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STATLINE
July 3, 2013  •  Volume 29, Number 14
Next Issue: July 18, 2013
© 2013 College of American Pathologists
 

In This Issue:

MoPath Gapfill Pricing Comments Due July 8

The public comment period on the gapfill pricing of Tier 1 and Tier 2 molecular pathology codes established by the Medicare Administrative Contractors (MACs), ends July 8, 2013.

CAP members, laboratories and test developers are encouraged to provide comments to MoPathGapfillInquiries@cms.hhs.gov to ensure CMS has accurate information from which to determine coverage and payment rates. Information may include cost data, test methodology, and any other information that would help CMS determine payment rates.

CMS is expected to publish final gapfill pricing decisions in September 2013 for 2013 and 2014. CMS has indicated there will be another 30-day reconsideration period after the final rates are posted in September.

Visit the CMS Website for more information, including pricing proposed by the MACs, and rate-setting rationale for certain tests from Cigna Government Services, Wisconsin Physician Services, Noridian, First Coast Service Options, and Palmetto.


CMS Clarifies Meaningful Use Requirements for Pathologists

Pathologists in integrated health systems can meet meaningful use objectives even if they do not enter information into Certified Electronic Health Record Technology (CEHRT), as long as the specified information is present in the EHR. Moreover, reports generated by a Laboratory Information System, LIS, can be defined as patient encounters and used as proxies for patient encounters in order to meet Meaningful Use (MU) objectives based on unique patients seen, according to a letter CAP received from CMS recently.

The clarification came in response to CAP’s inquiry regarding the CMS “Specialist Tipsheet” entitled Using Other Providers’ Data issued in May, on ways pathologists and other specialists could participate in EHR incentive programs.

Other highlights from CMS’s clarification include:

  • Location is defined as equipped with CEHRT if the record of the patient encounter that occurs at that location is created and maintained in the CEHRT, and can be accomplished if an eligible professional (EP) has access at that location to any CEHRT, whether ambulatory or inpatient.
  • Patient Information can be entered into the CEHRT by other providers, other staff, or through information exchanges with other systems.
  • Computerized Provider Order Entry (CPOE), would likely not apply to most pathologists, who would not meet the threshold of writing over 100 prescriptions per year, and would likely meet the exclusion for the requirement.

The CMS letter was sent from Denise M. Buenning MSM, deputy director of the Office of E-Health Standards and Services.


Bill Would Create Independent Panel to Oversee AMA-RUC

Rep. Jim McDermott (D-Wash.) last week introduced a bill, H.R. 2545, that would limit the role of physician groups in setting Medicare physician pay each year, and create a panel of independent experts to oversee the American Medical Association’s Relative Value Scale Update Committee (AMA-RUC) process.

This is not the first time Rep. McDermott, who is the ranking minority member on the Ways and Means health subcommittee, sought to impose greater control over Medicare physician pay. He introduced a similar bill in 2011, H.R. 1256, the Medicare Physician Payment Transparency and Assessment Act of 2011, which required the HHS Secretary to use contractors to identify and analyze services identified as being potentially misvalued physician services. The 2011 bill was referred to the health subcommittee but was not reported out of that committee.

The current bill seeks to achieve similar ends. Although the full text is not yet available, the summary says it would amend the Social Security Act to provide for an expert advisory panel regarding the relative value scale process used under the Medicare physician fee schedule.

Rep. McDermott’s press release says it would establish a panel of independent experts within the Medicare agency to identify distortions in the fee schedule and develop evidence to justify more accurate updates. The panel would be composed of members “without any direct conflicts of interest and would include patient representatives.

It would also be subject to the Federal Advisory Committee Act, which requires advisory bodies to hold open meetings and publish minutes.”

Under the bill, Medicare could continue to request work from the RUC, but the independent experts would both initiate such requests and review the RUC’s work product.

It was referred to the Committee on Energy and Commerce, and to the Committee on Ways and Means with no co-sponsors.


SGR Watch

One can never say if Congress will actually repeal and replace the Sustainable Growth Rate (SGR) formula, but there were two recent signs that the process is moving forward.

The first was the release of an “advanced legislative framework” for repealing the SGR, released by the Energy & Commerce Committee late last week. CAP staff is analyzing the framework, but the Committee’s press release provided some insight, stating the policy would repeal SGR and replace it with an improved fee for service system. It also said providers would have the option of leaving the fee for service system and opt instead for new ways of delivering care with a greater emphasis on quality and efficiency. The Committee said the framework had broad bi-partisan support in Congress, and was developed with input from over 80 stakeholder organizations, including CAP.

House Republicans have said they want to introduce a bill before the August recess.

The other noteworthy clue is less definitive. The Congressional Budget Office, which issues Federal budget updates twice each year, canceled the scheduled August budget update report, leaving in place the low $139 billion cost estimate for an SGR fix released in May. It is nearly $100 billion less than previous estimates.

There’s speculation that the estimate will go up when a new forecast is done, and maintaining the lower price tag through the end of the year will help Congress’s chances of paying for SGR repeal.

Statline will continue to follow SGR repeal.


NAME President Testifies at Congressional Hearing on National Standards for Medical Examiners

Accreditation and individual certification of forensic science professionals, specifically medical examiners, should be mandatory, according to Gregory A. Schmunk, MD, FCAP, president of the National Association of Medical Examiners, and Chief Medical Examiner of the Polk County Medical Examiners’ Office in Des Moines, Iowa, who testified before the Senate Committee on Commerce, Science, and Transportation last week.

Dr. Schmunk described the fractured system currently in place for assuring quality and consistency among medical examiners. NAME’s own professional practice standards for autopsy performance, in use since 2005, and its professional system of medicolegal office accreditation in place since 1974 are among a number of programs available. However, without federal or state mandates for accreditation, only 70 out of over 465 offices performing forensic autopsies are currently accredited in the United States.

“There needs to be a formal and federal entity which oversees forensic science and death investigation,” Schmunk testified. “We believe that by having this entity exist we could address most of our major concerns and specifically the continuity of quality.”

Schmunk also stated support for the recommendations made by the National Research Council (NRC) report, Strengthening Forensic Science in the United States: A Path Forward.

“We believe many of those recommendations, if implemented, could resolve many of the problems within the Medical Examiner community,” he said. In July of 2009, NAME passed a resolution strongly endorsing the recommendations of the Council and specifically endorsed the establishment of a National Institute of Forensic Sciences to promote the development of forensic science into a mature field of multidisciplinary research and practice based on scientific principles.

See more of Dr. Schmunk’s testimony.


Federal Health Program Carve-outs Offer No Protection From Anti-kickback Law

Physician practices that carve out federal health programs from their self-referral arrangements do not immunize themselves from anti-kickback laws, according to advisory opinion No. 13-03, issued by the Office of the Inspector General (OIG) in June.

The OIG was responding to a clinical laboratory company’s proposal to contract with physician practices to provide laboratory services to the practice’s patients who are not enrolled in federal health programs. The ruling was in line with the OIG’s consistent enforcement of anti-kickback laws, stating that such arrangements could generate prohibited remuneration and lead to the imposition of sanctions. The OIG published a similar opinion on a proposed anesthesia arrangement last year.

Arrangement

The clinical lab proposed establishing a new legal entity to contract with physician groups to help them set up their own labs (facility space, laboratory management and support, lease personnel, equipment, licenses, etc.). Physician groups would own and operate their laboratories and would be responsible for data collection and quality review as well as their own billing.

The physician groups would lease a separate laboratory suite for fair market value in a building operated by the management company of the clinical lab. The laboratory would color code private payer specimens to be performed in their laboratory, but would send out specimens for patients enrolled in federal health care programs. The requestor of the advisory opinion from OIG, the clinical laboratory, asked if this arrangement would constitute grounds for the imposition of sanctions related to the Federal anti-kickback statute.

Finding

The OIG’s opinion noted its long-standing concern about arrangements under which parties “carve-out” referrals of Federal health care program beneficiaries or business generated by Federal health care programs.

It noted that although the physician group laboratories would bill only for services for non-Federal health care program patients, participation in the proposed arrangement may increase the likelihood that physicians will order services from the clinical laboratory for federal health care program beneficiaries.

Further, the OIG expressed concern with the expansion of physician groups into the clinical laboratory business involving little or no business risk.


CAP-NHSP Secure Clinical Lab Exemption from Genetic Test Restrictions

In the waning days of the legislative session, the New Hampshire legislature reversed course and voted in favor of an amendment that shields pathologists from informed consent requirements of a patient’s genetic information during the course of laboratory testing. The College and New Hampshire Society of Pathologists (NHSP) collaborated with the state medical society to negotiate with proponents and the Senate sponsor of SB 135 that licenses genetic counselors, to adopt the amendment.

SB 135, which was amended in the House, removed an exemption for physicians from informed consent requirements when discussing or disclosing genetic test information within their medical practice or hospital. The CAP and NHSP were concerned that if the law was repealed clinical laboratories and pathologists would need an additional informed consent from a patient prior to discussing genetic test information with another health practitioner or requesting a second opinion. A legislative committee unanimously adopted the College and NHSP’s supported amendment so the “prior written and informed consent” requirement was not “construed to regulate or apply to genetic testing or genetic analysis” of a patient specimen by a clinical laboratory in New Hampshire.

The amended bill passed the New Hampshire legislature on June 26th and is expected to be signed by the Governor.

Bill Prompts HOD Speaker’s Call to Action

Passage of the NHSP/CAP amendment was not guaranteed, in part because it was discovered late in the legislative process. The two organizations mobilized quickly and won, but the experience prompted David Novis MD, FCAP, President of the New Hampshire Society of Pathologists, and Speaker of the CAP House of Delegates to urge members to get involved.

“We are fortunate the College was vigilant in monitoring this legislation which could have posed real problems for pathologists in our state,” he said. “This exemplifies why as pathologists we need to be engaged with our state pathology and medical societies, and support CAP on its advocacy efforts.”

As a result of that letter, the New Hampshire Society of Pathologists is establishing the standing position of representative to the New Hampshire Medical Society to ensure NHSP is aware of all state legislation impacting pathologists.


CAP Model ACO Legislation Introduced in New Jersey

Legislation to promote a pathologists’ role in Accountable Care Organizations (ACOs) in New Jersey was introduced last week in the state Assembly (A4302) by primary sponsor Assemblywoman Angelica M. Jimenez. Introduction of A 4302 was a collaborative effort between CAP and the New Jersey Society of Pathologists (NJSP), and is based on CAP’s model legislative language on ACOs. Similar legislation was introduced earlier this year in California and Illinois, and enacted last year in Massachusetts as part of that state’s healthcare reform initiative.

The legislation requires each ACO in New Jersey to work with a clinical laboratory in establishing a Clinical Laboratory Testing Advisory Board. The purpose of these boards is to advise the ACOs on “adoption of guidelines or protocols for clinical laboratory testing used for diagnostic purposes or disease management” and for “pathologist consultation on episodes of care.” The board would be required to include at least one physician, affiliated with the ACO and is a medical director of a laboratory regulated under CLIA.

The CAP Policy Roundtable’s Whitepaper on ACOs includes the advisory board recommendation detailed in the legislation in promoting quality and in furtherance of the ACO mission in controlling cost and optimizing delivery of medical care through appropriate testing.


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