STATLINE

Read the Latest Issue of STATLINE

In This Issue:

• 2016 CAP Policy Meeting Keynote Speaker: David Gregory
• Senate HELP Committee to Consider Key Biomedical Bills
• In Letter to Congress, CAP Advocates for Closing Self-Referral Loophole
• MedPAC to Offer the CMS Guidance on Alternative Payment Models

The CAP is pleased to announce our keynote speaker, former NBC Meet the Press moderator, David Gregory. David's keynote presentation will take place on Tuesday, May 3, 2016 in Washington, DC.

Renowned journalist David Gregory provides a firsthand analysis and running narrative of the Obama Administration, Congress and politics in America. David Gregory, former moderator of NBC News' Meet the Press, will share his insights on the latest Washington headlines, the current events facing our country and the upcoming 2016 race for the White House. Hear first-hand accounts of asking tough questions of some of the most powerful, influential-and infamous-people in the world. Prior to his Meet the Press duties, Gregory served as chief White House Correspondent for NBC News. Washingtonian magazine named Gregory one of Washington's 50 best and most influential journalists, labeling him the "firebrand in the front row" for his tough yet fair questioning at press conferences.

CAP 2016 Policy Meeting: Engage. Connect. Take Action.

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A key Senate committee is scheduled to consider a number of key biomedical innovation bills beginning February 9.

Rather than take up the 21st Century Cures Act (HR 6), a broad bill passed by the House in July, the Senate Committee on Health, Education, Labor, and Pension (HELP) has announced that the committee will hold a series of markups in February, March, and April on several smaller pieces of legislation. Chairman Alexander (R-TN) said he believes a piecemeal approach allows the HELP committee to first pass bipartisan bills and then take up the ones that are more controversial. The Committee then hopes to roll the piecemeal approach into a larger medical innovation bill, and eventual negotiation with the House "Cures" bill.

The Committee will hold its first markup session to consider seven bills on Tuesday, February 9. Health IT will be a significant focus since it is a bipartisan issue and a priority of Chairman Alexander. Among the bills expected to be marked up is a bipartisan Electronic Health Record (EHR) bill that is focused on decreasing unnecessary physician documentation; enabling patients to have easier access to their own health records, and allowing for EHRs more accessible to the entire health system.

At a second meeting on March 9, the committee is expected to consider legislation to modernize the FDA and the NIH and provide congressional support for the president's Precision Medicine initiative. A third markup has been planned for April 6, but the agenda has not been announced. It is not clear how the committee will deal with more controversial issues such as drug pricing, and how to pay for the initiative.

The CAP will provide members with more news on these issues in future editions of STATLINE.

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Citing evidence demonstrating increased utilization rates and costs in the Medicare program, the CAP advocated for closing the self-referral loophole impacting anatomic pathology (AP) services in a letter to members of Congress. Lawmakers had requested comments on challenges under the Stark Law that governs physician self-referral of patient services including what qualifies for in office ancillaries.

The CAP sent a January 29 letter to congressional leaders to the Senate Finance Committee and House Ways and Means Committee. The committees sought input on potential changes to the Stark Law to implement the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) and Accountable Care Organizations (ACOs)/shared savings programs. The CAP continues to have concerns regarding the self-referral of anatomic pathology services.

The CAP commented on the in-office ancillary services exception (IOASE) addressing the potential abuse of anatomic pathology services that impact patient care and significantly increases costs to the Medicare program. The IOASE is intended to allow certain simple ancillary services, such as blood tests or urinalyses, deemed necessary by a clinician to help inform the diagnosis and treatment of a patient during an office visit. AP services, however, are almost never provided during the patient's office visit.

"AP services are specialized physician services in which pathologists prepare and analyze biopsied tissues to diagnose the absence or presence of disease," the CAP letter stated. "Cancer is a prime example, where AP services identify the type and stage. These highly technical AP services often require at least 24 hours to be completed. As such, AP services differ greatly from routine clinical laboratory tests that reasonably can be performed while the patient is in the office, providing results rapidly at the point of care."

The CAP, along with coalition partners in the Alliance for Integrity in Medicare (AIM), which also provided the committees with a statement, advocated to close the Stark Law's IOASE. In addition, the CAP advocated for changes to Medicare's purchased diagnostic services rule intended to limit the ability of physicians to purchase diagnostic services performed by other entities and bill for those services at marked up prices. Over time, the rule has been diluted and loopholes in the anti-markup provision also allow for increased utilization and potential abuse. The CAP also advocated for fixing the provision in conjunction with closing the IOASE to prevent higher costs to the Medicare program.

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Based on its discussions at its most recent meeting, the Medicare Payment Advisory Commission (MedPAC) will be advising the Centers for Medicare and Medicaid Services (CMS) on specific design principles as it develops rules implementing alternative payment models (APMs).

The CMS is developing regulations to implement APMs and merit-based incentive payment systems (MIPS), which were mandated by the Medicare Access & CHIP Reauthorization (MACRA). The proposed regulations are expected this spring.

Under MACRA, clinicians who are qualifying APM participants will receive a five percent additional payment per year for each year that they qualify from 2019-2024. These clinicians will also receive a higher update in 2026 and later. To qualify, clinicians must receive a specified share of revenue (or beneficiaries) through an eligible alternative payment entity.

In a November 17 letter to the acting administrator of the CMS, the CAP said that it is looking forward to working with the agency on developing measures that reward the activities pathologists can and in many instances, already do undertake in alternative payment models for appropriate inclusion in determining comparability. While pathologists advise on patterns of utilization and ordering practices, collaborate with other clinicians on diagnostic and prognostic care of patients, and play a key role in harm reduction and infection control, the current Medicare performance measurement system has made it difficult to develop pathology measures that fit its program design and truly capture pathologists’ contributions, said the letter.

The CAP is optimistic performance measurement for purposes of determining comparability could more effectively lend themselves to pathologists' interventions and activities in an alternative payment environment, and recognize contributions that are so important to aligned and coordinated team-based care, population health, and health care systems.

New Design Principles

MedPAC staff members offered a number of principles they hope to see incorporated into the final design for APMs under the law, including:

• Beneficiary Inducement – The APM entity (Entity) should be able to share savings with beneficiaries including reduced cost-sharing to use ACO participants. MedPAC has already supported this notion in furtherance of beneficiary engagement.
• Regulatory Relief – The Entity should be given regulatory relief on historic requirements put in place to combat overuse (eg, 3-day rule before SNF transfer, etc.). This would apply only where two-sided risk is required. Again, this is not unprecedented, and the CMS has in its various models waived requirements under these circumstances.
• Number of Beneficiaries – The Entity must have a sufficient number of beneficiaries to avoid reward for random variation, etc.
• Level of Risk – The Entity must truly assume risk (ie for the difference between actual and expected spending.
• Beneficiary Attribution or Attestation – Beneficiaries would be "attributed" (based on experience) rather than an affirmative attestation by the beneficiary. There was not consensus among commissioners on this principle and acknowledgement that either approach is difficult in specialist APMs.

Other key points from the discussion:

• MedPAC seems to favor driving MIPS participants to the APM alternative under MACRA.
• There was consensus MACRA is very unclear on APMs and adequately addressing exceedingly complex issues. That said, many of the commissioners have been close to delivery system transformation and mentioned how exciting they found all of this. Many of them very much favor two-sided risk.
• There was a good bit of discussion around specialist models (whether it’s a problem if the focus turns out to be on certain specialists in certain or all communities; acknowledgement that in certain geographies, there might not be APMs or their panels might already be closed; how could a single specialty group manage population risk if that’s the long term goal unless it was cardiology for certain diagnoses or endocrinologists for diabetes).
• Not central to the discussion, but interesting, were (1) the need to harmonize accreditation (eg, NCQA ACO accreditation) with the CMS requirements, assuming that the CMS will need to certify/approve APMs and (2) a track record/evidentiary standard for new APM models. The CMS in its MACRA FAQs indicates that it does not need to test physician-focused payment models contemplated under MACRA.

The CMS is expected to release a final rule in the fall.

According to MedPAC staff, one implementation issue could be the definition of "risk in excess of a nominal amount." This could be defined as investment risk or as the difference between actual and expected spending. MedPAC's draft principles tend toward defining risk as actual versus expected spending.

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