View From 30,000 Feet by Mary Ellen Conway, RN, BSN


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What has happened with mandatory accreditation for DMEPOS Suppliers?

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View From 30,000 Feet by Mary Ellen Conway, RN, BSN

  1. 1. The View from30,000 Feet Accreditation has taken off. Where do we stand, and what’s coming next? I BY MARY ELLEN CONWAY, RN, BSN t’s time to take a 30,000-foot view of what has hap- pened with mandatory accreditation for DMEPOS suppliers. Where are we? What have we learned and where are we headed? Let’s go back a bit to review, and look ahead at what’s coming next. Accreditation History 101 In December of 2003, the Medicare Modernization Act was signed into law. This legislation required accreditation for any Part B supplier who planned to bill Medicare, whether they were a participating or non-participating supplier. The mandate included all Part B suppliers providing DMEPOS, such as pharmacies providing diabetic supplies, physicians providing “bent metal,” physical thera- pists providing rehab equipment, orthotists, pedorthists and more. The Centers for Medicare and Medicaid Services realized the need for a pro- cess that could ensure suppliers were meeting quality standards and to provide onsite visits. The agency turned to accreditation. Additionally, the MMA established a competitive bidding program for DMEPOS and required that all suppliers who wished to bid must be accredited. Since there was a wide disparity of requirements among existing accrediting organizations, CMS developed its own quality standards and said it would name approved, or “deemed status” accreditors that would adopt these standards. The agency also changed the way accreditation for DMEPOS (previously voluntary) was conducted, requiring that its accreditors provide the “items” each sup- plier was accredited to provide. Mary Ellen Conway, RN, BSN, is president of Capital Healthcare Group, LLC, Bethesda, Md., which provides health care management expertise in accreditation preparation and survey follow-up, operations assistance, design of quality improvement programs and outcome measures. You can reach her at 301/896-0193 or through www.capitalhealthcaregroup. com, or follow Conway on Twitter at @MEConway1.26 | JULY 2010 |
  2. 2. Most suppliers became accredited by having something that resembles a compliance “statement.” Watch for CMS to announce the date that all suppliers must have an identified plan that includes such items as scheduled record audits, specific and detailed annual compliance education for staff and much more.Today (and since 2008), if a supplier submits a claim for an were being processed (when the NSC got to it). The firestormitem that does not match the list of accredited items provided that ensued was their accrediting organization, the claim is denied. Suppliers sought the assistance of federal legislators, buy- In 2005, CMS issued its “Draft Quality Standards,” a 104- ing groups went to bat for their members and the situationpage document that was judged by many to be over-the-top was ugly. Suppliers who had provided services to Medicarein proposed requirements, among them having a certified beneficiaries as of the date of their accreditation were facingwound-ostomy nurse involved in the setup of every support huge financial losses since their reinstatements were occurringsurface and requiring a face-to-face meeting with all mail- weeks or even months after that date.order recipients. CMS received over 5,600 comments on the Additionally, the National Association of Chain Drug Storesdraft from the HME community. (NACDS) and the National Association of Community Phar- After digesting these comments, CMS issued its much simpli- macists (NCPA) were able to get emergency legislation passedfied 14-page “Final Quality Standards” on Aug. 14, 2006, and that allowed pharmacies an accreditation extension untilannounced the deemed status accreditors on Nov. 16, 2006. Jan. 1, 2010. Pharmacies that had voluntarily revoked their It wasn’t until 2007, however, that CMS announced the supplier numbers had to communicate with the NSCOct. 1, 2009, mandatory— or “drop dead”—accreditation dead-line for HME companies. The agency also announced that allsuppliers who planned to bid in Round 1 of competitive bid- Fact Sheet for Pharmaciesding would need to be accredited by Sept. 1, 2007. In July 2008, the Medicare Improvement for Patients and Early this month, CMS made available a new fact sheetProviders Act was passed. Along with the delay of competitive containing accreditation information for pharmacies under thebidding, this act also exempted physicians and other licensed Affordable Care Act, which amends the Medicare Improve-practitioners from the mandatory accreditation deadline. ments for Patients and Providers Act of 2008 by extending the deadline for pharmacy accreditation until Jan. 1, 2011. In In October 2008, CMS issued updates to the Final Quality addition, pharmacies that furnish DMEPOS may qualify for anStandards. These are the standards we operate under today. exemption if the pharmacy meets the following criteria:(You can find these standards on the CMS website at www. 1. The total billings by the pharmacy for DMEPOS are less 5 percent of total pharmacy sales for the previous threeAccreditationStandardsCMB.pdf.) calendar years; and 2. The pharmacy has been enrolled as a supplier of durable medi-But It Wasn’t Over Yet cal equipment, prosthetics, orthotics and supplies and has been issued a provider number for at least five years; and As the Oct. 1, 2009, accreditation deadline grew closer, sup- 3. No final adverse action has been imposed on the pharmacypliers who had dragged their feet were hoping for a delay, but in the past five years andCMS was not budging. 4. The pharmacy submits an attestation, in the manner and at In advance of the deadline, the agency sent out instructions the timeframe to be determined, that the pharmacy meetfor non-accredited suppliers advising those who were not going the criteria listed in 1-3 and 5. The pharmacy agrees to submit materials as requested dur-to be accredited by the deadline, or were unsure if they would, ing the course of an audit conducted on a random sampleto revoke their supplier number voluntarily via their 855-S form. of pharmacies selected annually.That way, CMS said, when suppliers did become accredited, According to the fact sheet:their number could be reinstated as of that date. Thousands N Total DMEPOS billings are considered as less than 5 percentof suppliers did as they were told and voluntarily revoked their of the total pharmacy revenue. For example, if a pharmacy isnumbers. The accreditors maintained a frantic pace, trying to part of a larger location, such as a grocery store that also has avisit as many suppliers as possible before the deadline. pharmacy or a pharmacy that sells other items; the total DMEPOS But just as we thought things might calm down, all hell sales would be less than 5 percent of the total pharmacy sales,broke loose. not that of the total grocery/store receipts. N Newly opened locations are required to be accredited because When a supplier number is deactivated, there is a mandatory they do not meet the exemption requirement of having beenone-year waiting period before the number can be reinstated, enrolled in the Medicare program as a DMEPOS supplier for atso thousands of 855-S forms poured into the National Supplier least five years. Therefore, newly opened locations within chainsClearinghouse in the weeks before the deadline from sup- or single locations would have to be accredited.pliers who were waiting on their surveys. Suppliers who did N If a location is part of a franchise, then that location is nothave their surveys and were accredited in the weeks following considered a chain and thus each location would have to receive a separate accreditation decision, if required. Accordingly, eachOct. 1 then sent their reactivation information back in. location in this case is reviewed separately to determine whether At that point, suppliers’ numbers were not being reinstated as it meets all of the exemption criteria.of their accreditation date but as of the date their applications28 | JULY 2010 |
  3. 3. again to reinstate them since now they were not subject to N Performance Improvement program. Do not let your PIthe deadline. requirements get away from you. Make sure you are tracking Since the October deadline, there have been additional de- the required indicators listed in the Final Quality Standards:velopments. The health care reform law provides an exemp- - Beneficiary satisfaction and complaints;tion from the accreditation requirement for pharmacies that - Timeliness of response to questions, problems andcan meet certain criteria. Early this month, CMS issued a fact concerns;sheet setting out the new information for pharmacies. (See - Impact of business practices on adequacy of beneficiaryaccompanying sidebar.) access to items, services, information; Note that there is no exemption for a new pharmacy. Pro- - Frequency of billing/coding errors;viders who wish to open a new pharmacy must be accredited, - Adverse events to beneficiaries due to inadequate service(s)whether or not they currently have an exempted site. Also, or malfunctioning equipment and/or item(s) (e.g injuries, acci-any pharmacy considering participating in the competi- dents, signs and symptoms of infection, hospitalization); andtive bidding program at any time mustbe accredited. Pharmacy providers who do not meetthese exceptions now have until Jan. 1,2011, to become accredited. Behind everyQuality Champion is a great coach.Now What? According to CMS, after all of the chaosof the last few years, there are currently98,675 suppliers, and much of the backlogat the NSC has cleared. So now that all of these companiesare accredited, what are the main areasthey need to watch not to let slide? Whatshould an “accreditation maintenance”program look like? If you are an accred-ited supplier, you have many balls to keepin the air in order to maintain your ac-creditation, but here are some that shouldbe key areas of focus: N Human Resources. Keep up with yourpersonnel files. Make sure all of your em-ployee files have signed job descriptions,completed orientation checklists for newemployees, competency evaluations uponhire and annually, current Tb vaccinationand Hepatitis B status (when applicable)as well as annual evaluations. These filescan easily get out of control, but they alsocan easily stay in control if you pay atten-tion to them each month. HQAA Coach: Stacy N Infection Control. Make sure youeducate your staff each year about blood-borne pathogens. Ensure they are wearinggloves when appropriate, washing their Expert guidance. Another reason to switch to HQAA.hands, using alcohol gel when needed and HQAA is the only CMS-approved HME accreditation organization that offers expertprotecting clean and dirty boundaries for coaches like Stacy. Coaches are with you throughout the entire documentationequipment both in your warehouse and process, answering your questions and helping you champion quality careon your delivery vehicles. in your organization. For more reasons to switch to HQAA, visit N Documentation. Audit your docu- Make sure that you havesigned copies of the complete paperworkcustomers receive. Check to be sureyou have complete orders for all items,and when physician notes are required, Become a Quality Champion.that you have complete documenta-tion on hand that includes all requiredelements. | JULY 2010 | 29
  4. 4. - Documentat ion of pat ient a nd sta f f N What is the accreditor’s schedule and what are the require- infections. ments for in-between? There are accreditors that provide ei- N Compliance program. The new health reform ther annual or triennial (every three years) accreditation. Some legislation requires that all health care provid- require follow-up that must be done at the 18 month mark of ers have a formal compliance program. Most suppliers your three year cycle. Know what you are getting into. became accredited by having something that resembles a N Fees paid vs. administrative costs. There are no savings compliance “statement.” Watch for CMS to announce in selecting an accreditor that charges a lower dollar amount the date that all suppliers must have an identified for your accreditation but causes you to add additional staff plan that includes such items as scheduled record au- and higher administrative costs in order to maintain yourdits, specific and detailed annual compliance education for accreditation. Research what your ongoing requirements arestaff and much more. before you jump to another accrediting organization. N Other services (infusion, home health). If you have otherYour Accreditation Timeline services, you’d be wise to get them all accredited by the same Another change since the October 2009 accreditation deadline body and meet similar requirements across the board, as wellis when you can expect to see your surveyor as having one survey that covers all areas.for re-accreditation. Note that CMS is enforcing N The process. Is the accreditor’s processthe accreditation “expiration” date. Remember Your electronic or paper? Can you get much For example, a supplier who had been Surety Bond, Too of the process accomplished prior toaccredited for three years as of Jan. 15, the survey?2006—once they filed re-accreditation According to CMS, some 11,000 N Conduct an “interview.” Talk to allpaperwork with the accreditor and met DMEPOS providers had their Medi- of the accrediting organizations you areall of their requirements—could expect care numbers revoked as a result of considering. Visit them at state shows,to see their surveyor generally any time the accreditation and surety bond Medtrade, their offices, wherever you can. requirements. Don’t let this happenbetween Oct. 1, 2008, and April 1, 2009, to you. Make sure you begin your ac- See how they relate to you, how they re-for re-survey. creditation renewal in plenty of time spond to your concerns, discuss what your Now, however, your accreditor needs to to avoid a lapse, and that you have perceptions are and ask questions.conduct your re-accreditation visit well in a surety bond in place to prevent a N Your peer’s experience. Ask your peersadvance of your expiration date so that if coverage gap. about their experience with their accredi-deficiencies are found, you have time to MLN Matters Article 6854 (MM6854), tor. Ask the accreditor you are consideringcorrect them, file a plan of correction, have released in March, outlines scenarios in if you can speak with some of the suppliers which suppliers are required to reportthe plan approved, complete a re-visit (if surety bond changes to the NSC. A DME- they have accredited whose companies areneeded) and file the updated information POS supplier must submit an addendum similar in size and scope to yours.with the NSC so that there is no lapse or to the existing bond (or, if preferred, agap in accreditation status. new bond) to the NSC if there is: What Have We Learned, and What’s You must begin accreditation renewal (1) a change in bond terms; Coming Next? (2) a change in the bond amount; ornine to 12 months before your expiration (3) a location on a bond covering We’ve seen that the pharmacy lobbyistsdate in order to have adequate time to multiple non-chain locations is being won a round in this battle by getting somecomplete the process. Be sure to contact added or deleted. of their constituents off of the hook for theyour accreditor early for guidance on your Medicare’s surety bond require- accreditation requirements. But those whoexpected timeframe. ments are summarized in detail in ar- choose to be exempt need to consider sev- ticle MM6392 on the CMS website at eral factors, such as the documentation thatSwitching Accreditors must be in place to support the low volume There are many reasons you might want The list of approved sureties can be of DMEPOS sales over the three-year periodto change accreditors. Just because CMS found on the Department of the Trea- and their inability to open a new location sury’s website at awarded “deemed status” to an accred- c570/c570_a-z.html. (which must be accredited) quickly.iting organization does not mean that every One of the most important items to con-payer requiring DMEPOS accreditation sider is that all Part B suppliers must haverecognizes all of them. You could find that your accreditor is surety bonds in place with the NSC. In the event that CMSnot recognized by some of your payer sources. decides that this non-accredited group poses an increased Other reasons to change might include switching from ac- fraud risk, this could become a new area of focused DMEPOScreditors that require annual renewals, leaving an organiza- claim review. And if a supplier is found to have billing errors,tion that you feel has requirements beyond the Final Quality that surety bond will be recovered quickly as the supplier’sStandards or simply having a bad experience with a particular fight against the judgment gets started.accrediting body. We know that you must make sure you’re accredited to pro- When you are considering switching accrediting organiza- vide any new products your considering. We’ve also learnedtions, what are the factors you should consider? that CMS is monitoring the now-designated “accreditation N CMS is not your only payer! There are many other Med- expiration date,” and that you must get going on your accredi-icaid and third-party payers that require accreditation, so tation renewal in plenty of time.make sure you select an organization that is approved by all Be sure to stay tuned for any additional updates as they oc-of your payers. cur in the next year.30 | JULY 2010 |