Life Science Compliance Update

December 14, 2017

Medical Societies Ask Congress to Preserve Patient Access to Critical Part B Therapies



Eleven medical societies – including the American College of Rheumatology, American Academy of Ophthalmology, American Society of Clinical Oncology and American Urological Association – are urging congressional leaders to preserve patients’ access to critical Part B drug treatments by preventing the Centers for Medicare & Medicaid Services (CMS) from penalizing physicians for providing high-quality care.


The societies recently sent a joint letter to the chairs and ranking members of the Senate Finance Committee, the House Ways & Means Committee, and the House Energy & Commerce Committee. In the letters, the groups warn of serious impacts to patient access to care should Congress fail to prevent CMS from applying Merit-based Incentive Payment System (MIPS) adjustments to Part B drug payments. They argue that it could jeopardize patients in the communities most in need of access to these important treatments.


“This policy will negatively impact patients’ access to critical life- and sight-saving treatments,” the letter states, as it would put at risk the ability of specialists to provide the physician-administered drugs on which their patients depend. Drugs covered under Medicare Part B include therapies that are typically administered by a physician, either in an independent practice or hospital outpatient setting. They are not generally available at pharmacies and are not part of Medicare Part D prescription drug plans. 


The letter alleges that the policy is “not consistent with Congressional goals in the bipartisan passage of the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA). Under MACRA, Congress established a range of bonuses and penalties to which Medicare providers could be subjected through MIPS payment adjustments. In its 2018 Quality Payment Program final rule, CMS announced that it will begin to impose these payment adjustments to Part B drug payments in addition to physicians’ services under the Medicare fee schedule, a decision that represents a significant departure from current policy.


The current Part B drug payment structure already makes it difficult for certain providers (especially small and rural providers) to shoulder the financial burden of procuring and administering expensive Part B drugs. The new MIPS policy change would only worsen this problem by creating extreme volatility and financial uncertainty for physicians who administer these therapies.  


“While we had substantial and bipartisan Congressional support for a message to CMS to reevaluate their interpretation of the MACRA statute, CMS did not heed that request. We now need Congress to act immediately to curtail this policy and ensure patients have access to all the services and treatments they need,” the letter states.


The letter also urges Congressional leaders to address the weighing of the MIPS cost score category.


“CMS has not outlined sound methodologies for risk adjustment for physicians with patient populations at risk for high resource use, and cost measures necessary under MIPS are still under development. Work remains to ensure that the new measures are developed and integrated in a way that accurately reflects the complexities of cost measurement and does not inadvertently discourage clinicians from caring for high-risk and medically complex patients. We believe that these methodologies and measures must be developed and validated before CMS moves forward with implementing this category,” the letter states.


The letter concludes with the following statement, “[t]aken together, these two issues could create a perfect storm for specialties whose patients depend on physician-administered drugs. We stand ready to work with you on ensuring the implementation of MACRA is successful.”

April 25, 2017

AMA Releases Satisfaction and Stress Survey Results of Physicians


At the end of March 2017, the American Medical Association (AMA) released survey findings that explored the experiences, perceptions, and challenges that are currently facing physicians in the current healthcare environment.

1,200 physicians, residents, and medical students (400 of each) participated in the online survey, which when respondents knew they would become physicians, who encouraged them down that path, what challenges they face professionally, and whether they are satisfied with their career choice.

According to the survey, nine in ten physicians are satisfied with their career choice, despite challenges common to each career stage. Three quarters of medical students, residents, and physicians said that helping people is a top motivator for pursuing their career and sixty-one percent of all respondents said they would encourage others to enter the field of medicine. Personal experiences as a patient, volunteer, and with family members played a role – across career stages – in realizing one’s calling to practice medicine. Additionally, seventy-three percent of respondents knew before they reached the age of twenty and/or graduated college that they wanted to be physicians, and nearly a third knew before by the age of twelve.

“Physicians may be discouraged at times, but almost every single one of us remains confident in our decision to enter medicine and continues to be driven by our desire to help our patients,” said Andrew W. Gurman, M.D., AMA president. “As an organization, the AMA is constantly striving to deliver resources that empower physicians to maximize time with their patients and help them succeed at every stage of their medical lives. Understanding the challenges physicians face, as well as their motivations for continuing on, is critical to fulfilling that mission.”

The AMA survey, which was conducted in February 2017, found administrative burden, stress, and lack of time were among the top three challenges of respondents. For residents, however, long hours and on-call schedules were also among their top challenges. More than half of students – fifty-three percent – indicated that stress was one of their top three challenges.

Despite these challenges, only thirteen percent of all respondents indicated they had regularly questioned their decision to practice medicine – and more than half of those cited burnout as their top reason for questioning.

These survey findings are released as the AMA launches a comprehensive brand initiative that strives to demonstrate to physicians, residents and medical students the many ways the AMA listens, supports and empowers them to succeed throughout their unique journeys with timely and relevant resources.

The brand initiative is expected to reach physicians through print, digital and social media platforms. It is intended to recognize and celebrate the core reasons that physicians choose the profession while also highlighting the broad array of initiatives and resources the AMA provides in support of physicians.

April 24, 2017

ACR Announces Health Policy Priorities


On March 31, 2017, the American College of Rheumatology announced its 2017 health policy priorities, providing detailed policy recommendations to improve access to care and treatments for the millions of Americans living with arthritis and other rheumatologic diseases. 

The policy prescriptions come in the wake of a new Centers for Disease Control and Prevention report showing arthritis prevalence is at an all-time high. According to the report, roughly fifty-four million Americans – one in four people – now live with arthritis, and they estimate that approximately seventy-nine million Americans will have arthritis by the year 2040.

“As the alarming CDC data indicates, now more than ever we need policies that ensure the one-quarter of Americans living with arthritis can access and afford specialized care,” said Sharad Lakhanpal, MD, MBBS, President of the American College of Rheumatology.

While the demand for arthritis care is growing, the pool of U.S. rheumatologists – doctors who provide specialized care to Americans living with arthritis and other rheumatologic diseases – is shrinking as more rheumatologists retire from the profession and fewer new doctors enter the rheumatology subspecialty. According to the ACR’s 2015 workforce study, the demand for rheumatology care exceeded the supply by 36 percent for adult rheumatologists and 33 percent for pediatric rheumatologists in 2015 – a gap that is projected to widen to 138 percent and 61 percent respectively by 2030.

The ACR’s policy priorities for 2017 include actions that Congressional and Administration leaders can take to ensure a thriving rheumatology workforce, as well as to address current healthcare access and affordability issues.

The ACR’s policy priorities for 2017 include:

  • Healthcare reform legislation that prioritizes affordable coverage for chronically ill patients, including coverage for Americans with pre-existing conditions, limits on out-of-pocket costs, and tax credits based on income. 
  • Repeal of the Independent Payment Advisory Board, an agency created under the Affordable Care Act (ACA) that has the power to impose arbitrary payment cuts on medical providers. These cuts would disproportionately impact small and rural rheumatology practices already struggling to stay financially viable.
  • Appropriate MACRA implementation, including optimizing the Merit-Based Incentive Payment System for rheumatology care and supporting a rheumatology-inclusive Alternative Payment Model.
  • Proper valuing of cognitive specialty care, including new ICD-10 service codes that more adequately reflect rheumatology care in reimbursement.
  • Adequate funding for FDA biosimilars review, to ensure the introduction of additional safe and effective therapies and lower biologic drug costs. 
  • Limits on overly restrictive insurance practices, including step therapy, prior authorization and specialty drug tiers.
  • Adequate insurance coverage for biologic therapies, including coverage of administration for complex drugs, and Medicare coverage of reimbursement at true ASP+6%.
  • Increased medical research funding for rheumatic diseases, including arthritis medical research funded by the National Institutes of Health, Centers for Disease Control and Prevention, and Department of Defense.
  • Interventions to address the rheumatology workforce shortage, including Medicare funding for general Medical Education, funding for additional rheumatology fellowship positions, and support for the Pediatric Subspecialty Loan Repayment Program.

“We look forward to working with Congressional leaders and the Administration to advance policies that ensure access to high-quality, specialized care for the 54 million Americans living with chronic and debilitating rheumatologic diseases,” concluded Lakhanpal.

You can find the full text of the ACR 2017 Health Policy Statements here.


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