CMS Proposed CY 2021 Payment Rules: What You Need to Know

ACCC and legal experts from Hogan Lovells US LLP provided an in-depth analysis of the proposed calendar year (CY) 2021 Medicare payment rules. Learn how the proposed Hospital Outpatient Prospective Payment System (OPPS) and proposed Physician Fee Schedule (PFS) rules could affect your cancer program or practice.

The OPPS proposed rule would continue many of the controversial policies CMS has implemented in recent years that have been upheld by the courts. These include the payment reduction for clinic visits at excepted (grandfathered) off-campus departments and the reduction in payment for drugs purchased under the 340B program.

Since the COVID-19 public health emergency (PHE) was declared earlier this year, CMS has issued waivers to increase flexibility and reduce regulatory burdens. In the PFS proposed rule, CMS proposes to make permanent, extend, or transition out of these new rules.

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Elizabeth (Beth) Halpern

Partner, Hogan Lovells

Beth Halpern helps health care clients achieve coverage and reimbursement for innovative technologies. She advises pharmaceutical and device manufacturers, health care providers, and trade associations about Medicare and other payers' policies and develops strategies to improve access to care. Beth helps clients advocate before administrative agencies and Congress, and she advises about Medicare law for clients involved in litigation.

In more than 10 years of practice, Beth has worked with clients on securing coding, coverage, and reimbursement for many new drugs, devices, and medical services. By analyzing the regulatory landscape, including Medicare's payment systems for drugs and biologicals, physicians, hospitals, dialysis clinics, and durable medical equipment, she has helped clients benefit from health reform and take advantage of incentive payments for new technologies. She advises clients not only about what the law is now, but also about how to change the law, drafting amendments to the Medicare law and successfully advocating for changes to regulations and coverage policies.

Beth frequently speaks at conferences on coverage, coding, and payment and testifies before advisory committees to the Centers for Medicare & Medicaid Services. During secondments to a large biotechnology company, Beth also served as in-house counsel, advising on government affairs and promotional compliance matters.

The American Health Lawyers Association recognized Beth as a member of the Hogan Lovells team of Pro Bono Champions for their work with the D.C. Appleseed Center on HIV/AIDS in the District of Columbia. Beth is a member of the Tahirih Justice Center's D.C. Advisory Council, and her work contributed to Hogan Lovells being recognized as Firm of the Year by Tahirih in 2015.

Beth Roberts

Partner, Hogan Lovells

For the past two decades, Beth Roberts has helped life science companies optimize the value of their innovations. She helps clients navigate the complex coding, coverage, and reimbursement challenges faced by their new technologies.

Beth counsels on Medicare and other health care issues and lobbies the U.S. Congress and regulatory agencies on her clients' behalf. Her clients include health care providers; pharmaceutical, biotechnology, and medical device manufacturers; investors; and professional and trade associations.

Beth is a creative problem solver who is passionate about improving patient access to care. She works collaboratively to solve bet-the-company issues in innovative ways. She helps turn reimbursement challenges and changes into business opportunities. She also explains complicated laws and regulations in a simple and straightforward way.

Beth guides clients from reimbursement strategy through implementation. She applies for new International Classification of Disease (ICD-10), Health Care Common Procedure Coding System (HCPCS), and Current Procedural Terminology (CPT) codes. She helps clients obtain favorable coverage for their products through the Local Coverage Determination (LCD) and National Coverage Determination (NCD) processes and advises on the opportunities and pitfalls of coverage with evidence development (CED) and parallel review. She also helps clients obtain appropriate payment, often through new technology add-on payments (NTAPs), drug and device pass-through payments, and new technology ambulatory payment classifications (APCs). Over and above, Beth advises on seizing opportunities through the Centers for Medicare and Medicaid Innovation (CMMI), including Accountable Care Organizations (ACOs) and the Oncology Care Model (OCM). When existing mechanisms do not work, Beth creates new solutions through policy initiatives or by amending the law.

Beth gains great satisfaction from her pro bono work and giving back to the community.

Christian G. Downs, JD, MHA (Moderator)

Executive Director, Association of Community Cancer Centers

Christian G. Downs, JD, MHA, is Executive Director of the Association of Community Cancer Centers. Mr. Downs brings more than 15 years of association management expertise, guiding associations in their work on national policy and educational programming. He has been instrumental in working with healthcare providers, the Centers for Medicare & Medicaid Services (CMS), and Congress on association–specific issues.

Mr. Downs led the Association of Community Cancer Centers' efforts on such critical issues as easing implementation of new regulations, ensuring patient access to new cancer therapies, and refining physician office payments for delivery of services.

Mr. Downs worked in the public policy department of the American Society of Clinical Oncology (ASCO) on physician office and billing and coding issues. Previously he administered a large tertiary care hospital, managed a physician multispecialty practice, and worked for the Education and Health Committee of the Virginia State Senate.

Mr. Downs received his master's degree in health administration from the Medical College of Virginia and his law degree from George Mason University with a special focus on regulatory and administrative law. He is a board member of the Patient Advocate Foundation and C–Change, a large coordinating organization for cancer groups.


Proposed Rules Webinar
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