problem, and has mandated that the FDA submit an annual report on this issue. Click here to read the most recent report to Congress.

Additionally, the Drug Shortage Resource Center is located on the ASCA website. This resource includes links explaining the history of the shortage, action steps if you suspect a shortage and/or price gouging, and a link to the American Society of Health Systems Pharmacists’ drug shortage resource. Their database allows you to easily look up drugs on the drug shortage list and identify potential substitutions.

Legislation

30. Where is legislation at in regards to Medicare implant reimbursement?

Currently, there is no legislation to specifically address Medicare implant reimbursement. Because the issue is extremely technical and does not require a statutory change made by Congress, ASCA is working directly with CMS to change Medicare’s device intensive policy. This strategy has already proven successful; the threshold for implant reimbursement was lowered in the 2015 payment rule. ASCA staff is continuing to press this issue and hopes for additional movement directly from CMS.

31. How are centers handling/posting and informing the patients for the Surprise Bill Act that was just enforced at the end of March?

This question refers to a New York State-specific regulation; please contact the New York Association of Ambulatory Surgery Centers (http://nysaasc.org/).

Political Involvement/Fly-Ins

32. Do you feel getting involved politically on a local level maybe the way to get the ASC reimbursements increased?

Building local relationships with legislators is a critical part of effecting change in ASC reimbursements and/or regulations. By building and maintaining a connection with your officials, you become known resource for members of Congress to reach out to when an issue arises.

Site Neutrality

33. Can u update us on OIG recommendation to lower HOPD to equalize outpatient fees?

In 2014, the Office of the Inspector General produced a report analyzing the current and future savings that ASCs provide within the Medicare program. This recommendation has not been acted upon, but was listed in the Agency’s March 2015 Compendium of Top 25 Unimplemented Recommendations.

34. Please discuss MedPACs discussion of lowering the HOPD fee schedule to ASC as a cost saver / ASCAs position on this.

ASCA is not in a position to endorse a policy to reduce payments to any Medicare providers. However, as Congress contemplates advancing site-neutral policies ASCA is working with legislators to ensure appropriate policy design.