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.

Red Flag Alert Requirements Apply to ASCs

The Federal Trade Commission has issued “Red Flag” Requirements for Financial Institutions and Creditors in an attempt to fight identity theft. And while there was some question as to whether these requirements would apply to Ambulatory Surgery Centers, it has been determined that ASCs qualify as “Creditors,” and so the regulations are applicable to ASCs. This means that ASCs have until August 1, 2009, to comply with the FTC’s Red Flag Requirements (the more recent compliance date was in May).

Ambulatory Surgery Centers (as well as Physician Offices) are defined as creditors because each is considered to extend credit to patients on a regular basis, renew credit or to arrange credit for others. The definition includes all entities that defer payment for services. While many ASCs and Physician Offices may have policies of collecting payment before services, I believe most give at least some patients a grace period from time to time and so would meet the definition of creditor.

To comply with the Red Flag Rules, ASCs must develop a written program that identifies and detects the relevant warning signs – or “red flags” – of identity theft. According to the FTC, these may include:

• unusual account activity
• fraud alerts on a consumer report, or attempted use of suspicious account application documents
• suspicious documents

The program must also:

• describe appropriate responses that would prevent and mitigate the crime and detail a plan to update the program
• be managed by the Board of Directors or senior employees of the financial institution or creditor
• include appropriate staff training
• provide for oversight of any service providers

Wow! What does all of that mean for you? Well, primarily that you have to get a written program in place by August 1. One way to setup your program is to go to the FTC website where you can find a pdf document that will walk you through setting up a program.

Another idea is to go to the ASC Association’s web site, where they have a sample Red Flags Policy for your use. (While you’re on the ASC Association’s web site, you might consider joining as they have many helpful resources for ASCs.) If you have any other questions about the Red Flag Program and how to implement one in your surgery center, contact Ortmann Healthcare Consultants at 803-252-7979!

Submitted by Chris McMenemy, VP Administration

Nevada ASCs-Mandatory Accreditation May Be in Your Future

Outpatient Surgery Magazine released an interesting article today regarding the status of Ambulatory Surgery Centers in Nevada as a result of the investigations into infection control deficiencies in many of the states ASCs. This is a must read for anyone involved with surgery centers in Nevada.

According to the article, two new pieces of legislation are being introduced in Nevada that will change the licensure and accreditation requirements for surgery centers. You can read the entire article here. Check back on our blog for more updates as these bills work their way through the Nevada Legislature.

Preparing for Medicares changes to Conditions for Coverage- Advanced Directives

One other piece of paper must be signed in advance of the date of the procedure, which is information concerning the ambulatory surgery center’s policies on advance directives, including a description of applicable State health and safety laws and, if requested, official State advance directive forms. As a part of this procedure, inform the patient of his or her right to make informed decisions regarding patient care. The law also requires that the ASC document in a prominent part (not defined) of the patient’s current medical record, whether the individual has executed an advance directive. As above, you must make plans to have this information provided and signed prior to the date of the surgery. This website is an excellent resource for finding your state’s laws concerning advanced directives.

You should begin planning for the process you will use to accomplish the task of getting this paperwork signed and verbally presented to your patients. May 18 isn’t that far away! If you feel you may need assistance bringing your policy manual or patient documents into compliance, contact Ortmann Healthcare Consultants at 803-252-7979 today!

Submitted by Chris McMenemy, VP Administration