Advocacy Update

Read the Latest Issue of Advocacy Update

• CAP Advocates to Address Testing Supply Shortages
• CAP, AMA Demands Congress Protect International Medical Graduates During COVID-19
• Reject Medicare’s Proposed Inpatient Hospital Pay Methodology, Increase CAR T-Cell Payment: CAP
• CAP Urges BCBS of NC to Align its Billing Policy with Medicare’s Rules
• FDA, CMS Release Information on COVID-19 Pool Testing
• HHS Releases Additional Information on Status of Provider Relief Fund Payments
• Webinar August 5: 2020 Medicare Payment for Pathologists
• Need a Break? Take the Advocacy News Quiz

To equip pathologists and the laboratories they lead with testing supplies needed to diagnose patients, the CAP and its leaders are lobbying the federal government to further assist laboratories with solving chronic shortages and supply chain issues as more than half a million patients now receive COVID-19 tests every day. CAP President Patrick Godbey, MD, FCAP spoke directly with officials from the Centers for Disease Control and Prevention (CDC) on July 8 about persistent shortage issues. And, in a letter to Vice President Mike Pence, the CAP partnered with a group of associations representing the laboratory community to further address obstacles to performing diagnostic tests for COVID-19.

Recent survey data collected by the CAP has shown laboratories have increased their testing capacity but they could do more if testing supply shortages were fixed and they had all the necessary supplies. For instance, 64% of laboratory directors responding to the survey reported difficulty in acquiring reagents for platforms/test kits to conduct COVID-19 testing.

Dr. Godbey spoke with the CDC by phone to ask for additional guidance on how states can obtain much-needed testing supplies and personal protective equipment (PPE) for laboratories. Dr. Godbey requested assistance in obtaining contact information for individuals in each state who are overseeing the supply chain for testing and PPE. He also asked for greater visibility into the process of supply allocation, demonstrating that the supplies are being distributed at the state level and are allocated in a way that reflects the greatest need.

CAP, Laboratory Community Ask VP for Help

In a July 8 letter to Vice President Pence, the CAP and seven other organizations representing laboratory professionals from regional, community, academic, hospital and public health laboratories asked the White House Coronavirus Task Force to address the several ongoing obstacles they face in performing diagnostic and serology tests for COVID-19.

“Our members are on the front lines responding to the public health crisis. Since our members were first able to start testing for COVID-19 they have experienced significant difficulty acquiring the supplies—test kits, nasopharyngeal and mid-turbinate swabs, transport media, and personal protective equipment—needed to perform COVID-19 testing,” the groups said. “Without proper testing supplies and PPE, our members continue to struggle to meet the demand for COVID-19 testing and help track its spread across our communities.”

In the letter, the groups also asked for the names and contact information for individuals charged with overseeing the supply chain in each state and for a transparent process for supply distribution.

In addition to the CAP, letter was signed by the American Association of Bioanalysts, the American Association for Clinical Chemistry, American Medical Technologists, the American Society for Microbiology, the Association of Public Health Laboratories, the Association for Molecular Pathology, and the National Independent Laboratory Association.

In response, the groups received a spreadsheet with contacts.

Access the contacts using your CAP members log-in

The CAP called on congressional leaders to act, and not limit access to the physician workforce through immigration restriction during a national health crisis. In a July 10 letter to Congressional leaders, the CAP urged House Speaker Nancy Pelosi (D-CA) and Senate Majority Leader Mitch McConnell (R-KY) to reverse the Administration’s current proclamation curbing immigration visas through the end of 2020 for international medical graduates.

In the letter, the CAP argued how important international medical graduates (IMGs) are to our nation’s health care system, as they currently represent 25% of the physician workforce. Currently, the US faces a physician shortage that will be further exacerbated by the retirement of many physicians.

“Accordingly, the entry of every IMG is in the US's national interest, especially during the current crisis, when physicians are needed in every specialty now more than ever,” the CAP stated in the letter. The CAP also supports improving our current IMG programs to increase patient access to care.

The June 22 amendment to the proclamation incorrectly removed the exemptions from the immigration freeze for physicians, nurses, or other health care professionals, creating an unnecessary burden on our health care system during the COVID-19 pandemic. The CAP urged Congress to address this error through legislative action.

“Our hope is that the Administration will reverse its position as was requested by the American Medical Association. Moreover, we encourage Congress to consider two pieces of legislation to address the COVID-19 response and overall physician shortages by passing the Health Workforce Resilience Act and Conrad State 30 and Physician Access Reauthorization Act,” the CAP stated in the letter.

The AMA also echoed the CAP concerns in a recent request to Congressional leaders with its letter, which included over 60 medical professional societies. The AMA urged Congress to use legislation to correct the ill-advised regulation that could jeopardize the health care system when skilled health care workers are in dire need.

The CAP urged the Centers for Medicare & Medicaid Services (CMS) to abandon its proposal to require hospitals to report the median payer-specific negotiated rates for inpatient services, by Medicare Severity-Diagnosis Related Group (MS-DRG), for Medicare Advantage organizations and third-party payers. The negotiated rates would then become public per the Hospital Price Transparency Final Rule, and recent executive orders on price transparency can be used to calculate inpatient payments. The CAP is concerned that the proposed change in methodology would not account for the cost of the professional component of clinical pathology services when implemented under the 2021 Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Medicare regulation. Additionally, the CAP and others from the cancer care community asked the CMS to expand critical Chimeric Antigen Receptor (CAR) T-cell therapy payment for patients, despite establishing coverage and payment in 2019.

In the July 10 letter, the CAP explained that laboratory medical directors provide valuable and necessary medical services for all patients and are professionally responsible and legally accountable for laboratory results. “For the CMS to change the MS-DRG payment methodology in a way that would implicitly fail to recognize the appropriate reimbursement for these services would prove detrimental to patients, as such services may not be paid other than by billing individual patients for them, as is presently the case for other payers whose hospital payments are proposed to be used as the basis for Medicare hospital payments.”

The CAP asked the CMS not to move forward this proposed market-based MS-DRG relative weight data collection and potential change in methodology for calculation. “It will not further the CMS' goal of paying market rates that reflect the cost of delivering care, and in particular, could do more harm in potentially excluding the professional component of clinical pathology,” the CAP stated in the letter.

Additionally, the CAP, along with the American Society for Clinical Oncology (ASCO), and the American Society of Hematology (ASH), urged the CMS to reconsider its payment methodology and increase the reimbursement for CAR-T cell therapies. Because of the CAP’s advocacy, the CMS proposed to increase reimbursements for CAR T-cell therapies in 2020. However, according to an ASCO and the ASH analyses, “the reimbursement rate is still insufficient to cover the cost of CAR-T therapy and related services, leaving providers with a financial loss.”

“The proposed reimbursement rates for 2021 will result in a financial loss to providers of approximately $180,000 per patient case. This level of reimbursement is unacceptable and will likely result in fewer services provided and more limited access to these life-saving cancer-targeted treatments,” as stated in the letter.

Pathologists have a critical role as integral members of the cancer patient management team during CAR T-cell therapy, notably the harvesting of blood-derived T lymphocytes to develop genetically modified autologous CAR-T cells. The CAP urged the CMS to take these issues into account as the agency updates the new proposed reimbursement rates for CAR T-cell therapy.

The CAP will engage with the CMS and will provide updates periodically.

The CAP asked BlueCross BlueShield (BCBS) of North Carolina to modify its proposed professional pathology billing guidelines, which is intended in part to inhibit the practice of “pass-through” or client billing. In a July 10 letter to the insurer, the CAP stated its support for the insurer’s efforts to address pass-through billing, but the CAP also expressed concerns with BCBS of North Carolina’s proposed billing guidelines that conflict with Medicare.

Medicare guidelines state the place of service is determined by the actual place where the patient-provider “face-to-face” interaction takes place. In the letter, the CAP explains that when an independent laboratory accepts specimens from physician offices, Medicare directs these laboratories to file such claims with the place-of-service code for a physician office. The proposed BCBS of North Carolina guideline would require independent laboratories to use a different place-of-service code. The CAP said this change would create a number of billing issues for independent laboratories, including fraud concerns, issues with state health plan contracts and secondary insurance coverage, and resulting financial difficulty.

In a January 29 letter, the CAP urged the insurer to continue with efforts to support direct billing practices. Direct billing practices align with the American Medical Association (AMA) ethics principles and are in the best interests of good patient care and cost control. On the other hand, pass-through billing incentivizes providers to choose laboratories based only on the lowest price for the service and encourages overutilization. Direct billing can ensure that perverse financial considerations do not influence physicians’ ordering of pathology services for their patients.

Read more about our advocacy with the private sector

Throughout June and July, the Food and Drug Administration (FDA) and the CMS has posted information about COVID-19 pool diagnostic testing. The FDA created a Molecular Diagnostic Template for Laboratories that contains instructions for adding sample pooling to an authorized EUA test, and other considerations.

The CAP encourages laboratories to evaluate the manufacturer’s instructions for use carefully and to use the FDA template if considering a testing approach using specimen pooling.

During the COVID-19 Public Health Emergency, laboratories performing COVID-19 pool testing do not require CLIA certification. Pool testing is not considered by the CMS to be COVID-19 diagnostic testing. Participants should not rely on information received from this type of testing for decision-making purposes.

If the laboratory chooses to pool specimens for testing, the laboratory must validate this as a modification to the manufacturer’s instructions, as stated in MIC.64790, unless the manufacturer’s instructions for the emergency use authorization allow for the pooling of specimens for testing. In addition, laboratories subject to US regulations must submit an emergency use authorization (EUA) request for the FDA's modification.

Here are the resources from the federal agencies:

• View the FDA guidance on COVID-19 Pool Testing
• View the CMS guidance on COVID-19 Pool Testing

The Department of Health and Human Services (HHS) released information for providers who applied for Provider Relief Fund. To determine the status of their Provider Relief Fund payment or application, providers should contact the Provider Support Line at (866) 569-3522 (for TTY, dial 711).

When calling, providers should have the last four digits of the recipient’s Tax Identification Number (TIN), the name of the applicant as it appears on the most recent tax filing, the mailing address for applicant as it appears on the most recent tax filing, and the application number (begins with either “DS” or “CR”) if they have applied to the Provider Relief Fun Payment Portal.

The CAP has developed a FAQ guide for members with questions related to the Provider Relief Fund payment, available online here.

For additional practice resources and information, please visit the CAP COVID-19 webpage.

The CMS will soon issue its proposed updates to the 2021 Medicare Physician Fee Schedule and the Quality Payment Program regulations, including the Merit-based Incentive Payment System (MIPS). The CAP will host an exclusive webinar to August 5 at 1 PM ET/ Noon CT where CAP experts will review regulatory changes that will impact payment for services and pathologists’ participation in MIPS.

Webinar presenters will be the Chair of the Council on Government and Professional Affairs Jonathan Myles, MD, FCAP; Chair of the Economic Affairs Committee W. Stephen Black-Schaffer MD, FCAP; and Vice Chair, Economic Affairs Committee Diana Cardona, MD, FCAP.

During the 60-minute webinar, attendees will learn about updates to the 2021 Medicare Physician Fee Schedule and the Quality Payment Program regulations and its impact on pathologists. The CAP panel will also answer questions from attendees.

Register today for the webinar

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