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Read the RheumWATCH archives on topics such as rheumatology advocacy, policy updates, insurance advocacy, and practice management.
The ACR and partnering physician specialist groups passed an AMA resolution opposing the proposed Medicare Part B payment demonstration during the AMA House of Delegates Annual Meeting, held June 11-15. The resolution states that the AMA will support and actively work to advance Congressional action to block the Medicare Part B payment demonstration in the event the Centers for Medicare & Medicaid Services (CMS) does not withdraw the demonstration.
A similar resolution authored by the ACR was introduced to the AMA House of Delegates by 11 national specialty provider groups, including the ACR, American Academy of Allergy, Asthma & Immunology, American Academy of Ophthalmology, American Association of Clinical Urologists, American College of Allergy, Asthma and Immunology, American College of Gastroenterology, American Gastroenterological Association, American Society of Cataract and Refractive Surgery, and American Society of Clinical Oncology.
“The CMS Part B payment demonstration, if not substantially modified and scaled back, would have a significant, negative impact on specialty providers and vulnerable Medicare patients. We applaud the AMA House of Delegates for passing the Part B resolution, which is an important step toward ensuring this payment proposal is not implemented as written,” said Dr. Gary Bryant, MD, FACR, chair of the ACR’s delegation to the AMA House of Delegates.
The ACR resolution outlined specialty providers’ concerns regarding the proposed Part B payment demonstration, including the fact that some specialties—such as rheumatology and gastroenterology—have very few Part B biologics available to patients, and these therapies do not have less expensive alternatives.
Other specialties, such as ophthalmology, must have Part B drugs and biologics compounded or repackaged before they can be used to treat certain conditions. Due to new federal and state drug compounding regulations, some physicians are experiencing increased difficulty accessing compounded or repackaged drugs and biologics.
The resolution also noted that biologics and chemotherapy drugs cannot be easily switched for less expensive options. Each patient’s immunology is unique, and due to their complexity, biologics and chemotherapy drugs cannot easily be interchanged.
In the event the Part B proposal is not withdrawn by CMS, the ACR resolution also called for significant modifications to the proposal, including:
Should CMS fail to respond to stakeholder input and withdraw or significantly modify the Part B drug payment demonstration project, the resolution authored by the American Society of Clinical Oncology and passed on June 15 by the AMA House of Delegates directs the AMA to support and actively work to advance Congressional action to block the demonstration if CMS proceeds with the proposal. It also directs the AMA to advocate against policies that are likely to undermine access to the best course of treatment for individual patients and to oppose demonstration programs that could lead to lower quality of care and do not contain mechanisms for safeguarding patients. It further directs the AMA to advocate for ensuring that CMS solicits and takes into consideration feedback from patients, physicians, advocates, or other stakeholders in a way that allows for meaningful input on any Medicare coverage or reimbursement policy that impacts patient access to medical therapies, including policies on coverage and reimbursement.
This work is only possible because ACR members join the AMA and renew their memberships each year. The ACR can Advance Rheumatology! more forcefully and serve you and your patients better by having a larger voice at the AMA. We’re asking that rheumatologists who are not current members of the AMA to please join now for 2016 so rheumatology can keep our seat and remain involved in steering the direction of the AMA. You can also contact ACR staff for assistance in becoming an AMA member or renewing your membership. If you are already an AMA member, make sure you have designated the ACR as your representative society.
The Centers for Medicare & Medicaid Services (CMS) has completed their initial set of provider revalidations and will resume regular revalidation cycles in accordance with 42 CFR §424.515. Section 6401 (a) of the Affordable Care Act established a requirement for all enrolled providers/suppliers to revalidate their Medicare enrollment information under new enrollment screening criteria.
To streamline the revalidation process and reduce provider/supplier burden, CMS implemented several processing improvements:
There are several ways to find your revalidation due date:
Revalidation is critical to your practice’s bottom line, so it is vital to revalidate before your due date to avoid a hold on your Medicare payments and a possible deactivation or lapse in your Medicare billing privileges. Also, CMS encourages providers to submit their revalidation within six months of the due date or when the notification is received from the Medicare Administrative Contractor.
Key reminders for providers and practice administrators:
Need assistance? To find out whether a provider/supplier has received a revalidation notice in the mail, visit the CMS website. For all other questions or additional information, contact your MAC. Get Medicare provider enrollment contact information for each state.
The ACR is finalizing its response to the major proposed MACRA rule that would implement an entirely new physician payment system for those who see Medicare patients, including the details of the Merit-Based Incentive Payment System (MIPS) and rules for Alternative Payment Model (APM) participation. You can weigh in on the rule, too, by filing comments with CMS by the June 27, 2016 deadline.
The ACR’s detailed response will cover key issues, including the following:
The ACR has developed tools and resources to help you prepare for and succeed in the new MACRA era.
When the nonpartisan Alliance for Health Reform held a national policy briefing on biosimilars issues this week, I was pleased to be able to represent the ACR and rheumatology’s viewpoints as part of the panel. FDA leaders joined me along with representatives of several leading national healthcare groups for an exciting and wide-ranging discussion of the emerging biosimilars market, including key policy and regulatory questions for patients, providers, and the healthcare system.
During the briefing I stressed the importance of current FDA regulatory efforts to ensure the safety and efficacy of biosimilars for patients. Full transparency is key for physicians to be able to prescribe safe and effective biosimilars. Patients need to know what they’re taking, and physicians need to know what they’re prescribing. This can be accomplished by using distinct names for biosimilars, having clear information on FDA drug labels, and implementing consumer-oriented pharmacy dispensing practices.
The ACR has had a number of conversations with the FDA and other stakeholders at both the federal and state levels about how to achieve that transparency, and we are fully supportive of the FDA’s efforts to implement distinct naming and transparent labeling for biosimilars.
I was also able to voice concern about potential biosimilar substitution practices by pharmacists without prior notification. We currently do not know what may happen when switching a patient back and forth between a biosimilar drug and its original reference biologic. It’s possible that switching may be safe and effective, the way a person can go back and forth between brand and generic versions of small molecule drugs. However, it’s also possible that a person who is switched from an original biologic to its biosimilar may become immune to the new biosimilar, and in a worse-case scenario, may become immune to the original biologic drug as well. This may cause the drugs not to work or even cause allergic reactions, which is why it is incredibly important that we protect patients against forced switching between biologics and biosimilars by insurance companies and pharmacy benefit management companies.
Also on the panel was Dr. Leah Christl, Associate Director for Therapeutic Biologics at the FDA. She said that biosimilar drug development was “very different from standalone drug development” and that demonstrating biosimilarity requires different types of data. When asked about the FDA’s draft guidance calling for distinct names for biosimilars, Dr. Christl said that having distinct names for biosimilar therapies will help to ensure pharmacovigilance—which includes the ability to monitor for, report, and track adverse reactions—and also help to prevent inadvertent substitutions.
I believe that prescribing physicians are “cautiously optimistic” about biosimilars and will welcome the opportunity to prescribe new treatment options as long as they are safely adopted into the market with full transparency and proper naming and labeling. Physicians likely will be most comfortable using biosimilars in patients who are just starting their first biologic treatment, as opposed to switching patients who are currently taking a biologic, due to the lack of clinical information about switching and adverse reactions.
Ultimately, the decision about whether to prescribe a biosimilar to a new patient – or to switch an existing patient from his or her current biologic therapy – will depend on a number of factors, including the clinical data surrounding the biosimilar, the patient’s condition and medical history, and whether the patient is having success with his or her current therapy. The cost of the therapy and the patient’s ability to afford it may also come into play. If the biosimilar represents a lower-cost yet clinically effective option, we will probably discuss this consideration with the patient, but the decision should be made by prescribers and patients – not third-party payers.
It’s easy to get lost in the weeds of regulatory issues, but biosimilars naming, labeling, and interchangeability issues have real and profound safety and health consequences for patients. We certainly appreciate the work of Dr. Christl and her colleagues at the FDA to ensure these therapies are safe and effective.
Access additional materials from the briefing.
Angus Worthing, MD
Member, ACR Government Affairs Committee