The ACR’s 2018 Legislative & Regulatory Priorities

A recent Politico article outlined the looming agenda facing Congress as 2018 begins: Fund the government, raise the debt ceiling, modify spending caps, address healthcare subsidies, allocate additional funds for disaster relief, and address the status of millions of undocumented young immigrants.¹

Amid all that activity, the ACR, through its Government Affairs Committee (GAC) and the advocacy work of ACR/ARHP members, continues to advocate for rheumatology professionals and patients.

The ACR’s Priorities
For 2018, the ACR has a long list of legislative and regulatory priorities to address at both the federal and state levels.

MIPS Adjustment/Part B Cost Elimination
Most immediately, says Angus Worthing, MD, FACR, FACP, GAC chair, we need to promote legislation that eliminates MIPS adjustments for Part B drug costs in MACRA, while pressuring the Centers for Medicare and Medicaid Services (CMS) to eliminate Medicare Part B costs or include Part D when calculating physician quality scores under the Merit-Based Incentive Payment System (MIPS) that was set up through MACRA along with an alternative payment model (APM) pathway for Medicare payment.

Under a rule finalized by the CMS in late 2017, items and services—including Part B drugs—furnished by providers on MACRA’s MIPS pathway (which applies to nearly all rheumatologists) would be subject to either a positive or negative adjustment. This is a significant departure from previous policy, which only applied penalties or bonuses associated with quality programs to payment for physician services, not to payments for items such as Part B drugs for which physicians are reimbursed. Estimates project a financial impact in the range of 16–19% for some specialties.²

The ACR also continues to work toward the development of a MACRA alternative payment model (APM) appropriate for rheumatologists.

Drug Prices, Access & PBM Transparency
Drug prices and access to drugs also continue to be a focus of the ACR’s legislative and regulatory efforts, says Dr. Worthing. These are “probably top of the radar screen for most Americans, many members of Congress and the ACR,” he says. “It’s a multifaceted problem that is very frustrating for us in this day and age when we have the tools to diagnose and treat severe disease, and it can be heartbreaking when patients can’t access medications they’re prescribed.”

Promoting greater awareness of the role pharmacy benefit managers (PBMs) play in what patients must pay for drugs, and increased transparency of PBM practices, are among the ACR’s priority efforts in 2018 intended to address cost and access.

“Drug prices are going up in part because of the rebate system that PBMs use to negotiate with drug makers to get drugs on their formularies,” explains Dr. Worthing. “Our goals for 2018 are to start with proper definitions. We have asked Congress to have CMS properly define what a rebate is and what fees are in the system. It’s the first step toward promoting transparency; if you don’t define things first, PBMs can use a shell game to change the rebates and call it a fee.”

The Senate Health, Education, Labor and Pensions Committee has already conducted two related hearings and several committees in the House have introduced a bill to promote PBM transparency. 

Without action, the cost-savings potential of biosimilars could be negated, Dr. Worthing says.

“When biosimilars come out and offer lower prices, the PBM system could derail that and prevent the very reason for biosimilars to exist from being successful,” he notes. “We are not only advocating for safe and effective biosimilars to be approved by the FDA, we are also advocating for a distribution system to get them to patients in a way that reduces prices and increases access to medications that patients need.”

Additional Priorities
Other priorities for 2018 include:

• Eliminating the physical therapy cap for Medicare beneficiaries;
• Ensuring that any legislation on healthcare reform prioritizes affordable and meaningful health insurance coverage for children and chronically ill patients;
• Preventing inappropriate non-medical switching;
• Addressing the rheumatology workforce shortage and maldistribution;
• Promoting insurance codes that adequately reimburse providers for cognitive care;
• Ensuring the availability of federal agency funding for rheumatology-related research;
• Promoting RISE as a tool to assist providers with MACRA;
• Streamlining prior authorization processes and forms; and
• Prioritizing bills that reform step therapy in states throughout the U.S.

How You Can Get Involved
There are a number of ways the ACR conducts its advocacy work, says Dr. Worthing, organizing “not only hundreds of meetings per year on Capitol Hill, we are also holding meetings and drafting letters and communications with coalitions of other provider and patient groups, and sending thousands of emails every year through the Legislative Action Center.”

Members can also contribute to RheumPac, the ACR’s nonpartisan lobbying arm.

The ACR’s efforts are “not designed to be partisan,” Dr. Worthing says. “This is almost always a bipartisan effort, and the ACR works with leaders on both sides of the aisle to ensure we best represent our members, our patients and our profession.”

Kelly April Tyrrell writes about health, science and health policy. She lives in Madison, Wis.

References

1. Alberta, T, Bade R. Paul Ryan sees his wild Washington journey coming to an end. Politico Magazine. 2017 Dec 18. https://www.politico.com/magazine/story/2017/12/14/paul-ryan-retire-speaker-ready-leave-washington-216103.
2. American Society of Clinical Oncology, American College of Rheumatology. Submission to the AMA House of Delegates on opposing inclusion of Medicare Part B drugs in QPP/MIPS payment adjustment [resolution]. 2017 Oct 12. https://www.ama-assn.org/sites/default/files/media-browser/public/hod/i17-225.pdf.

Sidebar: Top ACR Policy Priorities for 2018
Here’s a quick rundown of some of the ACR’s major priorities this year.

Federal Legislative

• Ensure appropriate implementation of MACRA, including regulatory reform, optimizing MIPS for rheumatology care, avoiding MIPS adjustments of Part B drug reimbursements, including Part D drug costs in cost measures or eliminating Part B drug costs from resource use, and supporting a rheumatology-related APM.
• Ensure any healthcare reform efforts prioritize affordable, meaningful health insurance coverage for chronically ill patients.
• Support interventions to address adult and pediatric rheumatology workforce shortages.
• Support increased funding for research by the NIH, CDC and DOD in rheumatic disease and related comorbidities.
• Promote greater awareness of pharmacy benefit managers’ (PBMs) role in drug pricing. Promote transparency of PBM practices.
• Repeal the arbitrary cap on Medicare outpatient rehabilitation services.

Federal Regulatory

• Ensure appropriate implementation of MACRA, including regulatory relief and deceasing administrative burden, optimizing MIPS for rheumatology care, avoiding MIPS adjustments of Part B drug reimbursements, including Part D drug costs in cost measures or eliminating Part B drug costs from resource use, and supporting a rheumatology-related APM.
• Increase awareness of and payment for cognitive specialists’ time, expertise and services; advance study of new service codes to reflect rheumatology care in reimbursement.
• Advance RISE as a tool to advance rheumatology by maximizing its use in MACRA and associated credit in MIPS; reduce barriers to use.
• Support a biosimilars marketplace that provides adequate funding for the FDA, adequate information on drug labels, meaningful suffixes, and protection from inappropriate substitution practices and forced switching.

State Legislative/Regulatory

• Prevent insurance plans from making changes that would negatively impact coverage of patients’ medications during a plan year (non-medical switching).
• Reduce the use and impact of step therapy formulary practices by all payers; support expeditious approval of step therapy exceptions.
• Ensure protection from inappropriate biosimilar substitution practices (e.g. without prior/timely prescriber notification) and forced switching.
• Promote greater awareness of PBMs’ role in drug pricing, and promote increased transparency of PBM practices.
• Streamline prior authorization processes and forms.