College of American Pathologists
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January 31, 2013  •  Volume 29, Number 3
Next Issue: February 14, 2013
© 2013 College of American Pathologists

In This Issue:

House Takes Aim at IPAB...Part II

House lawmakers wasted no time in the new session of Congress introducing a bill that would preempt formation of the Medicare Independent Payment Advisory Board (IPAB), the independent body mandated in the Affordable Care Act (ACA) to reduce the growth in Medicare spending.

The bi-partisan bill, Protecting Seniors’ Access to Medicare Act. H.R. 351, introduced last week by Representatives Phil Roe (R-Tenn.) and Allyson Schwartz (D-Pa.) to repeal IPAB, has 100 co-sponsors and support from over 350 provider groups including AMA and CAP.

The law calls for the creation of a 15-member board appointed by the president and confirmed by the Senate to study the Medicare program to determine if Medicare costs exceed certain spending targets, and if they do, to make specific recommendations to Congress on Medicare cuts to achieve the target. Congress could pass the IPAB’s recommendations or an alternative with equal savings. If Congress takes no action, the Secretary of Health and Human Services is bound to implement the IPAB plan. The Board would be prohibited from making proposals that ration care, increase Part B premiums, or change Medicare benefit, eligibility, or cost-sharing standards.

Unlike most other boards or commissions aimed at reducing health care costs or improving quality, the IPAB’s proposals are not simply advisory. They become law unless Congress adopts a substitute measure.

As laid out in ACA, the Board is also required to make non-binding recommendations on actions to improve quality and restrain health care costs in the private sector.

Last year, the House passed similar legislation to repeal IPAB. However, the Senate did not advance the bill and President Obama threatened a veto of the legislation. The President has reiterated his support for IPAB and has proposed strengthening its role with additional tools, such as an automatic sequester mechanism.

To date, no one has been named to the IPAB board, and opposition remains strong among many in Congress and in the medical community. Critics oppose formation of the IPAB because it circumvents congressional authority to debate, manage and legislate changes to the Medicare program.

“As a physician with more than 30 years experience, I find the ability of this board to intervene in the patient-doctor relationship particularly troubling,” said Rep. Roe said when introducing the bill.

Proponents have called it ‘MedPAC with teeth’. MedPAC is the Medicare Payment Advisory Committee, an appointed advisory group that advises Congress on ways to reduce or slow Medicare growth, but Congress is not bound to implement those recommendations.

CMS Issues Meaningful Use Tip Sheet for Specialists

CMS does not want the Meaningful Use (MU) program to exclude specialists according to a CMS tip sheet published this month clarifying ways specialists can earn incentives through the program.

In light of this new clarification from CMS, some pathologists, particularly those in large integrated, multi-specialty and academic medical centers, may be able to participate in the CMS Meaningful Use program in 2012.

Pathologists will continue to qualify for an automatic significant hardship exception to payment adjustments in 2015 based on their Medicare provider status in 2013. However, a recent CMS FAQ stated that automatic relief would be provided to those pathologists who are listed in Medicare’s enrollment system known as PECOS as code 22 (pathologists). CMS excluded pathologists listed in PECOS as code 69—clinical lab billing independently. CAP is advocating for CMS to reconsider this decision.

For those pathologists who want to try and qualify for incentives, the Meaningful Use for Specialists tip sheet explains at a high level how this might be possible.

For example, CMS is encouraging specialists using a shared EHR to count in the numerator those patients for whom other providers entered information, and specialists without a shared EHR may also use data supplied by referring physicians or other providers, or accessible through a Health Information Exchange (HIE) even if neither the HIE or the referring provider have certified EHR technology, as long as the specialists uses a certified EHR.

Visit CAP’s Policy Agenda Toolkit for up-to-date information on the Medicare Meaningful Use program, including updated FAQs by CAP’s policy experts.

Petitioners File Supreme Court Brief in Gene Patent Case

The effort to have the Supreme Court rule on the validity of gene patents moved a step forward this week as the ACLU on behalf of AMP, CAP and other petitioners filed its brief with the U.S. Supreme Court in the case Association for Molecular Pathology, et al. v. U.S. Patent and Trademark Office, et al. The case challenges Myriad Genetics’ patent claims on BRCA 1 and BRCA 2 genes.

The Petitioners brief asks the Supreme Court to reverse a Federal Circuit decision upholding the validity of gene patents on the following grounds:

  • “Isolated DNA” is not patentable subject matter, because isolated DNA does not have markedly different characteristics from any found in nature.
  • The challenged claims are not based on an “inventive concept” but instead claim products and laws of nature.
  • The challenged claims are alleged to preempt uses of products and laws of nature. And because isolation is a necessary step in any serious study, research, or clinical or commercial use of the native DNA, the patents preempt research and development.
  • cDNA is not patentable subject matter because cDNA is, at its simplest level, identical to DNA except the non-coding regions have been removed, and nature, not the inventors, determined which non-coding regions to remove.
  • Patent claims on isolated DNA violate the First Amendment because they amount to a grant of exclusive control over a body of knowledge.


The case was originally heard in the United States District Court for the Southern District of New York, which ruled that all the challenged claims were not patent eligible. Myriad appealed to the United States Court of Appeals for the Federal Circuit. The Appeals court overturned the previous decision, ruling that isolated DNA which does not exist alone in nature can be patented. The plaintiffs appealed to the Supreme Court, which granted cert and remanded the case back to the Federal Circuit Court of Appeals. The Federal Circuit Court of Appeals did not change its opinion, and on September 25, 2012, the American Civil Liberties Union and the Public Patent Foundation filed a petition for certiorari with the Supreme Court with respect to the second Federal Circuit Court of Appeals decision.

On November 30, 2012, the Supreme Court agreed to hear the plaintiffs’ appeal of the Federal Circuit Court of Appeals ruling. Oral arguments are expected to take place in mid-April, with a decision anticipated by June 2013.

HHS Increases Patient Protections in HIPAA Omnibus Final Rule

The HIPAA Omnibus Final Rule released last week strengthens privacy protections and casts a wider net on covered entities and standards governing privacy breach notification.

The rule implements statutory requirements mandated by the Health Information Technology for Economic and Clinical Health (HITECH) Act, enacted as part of the American Recovery and Reinvestment Act of 2009, and as required by the Genetic Information Nondiscrimination Act of 2008 (GINA). CAP Supports broader patient protections governing genetic information.

The new rule classifies genetic information as health information and prohibits most health plans, including group health plans, health insurance issuers (including HMOs) and issuers of Medicare supplemental policies, as well as those explicitly included in GINA, from using or disclosing genetic information for underwriting purposes. The rule also strengthens protections against employer use of the information.

In addition, family health histories and information about genetic services including genetic tests, genetic counseling, or genetic education that an individual or family member may receive are all considered genetic information, and are protected under HIPAA.

The rule extends the definition of business associate of a covered entity such that business associates now must have a business associate agreement with any subcontractor creating, receiving or transmitting PHI.

The “significant risk of harm” threshold for breach notification has also been lowered in the new rule. Any impermissible use or disclosure of protected health information (PHI) will be presumed to be a breach requiring notification, unless the covered entity or business associate demonstrates through a risk assessment that there is a “low probability that the protected health information has been compromised” or unless an exception applies. In addition, monetary penalties for noncompliance with the rule have increased and are also now tiered, with a maximum penalty of $1.5 million per violation.

The final rule is effective March 26, but covered entities and business associates have until September 23 to comply with its provisions.

New Jersey Legislature Amends Genetic Counselor Law

Lawmakers in the New Jersey Assembly unanimously approved a bill this week to remove genetic counselor’s statutory authority to interpret genetic tests and other diagnostic studies from their scope of practice. The bill also clarifies that physicians are categorically exempt from the genetic counselor licensure law.

The bill, A. 1757/S. 555, passed in the NJ Senate in June, and is now on its way to the Governor who has 45 days to sign or veto the legislation.

Before the Assembly vote, the amended bill was reported out of the Assembly’s Regulated Professions Committee. In addition, the full Assembly received a memorandum of support from the New Jersey Society of Pathologists, CAP, and the Oncology Society of New Jersey. The New Jersey Medical Society also supported the bill.

Passage of the bill is the result of a two-year collaboration between the New Jersey Society of Pathologists and the CAP to ensure New Jersey State law conforms to the scope of practice agreement between the CAP and the National Society of Genetic Counselors (NSGC).

ONC Surveys Labs on Health Information Exchange Requirements

The Office of the National Coordinator for Health IT (ONC) announced this week that it has begun a nationwide study on the current and potential use of health information exchanges (HIE) for sending lab results to ordering clinicians.

ONC’s stated focus is to determine the percentage of laboratory facilities that are able to send structured lab results electronically to ordering physicians, and the percentage of lab results that are currently being sent electronically in coded format to ordering physicians.

The survey findings will be used to establish a baseline level of laboratory information exchange in order to inform the HIE program’s activities and provide targeted assistance to states and territories in developing their laboratory information exchange strategies.

Notice of the study was published in the Federal Register in October 2012, and has support from both the CAP and the College of Healthcare Information Management Executives (CHIME).

In a letter to CAP members, CAP President Stanley Robboy, MD, FCAP encouraged laboratories to complete the survey if they are among the 14,000 randomly selected labs invited to participate.

“Your participation is important to the success of the survey and will provide a valuable benchmark to pathologists on our activities in these areas. In addition, data gathered by the ONC from this survey can assist the CAP in its policy efforts and guide the ONC on future policies for laboratory information exchange.”

ONC expects to receive completed surveys from more than 2700 hospital-based clinical labs and about 2,000 independent labs. Results of the survey will be posted on the ONC website this summer.

CAP Policy Meeting Speaker Reflects on the 2012 Election

Charlie Cook Soon after the election, political analyst Charlie Cook, of the Cook Political Report and the National Journal, ruminated on lessons learned from the election for both political parties. This excerpt was taken with permission from the Rhodes Cook Letter published December 2012.

If there is one word that might describe the electoral results in 2012, it is “reelected.” President Barack Obama was reelected, so in a sense was the Democratic Senate and the Republican House. At the state level, the GOP maintained its grip on the lion’s share of the nation’s governorships, while in state after state the parties already in control won even firmer legislative majorities.

Yet not all victories were equal. If this year’s elections were the Academy Awards, Democrats walked off with Oscars for Best Picture, Best Director, and the major acting prizes, while Republicans won for cinematography and costume design. In short, it was an election of both triumph and relief for the Democrats, and one of frustration and disappointment for the GOP.

Into Election Day, many Republican leaders believed the party was well positioned to score a Washington trifecta by winning the White House and both houses of Congress. The fact that they fell short has led the party into a period of introspection and soul searching.

Charlie Cook will be a featured speaker at the CAP 2013 Policy Meeting, an exclusive CAP-members only event at the Fairmont Hotel Washington DC, May 5–7, 2013. Hear more from Charlie Cook and others, register for the CAP 2013 Policy Meeting now. Registration is free for CAP members, and special hotel rates apply.

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