This Week – June 17, 2017

This Week in Washington, D.C.

  • OH House Introduces Anti-MOC Legislation: Please express your support
  • ACA Repeal Watch- Some Interesting Updates While Awaiting Senate Bill
  • U.S. Supreme Court rules on biosimilars
  • MACRA Tidbit for the Week: MedPAC is not a fan of MACRA

OH House Introduces Anti-MOC Legislation: Please express your support

Great news out of Ohio this week!  The Ohio State legislature has introduced the Patient Access Expansion Act (HB 273), which prohibits a physician from being required to secure maintenance of certification (MOC) as a condition of obtaining licensure, reimbursement, employment, or admitting privileges at a hospital or health care facility.

ACG is working closely with the Ohio Gastroenterology Society and Ohio State Medical Society and will be actively involved throughout the summer to improve this bill and get it passed through the state legislature.

ACG Members in Ohio: Please contact State Representative Theresa Gavarone and State Representative Terry Johnson to express your support for HB 273!


From ACG National Affairs Committee Chair, Whitfield L. Knapple, MD, FACG

ACA Repeal Watch- Some Interesting Updates While Awaiting Senate Bill

According to a report released this week by the Centers for Medicare and Medicaid Services (CMS), the House-passed American Health Care Act (AHCA) would leave 12.6 million more Americans uninsured over the next decade, and reduce federal spending by $328 billion.   This estimate is well below the 23 million more uninsured that the Congressional Budget Office (CBO) estimated in its May report.

“Taken together, we estimate that there will be 35 million uninsured in 2020 under the AHCA, a figure that is about 8 million higher than under current law. By calendar year 2026, the number of uninsured is estimated to increase from 31 million under current law to more than 43 million under the AHCA, an increase of roughly 13 million. The percentage of the U.S. population with health insurance coverage is estimated to decrease from 91.3 percent under current law in 2026 to 87.7 percent under the AHCA.”

It is very unlikely that the House-passed AHCA will be passed in Senate, however, as the Senate is developing their own plan.  As of now, Senate Republicans have yet to release this plan despite having the goal of a vote in July.  Senate Minority Leader Chuck Schumer (D-NY) released a letter to Majority Leader Mitch McConnell (R-KY) this week, serving as an invitation for a meeting with all Senators from each party to discuss the plans to repeal the Patient Protection and Affordable Care Act (ACA).  In his letter, Schumer called for an “open and robust debate” that would allow for every senator, rather than a select few, to have a voice in this important discussion on the future of U.S. health care.

The CMS report also highlights ACG’s concerns with the AHCA regarding cost-sharing and changes to Essential Health Benefits (EHBs): read the full blog here.


From ACG FDA Related Matters Committee Chair, Tedd Cain, MD, FACG

U.S. Supreme Court rules on biosimilars

As ACG updated you recently, the United States Supreme Court rules that biosimilar drug companies do not have to give brand named biologic manufactures 180-days of notice of their intent to sell the biosimilar until after it receives approval from the FDA.  In this case of Sandoz v. Amgen, Sandoz was seeking to market a biosimilar version of Amgen’s biologic Neupogen, and argued this 180 day notice effectively gives the brand company 6 additional months exclusivity.  The Supreme Court agreed with Sandoz’s argument, concluding that the Biosimilar Price Competition and Innovation Act allows the 180-day notice of marketing to come either before or after the biosimilar receives FDA approval.

The Supreme Court also vacated a second issue of whether a biosimilar drug company must engage in a patent-sharing process with the biologic drug company prior to FDA approval.  A federal appellate court had said this was not mandatory, but Amgen disagreed.  The Supreme Court said this issue should return to the lower court and determine whether a state-law injunction is available if a biosimilar company doesn’t share its patent information with the biologic maker.

MedPAC is not a fan of MACRA

This week, the Medicare Payment Advisory Commission (MedPAC) released its June 2017 Report to Congress and discussed MACRA.  While the reports are mandated by Congress, these MedPAC reports are just recommendations to Congress and CMS.  CMS and Congress are not required to implement these recommendations.  It is worth noting that MedPAC concludes what ACG Governors and ACG members have been educating Congress and CMS all along:

“As CMS has begun to implement these two paths [MIPS and APMs], it has become clear that MACRA sets up a complex system in which some signals to improve value may not be well aligned.  Although it is difficult to judge what sort of program will eventually result, the Commission is concerned by the direction the program is taking.”

ACG will continue to strive towards making MACRA less complex and administratively burdensome for ACG members and GI practices.  Some other highlights from the MedPAC report:

  • “Clinicians are reporting data now for the first year of implementation for MIPS in 2019. Over 40 percent of clinicians are exempt from the program, and CMS created a very minimal standard that can be met by reporting information on one quality measure. Some stakeholders may view this approach as positive because the reporting requirements are minimal, and there will be very little effect on payment. Other stakeholders, who have invested in reporting infrastructure, may view this approach as negative. In the following years, if CMS proceeds to standards that are more difficult to meet, reporting will become more burdensome. It is not clear that the resulting data collected by CMS will be useful in detecting high and low performance, and minor differences in clinician scores could result in major differences in payment.”
  • MedPAC recommends eliminating the current set of MIPS measures, and instead would rely on a much smaller set of population-based outcome measures. The proposed outcome measures would be calculated from reimbursement claims or surveys, with the goal of reducing reporting burden.
  • MACRA requires clinicians to meet certain alternative payment model (APM) thresholds to qualify for the 5% incentive payment. The incentive payment is calculated as a percentage of all of a clinician’s streams of revenues.  MedPAC recommends making this 5% reward based solely on the revenue coming through the qualified APM, and to instead make the incentive payment proportional to APM involvement.  From the report: ”Under MACRA, a clinician must reach a threshold of revenue coming through a qualified APM (e.g., 25 percent, 50 percent) to be eligible for the 5 percent incentive payment, and this payment is based on all of the clinician’s PFS revenue, even that which does not come through a qualified APM.  Therefore, if the threshold for revenue coming through the qualified APM is 25 percent, a practice with 24.9 percent of revenue generated through the qualified APM would not be eligible for the 5 percent incentive payment, while a similar practice with 25.0 percent of its revenue through the qualified APM would get a 5 percent incentive payment on all of its PFS revenue. This kind of payment cliff can introduce payment discontinuities, increase uncertainty, and appear inequitable. Therefore, we discuss making the payment reward proportional to the qualified APM-generated revenue. That is, there would be no threshold and the reward would be proportional: Any revenue coming through an qualified APM would secure the 5 percent payment incentive, but any other PFS revenue would not.”
  • As ACG members know from Making $ense of MACRA, there is a fund of $500 million per year (from 2019 to 2024) to reward clinicians with “exceptional performance” on their MIPS scores. MedPAC recommends that this fund instead go to qualified APMs, making the APM option more attractive.  Note—this recommendation would very likely require a change in the MACRA statute (via Congress).
  • MedPAC also recommends an APM that would be more attractive to small practices.