January 2016 Council Currents

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Senate Committee Approves Califf: The Senate Committee on Health, Education, Labor, and Pensions unanimously approved the nomination of Dr. Robert Califf to be the next Commissioner of the FDA on January 12. The NHC released a statement thanking the committee and urging the full Senate to confirm Dr. Califf.

CMS Letter to Issuers: CMS released its Letter to Issuers in the federally-facilitated marketplace (FFMs) for 2017, and the NHC submitted comments. The policies articulated in the letter apply to the certification process for plans available next year and the areas in which states performing plan management functions in the FFMs have flexibility.

2017 Benefit and Payment Parameters: The Department of Health and Human Services released the proposed rule on the Notice of Benefit and Payment Parameters for 2017 last year. The NHC submitted comments supporting many of the changes in the proposed rule due to their benefit to people with chronic conditions. However, the NHC also expressed concern about the potential for discriminatory plan design.

Patient-Focused Drug Development: DA announced that in order to help expand the benefits of the Patient-Focused Drug Development (PFDD) initiative, it is encouraging patient organizations to hold their own meetings to generate public input on disease areas. FDA said it does not guarantee the agency’s involvement in such meetings, but it “will be open to participating in a well-designed and well-conducted meeting on a case-by-case basis.” FDA recommends that patient organizations interested in conducting these meetings submit a letter of intent.

Proposed Gift Substantiation Regulation: The IRS announced that it will withdraw a proposed rule that would have permitted nonprofits to collect and report charitable gifts over $250 by filing a new form that included taxpayer identification or Social Security numbers. More than 200 nonprofit organizations, including the NHC, signed on to a letter urging the IRS to withdraw the proposal.

Clinical Outcome Assessment Compendium: The FDA is seeking feedback on the pilot version of the COA Compendium, which aims to foster patient-focused drug development. Comments will be accepted until March 14. Questions should be submitted to coacompendium@fda.hhs.gov.

Patient Assistance Programs: The Health and Human Services Office of Inspector General has issued modifications of two advisory opinions that deal with patient assistance programs (PAPs). Modified AO No. 07–06 was issued to a charity that runs a PAP that assists financially needy patients with certain chronic diseases, and that was previously approved to run a fund that provided assistance specifically to Medicare beneficiaries. Modified AO No. 11–05 deals with a charity PAP that provides financial assistance for genetic tests and cancer drugs. 

Proposed Guidance Development: CDRH has released a list of guidance documents it intends to publish this fiscal year and previously-issued final guidances that may be revised or withdrawn. The list includes guidances on Incorporating Patient Preferences into Medical Devices Premarket Approvals, Humanitarian Device Exemptions, and De Novo Classifications; Policy for Regulatory Oversight of Laboratory Developed Tests (LDTs); and Patient Access to Information.

Senate Finance Committee Chronic Care White Paper: The Senate Finance Committee Chronic Care Working Group released a white paper outlining policies being considered as a part of the committee’s effort to improve health care for people with multiple, complex chronic illnesses. Feedback can be sent to chronic_care@finance.senate.gov and will be accepted through January 26, 2016.