Source: https://www.federalregister.gov/documents/2011/10/24/2011-27176/medicare-and-medicaid-program-regulatory-provisions-to-promote-program-efficiency-transparency-and
Timestamp: 2016-12-07 09:05:09
Document Index: 521348158

Matched Legal Cases: ['§\u2009494', '§\u2009424', '§\u2009424', '§\u2009442', '§\u2009442', '§\u2009400', '§\u2009400', '§\u2009405', '§\u2009405', '§\u2009416', '§\u2009423', '§\u2009440', '§\u2009486', '§\u2009486', '§\u2009424', '§\u2009400', '§\u2009400', '§\u2009494', '§\u2009416', '§\u2009424', '§\u2009424', '§\u2009442', '§\u2009400', '§\u2009405', '§\u2009405', '§\u2009416', '§\u2009423', '§\u2009440', '§\u2009486', '§\u2009486', '§\u2009424', '§\u2009400', '§\u2009400', 'art 494', '§\u2009494', '§\u2009494', '§\u2009494', '§\u2009494', '§\u2009494', '§\u2009494', '§\u2009416', '§\u2009416', '§\u2009424', '§\u2009424', '§\u2009424', '§\u2009424', '§\u2009424', '§\u2009424', '§\u2009424', '§\u2009424', '§\u2009442', '§\u2009442', '§\u2009442', '§\u2009442', '§\u2009442', '§\u2009442', 'art 483', 'art 400', '§\u2009400', 'art 405', 'art 405', 'art 405', 'art 405', 'art 405', '§\u2009405', '§\u2009405', '§\u2009405', '§\u2009405', 'art 405', 'art 405', '§\u2009405', '§\u2009405', '§\u2009405', '§\u2009405', '§\u2009405', '§\u2009405', 'art 405', 'art 405', 'art 405', 'art 405', 'art 405', '§\u2009405', '§\u2009405', '§\u2009405', '§\u2009405', '§\u2009405', '§\u2009405', 'art 405', 'art 405', '§\u2009405', '§\u2009405', '§\u2009405', '§\u2009405', '§\u2009405', '§\u2009405', '§\u2009405', '§\u2009405', '§\u2009405', '§\u2009405', 'art 405', '§\u2009405', '§\u2009405', '§\u2009405', '§\u2009405', '§\u2009405', '§\u2009405', '§\u2009405', '§\u2009405', '§\u2009405', '§\u2009405', 'art 405', '§\u2009405', '§\u2009405', '§\u2009405', '§\u2009416', '§\u2009416', 'art 162', '§\u2009162', '§\u2009162', '§\u2009162', '§\u2009162', '§\u2009162', '§\u2009162', '§\u2009162', '§\u2009162', '§\u2009162', '§\u2009162', '§\u2009162', '§\u2009162', '§\u2009423', '§\u2009484', '§\u2009484', '§\u2009440', '§\u2009484', '§\u2009486', '§\u2009486', '§\u2009486', '§\u2009486', '§\u2009424', '§\u2009400', '§\u2009400', '§\u2009400', '§\u2009400', '§\u2009416', '§\u2009416', '§\u2009424', '§\u2009424', '§\u2009400', '§\u2009416', '§\u2009416', '§\u2009486', '§\u2009424', '§\u2009400', '§\u2009494', '§\u2009416', '§\u2009424', '§\u2009424', '§\u2009442', '§\u2009442', '§\u2009400', '§\u2009400', '§\u2009405', '§\u2009405', '§\u2009416', '§\u2009423', '§\u2009440', '§\u2009486', '§\u2009486', '§\u2009424', '§\u2009400', '§\u2009400', '§\u2009400', '§\u2009405', '§\u2009405', '§\u2009405', '§\u2009405', '§\u2009405', '§\u2009405', '§\u2009405', 'art 498', '§\u2009405', '§\u2009405', '§\u2009405', '§\u2009405', '§\u2009424', '§\u2009405', '§\u2009424', '§\u2009405', '§\u2009416', '§\u2009423', '§\u2009424', '§\u2009424', '§\u2009424', '§\u2009424', '§\u2009424', '§\u2009440', '§\u2009484', '§\u2009484', '§\u2009442', '§\u2009441', '§\u2009442', '§\u2009442', '§\u2009442', '§\u2009486', '§\u2009486', '§\u2009494', '§\u2009403', '§\u2009403']

:: Medicare and Medicaid Program; Regulatory Provisions To Promote Program Efficiency, Transparency, and Burden Reduction
65909-65926
2011-27176
1. End-Stage Renal Disease (ESRD) Facilities (§ 494.60)
3. Revocation of Enrollment and Billing Privileges in the Medicare Program (§ 424.535)
4. Deactivation of Medicare Billing Privileges (§ 424.540)
5. Duration of Agreement for Intermediate Care Facilities for the Intellectually Disabled (Referred to in Current Regulations as Intermediate Care Facilities for the Mentally Retarded) (§ 442.15 Through § 442.109)
1. OMB Control Numbers for Approved Collections of Information (§ 400.300 and § 400.310)
2. Removal of Obsolete Provisions Related to Initial Determinations, Appeals, and Reopenings of Part A and Part B Claims and Entitlement Determinations (§ 405.701 Through § 405.877)
3. ASC Infection Control Program (§ 416.44)
4. E-Prescribing (§ 423.160)
5. Physical and Occupational Therapist Qualifications (§ 440.110)
6. Definition of Donor Document (§ 486.302)
7. Administration and Governing Body (§ 486.324)
8. Requirement for Enrolling in the Medicare Program (§ 424.510)
1. Redefining the Term “Beneficiary” (§ 400.200 Through § 400.203)
1. ICRs Regarding End-Stage Renal Disease Facilities Condition for Coverage: Physical Environment (§ 494.60)
2. ICRs Regarding Condition for Coverage: Emergency Equipment—Ambulatory Surgical Centers (ASCs) (§ 416.44)
3. ICRs Regarding Revocation of Enrollment and Billing Privileges in the Medicare Program (§ 424.535)
4. ICRs Regarding Deactivation of Medicare Billing Privileges (§ 424.540)
5. ICRs Regarding Duration of Agreement for ICFs/ID (§ 442.15)
1. ICRs Regarding Display of Currently Valid OMB Control Numbers (§ 400.310)
2. ICRs Regarding Initial Determinations, Reconsiderations, Appeals, and Reopenings Under Medicare Part A and B (§ 405.701 through § 405.877)
3. ICRs Regarding Condition for Coverage: Infection Control—Ambulatory Surgical Centers (ASCs) (§ 416.44)
4. ICRs Regarding Standards for Electronic Prescribing (§ 423.160)
5. ICRs Regarding Physical Therapy, Occupational Therapy, and Services for Individuals With Speech, Hearing, and Language Disorders (§ 440.110)
6. ICRs Regarding Definitions (§ 486.302)
7. ICRs Regarding Condition: Administration and Governing Body (§ 486.324)
8. ICRs Regarding Requirement for Enrolling in the Medicare Program (§ 424.510)
1. ICRs Regarding General Definitions (§ 400.200)
2. ICRs Regarding Definitions Specific to Medicaid (§ 400.203)
https://www.federalregister.gov/d/2011-27176
In January 2011, the President issued Executive Order 13563, “Improving Regulations and Regulatory Review.” Section 6 of that order requires agencies to identify rules that may be “outmoded, ineffective, insufficient, or excessively burdensome, and to modify, streamline, expand, or repeal them in accordance with what has been learned.” In accordance with the Executive Order, the Secretary of the Department of Health & Human Services (HHS) published on May 18, 2011, a Preliminary Plan for Retrospective Review of Existing Rules (http://www.whitehouse.gov/​21stcenturygov/​actions/​21st-century-regulatory-system). As shown in the plan, the Centers for Medicare & Medicaid Services (CMS) has identified many obsolete and burdensome rules that could be eliminated or reformed to improve effectiveness or reduce unnecessary red tape and other costs, with a particular focus on freeing up resources that health care providers, health plans, and States could use to improve or enhance patient health and safety. CMS has also examined policies and practices not codified in rules that could be changed or streamlined to achieve better outcomes for patients while reducing burden on providers of care. CMS has also identified non-regulatory changes to increase transparency and to become a better business partner.
As explained in the plan, HHS is committed to the President's vision of creating an environment where agencies incorporate and integrate the ongoing retrospective review of regulations into Department operations to achieve a more streamlined and effective regulatory framework. The objective is to improve the quality of existing regulations consistent with statutory requirements; streamline procedural solutions for businesses to enter and operate in the marketplace; maximize net benefits (including benefits that are difficult to quantify); and reduce costs and other burdens on businesses to comply with regulations. Consistent with the commitment to periodic review and to public participation, HHS will continue to assess its existing significant regulations in accordance with the requirements of Executive Order 13563. Start Printed Page 65910HHS welcomes public suggestions about appropriate reforms. If, at any time, members of the public identify possible reforms to streamline requirements and to reduce existing burdens, HHS will give those suggestions careful consideration. Therefore, along with this proposed rule, we seek ideas from the public to help identify areas for possible reform.
Current regulations at 42 CFR part 494 provide Conditions for Coverage (CfCs) for Medicare-participating end-stage renal disease (ESRD) facilities. Effective February 9, 2009, these regulations were updated to include Federal Life Safety Code (LSC) provisions that we applied to ESRD facilities to standardize CMS regulations across provider types. When the new regulation was first promulgated, we believed that standardized application of the LSC was desirable and that the costs for ESRD facilities would not be excessive. However, we have since determined that standardization may not be appropriate given the non-residential and unique characteristics of ESRD facilities and the increased burden created by these requirements without the commensurate benefit. Chapters 20 and 21 of the National Fire Protection Agency's (NFPA) 101 LSC, 2000 Edition, were incorporated by reference in the ESRD regulations at § 494.60(e).
Dialysis patients are not anesthetized and are required at § 494.60(d)(2) of the ESRD regulation to be trained in emergency disconnect from their dialysis treatment and evacuation from the building;
The total average cost for a facility to meet all three would be $77,659. We suspect that the variability of the estimates may be due to different State Start Printed Page 65911and local requirements already in existence, differences in contractor costs, varying building characteristics (for example, age, size, construction type), and the inconsistent interpretations and applications of NFPA 101 that are prevalent across the nation. The wide range of estimates makes it difficult to determine an average cost related to implementation of NFPA 101. However, using the average costs for the individual structural requirements listed above, if 50 percent or 2,800 facilities required only renovation for hazardous area separation, the savings would be $47.5 million. If 2,800 facilities required renovation for all three structural requirements, the total savings from the burden reduction at the average estimate for all three would be $217 million.
Based on information gained since publication of the updated ESRD CfC, we have concluded that the enforcement of the Federal LSC requirements of NFPA 101 add costs out of proportion to any added protection that they may afford in dialysis facilities which are not at higher risk of fire penetration from adjacent industrial “high hazard” occupancies and where swift, unencumbered evacuation to the outside is available. Therefore, we propose revising § 494.60(e)(1) to restrict mandatory compliance with the NFPA 101 LSC to those ESRD facilities located adjacent to “high hazardous” occupancies and those facilities whose patient treatment areas are not located at grade level with direct access to the outside. This revision would retain the NFPA 101 LSC protections for those facilities in higher-risk locations while relieving burden on those for whom the subdivision of building space and other additional LSC requirements of NFPA 101 are unnecessary.
We note that all ESRD facilities would still be required to comply with State and local fire codes and safety standards under § 494.20. We also propose revising § 494.60(e)(2) to clarify which ESRD facilities must use sprinkler-equipped buildings: those housed in multi-story buildings of lesser fire protected construction types (Types II(000), III(200), or V(000), as defined in NFPA 101), which were constructed after January 1, 2008; and those housed in high rise buildings over 75 feet in height. We note that this revision would not change the meaning or intent of § 494.60(e)(2), but instead would clarify it. That provision states that dialysis facilities participating in Medicare as of October 14, 2008, may continue to use non-sprinklered buildings if such buildings were constructed before January 1, 2008, and State law so permits.
We propose to remove the list of emergency equipment at § 416.44(c)(1) through (c)(9) and propose at § 416.44(c) to require that ASCs, in conjunction with their governing body and the medical staff, develop policies and procedures which specify the types of emergency equipment that would be appropriate for the facility's patient population, and make the items Start Printed Page 65912immediately available at the ASC to handle inter- or post-operative emergencies. We are also proposing that the emergency equipment identified by the ASC meet the current acceptable standards of practice in the ASC industry. We believe that these proposed changes would enable ASCs to better meet current demands, while also ensuring ASCs have the flexibility necessary to respond to emergency needs and incorporate the use of modern equipment most suitable for the procedures performed in the facility.
On June 27, 2008, we published a final rule in the Federal Register (73 FR 36448) entitled “Medicare Program; Appeals of CMS or CMS Contractor Determinations When a Provider or Supplier Fails to Meet the Requirements for Medicare Billing Privileges.” In that rule, we added a new provision at § 424.535(c) to provide that: “After a provider, supplier, delegated official, or authorizing official has had their billing privileges revoked, they are barred from participating in the Medicare program from the effective date of the revocation until the end of the re-enrollment bar. The re-enrollment bar is a minimum of 1 year, but not greater than 3 years, depending on the severity of the basis for revocation.” The purpose of this provision was to prevent providers and suppliers from being able to immediately re-enroll in Medicare after their billing privileges were revoked.
Section 424.535(a)(1) and § 424.535(c), respectively, provide that—(1) Medicare billing privileges may be revoked when a provider or supplier is determined not to be in compliance with our enrollment requirements; and (2) a post-revocation re-enrollment bar of a minimum of 1 year shall be imposed.
We believe that the re-enrollment bar is unnecessary in certain situations. Accordingly, we propose to eliminate the re-enrollment bar in instances when providers and suppliers have not responded timely to requests for revalidation of enrollment or other requests for information initiated by CMS. Specifically, we propose revising § 424.535(c) to expressly provide that the re-enrollment bar would not apply if the revocation is based solely upon the failure of a provider or supplier to respond timely to a revalidation request or other request for information. We believe that this change is appropriate because the re-enrollment bar in such circumstances often results in unnecessarily harsh consequences for the provider or supplier and causes beneficiary access issues in some cases. We have learned of numerous instances when the provider's failure to respond to a revalidation request was unintentional; that is, the provider was not aware of the request due to, for instance, misrouted mail or a clerical mistake. This is different from other revocation reasons, which may be more serious; for example, we revoke providers that have been excluded from Medicare, Medicaid, or other Federal health care programs or that have been convicted of a felony under § 424.535(a)(2) and (a)(3), respectively. Finally, there is another, less restrictive regulatory remedy available for addressing a failure to respond timely to a revalidation request. This remedy is discussed below in section II.A.4.c.
On April 21, 2006, we published a final rule in the Federal Register (71 FR 20753) entitled “Medicare Program; Requirements for Providers and Suppliers to Establish and Maintain Medicare Enrollment.” As part of that rule, we established provisions for the deactivation of Medicare billing privileges at § 424.540.
We propose to revise § 424.540(a) to apply only to those providers and suppliers who do not submit a Form CMS-855I (the enrollment form for individual physicians and non-physician practitioners) to enroll in the Medicare program. Physicians and non-physician practitioners are deactivated most often due to billing inactivity. To reactivate their Medicare billing privileges, they must resubmit an enrollment application.
Further, the 12-month deactivation and reactivation processes also increase the workload and administrative costs of Medicare contractors. Accordingly, our proposal to revise § 424.540(a) would remove this unnecessary burden without jeopardizing our ability to detect and prevent fraud and abuse. We have issued guidance that requires our contractors to conduct certain verification activities to guard against physician and non-physician practitioner identity theft. We believe that this would lessen the danger that the unused billing numbers of these individuals would be accessed by others to submit false claims.
Section 424.540(a)(2) specifies that a provider or supplier's Medicare billing privileges may be deactivated if it fails to report a change to its enrollment information within 90 calendar days or, for changes in ownership or control, within 30 calendar days. We are not proposing to alter this provision. We believe it is necessary for providers and Start Printed Page 65913suppliers to understand the importance of furnishing updated enrollment information to the Medicare program, for incorrect or aged data can lead to improper payments.
We propose to add a new § 424.540(a)(3) that would allow us to deactivate, rather than revoke, the Medicare billing privileges of a provider or supplier that fails to furnish complete and accurate information and all supporting documentation within 90 calendar days of receiving notification to submit an enrollment application and supporting documentation, or resubmit and certify to the accuracy of its enrollment information. Although the deactivated provider or supplier would still have to submit a complete enrollment application to reactivate its billing privileges, it would remain enrolled in Medicare and would not be subject to other, ancillary consequences that a revocation entails: for instance, a prior revocation must be reported in section 3 of the Form CMS-855I application, whereas a prior deactivation need not. In fact, it is for this reason that we believe our proposal would reduce the burden on the provider and supplier communities.
Section 1910 of the Act provides for the certification and approval of Intermediate Care Facilities for the Intellectually Disabled (ICFs/ID). Current regulations at § 442.109 and § 442.110 address ICFs/ID provider agreements and limit the ICFs/ID provider agreements under Medicaid to annual time limits. We propose to remove the time limited agreements for ICFs/ID at § 442.16. We also are proposing to eliminate this requirement at § 442.15, § 442.109, and § 442.110. We propose to replace the requirement with an open ended agreement which, consistent with nursing facilities (NFs), would remain in effect until the Secretary or a State determines that the ICF/ID no longer meets the conditions of participation for ICFs/ID at subpart I part 483.
Part 400 subpart C requires the collection and display of control numbers assigned by the Office of Management and Budget (OMB) to collections of information contained in CMS regulations. The chart at § 400.310 that displays the OMB control numbers has not been updated since December 8, 1995. We believe that, it is no longer necessary to maintain the chart, because an inventory of currently approved CMS information collections, including OMB control numbers, is displayed on a public Web site at http://www.reginfo.gov/​public/​do/​PRAMain. The Web site provides more timely access to the OMB control numbers for CMS information collection requests than the process of publishing updates in the CFR. Also, as part of our quarterly notice of CMS issuances, which is published each quarter in the Federal Register, we will remind reviewers where they can find the most current list of information collections and OMB control numbers. For these reasons, we are proposing to remove and reserve subpart C since the content of the information contained in this subpart is obsolete and more readily available on the public Web site.
On November 15, 2002, we published a comprehensive proposed rule in the Federal Register (67 FR 69312), entitled “Changes to the Medicare Claims Appeal Procedures,” to implement the relevant claims and appeals provisions contained in the Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000 (BIPA) (Pub. L. 106-554). In this proposed rule, we established, in one location (part 405 subpart I), provisions governing all aspects of Part A and Part B claims appeals. In 2003, the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108-173) made further changes to the Medicare claims appeals process. On March 8, 2005, we published an interim final rule with comment period in the Federal Register (70 FR 11420) to implement provisions of the proposed Start Printed Page 65914rule, and to explain how the recently enacted MMA provisions would be implemented. On December 9, 2009, we published a final rule in the Federal Register (74 FR 65296) entitled, “Changes to the Medicare Claims Appeal Procedures,” responding to comments received on the interim final rule implementing part 405 subpart I.
In this rule, we propose to remove the obsolete provisions since it is our expectation that in the 6 years since publication of the March 8, 2005 interim final rule, any party with a pending pre-BIPA appeal would have received an appeal decision or would have brought the pending matter to our attention. We believe that removing these regulations would eliminate any possible confusion among Medicare beneficiaries, providers, suppliers, and their representatives with respect to the applicable appeal rights and procedures. However, while we believe that all pre-BIPA appeals have been processed, we cannot be completely certain that no pending pre-BIPA appeals currently exist. In order to ensure that parties receive due process for their claim disputes, we propose that any newly identified pre-BIPA appeals be handled under the current appeals provisions set forth in part 405 subpart I. (We note that all reopening actions, regardless of whether the determination or decision was made under the pre-BIPA process, initial determinations on claims, and, as explained above, initial determinations and appeals with respect to Medicare entitlement, are currently processed under the applicable procedures in part 405 subpart I.) We believe that maintaining a separate pre-BIPA claim appeals process in the unlikely event such an appeal is discovered is inefficient and impracticable. Using the current appeals process under subpart I, for all appeal requests filed on or after the effective date of this rule, as finalized, would reduce potential confusion about applicable appeal procedures, and would enable parties to take advantage of the reduced decision-making timeframes and other process improvements offered throughout part 405 subpart I (for example, panel reviews during the Qualified Independent Contractor (QIC) reconsideration process for claims denied as not medically reasonable and necessary (see § 405.968(c)), and the right to escalate cases to the next level of appeal when the QIC, Administrative Law Judge (ALJ) or Medicare Appeals Council does not issue a decision within the applicable adjudication timeframe (see § 405.970, § 405.1104, and § 405.1132).
Table 1—Pre-BIPA Part A AppealsPending Pre-BIPA level of appeal in part 405 subpart GAppeal resumes at the following level in part 405 subpart IReconsideration (§ 405.710)Redetermination (§ 405.940).ALJ Hearing (§ 405.720)QIC Reconsideration (§ 405.960).Departmental Appeals Board Review (§ 405.724)Medicare Appeals Council Review (§ 405.1100).
Table 2 below illustrates how we propose to process any pre-BIPA Part B appeals identified after the effective date of this rule, as finalized, under our current regulations at part 405 subpart I. If a party demonstrates that they requested a carrier review of an initial determination under subpart H, but did not receive a carrier review determination or dismissal, the party would be entitled to request a redetermination, followed by QIC reconsideration, ALJ hearing, Medicare Appeals Council review and judicial review in accordance with the provisions in part 405 subpart I. If a party demonstrates that they received a carrier review determination and requested a carrier hearing but did not receive a carrier hearing officer decision or dismissal under subpart H, the party would be entitled to request a QIC reconsideration followed by an ALJ hearing, Medicare Appeals Council review and judicial review in accordance with the provisions in part 405 subpart I. If a party demonstrates that they received a carrier hearing officer decision, and requested but did not receive an ALJ hearing decision or dismissal under subpart H, the party would be directed to request a QIC reconsideration, followed by an ALJ hearing, Medicare Appeals Council review and judicial review in accordance with the provisions in part 405 subpart I. Finally, if a party demonstrates that they received an ALJ hearing decision under subpart H, and requested but did not receive a decision, dismissal or denial of review notice from the Departmental Appeals Board under subpart H, the party would be Start Printed Page 65915entitled to request Medicare Appeals Council review under part 405 subpart I.
We are proposing that parties seek a QIC reconsideration before requesting and receiving a hearing before an ALJ under subpart I for several reasons. First, we note that several subpart I procedural requirements at the ALJ level of appeal are predicated on a QIC conducting a reconsideration. For example, the right to request an ALJ hearing under § 405.1000 and § 405.1002 is premised on a party being dissatisfied with a QIC reconsideration decision. In addition, under § 405.966(a)(2) and § 405.1028, absent a showing of good cause, evidence not submitted before the issuance of the QIC reconsideration by a provider, supplier, or beneficiary represented by a provider or supplier would be excluded from consideration by the ALJ. Thus, channeling appeals through the QIC reconsideration level would ensure that parties are afforded an opportunity to submit relevant evidence without having to demonstrate good cause for not submitting it during the pre-BIPA process. Second, we believe channeling pre-BIPA appeals through the QIC reconsideration process would benefit parties. For example, we believe parties would benefit from the panel review by physicians and other appropriate health care professionals at the QIC level when claims are denied as not medically reasonable and necessary under section 1862(a)(1)(A) of the Act. We also believe the administrative record would be more fully developed with respect to the medical and scientific evidence considered by such panels. Third, in order for a party to seek expedited access to judicial review under § 405.990, the party must first have received a QIC reconsideration, or the appeal must have been escalated from the QIC to the ALJ level (see, § 405.990(b)). To ensure a party may seek expedited access to judicial review, if such review is appropriate, we are proposing to channel pre-BIPA appeals through the QIC reconsideration process when the party has not received an ALJ decision. Finally, as noted above, we believe that having one set of rules apply to all appeals would eliminate the confusion and uncertainty regarding the appropriate procedures to follow should there be any existing pre-BIPA appeals.
Table 2—Pre-BIPA Part B AppealsPending pre-BIPA level of appeal in part 405 subpart HAppeal resumes at the following level in part 405 subpart IReview of Initial Determination (§ 405.807)Redetermination (§ 405.940).Carrier Hearing (§ 405.821)QIC Reconsideration (§ 405.960).ALJ Hearing (§ 405.855)QIC Reconsideration (§ 405.960).Departmental Appeals Board Review (§ 405.856)Medicare Appeals Council Review (§ 405.1100).
We propose to retain § 405.706, “Decisions of utilization review committees,” and redesignate the section as § 405.925 in subpart I. This regulatory provision explains that—(1) The decisions made by the utilization review committees are not initial determinations made by the Secretary within the meaning of section 1869 of the Act; (2) are not subject to the appeal; and (3) further explains how utilization review committee decisions may be used in payment and coverage decisions. In drafting the regulations under part 405 subpart I, we inadvertently omitted this section. For clarity, and to ensure that beneficiaries and providers understand that utilization review committee decisions are not appealable, and in furtherance of our goal to include all relevant claims appeals procedures in one place, we are proposing to retain § 405.706, and redesignate it as § 405.925.
In addition, we propose to retain § 405.874, “Appeals of CMS or a CMS contractor,” and redesignate the provisions as § 405.800, § 405.803, § 405.806, § 405.809, § 405.812, § 405.815, and § 405.818. These provisions set forth, among other things, the procedures related to denials of provider or supplier enrollment applications, revocations of Medicare provider or supplier billing privileges, and the appeal rights afforded to the parties to those determinations. As these procedures do not relate directly to initial determinations and appeals of Medicare claims, they were not included in part 405 subpart I. However, these provisions are not obsolete and are still applicable to provider and supplier enrollment actions. We also note that we are making minor technical edits to the current text to refine the section.
Finally, we also propose to remove § 405.753 and § 405.877 (“Appeal of a categorization of a device.”). These regulations are obsolete because they no longer comport with the definition of “national coverage determination” in section 1869(f) of the Act, as amended by section 522 of BIPA. The Food and Drug Administration's (FDA) categorization of a product as a category A device is not a determination of whether or not the item is covered under title XVIII of the Act. Under § 405.203(c), we use the FDA categorization in making a coverage decision. Thus, our decision (acting on the FDA's categorization) to deny a claim for a category A device is an initial determination that is subject to review through the claims appeals process.
Current regulations also contain a provision for infection control that is located within the physical environment standard in 42 CFR 416.44(a)(3). The requirement states that an ASC must establish a program for identifying and preventing infections, maintaining a sanitary environment, and reporting the results to the appropriate authorities. This regulatory requirement was part of the original CfCs first published for ASCs in 1982. Publication of the November, 2008 ASC final rule elevated the infection control requirements from a standard level under the Environment condition to a Start Printed Page 65916separate condition level requirement, thus making the regulatory requirement in the Environment CfC duplicative. The Infection Control CfC located at § 416.51 expands and broadens the infection control requirements that were part of the original ASC requirements in the Environment CfC. Therefore, we propose to remove the requirement at § 416.44(a)(3), located in the Environment CfC, as it is unnecessary and obsolete. We believe this change would alleviate any duplicative efforts and confusion regarding the infection control requirements.
In the November 7, 2005 final rule, we discussed the means for updating the Part D e-prescribing standards. In instances in which an e-prescribing standard has also been adopted as a HIPAA transaction standard in 45 CFR part 162, the process for updating the e-prescribing standard would have to be coordinated with the maintenance and modification of the applicable HIPAA transaction standard. In the January 16, 2009 final rule, entitled “Health Insurance Reform; Modifications to the Health Insurance Portability and Accountability Act (HIPAA) Electronic Transaction Standards” (74 FR 3296), we revised § 162.1102, § 162.1202, § 162.1302, § 162.1402, § 162.1502, § 162.1602, § 162.1702, and § 162.1802 to adopt the ASC X12 Technical Reports Type 3, Version 005010 (Version 5010), as a replacement of the current X12 Version 4010 and 4010A1 standards (Version 4010/4010A). Covered entities conducting HIPAA standards are required to use Version 5010 by January 1, 2012. The complete discussion of these standards may be found in the January 16, 2009 final rule (74 FR 3296).
In the same final rule, effective January 1, 2012, we revised § 162.1102, § 162.1202, § 162.1302, and § 162.1802 by adding a new paragraph (c) to each of these sections to adopt the NCPDP Telecommunication Standard Implementation Guide, Version D, Release 0 and equivalent NCPDP Batch Standard Implementation Guide, Version 1, Release 2 (collectively, Version D.0) in place of the NCPDP Telecommunication Standard Implementation Guide, Version 5, Release 1 and equivalent NCPDP Batch Standard Batch Implementation Guide, Version 1, Release 1 (collectively, Version 5.1), for the following retail pharmacy drug transactions: health care claims or equivalent encounter information; eligibility for a health plan; referral certification and authorization; and coordination of benefits.
Therefore, for consistency with the current HIPAA transaction standards, and the need for covered entities (prescribers and dispensers) to comply with HIPPA, we propose to revise § 423.160(b)(3), to—(1) Update Version 4010/4010A with Version 5010; (2) adopt the NCPDP Telecommunication Standard Implementation Guide, Version D, Release 0 (Version D.0) and equivalent NCPDP Batch Standard Implementation Guide, Version 1, Release 2 (Version 1.2); and (3) retire NCPDP Telecommunication Standard Implementation Guide, Version 5, Release 1 (Version 5.1) and equivalent NCPDP Batch Standard Implementation Guide, Version 1, Release 1 (Version 1.1), for transmitting eligibility inquiries and responses between dispensers and Part D sponsors with an effective date of January 1, 2012.
Medicare regulations at § 484.4 were updated through a November 27, 2007 final rule (72 FR 66406), effective January 1, 2008. While these personnel qualifications are detailed under home health services, we indicated in the preamble to the November 27, 2007 final rule, that therapy services must be provided according to the same standards and policies in all settings, to the extent possible and consistent with statute, and revised multiple regulations to cross-reference the personnel qualifications for therapists in § 484.4 to the personnel requirements in many other sections.
We are proposing at § 440.110 to remove the outdated personnel qualifications language in the current Medicaid regulations and instead cross reference the updated Medicare personnel qualifications for physical therapists and occupational therapists under § 484.4. This proposal has the potential to broaden the scope of providers that may be able to provide PT and OT services, by streamlining the qualifications so that certain providers are not excluded from providing services under Medicaid. In addition, it strengthens the consistency of standards across Medicare and Medicaid.
Contact: Adrienne Delozier, 410-786-0278.Start Printed Page 65917
Section 486.302 includes the following definition: “Donor document is any documented indication of an individual's choice in regard to donation that meets the requirements of the governing State law.” In recent years, the concept of the donor document and the opportunities for individuals to express their wishes concerning organ and/or tissue donation have changed. An individual can indicate his or her wishes not only on a driver's license through a State's Department of Motor Vehicles, but also on various registries or even in separate documents. Therefore, we believe that our definition in § 486.302 should be updated. Moreover, the focus on patient rights has increased over the last several years. For example, we published a final rule on November 19, 2010 entitled, “Changes to the Hospital and Critical Access Hospital Conditions of Participation to Ensure Visitation Rights for All Patients” (CMS-3228-F). In light of this increased focus, we believe that the current definition, does not fully allow for the various ways individuals can express their choices in the donor process. In addition, we believe it is important to emphasize that the decision to donate organs and/or tissue before death is the decision of the individual.
We propose replacing the current definition of “donor document” in § 486.302 with the following definition, “[D]onor document means any documented indication of an individual's choice that was executed by the patient, in accordance with any applicable State law, before his or her death, and that states his or her wishes regarding organ and/or tissue donation.” This new definition modifies the current definition in two ways. First, while the current definition refers to “an individual's choice” it does not recognize the right of the individual to identify their wishes more specifically. Donor documents may simply allow for the choice of whether or not to be an organ and/or tissue donor, however, some individuals may choose to use documents that allow them to express their wishes in more detail. For example, some people may choose to be an organ donor, but not a tissue donor. Others may not want to consent to the donation of specific organs. Therefore, we believe our proposed definition should cover documents or other ways for individuals to express their wishes more specifically, and we have modified the definition accordingly.
On May 31, 2006, we published a final rule in the Federal Register (71 FR 30982) entitled, “Conditions for Coverage for Organ Procurement Organizations (OPOs).” The final rule established several requirements, for OPOs at § 486.324, including a number of requirements related to the administration and governing body of an OPO. Due to an error in publishing the final rule, paragraph (e) was inadvertently inserted twice (71 FR 31052).
We are proposing to remove the duplicate paragraph (e), which appears immediately after § 486.324(d). It does not alter or change the legal requirement, nor does it create a change in information collection requirements or other regulatory burden.
We have identified an incorrect reference in § 424.510(a), due to a typographic error. We are proposing to replace the incorrect reference to paragraph (c) (the effective date for reimbursement for providers and suppliers seeking accreditation from a CMS-approved accreditation organization) with a reference to paragraph (d) (the enrollment requirements).
In response to comments from the public to discontinue our use of the term “recipient” under Medicaid, we have been using the term “beneficiary” to mean all individuals who are entitled to, or eligible for, Medicare or Medicaid services. We are proposing to add a definition of “beneficiary” in § 400.200 that applies to patients under the Medicare and Medicaid programs. We would remove the terms “beneficiary” and “recipient” from § 400.202 and § 400.203, respectively, and we would make a nomenclature change to replace “recipient” with “beneficiary” throughout 42 CFR chapter IV. The action to refer to beneficiaries instead of recipients has already been implemented. We are simply conforming our regulations to our current use of the term “beneficiary.” In creating this definition it is not our intent to exclude or include anyone who would or would not have previously been understood to be a beneficiary. We welcome comments on whether this definition could be improved to attain that objective.
We are proposing to change the terminology we use in the program currently called Intermediate Care Facilities for the Mentally Retarded. Section 1905(d) of the Act states that, “The term “intermediate care facility for the mentally retarded” means an institution (or distinct part thereof) for the mentally retarded or persons with related conditions * * *.” In 2010, Rosa's Law (Pub. L. 111-256) amended statutory language in several health and education statues, directing that “in amending the regulations to carry out this Act, a Federal agency shall ensure that the regulations clearly state—(A) That an intellectual disability was formerly termed “mental retardation”; and (B) that individuals with intellectual disabilities were formerly Start Printed Page 65918termed “individuals who are mentally retarded.”
CMS regulations at 42 CFR chapter IV include numerous references to “mental retardation.” These regulatory provisions reflect the statutory benefit category at section 1905(d) of the Act, which uses the term “mental retardation” in the facility type designation, “Intermediate Care Facility for the Mentally Retarded.” Rosa's Law did not specifically list the Act within its scope, and therefore did not require any change to existing CMS regulations. However, consistent with Rosa's Law and in response to numerous inquiries from provider and advocate organizations as to when CMS will comply with the spirit of Rosa's Law, we propose to adopt the term “intellectual disability” (as used under Rosa's Law) in our regulations at § 400.203. We would define the term “intellectually disabled” to mean the condition that was previously referred to as “mentally retarded” in section 1919(e)(7)(G)(ii) of the Act. This nomenclature change does not represent any change in information collection requirements or other burden for the provider community or the State survey agencies. Current forms may be used by the State survey agencies until current supplies are exhausted. The change would require revision of forms CMS-3070G and CMS-3070H, as discussed below.
Proposed § 416.44(c) would require ASCs to coordinate, develop, and revise ASC policies and procedures that would specify the types of emergency equipment required for use in the ASC's operating room. The equipment must be immediately available for use during emergency situations, be appropriate for the facility's patient population and be maintained by appropriate personnel. The burden associated with these requirements is the time and effort required by an ASC to develop revised policies and procedures governing the identification and maintenance of emergency equipment that would typically be required to address the intra- or post-operative emergency complications specific to the types of procedures performed in the ASC and the needs of their specific patient population.
We believe that approximately 5,200 ASCs would have to comply with these requirements. We estimate that proposed § 416.44(c) would impose a one-time burden of two hours associated with revising the policies and procedures pertaining to the list of the emergency equipment and supplies maintained and commonly used by the ASC during emergency responses to their specific patient population. The total burden associated with this task would be approximately 5,200 hours. The total cost associated with this requirement would be $468,000 (5,200 × $90—based on an hourly nurse's salary ($45.00 × 2 hours), including fringe benefits, as specified by the Bureau of Labor Statistics for 2009).
In this rule, we are proposing to restrict the deactivation provisions in § 424.540(a)(1) to providers and suppliers that do not complete the Form CMS-855I application. Physicians and non-physician practitioners would therefore not have their Medicare billing privileges deactivated if they did not bill Medicare for 12 consecutive months.
We estimate that an average of approximately 12,000 physicians and non-physician practitioners have been deactivated each year pursuant to § 424.540(a)(1). These individuals have been required to submit a complete Form CMS-855I application to their Medicare contractor in order to reactivate their Medicare billing privileges. With our proposed change, however, this step would no longer be necessary because the deactivation would not have occurred.
For purposes of this ICR, we estimate that 10,800 physicians and non-physician practitioners (or 90 percent of the aforementioned 12,000 total) would continue to submit Form CMS-855I (OMB No. 0938-0685) reactivation applications absent our proposed change. The estimated “per application” burden of completing the application is 5 hours, at a per hour cost of $50. This results in a total savings in collection of information costs for Medicare-enrolled physicians and non-physician practitioners of approximately $2.7 million per year (10,800 × 5 × $50). Consistent with this proposed change, we will submit a revision to control number 0938-0685 to the Office of Management and Budget for review.Start Printed Page 65919
In this rule, we are proposing to remove the chart at § 400.310 that display OMB control numbers because the information has become obsolete. This proposal would not produce any reduction or increase in burden, but would ensure that the public is viewing the most current information regarding OMB control numbers.
In this rule, we are proposing to remove the requirement at § 416.44(a)(3) regarding infection control that is duplicative of § 416.51. The removal of this requirement would not result in any reduced or additional burden on ASCs, but would alleviate any duplicative efforts and confusion regarding the infection control requirements.
In this rule, we are proposing the removal of the duplicate paragraph (e) of § 486.324. This proposal would not result in any change in information collection or other regulatory burden.
In this rule, we are proposing to correct a typographical error found in § 424.510(a). This proposal would create no change in information collection or other regulatory burden.
In this rule, we are proposing to add a definition of “beneficiary” in § 400.200 that applies to patients under the Medicare and Medicaid programs. This proposal would create no change in information collection or other regulatory burden.
We have examined the impact of this rule as required by Executive Order 12866 on Regulatory Planning and Review (September 30, 1993), Executive Order 13563 on Improving Regulation and Regulatory Review (February 2, 2011), the Regulatory Flexibility Act (RFA) (September 19, 1980, Pub. L. 96-354), section 1102(b) of the Social Security Act, section 202 of the Start Printed Page 65920Unfunded Mandates Reform Act of 1995 (March 22, 1995; Pub. L. 104-4), and Executive Order 13132 on Federalism (August 4, 1999).
Table 3—Section-by-Section Economic Impact EstimatesSectionFrequencyLikely savings or benefits ($ millions)A. Removes Unnecessarily Burdensome Requirements:1. End-Stage Renal Disease (ESRD) Facilities (§ 494.60)One-Time108.72. ASC Emergency Equipment (§ 416.44)One-Time18.53. Revocation of Enrollment/Billing Privileges (§ 424.535)Recurring10.04. Deactivation of Medicare Billing Privileges (§ 424.540)Recurring26.75. Duration of Agreement for ICFs/ID (§ 442.15-§ 442.109)Recurring<1B. Removes Obsolete or Duplicative Regulations:1. OMB Control Numbers for Information Collection (§ 400.300 and § 400.310)Recurring<12. Removal of Obsolete Provisions Related to Processing Part A and Part B Claims and Entitlement Determinations (§ 405.701 through § 405.877)Recurring<13. ASC Infection Control Program (§ 416.44)Recurring<14. E-prescribing (§ 423.160)Recurring<15. Physical and Occupational Therapist Qualifications (§ 440.110)Recurring<16. Definition of Donor Document (§ 486.302)Recurring(1)7. Administration and Governing Body (§ 486.324)Recurring<18. Requirement for Enrolling in the Medicare Program (§ 424.510)Recurring<1C. Responds to Stakeholder Concerns:Nomenclature Changes1. Redefining the Term “Beneficiary” (§ 400.200 through § 400.203)Recurring<12. Replace “Mental Retardation” terminology with “Intellectual Disability” (throughout 42 CFR title IV)Recurring(1)1 See Text.
There are two areas of potentially significant benefits, above and beyond cost savings to providers. First, improved organ donation consent language that would enable prospective donors to specify their intentions more clearly would have a positive effect on organ donation. There are approximately 8,000 cadaveric organ donors annually in the United States. These donors provide a total of about 21,000 transplanted organs (see the OPTN/SRTR Annual Report at http://optn.transplant.hrsa.gov/​ar2009/​). The decision to make a firm, written decision on whether or not to be a potential donor, and on the willingness of families to honor that decision, can turn on very small issues of personal preference. We believe that the change we propose could and likely would tip that decision in some cases. However, we do not have a basis for quantifying this potential increase in donations. We welcome comment on the extent to which this policy change may increase organ donation and any information that would assist in quantifying these impacts.Start Printed Page 65921
In addition, while Rosa's Law began the elimination of official Federal government use of the pejorative term “mental retardation,” our proposal would complete this step for CMS regulations. The reform undoubtedly has substantial value to millions of Americans, not only to the intellectually disabled but also to their families and friends, and also to the many millions who simply object to such labeling. However, we have no data that would enable a precise calculation of this value.
With respect to the revocation reform, the number of affected providers is certainly very small as a proportion of the total universe of over one million Medicare providers, of whom over 900,000 are physicians and other practitioners. Based on administrative data, we estimate that the number of affected physicians and other practitioners that would be affected by this reform is between 1,000 and 2,000, a fraction of one percent of these. We have no statistical data on the resultant economic effects; but if the average provider loses as little as $10,000 in billable Medicare patient care services as a result of deactivation, total lost business for 1,000 providers could be $10 million annually. In this regard, gross annual physician practice revenue in America approaches $1 million a year (see, for example, the practice expense data in http://www.modernmedicine.com/​modernmedicine/​article/​articleDetail.jsp?​id=​143141). Since Medicare pays about one third of revenue received for professional services such as physician care, the loss we estimate is one or two weeks of Medicare billing, on average. We welcome additional information on the likely magnitude and frequency of such losses.
As required by OMB Circular A-4 (available at http://www.whitehouse.gov/​omb/​circulars/​a004/​a-4.pdf), we have prepared an accounting statement. We estimate that the overall cost savings that this rule would create may approach $200 million in the first year. This includes the one-time savings related to ESRD reforms, as well as the savings to providers in lost billings, paperwork costs, confusion, and other burden reductions discussed throughout this preamble. There are also potentially substantial life-saving benefits that could reach hundreds of millions of dollars annually. Annualized savings are shown in the accounting statement below.Start Printed Page 65922
Table 4—Accounting Statement[Dollars in millions]CategoryPrimary estimateYear dollarsDiscount rate (%)Period coveredBenefits:Unquantified Qualitative Value of Lives Saved Through Increases in Organ DonationsPotentially hundreds of lives saved but no precise estimate201272012-16 Potentially hundreds of lives saved but no precise estimate201232012-16Annualized savings from reduced ESRD facility investments and reduced ASC costs (see Table 3)$30201272012-16 $30201232012-16Annualized savings to providers from billing improvements and other reforms (see Table 3)$40201272012-16 $40201232012-16Costs:None.Transfers:None.
Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) also requires that agencies assess anticipated costs and benefits before issuing any rule whose mandates require expenditures in any 1 year of $100 million in 1995 dollars, updated Start Printed Page 65923annually for inflation on either State, local, or tribal governments, or the private sector. In 2011, that threshold is approximately $136 million. This proposed rule mandates no new expenditures by either State, local, or tribal governments, or the private sector.
5. Subpart C, consisting of §§ 400.300 and 400.310, is removed and reserved.
7. Redesignate § 405.706 in subpart G as § 405.925 in subpart I.
8. Remove and reserve subpart G consisting of § 405.701 through § 405.705 and § 405.708 through § 405.753.
Appeals rights.
Impact of reversal of contractor determinations on claims processing.
Effective date for DMEPOS supplier's billing privileges.
Deadline for processing provider enrollment initial determinations.
§ 405.800
(ii) The right to appeal in accordance with part 498 of this chapter.Start Printed Page 65924
§ 405.803
§ 405.806
§ 405.809 Reinstatement of provider or supplier billing privileges following corrective action.
§ 405.812 Effective date for DMEPOS supplier's billing privileges.
If a CMS contractor, contractor hearing officer, or ALJ determines that a DMEPOS supplier's denied enrollment application meets the standards in § 424.57 of this chapter and any other requirements that may apply, the determination establishes the effective date of the billing privileges as not earlier than the date the carrier made the determination to deny the DMEPOS supplier's enrollment application. Claims are rejected for services furnished before that effective date.
§ 405.815 Submission of claims.
A provider or supplier succeeding in having its enrollment application denial or billing privileges revocation reversed in a binding decision, or in having its billing privileges reinstated, may submit claims to the CMS contractor for services furnished during periods of Medicare qualification, subject to the limitations in § 424.44 of this chapter, regarding the timely filing of claims. If the claims previously were filed timely but were rejected, they are considered filed timely upon resubmission. Previously denied claims for items or services furnished during a period of denial or revocation may be resubmitted to CMS within 1 year after the date of reinstatement or reversal.
§ 405.818 Deadline for processing provider enrollment initial determinations.
§ 416.44 Condition for coverage—Environment.
§ 423.160 Standards for electronic prescribing.
§ 424.510 Requirements for enrolling in the Medicare program.
§ 424.535 Revocation of enrollment and billing privileges in the Medicare program.
§ 424.540 Deactivation of Medicare billing privileges.
(2) The provider or supplier does not report a change to the information supplied on the enrollment application within 90 calendar days of when the change occurred. Changes that must be reported include, but are not limited to, a change in practice location, a change of any managing employee, and a change in billing services. A change in ownership or control must be reported within 30 calendar days as specified in § 424.520(b) and § 424.550(b).
§ 440.110 Physical therapy, occupational therapy, and services for individuals with speech, hearing, and language disorders.
(2) A “qualified physical therapist” is an individual who meets personnel qualifications for a physical therapist at § 484.4.
(2) A “qualified occupational therapist” is an individual who meets personnel qualifications for an occupational therapist at § 484.4.
§ 442.15 Duration of agreement for ICFs/ID.
(b) FFP is available for services furnished by a facility for up to 30 days after its agreement expires or terminates under the conditions specified in § 441.11 of this subchapter.
§ 442.16 [Removed and Reserved]
§ 442.109 Certification period for ICFs/ID: General provisions.
§ 442.110 Certification period for ICFs/ID with standard-level deficiencies.
§ 486.302 Definitions.
§ 486.324 [Amended]
§ 494.60 Condition: Physical environment.
(e) Standard: Fire safety. (1) Except as provided in paragraph (e)(2) of this section, by February 9, 2009, dialysis facilities that are located adjacent to high hazardous occupancies or do not provide one or more exits to the outside at grade level from the patient treatment area level, must comply with applicable provisions of the 2000 edition of the Life Safety Code of the National Fire Protection Association (which is incorporated by reference at § 403.744(a)(1)(i) of this chapter).
(2) Notwithstanding paragraph (e)(1) of this section, dialysis facilities participating in Medicare as of October 14, 2008 that require sprinkler systems are those housed in multi-story buildings of construction Types II(000), III(200), or V(000), as defined in the 2000 edition of the Life Safety Code of the National Fire Protection Association (which is incorporated by reference at § 403.744(a)(1)(i) of this chapter), section 21.1.6.3, which were constructed after January 1, 2008; and those housed in high rise buildings over 75 feet in height.