A notice to all ASCs accredited by AAAASF

Medicare has recently announced that the American Association for Accreditation of Ambulatory Surgery Facilities (AAAASF) is conditionally approved for an extension of its deeming authority until May 26, 2010. In order to maintain this deeming authority, AAAASF has made changes to their survey and reporting procedures.

According to the Medicare release issued November 27, “Review of AAAASF’s renewal application revealed that AAAASF has ongoing, serious, widespread areas of non-compliance, specifically (1) an inability to provide accurate and timely data on deemed providers; (2) lack of complete and accurate deemed facility survey files; and (3) an inadequate surveyor training and evaluation program. If it is determined that an accreditation organization has failed to adopt requirements comparable to Medicare conditions of participation, a conditional approval of the accreditation organization’s deeming authority for a period of up to 1 year may be granted. During that time the organization may make changes to its surveys and policies so that they are comparable to Medicare requirements. AAAASF has been put on a 180 day probationary period. Within 60 days after the end of AAAASF’s probationary period, a final determination will be made as to whether or not AAAASF’s ASC accreditation requirements are acceptable.”

This decision could have serious implications for many surgery centers who received accreditation/deemed status certification through AAAASF, especially if their deeming authority is revoked. Accreditation is optional for surgery centers, excluding those in states without licensure regulations that have instituted mandatory accreditation, and in many cases is a faster way to achieve Medicare certification than relying on the state agency to perform such surveys. The other options for accreditation/deemed status for ambulatory surgery centers includes Accreditation Association for Ambulatory Health Care (AAAHC) and the Joint Commision.

Update: A full copy of the CMS release is available on the AAAASF website.

Ortmann Healthcare Consultants will continue to monitor this story and provide updates as necessary!

Question of the Day: Can an ASC share space with a Medical Office?

Today’s question of the day is a question that is asked of Ortmann Healthcare Consultants frequently. Medicare regulations require the ASC to be a separate and distinct entity from other entities sharing space in a medical office building. The ASC cannot use space in other medical offices as ASC space, even for medical record storage. If the ASC is renting space from another office, the office must be closed while the ASC is open. Also, ASC employees must be ASC specific unless an employee lease agreement is in place and the employees are at the ASC during the hours it is in operation, and not moving back and forth between offices.

The only instance where we have seen an ASC “share” space with other medical offices is through the use of a shared reception area, where a patient enters the building through a shared space, registers with the receptionist at the registration desk and is then shown to the waiting room for the ASC. This waiting room must be specific to the ASC and cannot be shared with other offices.

If you have questions for Ortmann Healthcare Consultants, you can post them in the comments section of our blog or send them to Jessica.Miller@ortmannhealth.com.

Weathering the Storm

Emergency Management Planning is now a requirement for ambulatory surgery centers. An effective policy should be in place to respond to emergencies and the emergency management plan is an essential part of meeting this requirement. CMS has issued a checklist to assist you in writing your plan.
Here are a few key elements from the checklist to include:

• All Hazards Continuity of Operations (COOP) Plan: Develop a continuity of operations business plan using an all-hazards approach (e.g., hurricanes, floods, tornados, fire, bioterrorism, pandemic, etc) that could potentially affect the facility directly and indirectly within the particular area of location. Indirect hazards could affect the community but not the facility and as a result interrupt necessary utilities, supplies or staffing. Determine all essential functions and critical personnel.
• Collaborate with Local Emergency Management Agency: Collaborate with local emergency management agencies to ensure the development of an effective emergency plan.
• Develop Evacuation Plan: Develop an effective plan for evacuation, by ensuring provisions for the following are specified: Identification of person responsible for implementing the facility evacuation plan (even if no outside evacuation order is given), Multiple pre-determined evacuation locations (contract or agreement) with a “like” facility have been established, Evacuation routes and alternative routes have been identified, and the proper authorities have been notified, Adequate food supply and logistical support for transporting food is described, Procedure for protecting and transporting resident/patient medical records, Determine a method to account for all individuals during and after the evacuation.
• Facility Reentry Plan: Describe who will authorize reentry to the facility after an evacuation, the procedures for inspecting the facility, and how it will be determined when it is safe to return to the facility after an evacuation. The plan should also describe the appropriate consideration for return travel back to the facility.
• Review Emergency Plan: Complete an internal review of the emergency plan on an annual basis to ensure the plan reflects the most accurate and up-to-date information. Updates may be warranted for: Regulatory change, New hazards are identified or existing hazards change, After tests, drills, or exercises when problems have been identified, After actual disasters/emergency responses, Infrastructure changes, Funding or budget-level changes,etc.

The Emergency Management Plan should be incorporated into your Policy and Procedure manual. Make sure you staff is briefed on the plan and that its incorporation into the manual is reviewed and approved by the Board of Directors.

If you need further assistance preparing an emergency management plan to meet the new CMS Conditions for Coverage, contact Ortmann Healthcare Consultants at 803-252-7979. We’d be happy to help!

Submitted by Jessica Miller, Director of Regulatory Affairs

Massachusetts Deadline for Licensure of Clinics- December 12, 2009

In late June, the Massachusetts Department of Health began sending letters to ambulatory surgery centers across the state notifying them of the changes to licensure requirements for clinics under the new Chapter 305 regulations. According to the new regulations, ambulatory surgery centers are no longer exempt from licensure requirements. All ambulatory surgery centers will be required to seek licensure status by December 12, 2009.
For facilities that are Medicare certified or accredited, there is a deemed-by-accreditation licensure option. This option is available to Medicare certified and accredited ambulatory surgery centers that were in operation on August 10, 2008, or an ASC that was under construction on August 10, 2008 and that is in operation on December 12, 2009.

Furthermore, the Department expects that those ASCs planning to take advantage of the grandfathering provisions in chapter 305 will be applying for licensure as substantially the same entity that was in operation in August of 2008. The grandfathering provision does not apply to, for exmaple, a surgery center with one physician and one OR that in the interim has added two more physicians or another operating room. The Department would find that the newly-configured ASC was not in operation on August 10, 2008 and the ASC would be required to obtain a Determination of Need (DoN) prior to licensure. Similarly, if an ASC that operated as a single-specialty practice on August 10, 2008 seeks clinic licensure as a multi-specialty practice, the Department would find that the multi-specialty practice was not in operation on August 10 and therefore would need DoN approval prior to licensure. You can seek an advisory opinion from DoN if you have specific questions regarding changes in your facilities operation.

If you need more information, here is a copy of the updated regulations 105 CMR 140.000: Licensure of Clinics. Copies of the circular letters and required forms can be found at the DOH ASC Licensure website.

If you are an ambulatory surgery center in the state of Massachusetts and your facility needs assistance becoming compliant with the new regulations, contact Ortmann Healthcare Consultants. We have worked in Massachusetts, are familiar with the changes, and can assist your facility in completing the required paperwork for licensure. And as always, the sooner you complete this paperwork, the better!

Submitted by Jessica Miller, Director of Regulatory Affairs

Surviving Your Fire Safety Survey

Surgery centers undergo a number of inspections for everything from the certificate of occupancy, medicare certification and accreditation. The fire safety survey, also known as the NFPA 101 Life Safety Code, is an important survey that you will have to complete as part of medicare certification. Typically the State Agency for certification assists in setting up the fire safety survey, but due to budget cuts, they often defer to the accrediting agency. It is preferable that if your state will still provide the fire safety survey that you go with them because otherwise the accrediting agency will charge an additional fee for this survey.

Each state survey process varies but to prepare for this survey there are a few things you should have on hand. Ortmann Healthcare Consultants likes to prepare and organize our facilities paperwork into a binder system. Two binders are specifically helpful for the fire safety survey: construction documents, and ancillary agreements. In these binders you should have records regarding the fire alarm system, sprinkler system, and generators if applicable. The inspector will also ask to see fire drill records, depending on how long the facility has been open, and will review the policy and procedure for staff training.

It is also helpful to have handy a set of plans showing fire rated doors and walls. The inspector may want to use a ladder to physically inspect these partitions. Also make sure your medical gas, electrical, and mechanical rooms are free of any clutter. These spaces cannot be used for storage and nothing should be on the floor or around the major equipment.

There is a template available for the fire safety survey and we ask our architects to assist in completing the form so the surveyor may use it as a guide. If your facility is expecting a fire safety inspection, contact Ortmann Healthcare Consultants today to see how we can help!

Federal Funds Released to 12 States to Survey Ambulatory Surgery Centers

American Recovery and Reinvestment Act of 2009 (Recovery Act) Ambulatory Surgical Center Healthcare-Associated Infection (ASC-HAI) Prevention Initiative

Federal funds have recently become available for 12 states to survey ambulatory surgery centers. Kathleen Sebelius, Secretary for HHS, announced on July 31st that funding would be available for 12 states to survey more than 125 ambulatory surgery centers. The funding comes from the American Recovery and Reinvestment Act of 2009 (ARRA) and will be administered by CMS in the amount of $9.95 million.

The first 12 states to volunteer, and the amounts they were awarded are listed below:

• Arkansas- $14,000
• Florida- $16,250
• Indiana- $62,500
• Kansas- $53,500
• Maine- $13,500
• Maryland- $73,000
• Michigan- $53,000
• New Jersey- $125,000
• North Carolina- $34,000
• Oregon- $53,500
• Utah- $62,500
• Wyoming- $11,500
• Total for States & DC- $572,250

CMS believes the additional funding will assist in reducing the number of health care associated infections (HAI). The surveys will also ensure that facilities are following Medicare’s guidelines for infection control. The initiative includes the use of a new survey process and tool developed with the CDC. The tool is the infection control survey that is available at the end of the new Interpretive Guidelines issued by CMS.

The surveys should be completed by September 30, 2009. An additional $9 million in funding will be available in October for the remaining states to survey their ambulatory surgery centers. The CDC has also promised to make available an additional $40 million for states to create or expand their HAI prevention and surveillance efforts.
Additional information can be found at the following links:
Medicare Press Release
HHS’ 2009 Action Plan to Prevent Health care-Associated Infections

If you operate an ambulatory surgery center in one of the first 12 volunteer states and want to make sure your facility is prepared for a survey, contact Ortmann Healthcare Consultants at (803) 252-7979. We have the tools to help you prepare and a record of “No Deficiencies” for every licensure, accreditation, and certification survey we have participated in.

Georgia Certificate of Need Issues New Thresholds

Georgia has recently amended its Certificate of Need capital expenditures thresholds for single specialty physician owned ambulatory surgery centers and joint venture ambulatory surgery centers. These thresholds became effective on July 1, 2009. A copy of the memorandum containing the new thresholds is available here. Georgia CON Thresholds
So what does this mean for physicians and ASCs in GA? Hopefully the new thresholds will positivily impact the physicians ability to develop single specialty centers in GA as the thresholds have been increased from their historical limits. Costs which are not included towards the threshold are according to O.C.G.A. 31-6-40(a)(2)…” the expenditure or commitment of or incurring an obligation for the expenditure of funds to develop certificate of need applications, studies, reports, schematics, preliminary plans and specifications or working drawings, or to acquire sites;”…
For more information regarding the CON program in Georgia, please visit the GA CON website.

Red Alert- NY Office Based Accreditation Deadline is TOMORROW!

Tomorrow will be a day of reckoning for many office based surgery practices in New York. July 14th is the deadline by which all office based surgery practices must be accredited in order to continue practicing office based surgery in New York. Not only must you be accredited but the state must also have verification of your accreditation status. Those office based practices not in compliance will risk facing serious penalties if they continue to practice without accreditation. More information is available at the NY Department of Health website.

For those not in New York, you probably felt a little of the backlash if you have been trying to reach the accreditation agencies in the past week. They have been swamped with last minute requests and planning surveys.

If you are in New York, hopefully you were among the early birds in recognizing the importance of planning for your survey well before tomorrow’s deadline! If you would like to share your story, please leave it as a comment to this post. Ortmann Healthcare Consultants has personally been involved in the accreditation of two office based surgery practices in New York and it was certainly a challenge to bring our facilities up to speed since there has not been a regulation like this for them in the past!

Mandatory Revalidation- is your 855B up to date?

CMS recently announced that mandatory revalidation of Medicare information will begin in Summer 2009. Medicare enrollees will be required to revalidate every five years. Revalidation can also occur as a result of requesting a change to your Medicare information or the filing of a complaint. If Medicare contacts you for revalidation, you have approximately 60 days to respond to their request. If new documents are not submitted in this timeframe, CMS can impose a one to three year revocation of billing privileges before you could apply for billing privileges again!

In most instances, revalidation requires the completion of a new 855B, that lovely Medicare Enrollment form for Ambulatory Surgery Centers (and other Clinics/Group Practices). That also means submitting the required documentation. Sure, Medicare gives you the listing of required documents, but what about those last minute items that somtimes aren’t finalized by the time you submit your enrollment form? I’m talking about your state license, maybe your fax number, possibly even changes in your address! It is the providers responsbility to report any changes, and most have to be reported within 90 days of the change, 30 days for Change of Ownership. Revalidation does not require a new certification survey or provider agreement.

To prepare for revalidation there are two items in particular that should be reviewed:

• Legal Information- Review your Legal Name documents and ensure that what is reported to the IRS matches all other records and documents, especially for your NPI and 855B. This is a good item to review early because if you do detect an error or need to report a change to the IRS, it can take upwards of 2 to 4 weeks to receive updated documents.
• National Provider Identifier (NPI)- Log into the NPPES and review you NPI information to ensure your Medicare provider number is crosswalked in NPPES to the appropriate NPI. You should also review the Medical Director, legal businss name, and Tax ID information for consistency with what is reported on the 855.

If you are contacted regarding revalidation and don’t know where to start, or just need assistance completing the form and compiling the documentation, Ortmann Healthcare Consultants can help! We have been completing the 855B for our clients for years, let us put our experience to work for you! Call us at 803-252-7979.

Submitted by Jessica Miller, Director of Regulatory Affairs

Patient Disclosure for Same Day Surgery

Medicare announced today that it would allow for an exception for same day surgery when it comes to meeting the new standard of the patient signing informed consent and financial disclosure the day before the surgery. The ASC Association announced this news through an email press release. Below is an excerpt of that email.

“It is not acceptable for the ASC to provide the required notice for the first time to a patient on the day that the surgical procedure is scheduled to occur, unless:

• the referral to the ASC for surgery is made on that same date; and
• the referring physician indicates, in writing, that it is medically necessary for the patient to have the surgery on the same day, and
• that surgery in an ASC setting is suitable for that patient.

In such situations the ASC must provide the required notice prior to obtaining the patient’s informed consent. Cases of surgery occurring on the same day it is scheduled are expected to be rare, since ASCs typically perform elective procedures. Frequent occurrence of such cases may represent noncompliance with the advance notice requirement.”

More information is available on the ASC Association Website.