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The House of Representatives passed sweeping legislation to increase funding for cancer and precision medicine research, and also streamline the approval process for drugs and devices by the Food and Drug Administration (FDA).

Following the 2016 elections, the House and Senate announced a bipartisan agreement to pass the 21st Century Cures Act, a legislative effort that has been worked on and debated by lawmakers for the better part of two years. At this article's deadline, the Senate was poised to pass the bill. President Obama is also expected to sign the bill following the Senate’s vote.

The Cures bill includes provisions from the both the House version that passed in July 2015, and from the Senate Innovations bills that passed the Health Education Labor and Pension Committee (HELP) in April. The bill includes a $6.3 billion funding increase for the FDA, National Institutes of Health, and the White House precision medicine and "Cancer Moonshot" initiatives. The amount the NIH would receive totals $4.8 billion, of which:

  • $1.4 billion is for President Obama's Precision Medicine initiative
  • $1.8 billion is for Vice President Biden's "Cancer Moonshot" initiative
  • $1.5 billion is for the BRAIN Initiative, whose purpose is to accelerate diagnosis and treatment and improve our understanding of diseases like Alzheimer's.

Another component to the bill provides $1 billion in grants for states to address the opioid crisis. The bill also seeks to expedite interoperability among electronic health records (EHRs) by supporting a framework and common agreement for the secure exchange of health information.

Cures' LCD Reform is Inadequate

A local coverage determination (LCD) provision in the 21st Century Cures bill would require Medicare Administrative Contractors (MACs) to disclose information about a final LCD before it takes effect. However, the reforms do not create the transparency and accountability needed for a meaningful LCD process to benefit Medicare’s patients.

The CAP's legislation, the LCD Clarification Act (HR 5721/S 3392), does provide the reforms needed to ensure LCDs are made by qualified health experts through a transparent process and based on sound medical evidence.

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Editor's Note: STATLINE is featuring stories about the upcoming transition of power across the federal government over the next several months. These stories will highlight major news on President-elect Donald Trump's administration and both chambers of Congress, and the impact of these new developments on the pathology specialty.

To oversee Medicare and Medicaid, President-elect Donald Trump has nominated Congressman Tom Price, MD (R-GA) to be the next Department of Health and Human Services Secretary.

President-elect Trump announced Dr. Price's nomination on November 29. Dr. Price, an orthopedic surgeon, has represented Georgia’s sixth congressional district since 2005, and currently chairs the House Budget Committee. "Chairman Price, a renowned physician, has earned a reputation for being a tireless problem solver and the go-to expert on healthcare policy, making him the ideal choice to serve in this capacity," President-elect Trump said.

Through the years, Dr. Price has supported the CAP on a number of issues. Dr. Price was a lead sponsor on House legislation to repeal outdated cytology proficiency testing requirements, and he orchestrated passage of the bill twice. In addition, Dr. Price supported exempting pathologists and other hospital-based physicians from penalties under Medicare's meaningful use of electronic health record program. He also supported the CAP's efforts to extend the technical component (TC) grandfather.

Dr. Price is a member of the American Medical Association (AMA) House of Delegates representing the Medical Association of Georgia. As head of HHS, he could seek changes sought by physicians to Medicare payment reforms under the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA).

A vocal critic of "Obamacare," Dr. Price has voted dozens of times to repeal the Affordable Care Act. The repeal effort will continue under the Trump administration. "He is exceptionally qualified to shepherd our commitment to repeal and replace Obamacare and bring affordable and accessible healthcare to every American. I am proud to nominate him as secretary of health and human services," President-elect Trump said.

Trump also has nominated Seema Verma to be the next CMS administrator. Ms. Verma is the President, CEO and founder of SVC, Inc., a national health policy consulting company. Ms. Verma has worked extensively on a variety of policy and strategic projects involving Medicaid, insurance, and public health, working with state governors' offices, state Medicaid agencies, state health departments, state departments of insurance, as well as the federal government, private companies and foundations. She is best known for her work on Indiana's Medicaid redesign, the Healthy Indiana Plan advanced by then-Gov. Mitch Daniels and Healthy Indiana Plan 2.0 under the direction of Vice President-elect Mike Pence.

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In the state of Washington, a coalition consisting of the CAP and hospital-based physician societies advocated for state regulators to ensure health plans have adequate networks of providers and reasonable physician reimbursement rates for care that's provided out-of-network.

With the state exploring new regulation, the hospital-based physician coalition responded on November 30 to four questions posed by the Washington State Office of the Insurance Commissioner about balance billing for physician services provided out-of-network. The CAP has strongly advocated for regulators to ensure network adequacy of hospital based physicians, including pathologists, so that patients have reasonable access to hospital-based services. In August, the CAP supported the Washington State Society of Pathologists (WSSP) and its request to the Insurance Commissioner to institute regulatory criteria for evaluating the sufficiency of hospital-based physician providers in health plan networks. However, the commissioner declined the request.

In its November 30 response to a question regarding "surprise billing" laws enacted by other states, the coalition said it supports the payment provisions in New York that regulates all out-of-network physician payment at in-network facilities to be at the 80th percentile of the FAIR Health database, which was developed pursuant to a legal settlement between payers and state attorney generals. The FAIR Health database contains claims contributed by payers nationwide. A similar provision utilizing FAIR Health also exists in Connecticut for emergency services.

The coalition further urged the Insurance Commissioner to include network adequacy language found in policy adopted by the American Medical Association. The policy states that health plans should be required to document to regulators that they have met requisite standards of network adequacy at in-network facilities. In-network adequacy also should be both timely and geographically accessible.

The coalition also stated its support for the use of alternative dispute resolution or mediation mechanisms to resolve payment disputes between providers and payers.

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New York State Gov. Andrew Cuomo signed legislation to establish licensure requirements for pathologist assistants on November 29. The CAP had provided guidance on the bill and urged the governor to sign the bill into law.

In June, the New York State Legislature passed legislation to create a new licensure category for pathologists' assistants under state education law.

The effort to pass the licensure for pathologist assistants was led by the Greater New York Hospital Association with support and technical assistance from the CAP and New York State Society of Pathologists (NYSSPATH). The New York State Department of Health had urged establishment of the new licensure category because certain laboratory limited licensure categories, under which pathologist assistants currently practice was not considered adequate. The bill ensures that pathologists' assistants have an appropriate licensure category to continue their practice in the state.

Under the new law, pathologists' assistants are supervised by licensed physicians who practice anatomic pathology. Pathologists' assistants' scope of practice also includes preparing gross tissue sections for pathology analysis, performing postmortem examinations, and other functions and responsibilities. The bill expressly denies pathologist assistants any authority to diagnose or provide a medical opinion.

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The agency overseeing the Medicare program extended by one week its deadline for physicians to dispute a Medicare Physician Quality Reporting System (PQRS) or Value-Based Modifier (VBM) penalty by requesting an informal review. The new deadline is December 7.

For more information on the penalties, the CMS has published 2017 PQRS negative payment adjustment and value modifier informal review guides.

In September and October, individual physicians received letters regarding PQRS and VBM penalties for 2017 from the Medicare program.

Pathologists can confirm if they will be penalized in 2017 by accessing PQRS feedback reports for the 2015 program year. The reports include a payment adjustment assessment for next year. Physicians who did not satisfy quality reporting requirements in 2015 will face Medicare payment reductions of 2-6% in 2017 depending on the size of the practice. To access reports from the CMS, physicians will need an Enterprise Identity Management (EIDM) account with the appropriate role established. The CMS published a guide for using the EIDM system. The feedback reports can be viewed through the PQRS Analysis and Payment webpage.

Follow these steps to submit an informal review request:

  1. Go to the Quality Reporting Communication Support Page (CSP)
  2. In the upper left-hand corner of the page, under "Related Links," select "Communication Support Page"
  3. Select "Informal Review Request"
  4. Select "PQRS Informal Review"
  5. A new page will open
  6. Enter Billing/Primary Taxpayer Identification Number (TIN), Individual Rendering National Provider Identifier (NPI), OR Practice Site ID number and select "submit"

The CAP is aware that some pathologists have had their appeals denied, including those who successfully reported and some pathologists working in independent laboratories. If you have already gone through the appeal process and your appeal was denied, please send your denial letter and an explanation directly to Bobby Harris at the CMS ( who has agreed to look into these denials.

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STATLINE regularly features one of the many CAP members who have been champions for pathology in Washington and at the state level through our grassroots and PAC programs. If you would like to get involved, you can join PathNET, contribute to PathPAC, or join your state pathology society.

Name: Edward P. Fody, MD, FCAP
Position: Director of Pathology, Holland Hospital, Holland, MI

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

I have been involved with advocacy for pathology and medicine for decades. It's really easy (and fun) to get involved. Our elected leaders welcome your input. Don't be afraid—they don't bite. I recommend attending the Policy Meeting in Washington, DC, to get a good introduction.

Do you have a favorite memory or experience that stands out in your advocacy work?

Showing Pap smears to my congressman [House Energy and Commerce Committee Chairman Fred Upton (R-MI)] and having him state that he would cosponsor our legislation. Many lab tours. Showing up for lunch with my congressman in Washington and being treated like royalty because I was a constituent and big supporter. Fundraisers at my home. Having my state representative call me from the floor of the House and ask me how he should vote on a particular bill.

What do you find most rewarding about being an advocate for pathology?

The most rewarding aspect is seeing up close the influence you can have on the legislative process.

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