Specialty Docs Oppose Part B Drug Payment Model
On March 25, the Alliance of Specialty Medicine released a letter to Capitol Hill leadership opposing a Part B Drug Payment Model recently proposed by the Centers for Medicare and Medicaid Services (CMS), and asked Congress to urge CMS to permanently withdraw this model from consideration.

Specifically, CMS proposed to reduce the average sales price (ASP) add-on amount for Medicare Part B medicines over the course of a two-phase demonstration. Under Phase I, CMS would create two study cohorts; one cohort would receive Part B drug payments under the current payment methodology (ASP+6 percent), whereas the other cohort would receive a reduced add-on payment (ASP+2.5 percent) plus a flat fee of $16.80. Under Phase II, CMS would add value-based purchasing (VBP) tools currently employed by commercial health plans, pharmacy benefit managers, hospitals, and other entities that manage health benefits and drug utilization. CMS proposes that Phase I would begin in the summer of 2016 and Phase II would begin as early as January 1, 2017. This demonstration project would be mandatory for zip codes identified by CMS and would apply to all Part B drugs, with very limited exceptions.

News of the proposed model first leaked out when CMS posted guidelines to contractors in February. This posting appeared to have happened erroneously, as the agency quickly removed the guidelines from its website. The posting and subsequent hasty removal greatly worried the provider, patient, and manufacturer communities, as it indicated a major payment change was well underway, even though CMS had not engaged in any pre-rulemaking dialogue such as town halls or formal Requests for Information. Rather than pause to address any concerns, CMS only seemed to accelerate its timeline for beginning this sweeping payment demonstration. Within a month, CMS had issued the proposed rule containing the model.

While the Alliance shares the Administration's concern over rising drug prices, a reimbursement reduction for physicians fails to address this problem. In fact, a cut of such magnitude is likely to create access problems for patients who need immediate access to the right medication. Many of these patients already face complexities in their care and treatment options, and they should not face mandatory participation in an initiative that may force them to switch from their most appropriate treatment for financial reasons. Under this proposed payment model, patients would be forced to navigate a CMS initiative that could potentially lead to a halt in their ongoing treatment.

This is not the right way to manage the Medicare program for any beneficiary - let alone patients with serious conditions. These types of initiatives should be implemented in a targeted, patient-centered, and transparent way that accounts for the unique needs of beneficiaries. The nationwide scope of the proposed model and the unilateral way in which CMS has formulated it make this development extremely disconcerting to practicing specialists who prescribe Part B medications.

In addition to asking Congress to get the model withdrawn, the Alliance will also file comments on CMS's proposal by the May 9 deadline.

Physician Advisory Council Meeting:
July 11, 2016, Liasion Hotel, Washington, DC

Alliance Legislative Fly In:
July 12th & 13th, 2016, Capitol Hill, Washington, DC

NOTE: Participation in Alliance events is by invitation-only, with some exceptions. To learn more about how you or your organization can participate, please contact your organization's staff liaison to the Alliance or email us at info@specialtydocs.org.


Alliance in the News: " Specialists Caution Against Building MACRA on a Flawed Cornerstone" The Hill's Congress Blog.
- February 17, 2016

"Ensuring an Adequate Workforce for the 21st Century" Morning Consult.
- April 5, 2016

Breast Cancer Patient Education Act Signed Into Law
After four years of persistent advocacy, the Breast Cancer Patient Education Act (BCEPA), championed by Senators Roy Blunt (R-MO) and Sherrod Brown (D-OH), and Representatives Leonard Lance (R-NJ) and Kathy Castor (D-FL), was signed into law by President Obama as part of the FY2016 Omnibus Appropriations bill. The American Society of Plastic Surgeons (ASPS), the largest association of plastic surgeons in the world, representing more than 7,000 members and 94 percent of all American Board of Plastic Surgery board-certified plastic surgeons in the United States, strongly supported this legislation since its initial introduction in 2012 and proudly thanks the bill sponsors for their continued support and leadership in making this bill into law.

This important legislation will provide necessary information to patients about the availability of breast reconstruction and prostheses following their mastectomy. While the Women's Health and Cancer Rights Act of 1998 mandated that all insurance providers that offer coverage for breast cancer treatment must also cover breast reconstruction and prostheses, studies show that few patients are aware of their options. Greater awareness about these options is important, as breast reconstruction can be a critical part of the recovery process impacting the patient's psychological and sexual well-being.

The Need for Greater Awareness
According to the American Cancer Society, an estimated 231,840 new cases of invasive breast cancer were expected to be diagnosed among women in the United States in 2015. While some eligible women with breast cancer undergo breast reconstruction, many women - particularly those of racial and ethnic minority groups - are not informed about their care options. This is particularly concerning as African-American women under the age of 40 have a greater incidence of breast cancer than Caucasian women of the same age. Furthermore, breast cancer is the most common cancer among Hispanic women.

Less than half of all women requiring a mastectomy are currently offered breast reconstruction surgery1 and fewer than one in five elect to undergo the procedure.2 While there is little consensus as to why women do not choose to undergo the procedure following their mastectomy, a recent study in The Journal of the American Medical Association confirmed that almost one-fifth of women who do not undergo breast reconstruction reported a lack of knowledge regarding the procedure.3 The Breast Cancer Patient Education Act will allow patients to become more informed about their health care options as they decide upon a treatment plan with their physician.

About the Bill
The Breast Cancer Patient Education Act requires the Secretary of Health and Human Services to plan and implement an education campaign to inform breast cancer patients about the availability and coverage of breast reconstruction and other available alternatives post-mastectomy. Educational materials created by the Secretary of Health and Human Services will inform women of their right to breast reconstruction under federal law and provide women with information about when breast reconstruction or prostheses may be appropriate within their recovery plan. This campaign will support existing materials on breast cancer awareness already created by the Office of Women's Health and the Office of Minority Health. Because of this, the legislation will not require any additional funding.

Implementation through HHS
The American Society of Plastic Surgeons has written to Secretary Burwell to offer their assistance and experience as the Department develops patient education materials. The Consolidated Appropriations Act directs HHS to develop this educational campaign and to "consult with appropriate medical societies" related to breast cancer and breast reconstructive surgery. ASPS has tremendous interest and a wealth of experience in creating exactly the sort of educational materials that will be needed to meet the requirements of the breast cancer patient education campaign. ASPS encourages members of Congress to urge HHS to utilize the appropriate medical societies and experts in this field as they build this educational campaign.

1 Potter S, Mills N, Cawthorn S, Wilson S, Blazeby J. Exploring inequalities in access to care and the provision of choice to women seeking breast reconstruction surgery: a qualitative study. Br J Cancer. 2013 Sep 3.
2 Agarwal, Shailesh, Lisa Pappas, Leigh Neumayer, and Jayant Agarwal. "An Analysis of Immediate Postmastectomy Breast Reconstruction Frequency Using the Surveillance, Epidemiology, and End Results Database." The Breast Journal 17.4 (2011): 352-58. Print.
3 Morrow, Monica, Yun Li, Amy K. Alderman, Reshma Jagsi, DPhil, Ann S. Hamilton, John J. Graff, Sarah T. Hawley, Steven J. Katz. "Access to Breast Reconstruction After Mastectomy and Patient Perspectives on Reconstruction Decision Making." JAMA Surg. 2014;149(10):1015-1021. Print.

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The Alliance Endorses Measures to Address Physician Workforce Shortages
The Alliance of Specialty Medicine has endorsed another piece of legislation aimed at improving the nation's graduate medical education (GME) system and helping to preserve access to essential health services for many Americans.

H.R. 4774, the Training Tomorrow's Doctors Today Act, was introduced by Rep. Kathy Castor (D-FL) on the eve of "Match Day", Friday March 18th, an annual tradition when medical school students find out into which residency training program they have been selected. The legislation would increase the number of GME residency slots by 15,000 over the next five years, and calls for a report to study the needs of the U.S. health care system and allocate residencies accordingly.

In a letter to Rep. Castor thanking her for introducing the bill, the Alliance acknowledged the need to increase the number of available primary care providers, while also urging lawmakers to recognize the reality and potential impact of acute specialty physician shortages.

According to the Association of American Medical Colleges' (AAMC) April 2016 update of physician workforce projections, the demand for physicians will exceed supply by a range of 61,700 to 94,700 by 2025. While total shortages vary by specialty grouping, it is estimated that there will be a shortfall of between 37,400 and 60,300 non-primary care physicians. With 10,000 seniors aging into the Medicare program every day, the demand for physicians - especially specialty physicians - is projected to increase.

Specialty physicians require up to seven years of post-graduate residency training. By the time a true crisis manifests itself, it will be difficult to quickly correct it. The Alliance believes that H.R. 4774 is a thoughtful first step toward addressing the physician shortage crisis.

Tackling the severe physician manpower shortage will remain a legislative priority for the Alliance of Specialty Medicine. The Alliance has previously endorsed the Resident Physician Shortage Reduction Act of 2015 (H.R. 2124/S. 1148), introduced by Senators Nelson (D-FL) and Schumer (D-NY) and Representatives Crowley (D-NY) and Boustany (R-LA) in May of 2015.

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Mohs Surgeons Mobilize to Get Flawed Mohs Surgery Coverage Determinations Reversed
The American College of Mohs Surgery represents 1,300 fellowship-trained Mohs surgeons, making it the leading authority on the skin cancer procedure. As Medicare Administrators around the country are regularly revising their Local Coverage Determinations (LCDs), the ACMS often finds itself with the opportunity to educate MAs on the importance, and specifics, of Mohs surgery.

In early March 2016, ACMS President Dr. John Albertini and Public Policy Committee Chair Dr. Brent Moody spoke with Dr. RaeAnn Capehart, Medical Director for Novitas Solutions, Inc., the Medicare Administrator for 11 states and Washington, D.C. The group continued a dialogue regarding Novitas' LCD for Mohs Micrographic Surgery (MMS) and a new audit that denied claims submitted with a place of service (POS) code other than office or ambulatory surgery center on or after January 1, 2016.

"In order for a provider to bill procedure codes 17311-17315 (MOHS/MMS surgery codes), they must personally perform all components of the MMS; including excision, processing, and reading of the specimen slides," Novitas explained in a letter responding to the Mohs College's initial outreach. "When the services are performed in a hospital setting (including outpatient hospital POS 19 and 22), the processing and reading of the slides is performed by the hospital lab and pathologist. Therefore, the professional provider would not be able to bill for the complete service which is required in order to submit a claim to Novitas for MMS."

Though Mohs surgery is most often an outpatient procedure resulting in a bundled payment charge which includes pathology and supplies, and requires no general anesthesia or multiple visits or specialists, it is sometimes performed in the hospital setting.

Collaborating with Mohs surgeons in each jurisdiction, the ACMS compiled evidence refuting Novitas' supposition, including signed affidavits from hospital pathologists explaining that Mohs surgeons did in fact perform all components of MMS and that hospitals were not billing for these services. The ACMS also contacted CMS leadership in Washington, DC to assist with expediting a correction.

Following the dialogue with Drs. Albertini and Moody, and due to the efforts of a host of others including ACMS Private Sector Task Force Chair Dr. Howard Rogers, Dr. Capehart confirmed that Novitas removed the edit and that Mohs surgeons may resubmit previously denied MMS claims with hospital outpatient department POS codes for payment.

The ACMS will continue to advocate on behalf of its membership to ensure continued access to Mohs surgery, the gold standard in skin cancer treatment. Those with questions are encouraged to contact info@mohscollege.org.

Founded in 1967 by Dr. Frederic E. Mohs, the American College of Mohs Surgery (ACMS) is a membership organization of more than 1,300 fellowship-trained skin cancer and reconstructive surgeons specializing in the Mohs micrographic surgical technique used to treat skin cancer. Learn more at www.mohscollege.org.

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Join the most powerful group of specialty physicians!
Joining forces with specialty doctors from across the country helps amplify the concerns specialty doctors share. By working together, specialty medical organizations can work more effectively to influence health care policy and ensure our primary goal: to continue to provide our patients the optimal care they need. As a part of the non-partisan umbrella organization representing all of specialty medicine, your organization will:

  • Promote specialty specific issues as part of a larger coalition, increasing visibility and understanding of issues.
  • Help increase exposure for specialty medical care.
  • Gain access to insider information, background materials and research on health policy initiatives and the political landscape.
  • Receive expert analysis on proposed legislation.
  • Caucus with other specialty organizations at the AMA House of Delegates and other forums to promote key issues that are important to specialty physicians.
  • Coordinate physician and patient grassroots efforts through a large and robust network.
  • Participate in future Alliance Fly-In events in Washington, D.C. Past events have included Capitol Hill visits and presentations by health policy experts.
For information on joining the Alliance of Specialty Medicine, visit our website at www.specialtydocs.org or contact Vicki Hart at vhart@hhs.com

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