In contempo months, the Centers for Medicare and Medicaid Casework (“CMS”) has taken accomplish to strengthen and accumulate the Medicare acceptance activity that will affect all Medicare providers and suppliers. On April 21, 2006, CMS appear a final aphorism (“Final Rule”)1 establishing new acceptance procedures for all providers and suppliers, except those who opt out of the Medicare program. The Final Aphorism represents the aboriginal allocation of abundant rules apropos to enrolling in the Medicare affairs and advancement Medicare announcement privileges. CMS additionally has issued new versions of the Medicare acceptance applications, which already are in use.
According to CMS, the purpose of the new regulations, which booty aftereffect on June 20, 2006, is to barrier corruption of Medicare announcement numbers and to admission CMS added admission to admonition about enrolled providers and suppliers.
Important highlights include:
The Final Aphorism is essentially agnate to the proposed aphorism issued in 2003 (“Proposed Rule”).2 The best noteworthy changes are the accession of the aeon that would aftereffect in deactivation of announcement privileges for abortion to abide Medicare claims from six months to twelve months, the accomplishing of a phased-in admission for acute acquiescence of acceptance admonition by currently accommodating providers and suppliers, and addendum of the revalidation aeon from three to bristles years.
Although CMS brash the Final Aphorism and the new versions of the acceptance applications to beforehand the Medicare acceptance process, these changes may accession added questions than they answer. All providers and suppliers should agenda the cogent authoritative obligations imposed by the new regulations and, in ablaze of the penalties for non-compliance, booty absolute accomplish to comply.
CMS will abide to crave all providers and suppliers to abide an acceptance application, apperceive as the CMS 855, to accept in the Medicare affairs and to admission Medicare announcement privileges. The new regulations call the adapted agreeable of the acceptance appliance in accepted terms.
Despite requests to the contrary, CMS will abide to use assorted versions of the CMS 855, but CMS has fabricated efforts to abatement the authoritative accountability imposed on applicants with it contempo revisions. For instance, CMS has alone some sections of the applications, and the CMS 855 now includes a account of specific acknowledging affidavit in breadth 17 to adviser applicants in advancing their submissions.
One of the best cogent changes is that applicants charge accouter a National Provider Identifier (“NPI”) on the CMS 855 alike admitting the borderline for accepting an NPI is not until May 23, 2007.3 Applicants additionally charge accommodate a archetype of the NPI notification accustomed from the National Plan and Provider Enumeration System.
The new regulations accredit austere standards for submissions. CMS will adios an acceptance appliance if the appellant does not accommodate complete admonition aural sixty canicule of notification from CMS that it is incomplete, but may admission an addendum to an appellant who is “actively alive with CMS to dness any outstanding issues.”4
Applicants should not calculation on accepting extensions beneath this cryptic accepted and appropriately should accomplish every accomplishment to abide timely, complete applications. Bounce of an acceptance appliance is not accountable to appeal, but a provider or supplier may reapply.5
As allotment of the acceptance process, CMS has the adapted to accomplish an on-site inspection.6 In acknowledgment to comments agitation the on-site visits, CMS declared that it has the approved ascendancy to conduct these visits, which are its alone adjustment for acceptance that a provider and supplier is operational and is in acquiescence with Medicare’s requirements for participation.7
CMS antiseptic that this armpit appointment is abstracted and audible from analysis and acceptance visits conducted to ensure acquiescence with Medicare’s altitude of accord by assertive providers, such as hospitals, nursing homes, and home bloom agencies.8
For the best part, the ambit and attributes of the on-site visits, which will be conducted by CMS’s fee-for-service contractors, is undefined. Providers and suppliers acceptable will see overlap with accreditation inspections as able-bodied as with accompaniment and federal surveys and appropriately should accede how to absorb alertness into absolute behavior and procedures. The timing of on-site reviews additionally is cryptic because CMS beneath to set any deadlines for contractors authoritative antecedent acceptance determinations.
In acknowledgment to comments accustomed on the Proposed Rule, CMS antiseptic that it has not afflicted its activity on able announcement dates. As a result, providers and suppliers still may abide claims retroactively aloft achievement of the acceptance process, to the admeasurement acceptable by accepted regulations.9
Reporting Changes to Acceptance Information
A provider or supplier charge abide changes in acceptance information, forth with acknowledging documentation, aural ninety canicule of the change,10 with two exceptions. First, DMEPOS suppliers charge abide to address all changes aural thirty days. Second, a provider or supplier charge accord apprehension of a change in buying or ascendancy aural thirty days. The ramifications of declining to abide changes to acceptance admonition ahead were unclear, but the new regulations accurately accompaniment that a abortion to accede can beforehand to deactivation or aishment Medicare announcement privileges.
Reporting Changes in Buying or Control. Advertisement of changes in buying or ascendancy additionally is addressed in added genitalia of the Final Rule, including the adjustment on prohibition on the auction or alteration of announcement privileges. This adjustment addresses the requirements for a provider ability a change of buying (“CHOW”)11 in accordance with allotment 489, subpart A, of the Medicare regulations,12 and it establishes that “the accepted buyer and the -to-be new buyer charge complete and abide acceptance applications afore achievement of the change of ownership.”13
In the past, the regulations did not allege to this issue, and the CMS 855 did not acutely accompaniment whether such apprehension had to be accustomed afore or afterwards closing. However, the Medicare contractors about brash providers to accord apprehension as far in beforehand as accessible and to supplement with the Bill of Auction afterwards closing.
Both parties may ache after-effects for abortion to accede with the new filing requirements. The accepted owner’s abortion to abide a CMS 855 may aftereffect in sanctions alike afterwards the date of buying change.14
Further, if the -to-be new buyer fails to abide a CMS 855 “within 30 canicule of the change of ownership,” CMS may conciliate its accepted Medicare announcement number. Deactivation additionally may aftereffect if the appliance contains absolute omissions or if CMS questions whether it should alteration the provider agreement.15 These ambiguous breadth accord CMS advanced across to conciliate announcement privileges in this situation.
Further, providers may accept adversity acknowledging with the pre-closing notification requirements imposed by the Final Rule. In abounding cases, admonition bare for the acceptance appliance is not accessible and the date of the change is not assertive until the transaction absolutely closes.
Pre-change notification is decidedly unrealistic for about traded companies, which charge attach to a array of acknowledged limitations on disclosure, which could accomplish any acknowledgment ambiguous afore the absolute closing of the transaction. CMS responded to these apropos in allotment by advertence that it “understand[s] that not all acceptance admonition is accessible afore the change of buying [and that it] will assignment with the new owner(s) to ensure a seamless transition. . . .”16
However, accustomed the accessible penalties for acquiescence of abridged or abortive information, this account offers little abundance to providers who charge accord pre-closing notification.
The adjustment acclamation the auction or alteration of announcement privileges additionally speaks to changes in buying or ascendancy for suppliers who are not covered by allotment 489 of the regulations. Like the adjustment on advertisement changes in information, this adjustment additionally requires advertisement of a change in buying or ascendancy aural thirty canicule of the change.17
This thirty-day borderline replaces the antecedent borderline of ninety canicule for advertisement all changes. The adjustment accurately states that a change of buying consistent in a new tax identification cardinal requires achievement and acquiescence of a new acceptance appliance by the new owner.18 Suppliers should booty agenda of this new borderline on advertisement changes of buying and ascendancy because a abortion to accede may aftereffect in acting deactivation or, ultimately, aishment of Medicare announcement privileges.
Despite CMS’s attempts to analyze the notification requirements, the accord amid the assorted regulations acclamation the affair is, at best, unclear. For example, the adjustment on advertisement changes references advertisement “within” thirty days, but it does not acknowledgment the pre-closing notification affirmation applicative to providers covered by allotment 489.
Further, providers covered by a provider acceding charge accord apprehension “before” the change occurs, but the timing of this pre-closing acquiescence is uncertain.19 A provider or supplier ability a change in buying or ascendancy appropriately should argue the adapted Medicare architect and accomplished acknowledged admonition able-bodied in beforehand of the transaction to ensure acquiescence with these requirements.
Revalidation of Acceptance Information
One of the best arguable aspects of the Final Aphorism is the adjustment acute providers and suppliers to resubmit and revalidate the accurateness of acceptance admonition every bristles years.20 Although CMS initially proposed a three-year revalidation cycle, it was abiding by commenters to amplify the aeon to bristles years.21
CMS wisely absitively to apparatus a phased-in admission in acceptance of the ample cardinal of physicians who currently bill Medicare but accept never completed an acceptance application.22
CMS affairs to acquaint its contractors to activity new acceptance applications first, again to address and activity firsttime acceptance applications for providers and suppliers currently announcement Medicare in Budgetary Years 2006 and 2007, and, finally, to admit revalidations on a bound base in Budgetary Year 2006, with such activity accretion alpha in Budgetary Year 2008.23
CMS will acquaintance anniversary provider or supplier anon back it is time to revalidate acceptance information.24 Enrollees who accept never submitted a CMS 855 charge now do so. As a result, those who enrolled in the Medicare affairs above-mentioned to the use of the CMS 855 will charge to abide a all-inclusive bulk of admonition not ahead furnished to CMS. The revalidation activity will crave CMS’s contractors to activity a abundant aggregate of acceptance information. Although CMS has committed to phasing in this activity over the aing few budgetary years, CMS’s affirmation that its contractors can handle this workload should be beheld with a advantageous dosage of skepticism.
The provider or supplier charge abide a CMS 855 with complete and authentic information, including acknowledging documentation, for revalidation aural sixty canicule of accepting notification from CMS.25 A provider or supplier may seek added time to respond,26 but, as with antecedent applications, CMS did not clear a authentic accepted for acceding extensions.
Given this abridgement of accurateness and the abbreviate time anatomy for response, providers and suppliers should accept behavior and procedures in abode to ensure able allocation of responses to revalidation requests and acquiescence of authentic admonition in a adapted fashion.
As allotment of the revalidation process, CMS affluence the adapted to conduct added on-site inspections to appraise acquiescence with acceptance requirements and to affirm that the provider or supplier is, CMS’s in fact, operational.27 The regulations did not accredit any added standards apropos back contractors may adjudge to conduct an on-site inspection. Accustomed the across of the regulations, providers and suppliers acceptable will accept agitation admiration back such a analysis may activity and should adapt accordingly.
CMS additionally may accomplish non-routine revalidations of acceptance admonition and address recertification of the accurateness of acceptance admonition whenever necessary. This activity may accommodate a armpit visit.28 The Final Aphorism provided little admonition apropos the activity and timeframe for responding to non-routine revalidations. The account of accessible contest that could activate off-cycle revalidation is so ample that it offers little applied admonition apropos back such a analysis may occur.
Providers and suppliers should booty agenda of assertive appliance requirements that administer whether gluttonous enrollment, appointment changes to information, or activity through the revalidation process. While some of these requirements are new, others are absolute obligations that are important abundant to accreditation reexamination.
Certification Requirements. The new regulations crave a provider or supplier to accredit that it is in acquiescence with all applicative federal and accompaniment licensure requirements, including Medicare statutes and regulations, and that it does not administer or arrangement with afar or debarred individuals or entities.29 These acceptance requirements administer any time that a provider or supplier submits a CMS 855.
The acceptance apropos relationships with afar or debarred individuals or entities is cogent because it requires an acknowledging representation about which the appellant may or may not accept specific ability at the time of certification. Although abounding providers and suppliers accommodate such representations in their affairs and accomplish accepted accomplishments checks, they do not necessarily apperceive the cachet of all advisers or contractors at all times.
The new adaptation of the CMS 855 does not accommodate an authentic acceptance this broad,30 but CMS could seek to alter it anytime. Furthermore, the acceptance apropos acquiescence with Medicare laws, regulations, and affairs instructions could extend to this requirement. At a minimum, in ablaze of this accent on relationships with debarred or afar parties, all providers and suppliers should reevaluate their behavior and procedures for ensuring acquiescence in this area.
As mentioned above, the acceptance additionally includes (as it has in the past) a account apropos acquiescence with Medicare laws, regulations, and affairs instructions, and it accurately names the federal Anti-kickback Statute and the Stark Law. In added words, acquiescence with these rules and regulations is a pre-condition to accepting acquittal from the Medicare program.
As a result, this acceptance could accomplish it difficult for a provider or supplier to avert adjoin a False Claims Act case based on a approach of adumbrated acceptance because it has certified acquiescence with these statutes as a pre-condition to payment. Similarly, the CMS 855 requires the appellant to accede to advantage of Medicare overpayments, which could accroach any after acknowledged altercation apropos the provider or supplier’s obligation to acknowledgment a authentic overpayment.
Finally, providers and suppliers additionally should agenda the ample bent and civilian penalties for advisedly falsifying admonition in the acceptance application. Assorted federal statutes accredit the artifice of abundant fines as able-bodied as imprisonment. These penalties could administer to the commodity as able-bodied as to the individuals involved. Providers and suppliers appropriately should booty all all-important accomplish to ensure that acceptance applications accommodate authentic information.
Signature Requirements. Beneath the new regulation, CMS requires anniversary acceptance appliance to be active by an alone who has the ascendancy to bind the provider or supplier, both accurately and financially, and who has an buying or ascendancy absorption in the provider or supplier.31 The being who signs the appliance charge adjure to the accurateness of the admonition submitted and to the provider or supplier’s acquiescence with a cardinal of added requirements, including the acceptance statements ahead discussed.32 In ablaze of the accessible penalties for noncompliance, the attestant bears ample responsibility.
After antecedent enrollment, a “delegated official” may booty albatross for after updates or changes to acceptance information, provided that the delegated official is a W-2 managing agent of, or an alone with an buying or ascendancy absorption in, the provider or supplier.33 CMS clarified, for the aboriginal time, that a W-2 agent of the ancestor affiliation cannot serve as a delegated official of a accessory because he or she charge accept a “direct accord and affiliation with the applicant.”34 In ablaze of this development, providers and suppliers should ensure that the albatross to assurance the CMS 855 is appropriately delegated in all instances. Abounding organizations, abnormally those with assorted locations, may accretion that the accepted delegated official does not accommodated CMS’s requirements.
Denial of Enrollment
The Final Aphorism expands CMS’s acumen to abjure acceptance in the Medicare program. The accessible affidavit for abnegation are so ample that CMS could accretion breadth for abnegation in about any situation. For example, CMS may abjure acceptance if the provider or supplier is out of acquiescence with the Medicare acceptance requirements “at any time” and has not submitted a plan of antidotal activity as adapted by the regulations. 35
Another notable base for abnegation relates to a provider, supplier, or owner’s confidence for a abomination that CMS has bent is “detrimental to the best interests of the affairs and its beneficiaries.”36 Such offenses accommodate but are not bound to crimes adjoin persons, banking crimes, felonies that affectation absolute accident to the affairs or its beneficiaries, and bloom affliction fraud.37 A abnegation imposed on this base lasts at atomic ten years from the date of conviction.38
Unlike bounce of an application, abnegation of acceptance may be appealed, but the provider or supplier charge delay until the address is over afore appointment a new application. If no address is filed, a new appliance may be submitted afterwards the time for filing an address has lapsed. An address could booty a ample bulk of time, so, depending on the circumstances, acquiescence of a new appliance may be a wiser advance of activity in this situation.39
The Final Aphorism allows some adaptability in the case of a abnegation based on the provider or supplier’s accord with an afar or bedevilled alone or entity. In this situation, CMS may about-face the abnegation if the provider or supplier submits affidavit that it has concluded the relationship. Alike so, the adjustment is cryptic how connected such a changeabout may take.
A abnegation may accept acutely ample and damaging implications because, according to the Final Rule, a abnegation will account CMS to automatically analysis the acceptance of all added locations and actuate whether the abnegation warrants agnate adverse action.40 This affirmation could affectation decidedly austere complications for ample entities with assorted locations.
Revocation of a Medicare Announcement Number
The Final Aphorism establishes breadth for aishment of a Medicare announcement cardinal that are essentially agnate to the affidavit why CMS may abjure enrollment.41 The aishment becomes able aural thirty canicule of the antecedent aishment apprehension and after-effects in accompanying abortion of the provider acceding (if any).42 CMS may about-face a aishment based on an affiliation with an afar or bedevilled alone or commodity if the provider or supplier submits affidavit that it concluded the relationship.43
In free whether to abjure a Medicare announcement number, CMS explained that it will counterbalance the severity of the offenses, mitigating circumstances, affairs and almsman accident consistent from connected enrollment, achievability of antidotal activity plans, almsman admission to care, and any added pertinent factors.44 A provider or supplier may address revocation, but CMS will not accomplish acquittal while an address is pending.45 CMS promised to establish, in a abstracted regulation, a new activity for ambrosial denials and revocations.46
The aftereffect of a aishment is cogent and could accept adverse furnishings on providers and suppliers, abnormally those with assorted locations. Like the regulations administering abnegation of enrollment, the aishment regulations accompaniment that, already a provider or supplier cardinal is revoked, CMS charge automatically analysis the files of associated providers or suppliers.
Deactivation of a Medicare Announcement Number
Under the Final Rule, CMS may conciliate the announcement cardinal of a provider or supplier who does not abide any Medicare claims for twelve after agenda months or who fails to address a change in the admonition supplied on the acceptance appliance aural ninety canicule of back the change occurred (or aural thirty canicule for changes of buying and control).47 The Proposed Aphorism would accept beneath the cessation aeon to six months, but CMS absitively to absorb the accepted twelve-month period.48
When a announcement cardinal is deactivated, announcement privileges are briefly abeyant but can be adequate aloft the acquiescence of adapted or recertified information. Providers and suppliers whose announcement numbers are deactivated for any acumen added than non-submission of claims charge abide a new acceptance appliance and re-enroll in Medicare.49
This aphorism credibility to the accent of ensuring the capability of behavior and procedures accompanying to acceptance updates. If deactivation is for non-submission of claims, a provider or supplier charge artlessly recertify that the acceptance admonition currently on book with Medicare is still correct.50
Prohibition on Auction or Alteration of Announcement Privileges
The Final Aphorism prohibits a provider or supplier from selling, transferring, or acceptance accession commodity or alone to use its Medicare announcement number, except in accordance with reassignment or change of buying rules.51 In addition, CMS retained ample acumen to conciliate a Medicare announcement cardinal at any time afore the provider acceding is transferred to the new owner.52
The Final Aphorism brings some accurateness to the acceptance process, but in accomplishing so it imposes cogent new authoritative burdens and austere after-effects for non-compliance. All providers and suppliers should analysis the Final Aphorism and the adapted CMS 855 forms anxiously to ensure they are acquainted of the obligations imposed, abnormally accustomed the bound timeframes and the accessible penalties involved, and accomplish changes to accepted behavior and procedures as necessary.
1 71 Fed. Reg. 20754 (Apr. 21, 2006).
2 68 Fed. Reg. 22063 (Apr. 25, 2003).
3 69 Fed. Reg. 3434 (Jan. 23, 2004).
4 71 Fed. Reg. 20779 (42 C.F.R. 424.525(b)).
5 71 Fed. Reg. 20779 (42 C.F.R. 424.525(c), (d)).
6 71 Fed. Reg. 20776 (42 C.F.R. 424.510(c)(8)).
7 71 Fed. Reg. 20755, 20765.
8 71 Fed. Reg. 20757.
9 71 Fed. Reg. 20763.
10 71 Fed. Reg. 20778 (42 C.F.R. 424.520(b)).
11 According to the new adaptation of the CMS 855A, a CHOW about occurs back a provider is purchased by accession organization, and it after-effects in the alteration of the Medicare provider number, provider agreement, and outstanding debt. The CMS 855A distinguishes amid a CHOW and an accretion or merger, which occurs back a currently enrolled Medicare provider purchases or has been purchased by accession enrolled provider, and alone the buyer’s provider cardinal and tax identification cardinal remain. In the case of an acquisition/merger, the seller’s provider cardinal dissolves, but, in the case of a CHOW, the provider cardinal is transferred.
12 This aphorism about applies to institutional providers who accept a provider agreement, such as hospitals, accomplished nursing facilities, home bloom agencies, and hospices. See 42 C.F.R. 489.2(b).
13 71 Fed. Reg. 20781 (42 C.F.R. 424.550(b) (emphasis added). In the past, the instructions accompanying the CMS 855A directed the -to-be new buyer to book an appliance absolute admonition about the accepted owner, but both parties did not accept to accede with absolute filing requirements.
14 71 Fed. Reg. at 207781 (to be codification at 42 C.F.R. 424.550(b).
15 This affirmation seems to battle with 42 C.F.R. 489.18, which requires automated alteration of a provider acceding aloft a change in ownership.
16 71 Fed. Reg. at 20762.
17 71 Fed. Reg. 20781 (42 C.F.R. 424.550(c)).
19 The adjustment states that the -to-be new buyer charge abide its appliance “within” thirty canicule and does not accredit a specific borderline for the accepted owner’s submission. Based on these statements, one could betoken the pre-closing submissions are due thirty canicule afore the change of ownership, but the adjustment does not accurately accompaniment a pre-closing deadline.
20 71 Fed. Reg. 20778 (42 C.F.R. 424.515).
21 71 Fed. Reg. 20765.
23 71 Fed. Reg. 20764.
24 71 Fed. Reg. 20778 (42 C.F.R. 424.515(a)).
27 71 Fed Reg. 20778 (42 C.F.R. 424.515(c)).
28 71 Fed. Reg. 20778 (42 C.F.R. 424.515(d)).
29 71 Fed. Reg. 20778 (42 C.F.R. 424.520)).
30 For example, the accepted CMS 855B includes the afterward certification: “Neither this supplier, not any bristles percent or greater owner, partner, officer, director, managing employee, accustomed official, or delegated official thereof is currently sanctioned, suspended, debarred, or afar by [any accompaniment or federal bloom affliction program], or is contrarily banned from bartering casework to Medicare or added Federal affairs beneficiaries.”
31 71 Fed. Reg. 20777 (42 C.F.R. 424.510(d)(3)).
33 71 Fed. Reg. 20777 (42 C.F.R. 424.510(d)(3)(ii)).
35 71 Fed. Reg. 20779 (42 C.F.R. 424.530(a)(1)).
36 71 Fed. Reg. 20779 (42 C.F.R. 424.530(a)(3)).
37 71 Fed. Reg. 20779 (42 C.F.R. 424.530(a)(3)(i)).
38 71 Fed. Reg. 20779 (42 C.F.R. 424.530(a)(3)(ii)).
39 See 71 Fed. Reg. 20779 (42 C.F.R. 424.530).
40 Id. (to be codification at 42 C.F.R. 424.530(d)).
41 71 Fed. Reg. 20779 (42 C.F.R. 424.530(a)).
42 71 Fed. Reg. 20779 (42 C.F.R. 424.530(e)).
43 71 Fed. Reg. 20781 (42 C.F.R. 424.535(d)).
44 71 Fed. Reg. 20761.
45 71 Fed. Reg. 207781 (42 C.F.R. 424.545(a)).
46 71 Fed. Reg. 20765.
47 71 Fed. Reg. 20780 (42 C.F.R. 424.540(a)).
48 See 71 Fed. Reg. 20763.
49 71 Fed. Reg. 20780 (42 C.F.R. 424.540).
51 71 Fed. Reg. 20781 (42 C.F.R. 424.535(a)).
52 71 Fed. Reg. 20781 (42 C.F.R. 424.550(b)).
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