Alston & Bird Healthcare Week in Review, June 2, 2017

Regulations, Notices, & Guidance

• On May 30, 2017, the Department of Veterans Affairs (VA) issued a notice of intent entitled, Notice of Intent to Grant an Exclusive License. The notice of intent announces the VA’s Office of Research and Development, Technology Transfer Program tends to grant to Avicenna Medical, Inc., 3090 Dhu Varren Court, Ann Arbor, MI 48105, an exclusive license to the know-how documented in VA Invention Disclosure number 2016-186, entitled, “Med Rec Tool Plus (Navigator Tool).” The tool is a series of algorithms, embodied in software applications, to improve medication reconciliation.
• On May 30, 2017, the Department of Health and Human Services (HHS) issued a notice entitled, National Vaccine Injury Compensation Program List of Petitions Received. The notice announces the publication of petitions received under the National Vaccine Injury Compensation Program.
• On May 30, 2017, the Food and Drug Administration (FDA) issued a notice of petition entitled, Glo Eyes, LLC; Filing of Color Additive Petition. The notice announces that the FDA has filed a petition, submitted by Glo Eyes, LLC, proposing that the color additive regulations be amended to provide for the safe use of D&C Yellow No. 8 as a color additive in contact lens solution.
• On May 31, 2017, the National Institutes of Health (NIH) issued a notice entitled, Prospective Grant of Exclusive Patent License: Mutant IDH1 Inhibitors Useful for Treating Cancer. The notice announces that the National Center for Advancing Translational Sciences, an institute of the NIH, is contemplating the grant of an exclusive patent license to practice the inventions embodied in the Patent Applications listed in the Summary Information section of the notice to GeneXion Oncology, Inc., located in New York, NY. Comments are due by July 3, 2017.
•  On June 2, 2017, the NIH issued a notice entitled, Prospective Grant of Exclusive Patent License: Production of Attenuated West Nile Virus Vaccines. The notice announces that the National Institute of Allergy and Infectious Diseases, an institute of the NIH is contemplating the grant of an Exclusive Commercialization Patent License to practice the inventions embodied in the Patents and Patent Applications listed in the Summary Information section of the notice to the International Medica Foundation located in Shoreview, Minnesota, U.S.A. Comments are due by June 20, 2017.
•  On June 2, 2017, the NIH issued a notice entitled, Government-Owned Inventions; Availability for Licensing. The notice announces the availability for licensing of methods for treating cerebral edema and restoring blood-brain barrier integrity description of technology.

• June 23, 2017: The NIH announced a meeting of the Diabetes Mellitus Interagency Coordinating Committee (DMICC). The June 23, 2017 DMICC meeting will focus on Measurement Science and Glycemic Control.
• June 27 – 29, 2017: The VA announced a meeting of the Veterans’ Rural Health Advisory Committee. The meeting will include updates from Loannis A. Louganis VA Medical Center (LAL VAMC) leadership; Acting Executive Director of the Office of Rural Health; and Committee Chairwoman, as well as presentations by local health care subject matter experts.

II. Congressional Legislation & Committee Action

• The Senate has adjourned and will reconvene during the week of June 5, 2017.

• The House has adjourned and will reconvene during the week of June 5, 2017.

• On May 30, 2017, the Government Accountability Office (GAO) released a report entitled, Medicare Advantage: CMS Should Use Data on Disenrollment and Beneficiary Health Status to Strengthen Oversight. The report found that beneficiaries who left the 35 contracts with health-biased disenrollment tended to report leaving for reasons related to preferred providers and access to care. In contrast, beneficiaries who left the 91 contracts without health-biased disenrollment tended to report that they left their contracts for reasons related to the cost of care.
• On June 1, 2017, the Office of Inspector General (OIG) released their Spring 2017 Semiannual Report to Congress. The spring edition of the Semiannual Report to Congress covers OIG activities from October 2016 through March 2017. According to the OIG, historically, about 80 percent of the OIG's resources are directed to work related to Medicare and Medicaid. This is mirrored in the organization and content of the report.
• On June 1, 2017, the Congressional Budget Office (CBO) released a cost estimate of H.R. 2579, the Broader Options for Americans Act. According to the CBO, because the effects of the bill would be contingent upon enactment of subsequent legislation, the staff of the Joint Committee on Taxation (JCT) estimates that the bill would in isolation have no effect on revenues or direct spending relative to current law; therefore pay-as-you-go procedures do not apply. However, if the American Health Care Act of 2017 (AHCA) was enacted prior to this legislation, then relative to the new law the enactment of this bill could affect revenues or direct spending and, as a result, subsequent estimates of the effects of this legislation could change. The CBO and the JCT estimate that enacting the bill would not increase on-budget deficits or net direct spending by more than $5 billion in any of the four 10-year periods beginning in 2028.
• On June 1, 2017, the CBO released a cost estimate of H.R. 2581, the Verify First Act. According to the CBO, because the effects of the bill would be contingent upon enactment of subsequent legislation, the staff of the JCT estimates that the bill would in isolation have no effect on revenues or direct spending relative to current law; therefore pay-as-you-go procedures do not apply. However, if the AHCA was enacted prior to this legislation, then relative to the new law the enactment of this bill could affect revenues or direct spending and, as a result, subsequent estimates of the effects of this legislation could change. The CBO and the JCT estimate that enacting the bill would not increase on-budget deficits or net direct spending by more than $5 billion in any of the four 10-year periods beginning in 2028.
• On June 1, 2017, the CBO released a cost estimate of H.R. 2372, the Veterans Equal Treatment Ensures Relief and Access Now Act. According to the CBO, because the effects of the bill would be contingent upon enactment of subsequent legislation, the staff of the JCT estimates that the bill would in isolation have no effect on revenues or direct spending relative to current law; therefore pay-as-you-go procedures do not apply. However, if the AHCA was enacted prior to this legislation, then relative to the new law the enactment of this bill could affect revenues or direct spending and, as a result, subsequent estimates of the effects of this legislation could change. The CBO and the JCT estimate that enacting the bill would not increase on-budget deficits or net direct spending by more than $5 billion in any of the four 10-year periods beginning in 2028.

IV. Other Health Policy News

• On May 30, 2017, the Centers for Medicare & Medicaid Services (CMS) announced that it is readying a fraud prevention initiative that removes Social Security numbers from Medicare cards to help combat identity theft. The new cards will use a unique, randomly-assigned number called a Medicare Beneficiary Identifier (MBI), to replace the Social Security-based Health Insurance Claim Number (HICN) currently used on the Medicare card.
• On May 31, 2017, a group of 184 House Democrats and Republicans sent a letter and asked HHS Secretary Tom Price to issue a rule that would explicitly require qualified health plans to accept premium payments from third-party payers, including charities, places of worship and civic groups.
• On June 1, 2017, CMS issued a guidance entitled, Enforcement Safe Harbor for Product Discontinuation Notices in Connection with the Open Enrollment Period for Coverage in the 2018 Benefit Year Individual Market. According to CMS, consistent with previous guidance, in connection with the open enrollment period for coverage in the 2018 benefit year, CMS will not take enforcement action against an issuer for failing to send a product discontinuation notice with respect to individual market coverage at least 90 days prior to the discontinuation, as long as the issuer provides such notice consistent with the timeframes applicable to renewal notices.

V. ACA Repeal News

• On June 1, 2017, Senator Richard Burr (R-NC) told a North Carolina news station that “it's unlikely that we will get a health care deal, which means that most of my time has been spent trying to figure out solutions to Iowa losing all of its insurers.” Sen. Burr went on to say “I don't see a comprehensive health care plan this year.”