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The CAP continues to seek further clarification on the Common Rule after the Department of Health and Human Services (HHS) issued a six-month delay of new rules that require researchers to obtain consent before using non-identified biospecimens. On January 17, two days before a final rule that revised the Common Rule was scheduled to take effect, the HHS announced a six-month delay in the final rule’s effective and compliance date. The HHS has now issued an interim final rule whose effect is to postpone the compliance and effective dates of the revised Common Rule from January 19, 2018 to July 19, 2018. Through an interim final rule the HHS is delaying the effective date and the general compliance until July 19, 2018.

The Common Rule further requires clear and concise information for volunteers while freeing scientists to get broad consent to use their biospecimens and electronic records.

Industry stakeholders asked for a delay in the general compliance date of the 2018 Requirements of the Common rule, including certain carve-outs from the definition of “research,” exemptions, elimination of the continuing review requirement for certain categories of research, and the elimination of the requirement that institutional review boards (IRBs) review grant applications.

Moreover, the interim final rule is intended to provide additional time for necessary preparations to implement 2018 requirements.

With this delay, the CAP is asking the HHS for further clarification on areas where significant guidance is needed, for instance:

  • Applying the categories of the new exemptions themselves
  • Conducting limited IRB review
  • Developing and using broad consent
  • Utilizing the exemption for certain HIPAA covered activities
  • Understanding which federally supported or conducted nonresearch information collections qualify for exemption

The CAP has advocated in the past to remove proposed requirements for researchers to obtain consent before using non-identified biospecimens, but maintained current practice with respect to oversight of these specimens in the Common Rule.

Pathologists interact with specimens in many ways, but are primarily involved—in the laboratory setting—with the evaluation and diagnosis of blood, body fluids or tissue specimens. These evaluations usually have prognostic implications. Once these evaluations are completed, there are, in many instances, residual specimens remaining. An expansion of the proposed human research requirements could have diminished the effectiveness of researchers by requiring overlapping and incongruent administrative activities that are counter to research activities conducted within academic institutions today.

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William Kristol

The CAP is proud to announce that leading political commentator William Kristol will be one of the keynote speakers at the 2018 Policy Meeting. Mr. Kristol will touch upon how new regulations have impacted the practice of pathology during the Policy Meeting, which is scheduled April 30 – May 2, at the Washington Marriott in Washington, DC.

Mr. Kristol is the editor-at-large of The Weekly Standard, is a regular on ABC’s This Week and on ABC’s special events and election coverage, and appears frequently on other leading political commentary shows. Before starting The Weekly Standard in 1995, Mr. Kristol led the Project for the Republican Future, where he helped shape the strategy that produced the 1994 Republican congressional victory. Prior to that, Kristol served as chief of staff to Vice President Dan Quayle during the George H.W. Bush Administration and to Education Secretary William Bennett during the Reagan Administration. Before coming to Washington in 1985, Mr. Kristol was on the faculty of Harvard University’s Kennedy School of Government and the Department of Political Science at the University of Pennsylvania.

Besides Mr. Kristol, attendees at the Policy Meeting will hear from other notable health policy leaders and receive the latest information and analysis on the implementation of new Medicare and laboratory regulations. The Policy Meeting will also include discussions with congressional offices during the Annual Hill Day on May 2, which is the specialty's opportunity to focus on the federal issues most important to pathologists now and in the future.

The Policy Meeting is a benefit of CAP membership and there is no fee to register.

Register for the 2018 Policy Meeting.

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Alex Azar, a former pharmaceutical executive and George W. Bush administration official, was sworn in as the new Secretary of the Department of Health and Human Services (HHS) on January 29. Mr. Azar takes over this top position at HHS vacated by former Rep. Tom Price, MD, who resigned in September of 2017.

Mr. Azar is a HHS veteran, having previously served as deputy secretary and general counsel between 2001 and 2007. Until January 2017, he was the president of Lilly USA, an affiliate of global biopharmaceutical manufacturer Eli Lilly & Co. His nomination for HHS secretary was confirmed by the Senate by a 55-43 vote earlier in January.

STATLINE will continue to report updates from the Trump Administration.

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The Arizona Society of Pathologists (ASP), with the support of the CAP, is calling for an amendment to an Arizona genetic testing law that was enacted in 2016. The law is the subject of a pending bill HB 2450. The ASP sent a letter to the Arizona state House Health Committee and hopes an amendment to make changes to the bill will be accepted later this week. The current Arizona genetic testing law prohibits the ordering of a genetic test on a patient by a pathologist without “the specific written informed consent of the subject.”

Because the definition of genetic test is “overly broad,” and includes somatic mutations, “a pathologist, who is a non-patient facing physician, is legally hindered from ordering or requiring the performance of genetic testing to diagnosis a patient for optimal patient care,” said the ASP. Moreover, the ASP argues that the current definition, as it stands, infringes upon the current practice of pathology and would, ultimately, deter high-quality patient care.

Presently, most cancer diagnosis involves some form of genetic testing to help with treatment planning. In many of these cases, the pathologist orders the test and treatment decisions are made based upon an initial pathologist’s diagnosis of the specimen. Other states’ standard of care allows pathologists to order these tests as medically necessary without legal impediments. According to both the CAP and ASP, Arizona’s current broad definition unintentionally deters access to the most current diagnostic and therapeutic practices. Therefore, the proposed amendment from the ASP, with support from the CAP, will help refine the existing definition and ensure optimal patient care by removing any impediments to pathologist ordering and performing these tests.

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If your practice still needs to report their 2017 Merit-based Incentive Payment System (MIPS) data, the Centers for Medicare & Medicaid Services (CMS) Quality Payment Program has a 2017 MIPS Reporting Portal to help you avoid the penalty.

The new CMS portal is available on the Quality Payment Program website. Eligible clinicians can submit their 2017 performance data for the Quality Payment Program until March 31, 2018. However, if you have already submitted your 2017 MIPS data via the CAP 2017 MIPS Reporting Solution, then you are covered.

If your billing company has submitted claims data for your practice’s quality measures to the CMS, but not attested to your practice’s improvement activities, you still can report your improvement activities through the CMS portal. If you choose this option, each pathologist needs to attest in the CMS portal to their Improvement Activities as an individual pathologist, and not as a group.

CAP members should also be aware that the CMS reporting portal is not optimized for non-patient-facing clinicians yet, so the portal may not accurately reflect your score. The CMS assure the CAP that this will be fixed in the near future.

Eligible clinicians who need assistance with the data submission system may contact the Quality Payment Program by email at or toll free at 1-866-288-8292.

For a fact sheet on the Quality Payment Program data submission system, including more information for clinicians participating in APMs, please see:

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Freedman_S. Robert: Laboratory Professional

Each month, STATLINE features one of the many CAP members who are champions for pathology in Washington and at the state level through our grassroots and PAC programs. This month STATLINE caught up with S. Robert Freedman, MD, FCAP, who is in private practice in Palo Alto, California, where he spoke about his involvement in PathNET. If you would like to get involved, you can join PathNET, contribute to PathPAC, or join your state pathology society.

How did you first get involved in advocacy?

I became interested in advocacy during my term as President of the California Society of Pathologists. Working in a highly regulated state, I realized the significant impact of regulations on clinical laboratories and pathology practice, and the importance of effective interaction with legislators and relevant agencies. Subsequently, I became more aware of the importance of similar involvement on a federal level through activities with the CAP.

What advice would you give to someone who wants to be involved in advocacy?

A good way to get involved in advocacy is to attend meetings such as the Policy Meeting in Washington, DC, the House of Delegates, and local medical society town hall meetings. Also, become a reader of STATLINE, and follow state issues through your state societies. Try to meet and support your representatives at the local, state, and federal level when you have a chance. This can be extremely valuable to gain their trust for future meetings on specific issues relating to pathology and laboratory medicine.

What was your greatest fear or concern about becoming an advocate for the profession before you got involved? Was your fear/concern justified?

I think the reluctance to becoming involved in grassroots advocacy is the notion that it takes a great deal of time and effort. Sometimes, a little advocacy can have a major impact, and the effort can be personally rewarding. Advocacy activities have kept me informed of important issues, so I could best prepare my practice to deal with regulatory changes.

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