CMS Issues Proposed CY 2015 Medicare OPPS/ASC Rule

On July 14, 2014, the Centers for Medicare & Medicaid Services (CMS) published its proposed rule to update the Medicare Hospital Outpatient Prospective Payment System (OPPS) and the Ambulatory Surgical Center (ASC) Payment System rates and policies for calendar year (CY) 2015. The following are highlights of this major rulemaking:

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CMS Publishes Proposed MPFS Rule for 2015

On July 11, 2014, CMS published its proposed rule to update the Medicare physician fee schedule for CY 2015. The proposed rule reflects enactment of the Protecting Access to Medicare Act (PAMA) of 2014, which provides for a 0% update to the conversion factor (CF) for MPFS services furnished between January 1, 2015 and March 31, 2015. In the Proposed Rule, CMS estimates that with the application of a budget neutrality adjustment, the CF for the first quarter of 2015 would be $35.7977 (compared to $35.8228 in 2014). Under PAMA, the CF will be adjusted on April 1, 2015 according to the Sustainable Growth Rate (SGR) formula unless Congress takes additional legislative action. CMS does not speculate on the CF that will be applicable April 1, 2015 through December 31, 2015, but CMS previously estimated that the SGR would result in about a 20.9% cut in MPFS payments for 2015 if Congress does not again intervene. There is an expectation that Congress eventually will override this payment cut, but the timing and extent of any such relief cannot be assured at this time. Other key provision in the proposed rule include the following:

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CMS Proposes ESRD PPS Update for CY 2015

On July 11, 2014, CMS published a proposed rule to update the Medicare end-stage renal disease (ESRD) PPS for CY 2015, which CMS anticipates would increase total payments to all ESRD facilities by 0.3% compared to CY 2014. While CMS projects that the ESRD market basket update, as adjusted for MFP, would have been 1.6%, the “Protecting Access to Medicare Act of 2014” (PAMA) sets the CY 2015 ESRD payment update at 0.0 percent. After applying a proposed wage index budget-neutrality adjustment factor, CMS estimates that the CY 2015 ESRD PPS base rate would be $239.33 under the proposed rule. The proposed rule also would, among other things: rebase the ESRD bundled market basket using 2012 data; update outlier Medicare Allowable Payment (MAP) and fixed dollar loss amounts (which will increase payments to ESRD facilities for beneficiaries requiring higher resource utilization); revise the market basket measures; update the labor -related share value with a two-year transition; clarify the eligibility criteria for the low volume payment adjustment ; and implement a PAMA provision providing that payment for ESRD-related oral-only drugs will not be made under the ESRD PPS prior to January 1, 2024. CMS also proposes updates to the ESRD Quality Incentive Program (QIP) for payment years 2017 and 2018. Finally, the proposed rule would make significant changes to Medicare reimbursement policy for DME, prosthetics, orthotics, and supplies (DMEPOS). CMS will accept comments on the proposed rule until September 2, 2014.

CMS Proposes Major Changes to Medicare DMEPOS Payment/Coverage Policy Inside/Outside of Competitive Bidding Areas

On July 2, 2014, the Centers for Medicare & Medicaid Services (CMS) released a proposed rule that would make a series of significant changes to Medicare coverage and payment policies for durable medical equipment (DME), prosthetics, orthotics, and supplies (DMEPOS). Notably, the proposed rule would establish a methodology for adjusting Medicare DMEPOS fee schedule payment amounts across the country using information from the Medicare DMEPOS Competitive Bidding Program (CBP) – which CMS estimates would cut Medicare DMEPOS reimbursement by more than $7 billion in FYs 2016 through 2020. The proposed rule also would: test the use of bundled monthly payment amounts for DME and enteral nutrition under the CBP; modify CBP change of ownership (CHOW) and termination of contract rules; clarify qualifications for providing custom fitting services for orthotics; and revise Medicare hearing aid coverage policy. These provisions, which were part of a broader proposed rule that would also update the Medicare end-stage renal disease prospective payment system for 2015, are summarized in our Client Alert.

CMS Proposes Changes to Sunshine Act "Open Payments" Regulations in 2015 Medicare Physician Fee Schedule Rule

This post was written by Elizabeth Carder-Thompson, Katie C. Pawlitz, and Nancy E. Bonifant.

Today the Centers for Medicare & Medicaid Services (CMS) issued an advance copy of the CY 2015 Medicare Physician Fee Schedule (PFS) proposed rule, which includes certain changes to the regulations implementing the Physician Payment Sunshine Act, also known as the Open Payments program. These proposed changes come just three days after the inaugural deadline for applicable manufacturers and group purchasing organizations (GPOs) to report to CMS detailed information regarding payments and transfers of value made to physicians and teaching hospitals, as well as physician ownership information.

As previously reported, the Physician Payment Sunshine Act and related regulations require pharmaceutical and medical device manufacturers and GPOs to register with and submit to CMS data on their financial relationships with physicians and teaching hospitals. This financial data will be made publicly available on the CMS Open Payments website.

In the PFS proposed rule, CMS proposes the following changes to the Physician Payment Sunshine Act regulations:

  • Deleting the definition of “covered device” as duplicative of the definition of “covered drug, device, biological or medical supply”
  • Deleting the reporting exclusion for payments made to speakers at accredited continuing medical education events when certain requirements are met. Although CMS is deleting this express exclusion, it notes that such payments may still be excluded generally from reporting under the separate exclusion for indirect payments, which applies in those instances in which the applicable manufacturer is unaware of the identity of the covered recipient. In other words, the practical impact of this change may not be significant in the long run.
  • Requiring the reporting of the marketed name of the drug, device, biological, or medical supply related to the payment being reported. Previously, CMS finalized that for drugs and biologicals, manufacturers must report the market name of a related product, but that for devices and medial supplies, manufacturers could report either the name under which the product is marketed or the general therapeutic area or product category associated with the device or medical supply.
  • Requiring manufacturers to report stocks, stock options or any other ownership interest as distinct categories.

The proposed rule will be published in the Federal Register on July 11, 2014, and comments are due to CMS by September 2, 2014.

CMS Proposes 0.3% Cut in Medicare Home Health PPS Rates for CY 2015

Today CMS released its proposed rule to update Medicare home health prospective payment system (HH PPS) rates for CY 2015. CMS estimates that the rule would reduce Medicare payments to home health agencies by approximately $58 million (-0.3%) in 2015 compared to 2014 levels. Specifically, while CMS anticipates a 2.2% home health payment update percentage ($427 million increase), the increase would be more than offset by implementation of the second year of a four-year phase-in of the rebasing adjustments to the HH PPS rates, which would result in a -2.5% adjustment ($485 million decrease).

The proposed rule also includes a number of policy proposals, including: simplification of the face-to-face encounter documentation requirements and clarification of when such documentation is required; changes to the HH PPS case-mix weights; revisions to the home health quality reporting program; simplification of therapy reassessment timeframes; a revision to the Speech-Language Pathology personnel conditions of participation; and limitations on the reviewability of CMS’s decision to impose a civil monetary penalty for noncompliance with federal participation requirements. Finally, the rule discusses insulin injections under the HH PPS and the delay in implementation of ICD-10-CM, and it solicits comments on the HHA value-based purchasing.

The official version of the rule is scheduled to be published on July 7, 2014. CMS will accept comments until September 2, 2014.

CMS Planning Changes to Medicare Shared Savings Program/Accountable Care Organization (ACO) Rules

Yesterday CMS submitted to the White House Office of Management and Budget (OMB) a proposed rule to make changes to the Medicare Shared Savings Program, including provisions relating to Medicare payments to providers participating in ACOs. These changes would apply to existing ACOs and approved ACO applicants participating in the program beginning January 1, 2016. The text of the rule is not available until it is cleared by OMB and sent to the Federal Register.

Medicare Payment Adjustments for Low-Volume Hospitals and Medicare-Dependent Hospitals

On June 17, 2014, the Centers for Medicare & Medicaid Services (CMS) published a notice making changes to the Medicare payment adjustment for low-volume hospitals and to the Medicare-dependent hospital (MDH) program under the inpatient prospective payment system (IPPS). The adjustments, which were mandated by the Protecting Access to Medicare Act of 2014, apply to the second half of fiscal year (FY) 2014, or April 1, 2014 through September 30, 2014. The payment adjustments are expected to increase overall IPPS payments in FY 2014 by $227 million (an additional 0.24%) compared to the previous estimate of FY 2014 payments to all IPPS hospitals published in the IPPS final rule for FY 2014. Specifically, CMS estimates that approximately 600 hospitals qualifying as low-volume hospitals through September 30, 2014 will experience an increase in payments of approximately $161 million compared to CMS’s earlier estimate in the FY 2014 IPPS final rule, and 118 MDHs will experience an overall increase of approximately $66 million compared to CMS’s estimate in the final IPPS rule.

CMS Finalizes Updates to Medicare Advantage/Part D Policies for 2015

On May 23, 2014, CMS published a final rule revising the Medicare Advantage (MA) and Part D prescription drug program regulations to implement various statutory requirements, strengthen beneficiary protections, improve program efficiencies and payment accuracy; and clarify program requirements, generally effective for contract year 2015. CMS estimates that the proposed rule would reduce Medicare spending by $1.615 billion between 2015 and 2024. Among many other things, the final rule:

  • Requires that Part D “negotiated prices” be inclusive of all price concessions from network pharmacies except contingent price concessions that cannot reasonably be determined at the point-of-sale, effective beginning with contract year 2016. CMS also specifies that additional contingent amounts, such as incentive fees, that increase prices and that cannot reasonably be determined at the point-of-sale are always excluded from the negotiated price.
  • Implements an ACA requirement that MA plans and Part D sponsors report and return identified Medicare overpayments.
  • Addresses prescription drug abuse by, among other things, authorizing CMS to revoke a physician’s or eligible professional’s Medicare enrollment if he or she has a pattern of prescribing Part D drugs that is abusive and represents a threat to beneficiary health and safety or otherwise fails to meet Medicare requirements, or if the prescriber’s Drug Enforcement Administration (DEA) certificate of registration or state license is suspended or revoked. The rule also requires prescribers of Part D drugs to enroll in Medicare or have a valid record of opting out of Medicare as a condition of coverage for their prescriptions, effective June 1, 2015.

Note that CMS is not finalizing its proposed changes to the ACA “drug categories or classes of clinical concern” requirement; instead, CMS will maintain the existing six protected classes. CMS also is not finalizing its proposal to require consistently lower negotiated prices at pharmacies offering preferred cost sharing in light of its adoption of a different definition of negotiated price than originally proposed. Moreover, CMS is not finalizing its proposed “any willing pharmacy” contracting provisions, nor the proposed changes to limit the authorized levels of cost sharing, pending further study.

CMS Finalizes ACA Exchange, Insurance Market Standards for 2015 and Beyond

On May 27, 2014, CMS published a final rule updating ACA Affordable Insurance Exchange and insurance market standards beginning in 2015. Among other things, the rule addresses standards related to: standardized consumer notices regarding insurance product discontinuation and renewal; Qualified Health Plan (QHP) quality data reporting to support quality ratings for plans on the insurance marketplace beginning in 2016; non-discrimination standards; employee choice in the Small Business Health Options Program (SHOP); enforcement remedies in federally-facilitated exchanges; the imposition of civil money penalties for providing false or fraudulent information to the Exchange and for improperly using or disclosing information; updated standards for “Navigators” and other consumer assistance programs; increases the risk corridor calculation ceiling on allowable administrative costs and the floor on profits by 2% “to account for uncertainty and changes in the market prior to and during benefit year 2015”; and modifies the allocation of reinsurance collections if those collections do not meet projections. The rule also provides for an expedited prescription drug exceptions process based on exigent circumstances (defined as when an enrollee is suffering from a health condition that may seriously jeopardize the enrollee’s life, health, or ability to regain maximum function, or when an enrollee is undergoing a current course of treatment using a non-formulary drug). Under this provision, health plans must make coverage determinations within 24 hours after receiving the request; once an exception is granted, issuers must continue to provide the drug throughout the duration of the exigency. CMS states that it will continue to monitor this issue to consider whether it should propose additional standards.

CMS Formally Proposes Modified Electronic Health Record (EHR) Meaningful Use Timeline

CMS has published a proposed rule that would formally adopt a previously-announced change to the EHR meaningful use stage timeline. Specifically, the rule would extend Stage 2 through 2016 and begin Stage 3 in 2017 (instead of 2016). The proposed rule also would allow providers to use 2011 Edition Certified Electronic Health Record Technology (CEHRT) or a combination of 2011 and 2014 Edition CEHRT for the EHR reporting period in 2014; beginning in 2015, all eligible hospitals and professionals would be required to report using 2014 Edition CEHRT.  CMS will accept comments on the proposed rule until July 21, 2014.

CMS Proposes Medicare Prior Authorization Process for DMEPOS Subject to "Unnecessary Utilization"

CMS has just released a proposed rule that would require Medicare prior authorization (PA) for certain Medicare Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) items that the agency characterizes as “frequently subject to unnecessary utilization.“ As part of the rulemaking, CMS has developed a “Master List” of initial items that it considers to meet this standard based on being (1) identified in a GAO or HHS OIG national report published in 2007 or later as having a high rate of fraud or unnecessary utilization; or (2) listed in the 2011 or later Comprehensive Error Rate Testing (CERT) program's Annual Medicare FFS Improper Payment Rate Report DME Service Specific Overpayment Rate Appendix. CMS also proposes limiting the items on the Master List to those with an average purchase fee of at least $1,000 or an average rental fee schedule of at least $100 to allow CMS to focus on items with the largest potential savings for the Medicare Trust Fund. CMS proposes that the Master List will be “self-updating” annually, and that items generally will remain on the list for 10 years. Note, however, that presence on the Master List would not automatically require prior authorization. CMS would limit the PA requirement to a subset of items (called the “Required Prior Authorization List") “to balance minimizing provider and supplier burden with our need to protect the Trust Funds." CMS would publish the Required Prior Authorization List in the Federal Register with 60-day notice before implementation. CMS also proposes that the PA program could be implemented nationally or locally. The proposed rule does not announce the first items on the Required Prior Authorization List. Instead, CMS is seeking public comment on the number of items that should be selected initially and in the future, and the frequency with which CMS should select items.

The proposed PA process would not create new clinical documentation requirements for the selected DMEPOS items. Instead, the same information necessary now to support Medicare payment for the item would be submitted to the contractor, but before the item could be furnished to the beneficiary and before the claim could be submitted for payment. Upon receipt of a PA request, CMS or its contractors would determine whether the item complies with applicable coverage, coding, and payment rules, and then communicate a decision that provisionally affirms or non-affirms the request. CMS or its contractors would “make reasonable efforts” to provide a decision within 10 days of receipt of all applicable information, unless this timeline could “seriously jeopardize the life or health of the beneficiary,” in which case the target review period would be 2 business days.

The proposed rule also discusses, among other things: the process for updating the Master List; liability for an item on the Required Prior Authorization List if authorization is submitted and denied, the opportunity for unlimited PA resubmissions, and applicability to competitive bidding areas. The rule also would add a contractor's decision regarding prior authorization of coverage of DMEPOS items to the list of actions that are not initial determinations and therefore not appealable.  The official version will be published on May 28, 2014. CMS will accept comments on the proposed rule until July 28, 2014.

In a related development, CMS has announced that it is expanding its current demonstration for prior authorization for power mobility devices to 12 additional states. CMS also will launch two payment model demonstrations to test prior authorization for hyperbaric oxygen therapy and repetitive scheduled non-emergent ambulance transport; information from these models will inform future CMS policy decisions on the use of prior authorization.

CMS Adopts Final Rule to Reduce Provider Regulatory Burdens

On May 12, 2014, the Centers for Medicare & Medicaid Services (CMS) published a final rule that reforms federal health policy regulations that CMS has identified as unnecessary, obsolete, or excessively burdensome on health care providers and suppliers. The rule also is intended to eliminate or reduce requirements that impede quality patient care or that divert resources away from providing high quality patient care. CMS estimates that the rule will result in annual recurring savings of about $660 million, plus a $22 million one-time savings to long-term care facilities from a sprinkler deadline extension. Highlights of the wide-ranging rule include the following:

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CMS Proposes Medicare Hospice Payment Policies for FY 2015

On May 8, 2014, CMS published its proposed rule to update the Medicare hospice wage index for FY 2015 and make other payment and policy changes. CMS estimates that hospice payments would increase by 1.3% ($230 million) in FY 2015 compared to FY 2014. Specifically, CMS would update the hospice per diem rates by 2.0% (reflecting a 2.7% market basket increase that is reduced by 0.7 percentage points under ACA adjustments), but this update is partially offset by a 0.7 percentage point cut resulting from the use of updated wage data and CMS’s continued phase-out of its wage index budget neutrality adjustment factor. Hospices that fail to report quality data will have their market basket update reduced by 2 percentage points.

The proposed rule includes a number of policy provisions. For instance, CMS is proposing to require hospices to file a beneficiary Notice of Election (NOE) within three calendar days after the effective date of hospice election; if an NOE is not filed timely, the days from the effective date of election to the date of filing the NOE would be the financial responsibility of the hospice. Likewise, CMS is proposing to require hospices to file a notice of termination/revocation within three calendar days of a beneficiary’s discharge or revocation, unless the hospice has already filed a final claim. The rule also would, among other things: require the hospice to identify the attending physician on the election form; revise the applicability of quality reporting penalties to new hospices; provide that claims will be returned to providers if the claim lists a nonspecific symptom diagnosis as the principal hospice diagnosis; and require hospices to complete their hospice cap determinations within 150 days after the cap period and remit any overpayments at that time.

CMS also is soliciting comments on several policy issues, including definitions of “terminal illness” and “related conditions” that are intended to “strengthen and clarify the current concepts of holistic and comprehensive hospice care under the Medicare hospice benefit.” CMS also seeks comments on processes that Part D drug plan sponsors could use to coordinate with Medicare hospices in determining coverage of drugs for hospice beneficiaries and resolving disagreements between the parties. Comments on the proposed rule will be accepted until July 1, 2014.

CMS Proposes FY 2015 Update to Inpatient Psychiatric Facility PPS

On May 6, 2014, CMS published a proposed rule that would update prospective payment rates for Medicare inpatient hospital services provided by inpatient psychiatric facilities (IPFs) for FY 2015. Under the proposed rule, the federal per diem base rate would be increased by 2.0%, reflecting a market basket increase of 2.7%, offset by a 0.3 percentage point reduction and a productivity adjustment reduction of 0.4 percentage points (both of which were mandated by the ACA). CMS also anticipates a 0.1 percent overall increase in IPF outlier payments from the update to the outlier fixed-dollar loss threshold amount. When all FY 2015 proposed payment and policy changes are considered, CMS estimates that total payments to IPFs would increase by 2.1% compared to FY 2014 payments (approximately $100 million). The proposed rule also would, among other things, establish a new methodology for updating the cost of living adjustment (COLA) and expand quality measures under the IPF Quality Reporting Program. In the proposed rule, CMS also discusses its intention to propose an IPF-specific market basket for FY 2016, and the agency addresses various coding changes. CMS will accept comments on the proposed rule until June 30, 2014.

CMS Adopts PPS for Federally Qualified Health Centers (FQHCs), Amends CLIA Rules

CMS published a final rule on May 2, 2014 setting forth the methodology and payment rates for the new prospective payment system for FQHC services under Medicare Part B. FQHCs will transition to the new payment system beginning October 1, 2014, based on their cost reporting periods. Under the rule, Medicare generally will pay FQHCs a single encounter-based rate per beneficiary per day (initially set at $158.85), subject to certain adjustments and exceptions. For instance, the per diem rate is subject to a geographic adjustment factor, and it will be increased by 34% when an FQHC furnishes care to a patient that is new to the FQHC or to a beneficiary receiving a comprehensive initial Medicare visit. CMS is also allowing an exception to the single encounter-based payment when an illness or injury occurs subsequent to the initial visit, or when a mental health visit is furnished on the same day as the medical visit. CMS is accepting comments until July 1, 2014 on limited provisions impacting the FQHC PPS, including chronic care management, the use of new “G Codes” for Medicare payment to FQHCs under the PPS, and calculation of coinsurance for preventive services. Also as part of this rulemaking, CMS is finalizing a proposal to allow rural health clinics to contract with nonphysician practitioners when statutory requirements for employment of nurse practitioners and physician assistants are met. Finally, the rule amends the Clinical Laboratory Improvement Amendments (CLIA) of 1988 with regarding to enforcement actions for proficiency testing referral, in conformance with the Taking Essential Steps for Testing (TEST) Act of 2012.

CMS Proposes FY 2015 Update to Medicare IRF PPS

On May 7, 2014, CMS published its proposed rule to update Medicare payment policies under the inpatient rehabilitation facility (IRF) PPS for FY 2015. Under the proposed rule, rates would be updated by a 2.1% increase factor, which reflects a 2.7% market basket update, reduced by a -0.4% MFP adjustment and a -0.2 percentage point adjustment mandated by the ACA). Taking into account an additional 0.1% increase to aggregate payments resulting from an update to the outlier threshold, CMS expects IRF PPS rates to rise on average by 2.2% (or $160 million in aggregate) compared to FY 2014 levels. CMS proposes to freeze facility-level adjustment factors (e.g., adjustments for Low-Income Percentage, teaching status, and location in a rural area, if applicable) for FY 2015 and all subsequent years at FY 2014 levels while the effects of FY 2014 changes are evaluated. Among other things, the proposed rule would: revise the list of impairment group codes that presumptively meet the “60 percent rule” compliance criteria; add items to the IRF patient assessment instrument (PAI); and revise the IRF Quality Reporting Program to update measures and add a data accuracy validation policy. The proposed rule also discusses the transition from ICD-9-CM to ICD-10-CM for use on Medicare claims and IRF–PAI submissions (although this transition has been put on hold temporarily as a result of the Protecting Access to Medicare Act of 2014). CMS will accept comments on the proposed rule until June 30, 2014.

CMS Invites Comments on Sunshine Act "Open Payments" Dispute Resolution/Corrections Process

CMS is inviting comments on the Physician Payment Sunshine Act “Open Payments Program” dispute resolution and corrections process. As previously reported, the Physician Payment Sunshine Act requires pharmaceutical and medical device manufacturers and group purchasing organizations (GPOs) to register with and submit to CMS data on their financial relationships with physicians and teaching hospitals. This financial data will be made publicly available on the CMS Open Payments website. On May 5, 2014, CMS published a notice soliciting additional feedback on the dispute resolution and corrections process, under which covered recipients and physician owners or investors have an opportunity to dispute certain information regarding a payment or other transfer of value. Comments will be accepted until June 2, 2014.

CMS Issues FY 2015 Medicare SNF PPS Proposed Rule

This post was written by Susan Edwards.

The Centers for Medicare & Medicaid Services (CMS) published the fiscal year (FY) 2015 proposed skilled nursing facility (SNF) prospective payment system (PPS) rule on May 6, 2014 (Proposed Rule). CMS estimates that the Proposed Rule’s implementation would result in a $750 million increase in aggregate payments to SNFs during FY 2015 as compared to FY 2014. The Proposed Rule anticipates a market basket update of 2%, resulting from a market basket increase of 2.4 percentage points, reduced by the Multifactor Productivity Adjustment of 0.4 percentage points, as required by the Affordable Care Act (ACA). We discuss highlights of the Proposed Rule below, including: (1) the proposed wage index update; (2) a proposed policy change to the change of therapy (COT) Other Medicare Required Assessment (OMRA); (3) proposed revisions to the Civil Money Penalties (CMP) regulations; (4) CMS’s request for public comment on services excluded from consolidated billing; (5) CMS’s observations on therapy trends; and (6) CMS’s discussion regarding electronic health record (EHR) use in SNFs. CMS will accept public comments regarding the Proposed Rule until June 30, 2014.

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CMS Streamlines Medicare Requirements for Imaging Services Performed in ASCs and Hospital Radiopharmaceutical Preparation

This post was written by Paul Pitts and Thomas Greeson.

CMS has put on display a final rule that reforms Medicare regulations that CMS has identified as unnecessary, obsolete, or excessively burdensome on health care providers and suppliers. Two provisions address imaging services offered in ambulatory surgical centers (ASCs) and hospitals.

Supervision of Radiology Services in ASCs

CMS is reducing the requirements that ASCs must meet in order to provide radiological services to patients. Under the new rule radiology services performed as an integral part of surgical procedures in an ASCs are no longer required to be supervised by a radiologist. Instead, the ASC’s governing body must appoint an individual qualified in accordance with state law and the ASC’s policies who is responsible for assuring that all radiologic services are provided in accordance with the ASC Conditions of Coverage.

Under current rules, an ASC must have procedures for obtaining radiological services from a Medicare-approved facility to meet the needs of the ASC’s patients, and that radiologic services must meet the hospital Conditions of Participation (CoPs) for radiologic services. 42 C.F.R. 416.49(b). The hospital CoPs for radiologic services state, in part, that a qualified full-time, part-time, or consulting radiologist “must supervise the ionizing radiology services and must interpret only those radiologic tests that are determined by the medical staff to require a radiologist’s specialized knowledge.” 42 C.F.R. 482.26(c)(1). Interpretive guidance in Appendix L of the State Operation Manual provides further insight into this requirement. Namely, CMS has interpreted Section 482.26(c)(1) such that “[s]upervision of the radiology services may only be performed by a radiologist who is a member of the medical staff.” CMS directs surveyors to “[v]erify that supervision of the radiology services is restricted to a radiologist who is a member of the medical staff.”

CMS states in the final rule that it has learned that some of the hospital CoP requirements are unduly burdensome for ASCs to meet. In particular, the rule states that “the hospital CoP requirement to have a radiologist supervise the provision of radiologic services is unduly burdensome and overly aggressive, as many ASCs are having great difficulty locating a radiologist to supervise the minimal ASC radiologic services provided.”

In 2013 CMS initially proposed relaxing the supervision requirement by allowing any doctor of medicine (MD) or osteopathy (DO) qualified by education and experience in accordance with state law and ASC policy to supervise radiology services. Now, in this final rule, CMS provides additional flexibility by allowing any individual qualified by education and experience in accordance with state law and ASC policy (likely not a radiologist) to supervise radiology services. Depending on applicable state law, the individual charged with supervision need not be an MD or DO. However, they must be appropriately qualified to supervise the ASC’s use of safety precautions against radiation hazards, regular equipment inspection and hazard correction, regular review of radiation workers for the amount of radiation exposure, use of radiologic equipment only by qualified personnel, and maintenance of imaging results or records.

Preparation of Radiopharmaceuticals in Hospitals

CMS is modifying hospital requirements for in-house preparation of radiopharmaceuticals. Current hospital nuclear medicine services CoPs require that such services be performed by, or under the direct supervision of, an appropriately-trained registered pharmacist, MD, or DO. Direct supervision means that one of these professionals must be physically present in the hospital and immediately available during the preparation of all radiopharmaceuticals. CMS is revising the COP to remove the modifier “direct” from the in-house preparation supervision requirement. The presence of a pharmacist, MD, or DO will no longer be required during the delivery of off-hour nuclear medicine tests. According to CMS, these changes are based on the Society of Nuclear Medicine and Molecular Imaging recommendations on this issue.

The rule is scheduled to be published on May 12, 2014.

Older Entries

May 1, 2014 — CMS Releases Proposed Medicare Inpatient PPS/LTCH Update for FY 2015

April 28, 2014 — Proposed FY 2015 Medicare Payment Rules in the Pipeline

April 28, 2014 — CMS Proposes Updated Life Safety Code for Health Care Facilities

April 8, 2014 — RACs Correct $2.4 Billion in Medicare Claims in FY 2012

April 8, 2014 — CMS Announces System to Collect Hospice Care Data Beginning July 1, 2014

March 24, 2014 — Obama Administration Continues to Update ACA Insurance Exchange and Health Plan Regulations

March 20, 2014 — CMS Rule Increases FY 2014 Medicare Payments for Low-Volume Hospitals

March 19, 2014 — CMS Rule Requires Qualified Health Plans to Accept Certain Third-Party Premium Payments

March 4, 2014 — Preliminary FY 2014 DSH Allotments Announced

March 3, 2014 — CMS Takes First Steps to Cut Medicare DMEPOS Fees Based on Competitive Bidding Prices

February 18, 2014 — CMS Extends and Expands Moratoria on Enrollment of Home Health Agency, Ambulance Suppliers in Designated Areas

February 17, 2014 — CMS Seeks New Participants for Bundled Payments for Care Improvement Initiative

February 11, 2014 — CMS Invites Proposals for Frontier Community Health Integration Demonstration

January 30, 2014 — CMS Finalizes Rule to Strengthen Home- and Community-Based Services (HCBS) Options

January 29, 2014 — Reed Smith Client Alert: CMS/OIG Extend Protections for Electronic Health Record Donations

January 8, 2014 — CMS Proposes Updates to Medicare Advantage/Part D Policies for 2015

January 7, 2014 — CMS Proposes Emergency Preparedness Requirements for Medicare/Medicaid Providers

January 7, 2014 — CMS, FDA Extend Pilot Program for Parallel Review of Medical Products

January 7, 2014 — CMS Proposes 2015 Funding Methodology for ACA Basic Health Program

January 7, 2014 — CMS Issues Formally Updates 2014 Health Exchange Enrollment Deadlines

January 6, 2014 — CMS Seeks Comments on MSP CMP Policies, Appeals Process

December 27, 2013 — Final Rules Issued Extending Protections of Electronic Health Record Donations

December 10, 2013 — CMS Issues Final Medicare OPPS, ASC Policies for 2014

December 10, 2013 — CMS Updates Medicare Physician Fee Schedule, Other Part B Policies for CY 2014

December 10, 2013 — CMS Finalizes 2014 ESRD PPS Rates; Phases in ESRD Drug Utilization Cut

December 10, 2013 — CMS Proposed Rule on ACA Benefit and Payment Parameters for 2015

December 10, 2013 — CMS Boosts Provider Enrollment Fee for 2014

December 3, 2013 — CMS Adopts Changes to Medicare Payment, Coverage Rules for DMEPOS

November 25, 2013 — Medicare Home Health PPS Rates Cut 1.05% Under Final 2014 Rule

November 25, 2013 — CMS Seeks Input on Quality Ratings for ACA Exchange Plans

November 14, 2013 — CMS Invites Nominees for Members of Advisory Panel on Hospital Outpatient Payment

October 30, 2013 — CMS Finalizes ACA Exchange Program Integrity & Financial Oversight Standards

October 30, 2013 — CMS Releases Medicare Deductible, Coinsurance Amounts for 2014

October 30, 2013 — CMS Warns of Delay in Final CY 2014 Medicare Rules

October 29, 2013 — CMS Finalizes Medicare Conditions of Participation for Community Mental Health Centers

October 10, 2013 — HHS Proposes ACA Basic Health Program Regulations

October 10, 2013 — CMS Final Rule Refines FY 2014 DSH Payment Calculations

October 10, 2013 — CMS Proposes Rules for Medicare FQHC PPS, CLIA Amendments

October 9, 2013 — CMS Announces 2014 Amounts in Controversy Threshold Amounts for Medicare Appeals

October 9, 2013 — CMS Corrects FY 2014 Medicare Payment Rules

September 17, 2013 — CMS Finalizes ACA Exchange/Qualified Health Plan Financial Integrity and Oversight Standards

September 16, 2013 — CMS Releases ACA Medicaid DSH Funding Final Rule

September 11, 2013 — CMS Issues Technical Corrections to CY 2014 Proposed OPPS/ASC Rule

September 3, 2013 — Recent Updates to the Hospital Readmissions Reduction Program

August 28, 2013 — CMS Finalizes FY 2014 Medicare IPPS, LTCH Rates

August 28, 2013 — CMS Issues Final FY 2014 Medicare Inpatient Rehabilitation Facility (IRF) Rule

August 27, 2013 — CMS Publishes Final FY 2014 Medicare SNF PPS Rates, Policies

August 27, 2013 — CMS Finalizes Hospice Policies, Rates for FY 2014

August 27, 2013 — CMS Issues Final FY 2014 Inpatient Psychiatric Facility PPS Rates

August 27, 2013 — CMS Suspends Medicaid NARP Drug Data Collection

August 27, 2013 — Medicaid Disproportionate Share Hospital Allotments

August 12, 2013 — CMS Revises Medicare National Coverage Determination Process, Eases Path to Discontinue Outdated Coverage Policies

July 29, 2013 — CMS Issues Proposed OPPS, ASC Policies for 2014, Including Expanded OPPS Packaging Proposal

July 29, 2013 — CMS Announces First Temporary Moratoria on HHA, Ambulance Supplier Enrollment in High-Risk Areas under ACA Authority

July 29, 2013 — CMS Proposes Updates to Medicare Physician Fee Schedule, Other Part B Policies for CY 2014

July 29, 2013 — CMS Proposed Rule Calls for 9.4% Cut in CY 2014 ESRD PPS Rates

July 29, 2013 — CMS Finalizes ACA Health Insurance Exchange "Navigator" Standards

July 29, 2013 — CMS Issues Final Medicaid Eligibility/Enrollment Rule under the ACA

July 5, 2013 — CMS Proposes Updates to DMEPOS Payment, Coverage Rules

July 5, 2013 — Medicare Home Health PPS Rates to Drop under Proposed CY 2014 Rule

June 27, 2013 — CMS Finalizes Medicare/Medicaid Requirements for Long Term Care Facilities Providing Hospice Services

June 27, 2013 — IPPS/LTCH Rule Correction Notice

June 27, 2013 — HHS Releases Final ACA Exchange Rule on "Shared Responsibility" Payments

June 27, 2013 — CMS Proposes ACA Exchange/Qualified Health Plan Financial Integrity and Oversight Standards

June 11, 2013 — CMS Sets Provider Payment Rates Under the ACA Pre-Existing Condition Insurance Plan Program

June 11, 2013 — CMS Publishes Final ACA Small Business Health Option Program (SHOP) Rule

June 11, 2013 — CMS Finalizes Medicare Advantage/Part D Plan Medical Loss Ratio Rules

June 11, 2013 — CMS Seeks Additional Applicants for Bundled Payments for Care Improvement Program

June 11, 2013 — State DSH Allotments Methodology

May 14, 2013 — CMS Proposes Medicare IPPS and LTCH PPS Rates/Policies for FY 2014

May 14, 2013 — CMS Issues FY 2014 Medicare SNF PPS Proposed Rule

May 13, 2013 — CMS Proposes Hospice Payment Policies for FY 2014

May 13, 2013 — CMS Proposes Updated FY 2014 Medicare Payments and Other Policies for IRFs

May 13, 2013 — CMS Notice Prepares for Termination of Early Retiree Reinsurance Program

May 1, 2013 — CMS Proposed Changes to Medicare LTCH Payment Rates and Policies for FY 2014

April 25, 2013 — Proposed Rule Would Reward Medicare Fraud Tipsters up to $9.9 Million, Revise Medicare Provider Enrollment Regulations

April 15, 2013 — CMS Issues Final Rule on Federal Funding for Medicaid Expansion under the ACA

April 15, 2013 — CMS Proposes Revisions to Oversight Rules for Accreditation Organizations

April 15, 2013 — CMS Proposes Rules for Health Insurance Exchange "Navigators"

April 12, 2013 — CMS, OIG Propose Extension of Electronic Health Record Donation Protections

April 8, 2013 — Reed Smith Client Alert on Part B Inpatient Billing in Hospitals

March 28, 2013 — CMS Updates Hospital Part B Inpatient Billing Policy

March 28, 2013 — CMS Finalizes ACA Nursing Facility Closure Notification Rules

March 28, 2013 — Administration Proposes ACA Insurance Waiting Period Rule

March 28, 2013 — CMS Notice Corrects Hospital Readmissions Data

March 13, 2013 — CMS Requests Comments on New Forms to Disclose Competitive Bidding Contract Supplier Ownership Changes

March 13, 2013 — CMS Announces Changes to Hospital Payment Adjustments under the ATRA

March 5, 2013 — CMS Physician Payment "Sunshine" Final Rule -- Overview and Analysis

February 18, 2013 — CMS Proposes Medicare Advantage, Part D Drug Plan Medical Loss Ratio Rule and Advance 2014 Rate Information

February 18, 2013 — CMS, IRS Proposed ACA "Shared Responsibility" Payment/Exemptions Rules

February 18, 2013 — CMS Proposes Reforms to Reduce Provider Regulatory Burdens

February 18, 2013 — CMS Seeks Input on Use of Clinical Quality Measures for Medicare Physician Quality Reporting

February 1, 2013 — CMS Releases Physician Payments Sunshine Act Final Rule

January 30, 2013 — CMS Proposes Changes to Medicaid Eligibility, Benefits, and Appeals Rules

January 30, 2013 — CMS Seeks Suggestions for Surveys on Hospice and Hospital Outpatient Surgery Department/Ambulatory Surgery Center Care

January 14, 2013 — Hospital Readiness for Electronic Quality Reporting

December 17, 2012 — CMS Seeks Comments on Measures of Patient Experiences with Emergency Department Care

December 17, 2012 — Interim Rule Revises EHR Certification Criteria, Incentive Program Specifications

December 17, 2012 — CMS Announces 2013 Provider Enrollment Application Fee Amount

November 29, 2012 — HHS Proposes Standards for Essential Health Benefits, Actuarial Value, and Accreditation under the ACA