ePolicy News January 2017

Tuesday, January 10, 2017

Guesstimating Health Policy Initiatives for the Trump Administration

Who are the people and what are some of the policies Trump Administration staff are likely to pursue over the next four years?

On Jan. 20, President-elect Donald Trump will be sworn in as the 45th President of the United States. By then, Congress will have already started the confirmation process to fill some of the many cabinet positions and political positions that will round out Donald Trump's administration. What follows here is a brief report on the nominees or possible nominees for the primary healthcare agencies of concern to pathology and laboratory medicine and some of the policies that may be implemented at these agencies.

Department of Health and Human Services

Donald Trump has nominated Representative Tom Price (R-GA) to head the U.S. Department of Health and Human Services (HHS). Rep. Price, an orthopedic surgeon and member of the American Medical Association, is the chairman of the House Budget Committee and is a well-recognized advocate for the repeal of the Affordable Care Act (ACA) (aka, "Obamacare"). Repeal of the ACA (See following article) is likely to be the healthcare policy initiative most likely to define the Trump administration healthcare agenda and to dominate Rep. Price's tenure at HHS. In addition to repealing Obamacare, Rep. Price has favored Medicare premium support, which would transform Medicare into a voucher program that would provide full or partial financial support for the purchase of private health insurance. He is also a supporter of balanced billing (also known as "surprise billing"), which would allow physicians to bill patients for any amounts charged for services that are not covered by the patient's insurance. Rep. Price has also been a supporter of increased federal funding for scientific research.

Centers for Medicare and Medicaid Services

Seema Verma is Trump's pick to head the Centers for Medicare and Medicaid Services (CMS). CMS is the largest agency under HHS, and its budget accounts for 85 percent of the Department's $1 trillion in spending outlays. She is the architect of current Indiana Gov. (and Vice-President-elect) Mike Pence's Medicaid expansion, which extended healthcare benefits to more than 300,000 individuals. While most state Medicaid programs do not require enrollees to pay part of the cost for the care they receive, Indiana's new plan does. Verma also helped develop the previous overhaul of the state's Medicaid program under the prior governor, Mitch Daniels. These experiences mean she is very familiar with CMS. But as one Washington newsletter pointed out, "She has no experience with Medicare, the more politically sensitive program."

Food and Drug Administration

President-elect Trump has not nominated an FDA commissioner yet, but several names have been discussed, and both suggest certain policy changes may be in store for the Agency. The two individuals reportedly under consideration are Scott Gottlieb, MD and Jim O'Neill. Dr. Gottlieb is a resident fellow with the American Enterprise Institute, a conservative think tank. Mr. O'Neil is a managing director of a global investment firm, who previously serviced as a principal associate deputy secretary for the U.S. Department of Health and Human Services under Pres. George W. Bush. One of the policy shifts that may end up being integrated into the FDA is "progressive approval," a controversial approach allowing the FDA to permit pharmaceuticals and medical devices, such as laboratory testing devices, to enter the market once safety has been established. Efficacy of the product, however, would be established after the product has entered into the marketplace.

In recent years, the FDA attempted to increase the regulatory oversight of laboratory-developed tests (LDTs), a plan that has recently been temporarily shelved. However, if progressive approval were implemented into the FDA review process, it would seem unlikely that any substantial increase in the regulatory requirements for LDTs—such as requiring these devices to be approved by the Agency or a third-party or even requiring LDTs to demonstrate clinical validity—will occur over the next four years. It is also possible under such an approval system that the regulatory oversight currently applied to In Vitro Diagnostics could be lessened.

National Institutes of Health

No names have been floated yet as a successor to current National Institutes of Health (NIH) Director Francis Collins. That said, given certain conflicting comments made by the President-elect's possible new staff, have raised questions about what is in store for this federal agency. For example, funding for NIH always seems to be a Congressional priority. However, funding for the agency has remained relatively flat over last decade, resulting in a 22 percent loss in purchasing power. The recent passage of the 21st Century Cures Act would seem to suggest a new commitment to increasing funding for the agency, as Congress called for increasing funding by $1.4 billion over 10 years for a Precision Medicine Initiative, $1.8 billion for Vice President Joe Biden's cancer moonshot, and $1.6 billion for the brain research. Yet, the most recent continuing resolution provided only $352 million in additional funding to NIH.

HHS Secretary-nominee Tom Price has been supportive of increased funding for NIH. However, Rep. Mick Mulvaney, (R-SC), President-elect Trump's nominee to head the Office of Management and Budget (OMB)—the federal agency responsible for developing the President's budget and for negotiating spending levels with Congress--has expressed skepticism whether the federal government should be funding scientific research. Two weeks before Congress finally passed more than $1 billion to fight the spread of Zika and its effects, Rep. Mulvaney wrote, "[D]o we need government-funded research at all?"

Centers for Disease Control and Prevention

The Trump transition team has not identified a new CDC Director, nor have any names been suggested. It's unclear what Trump's policy commitment is to CDC and its mission. During the course of the campaign, his position on CDC's importance may have evolved. Initially, then-candidate Trump did not seem committed to CDC's cause. However, toward the end of the campaign, he spoke more favorably of the Agency's mission. Moreover, Vice President-elect Mike Pence has been supportive of CDC and its key programs during his tenure in Congress.

AMA Opposes Repeal without ReplaceMENT

On Jan. 3, the American Medical Association wrote Congressional Leadership opposing the repeal of the Affordable Care Act (ACA) ("Obamacare") without outlining what will replace it. In his letter to House and Senate leadership, AMA Chief Executive Officer and Executive Vice President James L. Madara, M.D., a pathologist, wrote that "before any action is taken…that would potentially alter coverage, policymakers should lay out for the American people, in reasonable detail, what will replace current policies." This is necessary, the AMA asserts, because "patients and other stakeholders should be able to clearly compare current policy to new proposals so they can make informed decisions about whether it represents a step forward in the ongoing process of health reform."

The AMA letter outlines three key principles that it would support as part of any Congressional reform of existing healthcare laws: (1) make coverage more affordable, (2) provide greater choice, and (3) increase the number of those insured. The AMA's letter sites its longstanding history of advocating for these patient-centric healthcare reforms.

The AMA's advocacy is similar to that employed by a number of other healthcare organizations, including hospital groups, insurers, and physicians organizations, which have expressed concern about not enacting or unveiling a replacement prior to repealing the law. On Jan. 6, the American Hospital Association and Federation of American Hospitals released a report arguing that repealing the ACA "could cost hospitals hundreds of billions" and said in a letter to Congressional leaders that "any reconsideration of the ACA should be accompanied at the same time by provisions that guarantee similar coverage to those who would lose it."

House Speaker Paul Ryan (R-WI) and Senate Majority Leader Mitch McConnell (R-KY) have repeatedly vowed to repeal the ACA. The AMA letter adds to the debate within the Congressional Republican caucus with regard to whether Republicans should establish an ACA alternative as part of its repeal or to do so afterwards. Republican leadership has yet to unveil or endorse a specific alternative to the ACA.

A copy of the AMA letter is reprinted below.

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Dear Majority Leader McConnell, Leader Schumer, Speaker Ryan and Leader Pelosi:

On behalf of the physician and medical student members of the American Medical Association (AMA), I am writing regarding our ongoing commitment to reform of the health care system and potential legislative actions during the first months of the 115th Congress.

The AMA has long advocated for health insurance coverage for all Americans, as well as pluralism, freedom of choice, freedom of practice, and universal access for patients. These policy positions are guided by the actions of the AMA House of Delegates, composed of representatives of more than 190 state and national specialty medical associations, and they form the basis for AMA consideration of reforms to our health care system.

Health system reform is an ongoing quest for improvement. The AMA supported passage of the Affordable Care Act (ACA) because it was a significant improvement on the status quo at that time. We continue to embrace the primary goal of that law—to make high quality, affordable health care coverage accessible to all Americans. We also recognize that the ACA is imperfect and there a number of issues that need to be addressed. As such, we welcome proposals, consistent with the policies of our House of Delegates, to make coverage more affordable, provide greater choice, and increase the number of those insured.

In considering opportunities to make coverage more affordable and accessible to all Americans, it is essential that gains in the number of Americans with health insurance coverage be maintained.

Consistent with this core principle, we believe that before any action is taken through reconciliation or other means that would potentially alter coverage, policymakers should lay out for the American people, in reasonable detail, what will replace current policies. Patients and other stakeholders should be able to clearly compare current policy to new proposals so they can make informed decisions about whether it represents a step forward in the ongoing process of health reform.

We stand ready to work with you to continue the process of improving our health care system and ensuring that all Americans have access to high quality, affordable health care coverage.

James L. Madara, MD

ASCP Presses CMS on Pathology and Laboratory Concerns

In December and early January, ASCP wrote several letters to the Centers for Medicare and Medicaid Services (CMS), urging changes to key policies concerning pathology and laboratory medicine: the Medicare Access and CHIP Reauthorization Act (MACRA) and Medicare Physician Fee Schedule. On MACRA, ASCP wrote separate letters to CMS on the MACRA Implementation Final Rule as well as CMS's recently outlined Patient Relationship Categories and Codes. ASCP also provided comments on the CY 2017 Medicare Physician Fee Schedule Final Rule.

MACRA Implementation Final Rule

The MACRA Implementation Final Rule comments reiterated ASCP's position that pathologists should be able to meaningfully participate in Medicare quality payment programs while concurrently being protected from undue reporting and/or negative payment adjustments. ASCP remains concerned about the weighting of the two Quality Payment Program (QPP) categories for which pathologists can report—Improvement Activities (IA) and Quality—at 15 percent and 85 percent, respectively. ASCP's comments again reflected our belief that it is inappropriate that a lack of measures in one or more of the performance categories should be detrimental to specialty clinicians. As a result, ASCP argued that the IA category should be weighted more heavily (e.g., 50 percent IA and 50 percent Quality). Additionally, the Society thanked the Agency for building flexibility into the program to give clinicians room to transition to the new Medicare payment scheme.

CMS's Patient Relationship Categories and Codes.

ASCP also wrote CMS regarding its efforts to establish patient relationship categories and codes for measuring resource use in the new QPP as required by MACRA. CMS released a draft of these categories in April, 2016, and an updated version in response to public comment in December. ASCP's comments on the original draft were taken into consideration in the updated draft, and we are pleased that CMS continues to solicit feedback on this topic. Broadly, ASCP agrees with the updated definitions of clinician-patient relationships, but urges the Agency to continue to take non-patient facing clinicians into consideration when developing these categories and codes, and to make reporting as easy as possible by creating specialty-specific codes. 

Medicare Physician Fee Schedule Final Rule

Finally, ASCP's also submitted comments in response to the CY 2017 Medicare Physician Fee Schedule Final Rule. ASCP thanked the Agency for not adopting (as recommended by ASCP) a number of cuts to pathology services it had proposed earlier in the year. That said, ASCP disagreed with the Agency on several specific payment changes. For example, ASCP raised concern about CMS's rejection of the American Medical Association (AMA) Relative Value Scale Update Committee's recommendations pertaining to the Prostate Biopsy G-code G0416. ASCP argued that the recommendations of an expert panel assembled to identify the resources involved in providing this service represented the best approach to valuing this service appropriately. ASCP also disagreed with CMS's final policies regarding the application of a discount factor applied to add-on codes for immunochemistry and immunofluorescence services. Further, ASCP urged the Agency's to reconsider its pricing of Flow Cytometry add-on code, 88188. ASCP maintains that the methodology utilized by CMS undervalues the service. A copy of ASCP's comments on the rule can be accessed here.

Healthcare Changes Loom in 2017

ASCP President William E. Schreiber, MD, FASCP, recently authored an article for ASCP's ONELab blog regarding several important regulatory changes for affecting pathology and laboratory medicine in 2017. The first is the revaluation of the Clinical Laboratory Fee Schedule with data reporting required between Jan.1—March 31, 2017; the second is Medicare's new Quality Payment Program that transforms the way clinicians are paid in the coming years.

CMS Reissues Previous Prohibition on "Per-Click" Rental Charges

As part of the Medicare Physician Fee Schedule (PFS) Final Rule released in November, the Centers for Medicare and Medicaid Services (CMS) reissued a ban on certain unit-based (or "per-click") rental arrangements that could otherwise qualify for the Stark Law rental or office space or equipment exception. CMS initially determined that under the Stark Law, otherwise known as the Physician Self-Referral Law, certain per-unit of service rental charges on office space and equipment were permitted.

In response to the 2015 ruling in Council for Urological Interests v. Burwell, on Nov. 15, 2016, CMS reissued its ban on per-click rental charges in both office space and equipment lease arrangements. The rule, effective Jan. 1, 2017, clarifies that the prohibition only applies where the lessor generates payment from the lessee by referring patients to the lessee for a service provided using the rented space or equipment. As the rule stands, providers should be aware of this prohibition and ensure that any/all lease agreements entered into with a referral source (or an entity to which the provider sends referrals) meets the applicable requirements for the Stark exceptions for office space or equipment leases.

ASCP continues to participate in the Alliance for Integrity in Medicare (AIM) Coalition, which supports reform of the Stark Law's In-Office Ancillary Services exception to end abusive billing practices of pathology services by referring physicians.

ASCP Partnering with ASCLS on its Annual Legislative Symposium

The American Society for Clinical Laboratory Science (ASCLS) has announced that its 2017 Legislative Symposium will be held March 20-21.  The meeting, which will bring together members of ASCLS, ASCP the Clinical Laboratory Management Association, the Association of Genetic Technologists, and the American Medical Technologists for a round of policy briefings on issues of concern to laboratory medicine.  In addition, attendees will meet with their elected representatives in Congress to inform them of critical policy issues. 

The meeting offers a wonderful opportunity for individuals to learn more about the political and legislative processes in Washington and to help shape those policies in a manner benefitting patient care and your profession. This year's Legislative Symposium will be held at the Hilton Alexandria Old Town in Alexandria, VA.


For more information regarding ASCP's advocacy initiatives and policy positions, please contact ASCP's Center for Public Policy at (202-347-4450).


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