presented by: jeffrey s. baird, esq. © 2015 brown & fortunato, p.c

Buying and Selling, Transferring Patient Files After a Sale, Calling

Patients After a Purchase, and Restarting the 36 Months

Presented by:

Jeffrey S. Baird, Esq.

© 2015 Brown & Fortunato, P.C.

A DME supplier cannot sell patients. A DME supplier cannot sell patient files.

What the Law Says

A DME supplier can enter into a bona fide agreement to sell hard assets, and in conjunction with the sale of hard assets, also transfer patient files.

The stockholder of a DME supplier (that is a corporation) can sell his stock to a person or entity.

What the Law Says

Purchase the stock of the DME supplier. Purchase the assets of the DME

supplier.

Two Approaches

Stock Purchase

John Smith owns all of the stock in ABC Medical, Inc., a DME supplier.

Smith will sell his stock certificate to XYZ Medical, Inc.

Stock Purchase

ABC becomes the wholly-owned subsidiary of XYZ.

ABC and XYZ remain separate legal entities. XYZ just so happens to own ABC.

Stock Purchase

ABC keeps “humming along” the same as it always has….same tax ID #, same PTAN, etc.

No break in billing.

Stock Purchase

Notice of the change of ownership (“CHOW”) must be given to the NSC, state licensing agencies, state Medicaid programs, accrediting organizations, surety bond issuer, and perhaps to third party payors.

Stock Purchase

Let’s say that ABC gets hit with claims after closing for activities occurring before closing.

These claims will affect ABC. Subject to limited exceptions, the claims

will not flow up the food chain and be asserted against XYZ.

Stock Purchase

XYZ can protect itself as follows:- Through due diligence- Personal indemnification by Smith- 75% of purchase price paid at closing- 25% of purchase price paid after closing

XYZ can offset in the event that Smith and ABC breach their “reps and warranties”

Stock Purchase

Mutual Non-Disclosure Agreement ABC gives financial documents to XYZ Letter of Intent XYZ conducts due diligence Closing occurs. This is when the Stock

Purchase Agreement is signed and XYZ pays a portion of the purchase price.

Stock Purchase - Mechanics

Asset Purchase

After closing, Smith will continue to own ABC.

ABC will have fewer (or no) hard assets, but will have the purchase price paid by XYZ.

Asset Purchase

If post-closing claims are asserted against ABC, then they are not XYZ’s problem.

In an asset acquisition, the purchaser does not assume any of the seller’s obligations….unless the purchaser chooses to do so.

Asset Purchase

Mutual Non-Disclosure Agreement Seller gives financials/related documents to

buyer LOI executed Buyer conducts due diligence Closing occurs: Asset Purchase Agreement

signed, seller executes a Bill of Sale, and buyer pays money to seller

Asset Purchase - Mechanics

Documentation Requirements

Medicare Program Integrity Manual indicates that a new physician order is required “when there is a change in the supplier.”

CMS to B&F: New orders are required where one supplier purchases the assets of another

Asset Acquisition: Documentation Requirements Imposed on Purchaser

PIM: “In cases where two ore more suppliers merge, the resultant supplier should make all reasonable attempts to secure copies of all active CMNs or DIFs from the supplier(s) purchased. This document should be kept on file by the resultant supplier for future presentation to the DME MACs, DME PSCs, or ZPICs.”


The Claims Processing Manual states that “an assignment is an agreement between a physician (or other supplier of services) and an enrollee where the enrollee transfers to the physician his/her right to benefits based on covered services specified on the assigned claim.”

Because an AOB is an agreement between a beneficiary and a particular supplier, a non-participating supplier that purchases the assets of another must obtain a new AOB.


If a purchasing supplier is a participating supplier, it will not be required to obtain a new AOB.

Medicare payment regulations: “when payment is for services furnished by a participating physician or supplier, the beneficiary (or the person authorized to request payment on the beneficiary’s behalf) is not required to assign the claim to the supplier in order for an assignment to be effective.”


PIM states that suppliers are required to maintain proof of delivery documentation in their files. The three methods of delivery are (1) supplier delivering directly to the beneficiary or authorized representative; (2) supplier utilizing a delivery/shipping service to deliver items; and (3) delivery of items to a nursing facility on behalf of the beneficiary.


There is no written guidance that specifically addresses the question of whether new delivery tickets must be obtained by a supplier after an asset purchase.

It stands to reason that obtaining new delivery tickets would not be possible as delivery of an item is a discrete event that can only be documented at the time of occurrence by the one who carried it out.


Contacting Seller’s Patients

Telephone Solicitation Statute and Supplier Standard #11: a supplier may not call a Medicare beneficiary (a prospective customer) unless the beneficiary has given his prior written permission to be called.

Contacting the Seller’s Patients After an Asset Purchase

As a condition to completing the asset purchase, the buyer should required the seller to send the patient written notice regarding the asset purchase.

The letter should inform the patient that unless he objects, the patient’s files will be transferred to the buyer.


With the notice letter, the seller should send a separate consent card to be completed and returned by the patient, giving the buyer written consent to call the patient directly.


When Can You Restartthe 36-Month Cap?

►A new 36-month rental period can begin only in the following additional situations:• After the 5-year reasonable useful lifetime of the

oxygen equipment has expired if the beneficiary elects to obtain new oxygen equipment,

• Specific incident of damage beyond repair (e.g., dropped and broken, fire, flood, etc.) or the item is stolen or lost,

When Can You Restart the 36-Month Cap?

• During the 36-month rental payment period if break-in-need for at least 60 days plus the days remaining in the month of discontinuation and new medical necessity is established.

When Can You Restart the 36-Month Cap?

After the 5-Year Reasonable Useful Lifetime (RUL) Period

Has Expired

►RUL for oxygen equipment is 5 years.►At any time after the end of the 5-year RUL for

oxygen equipment, the beneficiary may elect to receive new equipment; thus, beginning a new 36-month rental period.

After 5-Year RUL Has Expired

►Five-year period begins on the initial date of service and runs for five years from that date. It is not based on the actual age of the equipment.

►It does not re-start if there has been a change in oxygen modality, change out of equipment, or change in supplier.


►When the RUL of a beneficiary’s portable oxygen equipment differs from the RUL of the beneficiary’s stationary oxygen equipment, the RUL of the stationary oxygen equipment shall govern for both types of oxygen equipment, i.e., stationary and portable.


►If the RUL end date of the portable oxygen equipment is before the RUL end date of the stationary oxygen equipment, the RUL end date of the portable oxygen equipment is extended to coincide with the RUL end date of the stationary oxygen equipment.


►If the RUL end date of the portable oxygen equipment is after the RUL end date of the stationary oxygen equipment, the end date of the RUL of the portable oxygen equipment is shortened to coincide with the RUL end date of the stationary oxygen equipment.


►When the end date of the RUL of the stationary oxygen equipment occurs, the beneficiary may elect to obtain replacement of both the stationary and the portable oxygen equipment.


►If the beneficiary elects to obtain replacement of the stationary and the portable oxygen equipment, both types of oxygen equipment must be replaced at the same time; and a new 36-month rental period and new RUL is started for both the replacement stationary oxygen equipment and the replacement portable oxygen equipment.


►A beneficiary who resides in a DMEPOS competitive bidding area (CBA) may obtain replacement of both the stationary and portable oxygen systems only from a contract supplier having a competitive bidding contract for the CBA in which the beneficiary permanently resides.


►If the beneficiary elects not to receive new equipment after the end of the 5-year RUL and if the supplier retains title to the equipment, all elements of the payment policy for months 37-60 remain in effect.

►There is no separate payment for accessories or repairs.


►If the beneficiary was using gaseous or liquid oxygen equipment during the 36th rental month, payment can continue to be made for oxygen contents.


►If the beneficiary elects not to receive new equipment after the end of the 5-year RUL and if the supplier transfers title of the equipment to the beneficiary, accessories, maintenance, and repairs are statutorily non-covered by Medicare.

►Contents are separately payable for beneficiary-owned gaseous or liquid systems.


Specific Incident of Damage Beyond Repair (e.g., Dropped

and Broken, Fire, Flood, etc.) or the Item Is Stolen or Lost

►A specific incident of damage to equipment is required, such as equipment falling down a flight of stairs as opposed to equipment that is worn out over time.

►New 36-month cap rental period cannot be started if equipment is replaced due to malfunction, wear and tear, routine maintenance, or repair needed.

Lost, Stolen, or Incident Resulting in Damage Beyond Repair

►A new 36-month rental period and new RUL is started on the date that the replacement equipment is furnished to the beneficiary.

►Claims for the replacement of oxygen equipment for the first month of use only are billed using the HCPCS code for the new equipment and the RA modifier.


►You must include on the claim for the first month of use a narrative explanation of the reason why the equipment was replaced and supporting documentation must be maintained in your files.


►For example, if equipment was stolen, you should keep a copy of the police report in your files.

►For lost or irreparably damaged equipment, you should maintain any documentation that supports the narrative account of the incident.


►AFTER expiration of the 36-month cap rental period, supplier of oxygen equipment must continue providing oxygen contents to the beneficiary during ANY period of medical need for the remainder of the 5-year RUL of the equipment.


Replacement Equipment

►Initial CMN and claim for replacement equipment• Initial Date should be the date of delivery of the

replacement oxygen equipment.• Claims for the initial rental month (and only the initial

rental month) must have the RA modifier (replacement of DME item) added to the HCPCS code for the equipment when there is replacement due to RUL or replacement due to damage, theft, or loss.


• Claims for the initial rental month must include a narrative explanation of the reason why the equipment was replaced and supporting documentation must be maintained in the supplier's files.


►Recert CMN for replacement equipment• Repeat testing is not required.

Enter the most recent qualifying value and test date. This test does not have to be within 30 days prior to the Initial

Date. It could be the test result reported on the most recent prior

CMN.

• There is no requirement for a physician visit that is specifically related to the completion of the CMN for replacement equipment.


During 36-Month Cap Period After 60-Plus Day Break in Medical Need

►If beneficiary enters hospital or skilled nursing facility or joins Medicare HMO and continues to need/use oxygen, when the beneficiary returns home or rejoins Medicare FFS, payment resumes where it left off.


►If need/use of oxygen ends for less than 60 days plus the remainder of the rental month of discontinuation and then resumes, payment resumes where it left off.• During the 36-month rental period, if need/use of

oxygen ends for more than 60 days plus the remainder of the rental month of discontinuation and new medical necessity is established, a new 36-month rental period would begin.


►New Initial CMN• The blood gas study must be the most recent study

obtained within 30 days prior to the Initial Date.►The beneficiary must be seen and evaluated by

the treating physician within 30 days prior to the date of Initial Certification.


►If there is an interruption in medical necessity of greater than 60 days plus the days remaining in the last paid rental month, once the need resumes, the supplier would collect supporting documentation (made available upon request) of the new medical need including, but not limited to:


• New prescription (detailed written order, written order prior to delivery if required)

• New Initial CMN (with new qualifying oxygen test results performed within 30 days of new initial date)

• Documentation supporting new medical need• Documentation explaining interruption of need• Documentation supporting length of interruption (e.g., pick up

date, new delivery date)


• The claim for the first month of the new rentals meeting the above documentation should include: New Initial CMN Narrative statement, "Break in medical need greater than 60

days."


►During months 37-60, if need/use of oxygen ends for more than 60 days plus the remainder of the rental month of discontinuation and new medical necessity is established, a new rental period does not begin.

►The supplier who provided the oxygen equipment during the 36th rental month must provide all necessary items and services for the duration of the RUL.


Affordable Care Act (ACA) 6407, Written Order Prior to

Delivery (WOPD), and Face-to-Face Requirements

►Applicable to the following items:• E0424, E0431, E0433, E0434, E0439, E0441, E0442,

E0443, E0444►These items require an in-person or face-to-face

interaction between the beneficiary and their treating physician prior to prescribing the item, specifically to document that the beneficiary was evaluated and/or treated for a condition that supports the need for the item(s) of DME ordered.

ACA 6407 Requirements

►A dispensing order is not sufficient to provide these items.

►A WOPD is required.


►A new face-to-face examination is required each time a new prescription for one of the specified items is ordered.

►A new prescription is required by Medicare:• For all claims for purchases or initial rentals• When there is a change in the prescription for the

accessory, supply, drug, etc., all claims for purchases or initial rentals

• For all claims for purchases or initial rentals


• If a local coverage determination requires periodic prescription renewal (i.e., policy requires a new prescription on a scheduled or periodic basis) all claims for purchases or initial rentals

• When an item is replaced• When there is a change in the supplier• When required by state law

►The face-to-face examination must be within 6 months prior to the date of the WOPD.


Oxygen Patients ofBankrupt DME Supplier

►Competitive bidding is forcing a number of DME suppliers to close their doors.

►Many of these suppliers are having to go into bankruptcy.

Oxygen Patients of Bankrupt DME Supplier

►The guidance issued by CMS related to payment for replacement oxygen equipment in bankruptcy situations is contained in Section 50.4 of Chapter 20 in the Medicare Claims Processing Manual.


► It states, “when a supplier files for Chapter 7 or 11 bankruptcy … and cannot continue to furnish oxygen to its Medicare beneficiaries, the oxygen equipment is considered lost in these situations and payment may be made for replacement equipment. For replacement oxygen equipment, a new reasonable useful lifetime period and a new 36-month payment period begins on the date of delivery of the replacement oxygen equipment.”


►The supporting documentation that will be required to verify that the supplier declared bankruptcy depends on whether the bankruptcy is a Chapter 7 (liquidation) or a Chapter 11 (reorganization). For a Chapter 7, the “supporting documentation must include court records documenting that the previous supplier filed a petition for a Chapter 7 bankruptcy in a United States Bankruptcy Court … .”


►For a Chapter 11, the “supporting documentation must include Court records documenting that the previous supplier filed a petition for a Chapter 11 bankruptcy in a United States Bankruptcy Court; and documents filed in the bankruptcy case confirming that the equipment was sold or is scheduled to be sold as evidenced by one of the following:


• [1] The Court order authorizing and/or approving the sale; or

• [2] Supporting documentation that the sale is scheduled to occur or has occurred, e.g., a bill of sale, or an asset purchase agreement signed by the seller and the buyer; or

• [3] A Court order authorizing abandonment of the equipment.”


►Because this policy contemplates the establishment of a new reasonable useful lifetime, it should allow for a new 36-month payment period regardless of whether a patient of the bankrupt supplier was still in the 36-month rental payment period or the non-rental payment period consisting of rental months 37-60.


►As with any other situation in which oxygen equipment is lost and replacement equipment is furnished, the RA modifier must be submitted on the claim and a narrative explanation should be included on the claim.


►In addition, the replacement supplier must obtain the necessary qualifying documentation, including the blood gas testing results, a new order and/or CMN, and proof of delivery.


Abandonment ofOxygen Patients

► In late August 2013, CMS published the following announcement regarding “abandonment” of patients:• MLN Connects Provider eNews 08/22/13• Replacement of Home Oxygen Services in the Event

That a Supplier Exits the Medicare Oxygen Business

Abandonment of Oxygen Patients

• Effective immediately, CMS will allow for the replacement of oxygen equipment in cases where a supplier exits the Medicare oxygen business and is no longer able to continue furnishing oxygen and oxygen equipment. In these instances, the oxygen equipment will be considered lost and a new 36-month rental period and reasonable useful lifetime will begin for the new supplier furnishing replacement oxygen equipment on the date that the replacement equipment is furnished to the beneficiary.


• Suppliers exiting the Medicare oxygen business with patients that they were unable to transfer to new suppliers should be aware that they are in violation of the statutory and regulatory requirements for furnishing oxygen equipment both before and after the payment cap.


• As such, oxygen suppliers that do not fulfill their oxygen obligations and voluntarily exit the Medicare oxygen business are not in compliance with the Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) supplier standards set forth at 42 CFR 424.57(c).


► This announcement is likely intended to deter (and punish) DME suppliers that abandon their patients at or near the end of the 36-month rental period by closing their doors or exiting the Medicare oxygen business.


► This announcement likely does not apply to a supplier that assumes responsibility for patients who transfer to the supplier pursuant to a bona fide asset sale.

► In a bona fide asset sale, the seller does not exit the Medicare oxygen business without insuring its patients are taken care of.


►The asset sale allows for the continuation of patient support and service; therefore, there is no abandonment.

►This announcement appears to be meant to deter DME suppliers that provide DME products in addition to oxygen equipment from voluntarily leaving the Medicare oxygen business without fulfilling their oxygen obligations to patients.


►The “deterrence” is CMS’s statement that such abandonment is a violation of the DMEPOS supplier standards and could lead to the revocation of the DME company’s Part B supplier number.

► It appears that CMS does not want a DME supplier that provides a variety of products to drop its oxygen business because it is no longer profitable.


►This is particularly relevant in the competitive bidding arena.

►A DME supplier may be motivated to walk away from its oxygen business after losing out on a competitive bid contract.

►Without the influx of new patients, the Medicare oxygen business can quickly become unprofitable.


►CMS will likely use this announcement to protect oxygen patients in the event their supplier walks away from the business leaving the patients “abandoned” with nowhere to go for equipment repairs.

►Allowing the 36-month rental period to restart by classifying the equipment as “lost” is an incentive for new suppliers to assume responsibility for the abandoned patients.


Oxygen Patients ofClosed DME Supplier

►DME MAC Jurisdiction A posted an article on 12/19/13 entitled “Supplier ‘Abandonment’ of Beneficiaries and Oxygen Equipment.” The article provides the following:

• In the event the DME supplier voluntarily exits the Medicare oxygen business and is no longer able to continue furnishing oxygen and oxygen equipment, the replacement oxygen and oxygen equipment will be deemed to be “lost” under Medicare regulations.

Oxygen Patients of Closed DME Supplier

• The regulations provide that a patient may elect to obtain a new piece of equipment if the equipment has been in continuous use by the patient for the equipment’s reasonable and useful lifetime or has been lost, stolen, or irreparably damaged.


• When considering “lost” equipment, the DME MACs will establish a new 36-month rental period and reasonable useful lifetime for the new supplier beginning on the date that the replacement equipment is furnished to the beneficiary.


►The article reminds suppliers (voluntarily exiting the Medicare program) that they are in violation of their regulatory obligations.

►The regulations state that• the supplier that received the 36-month rental payment must

continue furnishing the oxygen equipment during any period of medical need for the remainder of the equipment’s reasonable useful life and


• subject to a few exceptions, the supplier that furnishes oxygen equipment in the first month during which payment is made must continue to furnish the equipment for the entire 36-month period of continuous use unless medical necessity ends.


►The article then states that oxygen suppliers that do not fulfill their oxygen obligations and voluntarily exit the Medicare oxygen business are not in compliance with the supplier standards.

►The article gives the following instructions to suppliers that are voluntarily exiting the Medicare oxygen market.• These suppliers must provide a 90-day notice to the beneficiary

of the supplier’s intention to no longer provide oxygen therapy services.


• The notice must be provided in writing and must take one of two forms:• a letter to the beneficiary notifying him/her of the supplier’s intention

to discontinue oxygen therapy services the letter must specify a date upon which this will occur or

• working with the beneficiary, a letter to the new supplier that transfers the provision of oxygen therapy services to the new supplier as of a specific date.


►The article then gives the following instructions to the new supplier that assumes responsibility for beneficiaries of suppliers that have elected to voluntarily exit the Medicare oxygen business.• The claims for replacement equipment must

• include the RA modifier (replacement of a DME item) on the claim line for the replacement equipment and

• document in the narrative field of the claim that “Beneficiary acquired through supplier voluntarily exiting Medicare program” (or a similar statement).


►In the event of an audit, the new supplier should be prepared to provide documentation demonstrating that the beneficiary was transferred from a supplier exiting the Medicare oxygen program.


►Examples of documentation to meet this requirement are either• copy of notice sent to the beneficiary from the old supplier

indicating that the supplier’s services were being terminated or• letter from the old supplier to the new supplier indicating

transfer of the beneficiary due to the voluntary exit from the Medicare program.


►The article further states that if the new supplier is unable to obtain the required documentation, the new supplier may not append the RA modifier to the claim and may not initiate a new 36-month capped rental period.

►Lastly, the article reminds all suppliers (accepting transfers of beneficiaries) that all Medicare rules apply (e.g., new order, new initial CMN, and medical necessity documentation).


►The other three jurisdictions have issued the same or similar instructions.


The “take away” for the DME supplier exiting the market is:• if it can sell its business to another supplier, thereby

insuring the orderly transition of oxygen patients, that is the preferable course of action to take.

If the exiting supplier cannot find a buyer for its business, it needs to give the required advance notice to the beneficiary.


The “take away” for the new supplier that intends to bill for the entire 36 months is• that the supplier needs to properly submit the claim

and obtain the necessary documentation to withstand an audit.


Noncompliant Oxygen Patients: legal steps

► A growing challenge to a DME supplier is what to do with noncompliant oxygen patients. A supplier probably could reasonably conclude that the absence of a fully compliant recertification CMN is a technical fault to be remedied by the pickup of equipment. Likewise, there must be information in the beneficiary’s medical record to support that the item continues to be used by the beneficiary and remains reasonable and necessary. If there is no medical evidence that the item is reasonable and necessary, the supplier is no longer required to provide service to the beneficiary.

► That being said, a concern is that the supplier may have exposure if it picks its equipment up against the beneficiary’s wishes and the beneficiary later alleges that he was injured as a result. This risk can be reduced by having the beneficiary return the item voluntarily.

Noncompliant Oxygen Patients: Legal Steps

►Several FAQs address oxygen patients whose physicians refuse to provide information needed to establish medical necessity. The FAQ responses state that the supplier has a right to refuse to service a patient but also urge suppliers to communicate with both beneficiaries and their physicians to mitigate the noncompliance issue.


►The bottom line is that, although the DME supplier has the right to refuse service to noncompliant beneficiaries, there is risk in exercising this right. In order to reduce the number of beneficiaries who do not recertify in the first place, the supplier may wish to take the following steps:


►Reminder letters: The supplier can send letters to both the physician and the beneficiary (a) before or contemporaneously with the beneficiary’s receipt of the item; and (b) 120, 90, 60 and 30 days before the date recertification is due. The supplier can also use this opportunity to educate the beneficiary about fire safety to satisfy accreditation requirements.


► Lapse notification: If the beneficiary does not recertify, the supplier can send a letter to both the beneficiary and the ordering physician notifying the beneficiary that:• his certification has ended; and• the supplier will pick up the item in 30 days unless recertification

documentation is received within 15 days [providing a specific date and time the equipment will be picked up]. Alternatively, the supplier can offer to provide a return shipping package to return the item by mail.


► This letter should also list other suppliers from which the beneficiary can obtain a similar item. In most cases, this notification to the physician and the beneficiary should result in recertification.


► Gift card incentive: The DME supplier may wish to offer a $25.00 gift card to beneficiaries upon return of the item to the supplier. This is low risk under federal and state anti-kickback laws because the purpose of the card is not to induce referrals nor induce a person to become a patient of the supplier, but rather to give the patient an incentive to return the item.


► Despite best efforts, some beneficiaries will refuse to either recertify or return the item to the supplier. In this case, the risks of demanding the item’s return may outweigh the benefits and, therefore, the supplier may decide that these beneficiaries be permitted to keep the item. The supplier can then periodically contact the beneficiary and offer a gift card in exchange for the item’s return.


► Relevant FAQ’s:► Q11: What should suppliers do if a physician refuses to

provide information needed to establish medical necessity?

► A11: One option is to use the “Dear Physician” letters we have on our web site. These are letters written by our medical director, basically, from one doctor to another advising them that it is their obligation to provide this information in order for the patient to be reimbursed for the item they prescribed. Also, you can get the beneficiary involved and have them contact the physician for the information. If they still refuse to provide the documentation, it is your right to refuse to service this patient.


► Q23: What can we do if a physician refuses to provide documentation that is needed to establish medical necessity?

► A23: “Dear Physician” letters on our web site will help assist in obtaining this information. You can also get the beneficiary involved and have them assist in obtaining the documentation from the physician.


► Q37: We have an initial CMN for oxygen that the doctor completed. When the recertification is due, the doctor will not complete the CMN stating he has not seen the patient within the past year. As a provider, do we have any recourse? What do we need to do since the physician will not sign for a recertification?


► A37: Suppliers need to educate the beneficiary as well that they need to have a visit with their physician prior to their recertification in order for Medicare to reimburse their oxygen claims. This visit will also help to justify continued need and continued use.


► Q2: Can we refuse to service a beneficiary if the doctor is noncompliant in getting us the required documentation?

► A2: Yes, this is your option as a Medicare provider. You can inform the patient that the referring physician does not provide adequate documentation to determine if the item is reasonable and necessary according to Medicare guidelines.


OIG Restrictions on Provision of Home Oxygen Prior to

Qualification and on ConductingPre-Screens

► On November 8, 2006, the OIG posted Advisory Opinion No. 06-20 that sets out a restrictive OIG view towards two business practices pertaining to home oximetry testing.

► Pursuant to the first practice, the HME company would provide Medicare beneficiaries with free home oxygen until the beneficiaries qualify for Medicare coverage for oxygen.

OIG Restrictions on Provision of Home Oxygen Prior to Qualification and on Conducting

Pre-Screens

► Under the second practice, the HME company would pre-screen beneficiaries by running overnight pulse oximetry tests on them and then reporting the test results to the physician.

► The OIG stated that the practices would implicate both the Civil Monetary Penalties (“CMP”) statute and the Medicare/Medicaid anti-kickback statute.


Pre-Screens

►In making this statement, the OIG offered its opinion that• (i) both programs would constitute remuneration to the

beneficiaries who receive them; • (ii) the remuneration provided under the practices would

be likely to influence beneficiaries to select the HME company (providing the free services) as their supplier of oxygen or other Medicare - payable goods and services; and


Pre-Screens

• (iii) the HME company (providing the free services) would know, or should know, that the provision of items and services under the two practices would be likely to influence beneficiaries’ selection of the company for oxygen or other Medicare-payable supplies.


Pre-Screens

►In reviewing the Advisory Opinion, the following observations can be made:• The Advisory Opinion is not intended to prevent the HME

company from providing care (ordered by the treating physician) for existing patients of the HME company that are enrolled in disease management programs, COPD pathways or similar types of programs.

• If an HME company has a patient enrolled in such a program, and if an assessment (including oximetry) is ordered by the treating physician, then the HME company can perform the assessment.


Pre-Screens

• Note that the patient must have a diagnosis that fits the need for the assessment. Examples would include COPD or CHF.

• Documentation would need to support that the assessment was ordered.

• Assessment documentation would include not only SpO2, but presumably also auscultation, respiratory rate and pulse rate.

• If the assessment findings indicate that the patient is experiencing a decline in his/her condition or additional health issues, the patient’s physician should be notified.


Pre-Screens

• The physician will need to make the decisions regarding further assessment and/or intervention.

• Other than as discussed above, an HME company may not provide a free oximetry screening. In other words, the HME company cannot provide free services that would potentially result in the beneficiary choosing the HME company as his/her supplier.

• An HME company may not set up free oxygen while waiting for a qualifying test. If a physician tells the HME company that an emergency exists and that the patient must immediately be set up on oxygen, then the best case scenario would be for the patient to go to an IDTF for testing.


Pre-Screens

• Keep in mind that an emergency room is not a good choice for testing, as Medicare would view that as emergent care; thus, the patient would not be in a “chronic stable state.”

• An alternative is for the HME company to complete an ABN and have the patient sign it in advance of setting the patient up on oxygen. The ABN would advise the patient that Medicare will not pay for oxygen until the patient has a qualifying oxygen test, and inform the patient that he/she will be financially responsible for the oxygen until the patient qualifies.


Pre-Screens

• Should the patient later qualify under the appropriate testing standards, the HME company may, at that point, accept assignment.

• The HME company is not prohibited from advising the physician of the need for re-certification testing, or testing needed due to a change in insurance carrier.


Pre-Screens

Overnight Oximetry Testing: Things a DME Supplier

Can Do

►DME supplier can receive an order for a pulse oximetry test from a physician and forward the order to the IDTF.

►DME supplier can deliver a pulse oximetry test unit and related technology, used to collect and transmit overnight oximetry test results to the IDTF, to a beneficiary’s home.

Things a DME Supplier Can Do

►DME supplier can use related technology to download overnight pulse oximetry test results from a sealed testing unit and transmit those results to the IDTF.


►DME supplier can request an order from a physician for oximetry testing for a patient in the following situations:• A supplier furnishing oxygen to a beneficiary

may contact the beneficiary or the physician as a reminder if a recertification oximetry test is needed or if testing is required for other reasons such as a change in insurance.


• A supplier with an initial order for oxygen where no oximetry test has been performed, or where the tests results are expired or invalid (e.g. the test was performed three days before discharge instead of two), may contact the physician or the beneficiary to inform him or her that a new test is required.


• As part of a clinical evaluation for patients receiving respiratory services from a supplier, the supplier may communicate the beneficiary’s symptoms to the physician. The physician may use this information to determine what further assessment should be performed in order to further evaluate the beneficiary’s condition.


►Under certain circumstances a DME supplier may do the following:• Educate physicians or their staff regarding the

screening of patients for disease states that may require DME.

• Educate physicians on Medicare documentation guidelines.

• Provide a pre-filled prescription to a physician for his/her review and signature based on at least a verbal order from the physician.


Overnight Oximetry Testing: Things a DME Supplier

Cannot Do

► DME supplier cannot perform qualifying oximetry tests.

► DME supplier cannot create written instructions on the proper operation of overnight pulse oximetry test equipment, provide verbal instructions, answer questions from the beneficiary, apply or demonstrate the application of the testing equipment to the beneficiary, or otherwise participate in the conduct of the test being performed by an IDTF.

Things a DME Supplier Cannot Do

►DME supplier cannot access or manipulate IDTF pulse oximetry test results.

►DME supplier cannot loan pulse oximeters to physicians.

►DME supplier should not provide a physician with a pre-filled prescription or order without at least a verbal order from a physician.


►DME supplier cannot be involved in delivery, pickup, or any other aspect of home sleep test.

►DME supplier cannot perform free “screening” oximetry or home sleep test on patients.


THE END

A production of:Brown & Fortunato, P.C.

905 S. Fillmore, Suite 400Amarillo, TX 79101

806-345-6300www.bf-law.com

Jeffrey S. Baird, [email protected]

806-345-6320

mailto:[email protected]

Buying and Selling, Transferring Patient Files After a Sale, Calling Patients After a Purchase, and Restarting the 36 Months

GAMES Annual Meeting – 8/16/2015

27B7885.ppt

presented by: jeffrey s. baird, esq. © 2015 brown & fortunato, p.c

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