Trump Administration Issues Proposed Rule on Importation of Prescription Drugs

The proposed rule applies to drugs that meet FDA labeling standards and impose no risk to health and safety. The import rule excludes controlled substances, biological products and intravenous drugs. (FDA's Safe Importation Action Plan.)

Comments on the NPRM are being accepted for 75 days after publication in the Federal Register and comments on the draft guidance are being accepted for 60 days after publication in the Federal Register.

Read the HHS press release.
Read Importation of Prescription Drugs Proposed Rule.
Read new draft guidance for industry.

FDA Approves Enzalutamide for Metastatic Castration-Sensitive Prostate Cancer

On Dec. 16, 2019, the U.S. Food and Drug Administration (FDA) approved enzalutamide (Xtandi, Astellas Pharma Inc.) for patients with metastatic castration-sensitive prostate cancer (mCSPC).

FDA previously approved enzalutamide for patients with castration-resistant prostate cancer.

Read the FDA announcement.

Posted 12/17/2019

Senate Confirms Dr. Stephen Hahn as U.S. FDA Commissioner

On Dec. 12, 2019, the U.S. Senate voted to confirm radiation oncology Stephen Hahn, MD, FASTRO, as the next Commissioner of the U.S. Food and Drug Administration (FDA).

Posted 12/12/2019  

FDA Approves Atezolizumab + Chemotherapy for Metastatic Non-Squamous NSCLC

FDA Approves New Treatment Option for CLL Under International Collaboration

CMS Issues Rules on Price Transparency for Hospitals and Health Insurance Issuers

On Nov. 15, the Centers for Medicare & Medicaid Services (CMS) issued two rules that aim to increase price transparency and increase competition among all hospitals, group health plans, and health insurance issuers in the individual and group markets. The agency finalized the calendar year (CY) 2020 Outpatient Prospective Payment System (OPPS) & Ambulatory Surgical Center (ASC) Price Transparency Requirements for Hospitals to Make Standard Charges Public rule, and issued the Transparency in Coverage Proposed Rule. Both rules (final and proposed) require that pricing information be made publicly available.

The final "Price Transparency Requirements for Hospitals to Make Standard Charges Public" rule will require hospitals to make their standard charges public in two ways starting in January 1, 2021:

• Comprehensive Machine-Readable File: Hospitals will be required to make public all hospital standard charges (including the gross charges, payer-specific negotiated charges, the amount the hospital is willing to accept in cash from a patient, and the minimum and maximum negotiated charges) for all items and services on the Internet in a single data file that can be read by other computer systems. The file must include additional information such as common billing or accounting codes used by the hospital (such as Healthcare Common Procedure Coding System (HCPCS) codes) and a description of the item or service to provide common elements for consumers to compare standard charges from hospital to hospital.
• Display of Shoppable Services in a Consumer-Friendly Manner: Hospitals will be required to make public payer-specific negotiated charges, the amount the hospital is willing to accept in cash from a patient for an item or service, and the minimum and maximum negotiated charges for 300 common "shoppable services" in a consumer-friendly way and update the information at least annually.

CMS fact sheet on final rule.
Access final rule.

CMS states that the proposed "Transparency in Coverage" rule is issued in response to an Executive Order dated June 24, 2019. The Department of Health and Human Services, the Department of Labor, and the Department of the Treasury are collectively issuing the proposed rule. As written, the rule would require that most employer-based group health plan and health insurance issuers provide up-front disclosure of price and cost-sharing information to participants, beneficiaries, and enrollees. 

If finalized, the "Transparency in Coverage" proposed rule would require health plans to:

• Provide consumers with real-time, personalized access to cost-sharing information, including an estimate of their cost-sharing liability for all covered healthcare items and services, through an online tool that most group health plans and health insurance issuers would be required to make available to all of their members, and in paper form, at the consumer’s request. This would allow consumers to shop and compare costs between specific providers before receiving care.

Disclose on a public website their negotiated rates for in-network providers and allowed amounts paid for out-of-network providers. Making this information available to the public is intended to drive innovation, support informed, price-conscious decision-making, and promote competition in the healthcare industry.  

Access a CMS fact sheet on the proposed rule.
Access the proposed rule.

More details are available in the HHS press release.

FDA Grants Accelerated Approval to Zanubrutinib for Mantle Cell Lymphoma

FDA Office of Hematology Oncology Products, Now Called Office of Oncologic Diseases

On November 5, the U.S. Food and Drug Administration (FDA) announced that the FDA's office responsible for reviewing applications for new and existing cancer therapies has reorganized and been renamed as part of modernization plans approved in September 2019.

The Center for Drug Evaluation and Research (CDER) Office of Hematology and Oncology Products (OHOP) has been reorganized and renamed the Office of Oncologic Diseases (OOD).

Richard Pazdur, M.D., who joined the FDA in 1999 as director for the Division of Drug Oncology Products and became the OHOP Director in 2005, is the acting director of OOD.

Read FDA press release.

Posted 11/06/2019

CMS Issues RFI on Oncology Care First Model

Late Friday, Nov. 1, the Center for Medicare and Medicaid Innovation (the Innovation Center) released an informal Request for Information (RFI), on value-based payment to support high-quality oncology care. In the Nov. 1 announcement the Innovation Center stated they hope to gather feedback during today's Public Listening Session that will outline a potential Oncology Care First (OCF) Model. 

The Innovation Center stated Friday at the Nov. 4 Public Listening Session and in submitted written feedback, they hope to solicit stakeholder input on the following targeted topics:

1. The potential OCF Model would seek to improve health outcomes and quality of care for Medicare beneficiaries with cancer. How could the potential model support participants’ care transformation through practice redesign activities? Specifically, how could the potential model build on lessons learned from the implementation of the practice redesign activities included in the Oncology Care Model (OCM)? What revisions or additions should be made to the OCM practice redesign activities in the potential model?
2. We welcome feedback on the potential payment methodology, including the structure and design of the monthly population payment and the performance-based payment. We are considering the inclusion of additional services in the monthly population payment, such as imaging or lab services, and seek feedback on adding these or other services to the monthly population payment.
3. We encourage feedback on the conceptualized risk arrangements, in particular, how a downside risk arrangement might be best constructed in terms of the level of risk.

We invite feedback on the interest of physician group practices (PGPs) and hospital outpatient departments (HOPDs) in participating in a potential OCF Model. We are particularly interested in hearing from PGPs and HOPDs about the conceptualized participation eligibility parameters (e.g., the grouping concept), and whether they think that meeting those parameters would be feasible. We also invite feedback from potential payer partners, including commercial payers and state Medicaid agencies. We welcome suggestions about the model concept that would better incentivize participation in the potential model.

CMMI Public Listening Session on Potential Oncology Payment Model
Monday, Nov. 4, 2019
1:00 to 4:00 PM EST

CMS to Hold Nov. 6 Call on PFS and OPPS Final Rules

On Wednesday, November 6 from 2:15 p.m. to 3:45 PM, EST, the Centers for Medicare & Medicaid Services (CMS) through the CMS Medicare Learning Network is holding a call on provisions in the CMS CY 2020 final Outpatient Prospective Payment System and Physician Fee Schedule and Quality Payment Program final rules.

Register Here.
A question and answer session follows the presentation.

Target Audience: Medicare Part B fee-for-service clinicians; office managers and administrators; state and national associations that represent health care providers; all hospitals operating in the United States; and other stakeholders. 

Posted 11/04/19