Read the Latest Issue of Advocacy Update
May 14, 2019
In This Issue:
- White House Hosts Event on Surprise Bills; CAP Advocates to Protect Patients
- HHS Tells Congress: FDA has Jurisdiction on Laboratory-Developed Tests
- Federal Lawmakers, CAP Concerned About Sufficient Patient Access to CAR T-Cell Treatments
- CMS Hosts MIPS Group Participation Webinar
- Test Your Advocacy Knowledge - Take Our News Quiz
- 2019 Practice Characteristics Survey Is Open
White House Hosts Event on Surprise Bills; CAP Advocates to Protect Patients
During a White House event with patients and lawmakers on May 9, President Donald J. Trump called on Congress to end surprise medical billing by enacting legislation that follows a set of principles protecting patients from out-of-network balance bills when they seek treatment from in-network hospitals.
“This initiative is one of many steps we are taking to deliver better care at lower costs, and to save American patients thousands of dollars, and give greater peace of mind,” President Trump said. “These bills have ruined people’s lives. I ask Democrats and Republicans to come together and act on this quickly.”
The White House principles focus on ensuring:
- Patients receiving emergency care are not forced to shoulder costs not covered by their insurer.
- Patients receiving scheduled care have information about whether providers are in or out of their network and what are the costs of care.
- Patients do not receive surprise bills from out-of-network providers they did not choose.
- Federal health care expenditures do not increase.
The CAP also continues to work with Congress to protect patients from surprise out-of-network medical bills. Pathologists have asked their elected officials to hold patients financially harmless during surprise medical bill scenarios, set network adequacy standards, and establish a fair reimbursement system when care is provided by an out-of-network provider at an in-network facility or hospital.
Pathologists can continue to urge their representatives and senators to pass reforms supported by the CAP by using the advocacy action center.
HHS Tells Congress: FDA has Jurisdiction on Laboratory-Developed Tests
Officials with the Department of Health and Human Services (HHS) stated support for a regulatory approach and key provisions specified in draft House legislation on the oversight of laboratory-developed tests (LDTs).
In April, the HHS completed its review of the draft LDT legislation, the Verifying Accurate Leading-edge IVCT Development (VALID) Act, and provided the bill’s sponsors with a technical assistance document. While the technical assistance document cannot be interpreted as approval or endorsement of the VALID Act, the HHS signaled its support for the legislation’s approach in defining a role for the FDA to provide oversight of LDTs.
“HHS maintains that FDA’s longstanding history and experience in premarket review of diagnostics and deep knowledge of clinical research methodology pertinent to establishing analytical and clinical validity make FDA the appropriate agency for jurisdiction over IVCTs,” the HHS said. The HHS added that the VALID proposal did not duplicate current CLIA requirements for laboratories.
Since 2009, the CAP’s principles for LDT oversight have been to ensure quality laboratory testing for patients, allow for innovation in laboratory testing, and prevent an undue administrative or regulatory burden on laboratories. The CAP’s position on this issue has also included a role for the FDA.
On the VALID Act, the CAP remains engaged with the bill’s sponsors to discuss provisions in the bill and address concerns from pathologists. The VALID Act is considered a step forward from previous iterations of LDT oversight proposals, such as the Diagnostic Accuracy and Innovation Act (DAIA). The CAP strongly opposed DAIA for being overly complex, burdensome to laboratories, and its inclusion of extraneous provisions that had nothing to do with LDT oversight. The draft VALID Act omitted these unnecessary provisions.
The CAP will continue to monitor the legislation and report on its progress.
Federal Lawmakers, CAP Concerned About Sufficient Patient Access to CAR T-Cell Treatments
The CAP and federal lawmakers are concerned if the Centers for Medicare & Medicaid Services (CMS) has incorporated enough flexibility for patients before it finalizes a Medicare national coverage determination (NCD) decision for life-saving chimeric antigen receptor T-cell (CAR T-cell) cancer treatment on May 17.
On May 8, both Republican and Democratic legislators urged the CMS to make sure its NCD for the CAR T-cell cancer treatment incorporated the much-needed flexible patient access. The CAP also urged the CMS to include a flexible process that allows for evolving cancer therapy technologies for cancer patients and to ensure recognition of the life-saving role that pathologists play in the CAR T-cell treatment process in its March 15 comments to the agency.
In their May 8 letter, Sens. Johnny Isakson (R-GA), Tom Carper (D-DE), Tim Scott (R-SC), Marsha Blackburn (R-TN) Doug Jones (R-AL), Kyrsten Sinema (D-AZ), and Jon Tester (D-MT) raised concerns to the CMS that the current coverage proposal is too restrictive.
In a proposal by the CMS for Coverage with Evidence Development (CED), which would cover FDA-approved CAR T-cell therapies, the CAP said the CMS should ensure that the final coverage policy is flexible for new technologies and that the agency creates clear guidance for reimbursements for all CAR T-cell therapy care-team physicians, including pathologists. The proposed coverage policy would require Medicare to cover the CAR T-cell therapy nationwide when it is offered in a CMS-approved registry or clinical study, in which patients are monitored for at least two years post-treatment. The CMS issued this proposed regulation on February 15.
The CAP has engaged with the CMS on this issue to ensure flexibility for patient treatment and will continue to discuss the proposed patient registry as it affects pathologists.
CMS Hosts MIPS Group Participation Webinar
The CMS will host a webinar to review how your practice can participate as a group in the 2019 Merit-based Incentive Payment System (MIPS) program. The webinar is Thursday, May 16 at 1 PM ET.
During the webinar, CMS experts will discuss and answer questions regarding:
- Group participation basics
- Eligibility and registration
- Data collection and submission
- Reporting requirements
- Payment adjustments
- Resources and technical assistance
If your practice is considering group participation for 2019 MIPS, the CAP highly encourages to attend this webinar. To register for the webinar, click and follow the prompts: https://engage.vevent.com/rt/c...
As always, the CAP has MIPS resources for pathologists and experts available to answer your specific questions at email@example.com. For more information about the Quality Payment Program and MIPS, please check out http://qpp.cms.gov/.
Test Your Advocacy Knowledge - Take Our News Quiz
2019 Practice Characteristics Survey Is Open
This is the last week for the CAP 2019 Practice Characteristics Survey, and you can help by providing data from your pathology practice regarding your economic, demographic, and market trend information in the evolving business environment. The survey is open until May 17.
Respondents are eligible for a drawing for either one of three Amazon gift cards or Apple Watch® Series 4 wrist-wearable device. Last week Charlene Hellman, MD, FCAP, of Knoxville, TN, won a $150 Amazon gift card for completing the survey. You can still take the survey and be eligible for a prize next week, including an Apple Watch™. Pathologists who respond to the survey will have early access to survey results via an exclusive webinar.
If you have not received your invitation, please contact us at firstname.lastname@example.org. This survey is available to board-certified pathologists who are currently practicing in the US. The survey excludes full-time retirees, pathologists practicing in different countries, and junior members of the CAP.
The survey should not take more than 15 minutes to complete. The CAP will share the survey findings with its members in a full report and provide early access to the data to those who finish the survey. If you have not received your invitation, you can take the survey.