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ePolicy News January 2014

Monday, January 6, 2014



HHS Responds to Advocacy Efforts, Laboratories finally relieved of EHR Gifting Burden!

On Dec. 23, the Department of Health and Human Services Office of Inspector General (OIG) and the Centers for Medicare and Medicaid Services (CMS) released companion rules extending a provision allowing certain healthcare entities to essentially gift Electronic Health Record (EHR) systems without violating the Stark or Anti-kickback laws. Though previously included in the list of entities safe harbored under this provision, the final rules differ from the proposed rules in their exclusion of laboratories from this list. This means that laboratories will no longer be allowed/expected to gift EHRs to (referring) physicians.

ASCP has long advocated for the removal of laboratories from the list of entities protected under the EHR safe harbor, citing the practice as a direct violation of the Stark and Anti-kickback laws. ASCP has continually communicated to CMS that, due to the unique referral-based nature of the pathology specialty, allowing laboratories to gift EHRs has generated a slippery slope effect resulting in the essentially forced exchange of EHRs for referrals. Thus, laboratories are inadvertently forced to fund EHRs in order to sustain their referral base and compete with other laboratories looking to broaden their referral base. ASCP has also pointed out that the inclusion of laboratories under the EHR safe harbor yields unfair irony, in that pathologists are unable to participate in the EHR Incentive program but are allowed to fund EHRs for physicians that are able to participate. Most importantly however, ASCP has noted the potential harm to patients that may result from a physician selecting a laboratory for patient referral based on enhanced financial gain for their practice rather than enhanced quality of services for their patients.

ASCP is pleased that our voices have been heard on behalf of our members. ASCP will continue to advocate for a permanent hardship exemption for pathologists under the EHR Incentive Program.

Recent Advocacy References:

In May, ASCP co-signed a letter, along with other organizations representing the pathology and laboratory community, urging Congress to express support to the OIG for excluding laboratories as eligible donors under any extension of the current federal safe harbor for EHR donations.

In September, ASCP communicated our concerns that laboratory gifting of EHRs was in direct violation of the Stark Act in our comment letter submitted to CMS in response to the CY 2014 Medicare Physician Fee Schedule Proposed Rule.

In December, ASCP submitted a proposal to CMS requesting the extension and modification of the Physician Quality Reporting System (PQRS): Maintenance of Certification (MOC) Program. ASCP strengthened support for this proposal with evidence that existing quality reporting programs place undue burden on pathologists. ASCP took this opportunity to reiterate, in detail, our concerns around EHR gifting. ASCP also estimated the total negative impact on pathologists’ reimbursement resulting from failure to participate in all of the CMS-developed quality reporting programs.




Though Budget Act Contains Temporary SGR Fix, ASCP Looks Ahead Toward Permanent SGR Repeal

On Dec. 26, 2013, President Obama signed into law H.J. Res. 59, the Bipartisan Budget Act of 2013, which includes the Pathway for SGR Reform Act of 2013. The law extends Medicare provider payment cuts under existing sequestration authority for two years. It also effectively averts the roughly 24-percent reduction in Medicare reimbursement rates that was set to take place on Jan. 1, 2014 as a result of the flawed Sustainable Growth Rate (SGR) payment formula. In lieu of these cuts, a 0.5-percent positive update will be applied to Medicare claims with dates of service on or after Jan. 1 through March 31. After all adjustments, this results in a 2014 conversion factor of $27.2006.

This temporary payment patch is intended to bide Congress more time to finalize pending legislation that would permanently repeal the SGR policy and replace it with a period of stable payment followed by a shift to pay-for-performance reimbursement. Bipartisan SGR reform bills have been overwhelmingly approved by the U.S. Senate Finance Committee as well as the Ways and Means Committee and Energy and Commerce Committee in the U.S. House of Representatives. However, moderate differences in the measures must still be resolved and spending offsets still need to be identified. It is unclear whether Congress will be able to come to an agreement on permanent SGR repeal legislation prior to the April 1 expiration of the temporary payment patch or will opt to legislate yet another temporary fix.

Nonetheless, ASCP is keeping a watchful eye on Congressional movement toward complete SGR repeal. In December 2013 the Congressional Budget Office (CBO) lowered the estimated cost of SGR repeal for a second time down to $116.5 billion over 10 years. The cost was initially estimated by CBO at $271 billion in August 2012 but then cut nearly in half to $139 billion in CBO’s updated estimate, announced in February 2013. The twice reduced price tag of SGR repeal expedites the need for Congress to take action now and identify SGR repeal pay-for as soon as possible.

ASCP is currently working with our partners in the Alliance for Integrity in Medicare (AIM) coalition to urge Congress to include Stark reform as a potential pay-for in SGR repeal legislation. Specifically, ASCP encourages the removal of anatomic pathology services from the in-office ancillary services exception to the Stark law. In support of this request, ASCP cites recent studies from both the Government Accountability Office (GAO) and Health Affairs suggesting that closing the self-referral loophole for anatomic pathology services will result in decreased overutilization and costs. In demonstration of the potential savings associated with Stark reform, AIM is working to get U.S. Rep. Jackie Speier’s (D.–Calif.) Stark reform bill, the Promoting Integrity in Medicare Act (H.R. 2914), scored by the CBO. AIM also recently met with the White House Administration in effort to get Stark reform included in the President’s CY 2015 budget proposal, anticipated for release in February. ASCP will keep our members abreast of all future developments around both SGR repeal and Stark reform, whether separate or combined initiatives take shape.




Physician Payment Transparency Reporting Begins in 2014

In February 2013, the Centers for Medicare and Medicaid Services released its final rule implementing the regulatory requirements for the Physician Payment Sunshine Act. The PPSA required the establishment of a transparency program, now known as Open Payments. The program requires certain manufacturers and group purchasing organizations (GPOs) to report to CMS information on payments or transfers of values to physicians and teaching hospitals. Applicable payments or transfers may be direct, indirect, or through third parties.

The following information provides an overview of the Open Payments Program and links to helpful resources. The information bellow is derived largely verbatim from CMS’s Open Payments Website, which is accessible here.


Participation in Open Payments

The Open Payments initiative is intended to create greater transparency around the financial relationships of manufacturers, physicians, and teaching hospitals. The program requires that the following information is reported annually to CMS:

  • Applicable manufacturers of covered drugs, devices, biologicals, and medical supplies to report payments or other transfers of value they make to physicians and teaching hospitals to CMS.
  • Applicable manufacturers and applicable group purchasing organizations (GPOs) to report to CMS certain ownership or investment interests held by physicians or their immediate family members.
  • Applicable GPOs to report to CMS payments or other transfers of value made to physician owners or investors if they held ownership or an investment interest at any point during the reporting year.
  • CMS will collect this data, aggregate it, and publish it on a public website.


How Open Payments Works

Applicable manufacturers and applicable GPOs can begin collecting financial relationship data on Aug. 1, 2013. Applicable manufacturers and applicable GPOs will report the data for August through December of 2013 to CMS by March 31, 2014, and CMS will release the data publicly by Sept. 30, 2014. Beginning in 2014, they will be required to register on a CMS website and will submit data using submission file specifications (formerly known as data collection templates). In 2014, physicians and teaching hospitals will be able to:

  • Register to access their data prior to public posting;
  • Initiate data disputes; and
  • Work with applicable manufacturers and applicable GPOs on dispute resolution.

To ensure data accuracy, CMS is required to conduct audits of the data submitted and levy civil monetary penalties against applicable manufacturers and applicable GPOs for failing to submit data or submitting inaccurate data.


Do Physicians Have to Participate in Open Payments?

Physicians are not required to register with or send any information to Open Payments. However, to make sure [CMS has] the right information, [the agency encourages] physicians to:

Physicians who notice an inaccuracy will be able to dispute the information and work with applicable manufacturers and applicable GPOs to resolve disputes.


CMS’s Open Payments Website:

CMS Fact Sheets and User Guides:

AMA Toolkit for Physician Financial Transparency Reports (Sunshine Act)

ASCP Spreads the Choosing Wisely Message

As part of ASCP’s Choosing Wisely initiative, a new online toolkit is now available that seeks to raise public awareness about appropriate test utilization and to assist patients in taking an active role in choosing care that is truly necessary. Pathologists and laboratory professionals are encouraged to use the toolkit resources, including articles, PDF guides, posters, podcasts, and handouts, to help inform and educate colleagues about appropriate test ordering.

ASCP was invited by the American Board of Internal Medicine (ABIM) to represent pathology in Choosing Wisely, a nationwide campaign to help reduce testing that is unnecessary and may even cause harm. ASCP is joined in the effort by more than 50 other medical specialty organizations across the country that have each recommended five tests or procedures where there is overuse and waste.

As part of this grassroots effort, ASCP presented a symposium, “Choosing Wisely: How California Pathologists Can Influence Appropriate Testing,” in collaboration with the California Society of Pathologists (CSP) at their annual conference last month in San Francisco.

George D. Lundberg, MD, MASCP, former editor of The Journal of the American Medical Association (JAMA) and Medscape, a long-time proponent of prudent medical practice, was among several prominent speakers at the symposium, which was designed to help California pathologists implement ASCP’s Choosing Wisely best practices, impact positive patient outcomes that also reduce expenses, and overcome communication, organizational, and systems barriers.

The Society was awarded funding by the ABIM Foundation to promote dialogue aimed at reducing inappropriate tests and procedures that improve patient care and reduce costs. Support for the grant comes from the Robert Wood Johnson Foundation and extends the efforts of the ABIM Foundation’s Choosing Wisely campaign in local communities across the nation.

ASCP is planning more Choosing Wisely symposia in other communities across the country in the upcoming year.




Laboratories Play Key Role in Improving Public Health

Cutting edge technologies that advance progress in identifying HIV/AIDS, TB, malaria, and emerging infectious diseases in the United States and abroad was the main theme of the panel discussion assembled by the Centers for Disease Control and Prevention (CDC) and AdvaMedDx on Capitol Hill. According to the speakers, laboratories and laboratory professionals play a central role in improving public health through the utilization of innovative diagnostic tools. For instance, the CDC’s global health work has been instrumental in detecting outbreaks such as Ebola and Marburg hemorrhagic fevers by installing laboratories in areas that were previously incapable of testing for these diseases. Training of health workers to effectively use new rapid diagnostic tests on diseases such as malaria has contributed to reduced child mortality rates. Furthermore, the Field Epidemiology and Laboratory Training Programs (FELTP), who have built sustainable capacity for detecting and responding to health threats have responded to 709 outbreaks and supported 845 surveillance activities thus far. The timing of the meeting was set around the 2013 World AIDS Day. John Hackett Jr., PhD, Senior Research Fellow and Director of Diagnostics Infectious Diseases at Abbott Laboratories provided the audience updates on innovations in detecting HIV earlier than traditional tests. Early detection through improved technologies has provided patients with the knowledge of their HIV status which had led early therapy and transmission prevention.

Since its inception, ASCP's Institute's Center for Global Health has been working around the world since to improve laboratory quality and patient health outcomes. ASCP staff and consultants have facilitated more than 120 trainings, workshops, and mentorships, as well as trained more than 2,200 laboratory professionals and medical laboratory instructors worldwide. These activities have comprised subject-specific, hands-on trainings, as well as university curriculum improvement, teacher trainings, and laboratory accreditation and quality improvement projects.


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