CMS Releases List of Teaching Hospitals; Educational Efforts and Requests for Additional Clarification Regarding the Physician Payment Sunshine Final Rule Continue

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

In preparation for data collection to begin under the Physician Payment Sunshine Act Final Rule on August 1, 2013, the Centers for Medicare & Medicaid Services (CMS) released yesterday the list of teaching hospital covered recipients to which payments and other transfers of value must be reported by applicable drug and device manufacturers.  The list, which will be updated annually by CMS at least 90-days before the beginning of a reporting year, can be found on CMS’ National Physician Payment Transparency Program: OPEN PAYMENTS website and includes approximately 1,100 legal business names that are organized by state and tax identification number.

CMS also announced this week that it will be holding a National Provider Call on Wednesday, May 22, 2013 at 2:30 PM EST, directed at physicians and teaching hospitals.  The agenda for the call includes an overview of the Final Rule, key dates, the role of covered recipients and resources available to covered recipients.

Meanwhile, stakeholders and their representatives, including the American Medical Association (AMA) and the Advanced Medical Technology Association (AdvaMed), have continued to seek additional clarification from CMS on a variety of outstanding questions.  These questions include whether journal reprints provided by a manufacturer to a physician or teaching hospital have a discernible economic value that triggers reporting requirements, what constitutes a payment or transfer of value to a teaching hospital as opposed to payments or transfers of value to an employee of the teaching hospital, and more.  Ideally, CMS will issue further guidance on these issues in sufficient time for applicable manufacturers to prepare for the data collection deadline this summer.

Sunshine Physician Payment Final Rule Overview and Analysis

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

On February 1, 2013, the Centers for Medicare & Medicaid Services (CMS) of the Department of Health and Human Services (HHS) released the long-awaited Final Rule to implement the “Sunshine” provisions of the Affordable Care Act of 2010 (ACA). The Sunshine provisions - intended to provide increased transparency on the scope and nature of financial and other relationships among manufacturers, physicians, and teaching hospitals - require that certain manufacturers of drugs, devices, biologicals, and medical supplies covered by Medicare, Medicaid and CHIP report annually to HHS identified payments or transfers of value they have made to physicians and teaching hospitals. In addition, they require manufacturers and certain group purchasing organizations (GPOs) to report to HHS information on physician ownership and investment interests.

The Final Rule provides needed clarity on some troubling aspects of the proposal, however, it leaves a number of questions unanswered. Please click here to read our detailed analysis of the Sunshine provisions, including an overview and summary of the Rule as well as discussion of the important issues that stakeholders should be considering as they prepare for Sunshine implementation.

Affordable Care Act and the Post-Election Implications for Radiology

This post was written by Thomas W. Greeson and Paul W. Pitts.

As the dust settles from Tuesday’s election, pundits and prognosticators are predicting the future of the world based on highly charged and deeply polarized perspectives. Those predictions are sweeping in scope and many we have seen tend toward dire scenarios - even for the diagnostic imaging industry. The more prudent course is to step back for a moment and assess the situation in a more pragmatic and dispassionate way. With this in mind, we wanted to take this opportunity to describe what we expect to see as health reform efforts continue.

In planning for the future, it is vital to take into account that there are things we know for certain, things that are unknown at the moment and things that are simply unknowable. We have to do planning, preparation and decision making taking those factors into consideration. In every situation where change happens (and change happens constantly) there are threats and opportunities. Often we miss the opportunities because we are so focused on the loss of the known and familiar. The well-known adage, “Success is where preparation meets opportunity” applies here. The radiology practice that carefully considers how to position itself for a future that has not fully revealed itself is more likely to be ready to seize the opportunities that come with change.

The Affordable Care Act is here to stay as a result of President Obama’s reelection. Even if Governor Romney had been elected, changes to the health system were inevitable. In some markets, accountability, transparency and greater integration is being driven as much by commercial payers as from the government. We don’t expect everyone to agree with the following comments, but this is how we see the short and mid-term time horizon:

  • Continuing Integration. CMS will continue to foster integration efforts via its shared savings program that calls for creation of accountable care organizations (ACOs) to coordinate care, encourage use of evidence-based measures, reduce costs and achieve betters outcomes for patients. Many of you practice in hospitals that want to be the drivers of ACOs and other integrated delivery systems. Although these organizations are centered around primary care providers, imaging is a necessary component of any ACO’s portfolio of services. The prudent group will try to find some way to “be at the table” to help shape the governance, appropriateness of the imaging service and especially, to shape the compensation model. While we expect these integration efforts to continue, we do not believe that employment by hospitals is the necessary fate of most radiologists. We feel it is critical for the group culture of radiologists to endure to allow radiologists to determine selection and retention of radiologists, scheduling of services and the compensation of individual radiologists. Employment is not necessary to achieve that group role. A carefully drawn contractual agreement can address a health system’s desire for integration while preserving the independence of a radiology practice. CMS requires all ACOs to be legal entities. Many radiology groups may want to consider taking an investment interest in the legal entity organized to operate as the ACO and strive to have key governance and committee roles in those organizations.
  • The Value Proposition. The challenge for the specialty may be a contest between commoditization of the professional services via teleradiology and the local delivery of those same services. The groups that succeed in offering a viable alternative to cost-based marketing of radiology services will learn to sell the value proposition for their services locally. Technology will play a key role, but so will the willingness of radiologists to truly offer consultative services that will be valued by local referring physicians, hospital administrators and payers. Radiologists can be the gatekeepers for appropriate care. There is a need for your role in controlling appropriateness and overall imaging costs in a manner that complies with the fraud and abuse laws and rules governing participation in Medicare.
  • Ventures. The efficiency and patient preference for free standing imaging is unlikely to change. It is even more likely, however, that such free standing facilities will be part of the offerings of an integrated delivery system. Hospitals, will likely have some ownership in an increasing percentage of the outpatient imaging that is delivered in this country. Not all of those facilities will be provider based. It is incumbent, therefore, that radiologists understand the Medicare enrollment rules and the options that are available as they work with their hospitals in organizing free standing imaging services. Here again, we recommend that radiologists work to “be at the table” and strive for ownership and participation in the governance and management of these facilities.
  • Regulatory Awareness. The government is likely to double down in its enforcement activities. Radiologists operate under a complex set of rules and guidelines. Radiology groups will have to remain vigilant to understand the rules that govern how your services are ordered, delivered and billed for Medicare patients. We anticipate those rules could apply to the delivery of certain non-Medicare patients as well.
  • Antitrust and Competition. As health systems continue their efforts to control costs through integration of all stages of care, we foresee greater competition in delivery of imaging services in the future and more disputes regarding whether health systems and large practices misuse their market power.
  • Curtailment of Self-Referral. After more than two decades of radiologists’ advocacy for retrenchment of self-referral, the regulatory climate appears more favorable than ever toward a roll back of in-office imaging. Both governmental and private payers appear now to perceive how the conflicts of interest caused by referral to a physician’s own imaging services is a driver in increased health care costs. The report of the General Accountability Office released last month contained specific policy suggestions for curbing self-referral. As payers adopt various strategies for steering patients away from centers that are higher priced and high utilizers of imaging services, centers owned and operated by radiologists or by radiologists and hospitals are likely to be very competitive in many markets.

Bottom line, we believe that the groups that prepare for these changes, and look for opportunities as a result of these changes, will not only survive but can thrive in the health care delivery system that will emerge.

House Approves ACA Device Tax Repeal Bill in Face of Veto Threat

This post was written by Ruth N. Holzman, Angelo Ciavarella and Debra A. McCurdy.

Yesterday the House approved by a vote of 270-146 legislation to repeal the ACA’s controversial 2.3% excise tax on the sale price of certain medical devices, which is scheduled to apply to sales after December 31, 2012. The repeal provision is included in H.R. 436, the Health Care Cost Reduction Act of 2012, which also would: repeal ACA provisions that disqualify expenses for over-the-counter medicine under certain health savings arrangements; allow employees with health flexible savings arrangements funded through salary deductions to “cash out” any remaining balance at year-end (up to $500), and treat such funds as taxable compensation; and require individuals who receive ACA health insurance exchange subsidies to which they are not entitled to repay the full amount of overpayments. The bill now moves to the Senate, where its fate is uncertain, particularly since the Administration has threatened to veto the bill. According to the Administration, the medical device industry will benefit from expanded health insurance coverage under the ACA, and a repeal would “fund tax breaks for industry by raising taxes on middle-class and low-income families.”

House Leaders Plan June Vote on ACA Medical Device Tax Repeal

This post was written by Debra A. McCurdyRuth N. Holzman, and Angelo Ciavarella

A vote on legislation to repeal the ACA’s medical device excise tax could come in June, House Majority Leader Eric Cantor announced today.  The ACA imposes a 2.3% excise tax on the sale price of medical devices sold by the manufacturer, producer, or importer of the device after December 31, 2012. Citing the negative impact of this “draconian tax” on jobs in the medical device industry, Cantor plans a vote on H.R. 436, which would repeal the medical device tax, as early as the week of June 4, 2012. The bill would then await Senate action.

10-Year 'Look Back' Proposed for Identification and Return of Medicare Part A and B Overpayments

This post was written by Scot T. Hasselman, Julia Krebs-Markrich, Thomas W. Greeson and Paul W. Pitts.

Providers and suppliers have until April 16, 2012 to comment on the proposed rule to implement provisions of Section 6402(a) of the Affordable Care Act that require “persons” receiving Medicare and Medicaid funds to report and return overpayments no later than 60 days after the date on which the overpayment was identified or, if applicable, the date any corresponding cost report is due.

The proposed rule, which is currently limited to Medicare Part A and B providers and suppliers, is important because it clarifies when and how an overpayment must be returned. If promulgated in final form as currently drafted, the rule would also subject providers and suppliers to a 10-year “look back” period, meaning providers and suppliers would have liability for the 10 years preceding the date an overpayment is received. The proposed rule has serious implications for provider and supplier operations if adopted as proposed. Providers and suppliers should consider using the public comment period to voice their concerns while it might still make a difference.

To learn more about the proposed rule and its implications, read the full alert.

CMS Awards "Survey Of Retail Prices" Contract To Myers and Stauffer - Moves One Step Closer To Average Acquisition Cost

On July 8, 2011, Centers for Medicare & Medicaid Services (CMS) announced that it had awarded Myers and Stauffer, LC a contract to prepare a monthly survey of retail community pharmacy ("RCP") prescription drug prices. The contract is in furtherance of CMS’s commitment to develop and publish “Average Acquisition Cost” ("AAC") data reflecting RCPs’ purchase costs for all covered outpatient drugs, for potential use by State Medicaid agencies in rate-setting. The details regarding how AAC will be collected, calculated and reported could be significant for pharmacies, manufacturers and other industry participants. 

To learn more about this development regarding AAC, please see the full post written by Bob Hill, Joe Metro, Dan Cody, Vicky Gormanly on Reed Smith's Health Industry Washington Watch.