Alston & Bird Healthcare Week in Review, June 10, 2017

I. Regulations, Notices, & Guidance

• On June 5, 2017, the Department of Health and Human Services (HHS) issued a notice entitled, Nurse Education, Practice, Quality and Retention - Veteran’s Bachelor of Science Degree in Nursing Program. The notice announces that the Health Resources and Services Administration (HRSA) is providing single-source awards to two cohorts of current Nurse Education, Practice, Quality and Retention (NEPQR) - Veteran’s Bachelor of Science Degree in Nursing (VBSN) Program recipients. The purpose of the NEPQR-VBSN program is to provide training to veterans and equip them with the tools necessary to successfully transition into civilian nurse professional careers.
• On June 5, 2017, HHS issued a notice entitled, Ryan White HIV/AIDS Program, Part C Early Intervention Services Grant Under the Ryan White HIV/AIDS Program. The notice announces that HRSA will provide one-time noncompetitive single-source award to Staywell Health Care, Inc. The purpose of the RWHAP Part C EISEGA is to provide HIV primary care in the outpatient setting to targeted low income, underinsured, and uninsured people living with HIV.
• On June 5, 2017, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule entitled, Medicare and Medicaid Programs; Revision of Requirements for Long-Term Care Facilities: Arbitration Agreements. The proposed rule would revise the requirements that Long-Term Care (LTC) facilities must meet to participate in the Medicare and Medicaid programs. Specifically, it would remove provisions prohibiting binding pre-dispute arbitration and strengthen requirements regarding the transparency of arbitration agreements in LTC facilities. The proposed rule would support the resident’s right to make informed choices about important aspects of his or her health care. In addition, this proposal is consistent with our approach to eliminating unnecessary burden on providers. Comments are due by August 7, 2017.
•  On June 6, 2017, the Food and Drug Administration (FDA) issued a final rule; technical amendment entitled, Humanitarian Use Devices; 21st Century Cures Act. The FDA amending regulations to reflect changes recently enacted into law by the 21st Century Cures Act. Specifically, certain requirements related to humanitarian device exemptions (HDEs) and institutional review boards (IRBs) for devices have changed.
• On June 6, 2017, the Drug Enforcement Administration (DEA) issued a final order entitled, Schedules of Controlled Substances: Placement of Acetyl Fentanyl into Schedule I. With the issuance of the final order the DEA will maintain the placement of the substance acetyl fentanyl (N-(1-phenethylpiperidin-4-yl)-N-phenylacetamide), including its isomers, esters, ethers, salts, and salts of isomers, esters and ethers, in schedule I of the Controlled Substances Act.
• On June 8, 2017, the FDA issued a notice entitled, Medical Devices; Validated Instructions for Use and Validation Data Requirements for Certain Reusable Medical Devices in Premarket Notifications. The notice announces that the FDA has determined that it is necessary for manufacturers of certain reusable medical devices to include in their premarket notifications (510(k)s) instructions for use which have been validated and validation data regarding cleaning, disinfection, and sterilization, for which a substantial equivalence determination may be based. The notice includes a list of these reusable devices that will require validated instructions for use and validation data in their premarket notification. The FDA is publishing this list in accordance with the requirements established by the 21st Century Cures Act.
• On June 8, 2017, CMS issued a request for information entitled, Reducing Regulatory Burdens Imposed by the Patient Protection and Affordable Care Act & Improving Healthcare Choices to Empower Patients. Executive Order 13765, “Minimizing the Economic Burden of the Patient Protection and Affordable Care Act Pending Repeal,” directs the Secretary of HHS to achieve these aims. HHS seeks comment from interested parties to inform its ongoing efforts to create a more patient-centered health care system that adheres to the key principles of affordability, accessibility, quality, innovation, and empowerment. Comments are due by July 12, 2017.
•  On June 9, 2017, the Centers for Disease Control and Prevention (CDC) issued a notice of charter renewal.  The notice announces that under Public Law 111-347 (The James Zadroga 9/11 Health and Compensation Act of 2010) and the Federal Advisory Committee Act (Public Law 92-463) of October 6, 1972, that the World Trade Center Health Program Scientific/Technical Advisory Committee has been renewed for a 2-year period through May 12, 2019.

• June 26, 2017: The FDA announced a public advisory committee meeting of the Science Board to the FDA. The Science Board will hear an update on the FDA's biotechnology activities related to plant-derived food and animals and will hear a report from the National Antibiotic Resistance Monitoring System Review Subcommittee.
• July 10 – 11, 2017: The FDA announced a public workshop entitled, Bacteriophage Therapy: Scientific and Regulatory Issues. The purpose of the public workshop is to exchange information with the medical and scientific community about the regulatory and scientific issues associated with bacteriophage therapy.
• July 13, 2017: The FDA announced a public advisory committee meeting of the Oncologic Drugs Advisory Committee. During the morning session, the committee will discuss biologics license application (BLA) 761028 for ABP 215, a proposed biosimilar to Genentech/Roche’s AVASTIN (bevacizumab), submitted by Amgen Inc. The proposed indications/uses for this product are: (1) For the first- or second-line treatment of patients with metastatic carcinoma of the colon or rectum in combination with intravenous 5-fluorouracil-based chemotherapy; (2) in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy, for the second-line treatment of patients with metastatic colorectal cancer who have progressed on a first-line ABP 215-containing regimen; (3) for the first-line treatment of unresectable, locally advanced, recurrent or metastatic non-squamous, non-small cell lung cancer in combination with carboplatin and paclitaxel; (4) for the treatment of glioblastoma with progressive disease in adult patients following prior therapy as a single agent; (5) for the treatment of metastatic renal cell carcinoma in combination with interferon alfa; and (6) in combination with paclitaxel and cisplatin or paclitaxel and topotecan for the treatment of persistent, recurrent, or metastatic carcinoma of the cervix. During the afternoon session, the committee will discuss BLA 761074 for MYL-1401O, a proposed biosimilar to Genentech Inc.’s HERCEPTIN (trastuzumab), submitted by Mylan GmbH. The proposed indications/uses for this product are: (1) For adjuvant treatment of HER2 overexpressing node positive or node negative (ER/PR negative or with one high risk feature) breast cancer; (a) as part of a treatment regimen consisting of doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel; (b) with docetaxel and carboplatin; or (c) as a single agent following multimodality anthracycline based therapy; (2) in combination with paclitaxel for firstline treatment of HER2-overexpressing metastatic breast cancer; (3) as a single agent for treatment of HER2-overexpressing breast cancer in patients who have received one or more chemotherapy regimens for metastatic disease; and (4) in combination with cisplatin and capecitabine or 5-fluorouracil, for the treatment of patients with HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma who have not received prior treatment for metastatic disease.
• July 13 -14, 2017: The CDC announced a meeting of the Healthcare Infection Control Practices Advisory Committee (HICPAC). The agenda will include updates on CDC’s activities for prevention of healthcare associated infections (HAIs), an update on the Division of Healthcare Quality Promotion’s (DHQP) modeling activities, updates on the Guideline for Prevention of Infection in Neonatal Intensive Care Unit (NICU) Patients and the Guideline for Prevention of Infection in Healthcare Personnel, and updates from the following HICPAC workgroups: the workgroup on antibiotic stewardship principles for inclusion into clinical practice guidelines, the workgroup on updating the CDC recommendation categorization scheme, the workgroup on developing CDC recommendations for products and practices, and the National Healthcare Safety Network (NHSN) Surveillance Workgroup.
• July 17, 2017: The FDA announced a public workshop regarding development of rabies monoclonal antibody products to be used in conjunction with licensed rabies vaccine as part of a rabies post-exposure prophylaxis (PEP) regimen. The public workshop is intended to provide information for, and gain perspective from, health care providers, other U.S. Government Agencies, academic experts, industry, and other stakeholders on various aspects of development efforts pertaining to animal models, laboratory assays, and clinical trials.

II. Congressional Legislation & Committee Action

• On June 7, 2017, the Senate Finance Committee held a hearing on the nominations of Eric Hargan to be Deputy HHS Secretary; David Malpass to be Treasury Undersecretary; Andrew Maloney to be Deputy Treasury Undersecretary; and Brent McIntosh to be Treasury General Counsel.
• On June 7, 2017, the Senate Veterans’ Affairs Committee will hold a hearing entitled, Examining the Veterans Choice Program and the Future of Care in the Community. The witnesses included The Honorable David Shulkin, M.D., Secretary of Veterans Affairs, Department of Veterans Affairs; Jeff Steele, Assistant Director of National Legislative Division, The American Legion; Adrian Atizado, Deputy National Legislative Director, Disabled American Veterans; Carlos Fuentes, Director of the National Legislative Service, Veterans of Foreign Wars; Gabriel Stultz, Legislative Counsel, Paralyzed Veterans of America.
• On June 8, 2017, the Senate Finance Committee held a hearing on the President’s FY 2018 HHS budget. Secretary Tom Price was the sole witness.

• On June 7, 2017, the House Ways and Means Health Subcommittee held a hearing entitled, Promoting Integrated and Coordinated Care for Medicare Beneficiaries. The witnesses included Gretchen Jacobson, Associate Director, Kaiser Family Foundation’s (KFF) Program on Medicare Policy; Cheryl Wilson, Chief Executive Office, St. Paul’s Senior Services (SSS); Dr. David Grabowski, Professor of Health Care Policy, Department of Health Care Policy at Harvard Medical School (Harvard); and Dr. Mark Fendrick, Executive Director, University of Michigan Center for Value-Based Insurance Design (V-BID).
• On June 7, 2017, the House Energy and Commerce Committee will hold a markup of H.R. 1222, Congenital Heart Futures Reauthorization Act of 2017 (as amended by the Subcommittee on Health on May 18, 2017); H.R. 1492, Medical Controlled Substances Transportation Act of 2017; H.R. 2410, Sickle Cell Disease Research, Surveillance, Prevention, and Treatment Act of 2017; and H.R. 2430, FDA Reauthorization Act of 2017 (as amended by the Subcommittee on Health on May 18, 2017). All pieces of legislation were favorably reported.
• On June 8, 2017, the House Energy and Commerce Oversight and Investigations Subcommittee held a hearing entitled, Examining the Role of the Department of Health and Human Services in Health Care Cybersecurity. The witnesses included Emery Csulak, Chief Information Security Officer and Senior Privacy Official, Centers for Medicare and Medicaid Services, Co-Chair, Health Care Industry Cybersecurity Task Force; Steven Curren, Director, Division of Resilience, Office of Emergency Management, Office of the Assistant Secretary for Preparedness and Response, U.S. Department of Health and Human Services; and Leo Scanlon, Deputy Chief Information Security Officer, HHS.
• On June 8, 2017, the House Ways and Means Committee held a hearing on the HHS 2017 budget. The sole witness was HHS Secretary Tom Price.

• On June 5, 2017, the Office of Inspector General (OIG) released a report entitled, Wisconsin State Medicaid Fraud Control Unit: 2016 Onsite Review. The report found that for fiscal years (FY) 2013 through 2015, the Wisconsin Unit reported significant results including 24 convictions, 24 civil judgments and settlements, and combined criminal and civil recoveries of approximately $137 million. According to the report, this amounted to recovery of more than $32 for every $1 spent in the review period. However, the OIG identified several operational deficiencies and found a lack of current and comprehensive written policies and procedures, which may have contributed to the Unit's noncompliance with Federal regulations and nonadherence to certain performance standards. Specifically, of the 41 Unit case files that the OIG reviewed, 28 lacked documentation of supervisory approval to open the cases, and 24 lacked documentation of periodic supervisory reviews. The Unit did not report half of its convictions and one adverse action to Federal partners and reported others outside of required timeframes. Furthermore, the Unit lacked a written training plan for its professional employees and investigated five cases outside of its grant authority. Finally, the Unit did not always maintain adequate internal controls related to personnel and accounting.
• On June 9, 2017, the OIG released a report entitled, Round 2 Competitive Bidding for CPAP/RAD: Disrupted Access Unlikely for Devices, Inconclusive for Supplies. The report found that nearly all beneficiaries who in 2013 started using CPAP/RAD devices appeared to have continued access to them after Round 2 of the Competitive Bidding Program for DME began. The OIG’s surveys provided some anecdotal context for a sample of beneficiaries for whom payments for devices stopped. For example, physicians told the OIG that the beneficiaries still needed CPAP/RAD devices, and beneficiaries generally reported continuing to use them. For CPAP/RAD supplies, the OIG found that Medicare payments stopped for 46 percent of beneficiaries in Round 2 competitive bidding areas compared to 33 percent in areas that were not competitive bidding areas. About half of the beneficiaries the OIG surveyed reported needing supplies, and nearly all of these beneficiaries reported getting needed supplies.

IV. Other Health Policy News

• On June 5, 2017, CMS issued an informational bulletin entitled, Updated 2017 Spousal Impoverishment Standards. The bulletin provides an update to the 2017 Supplemental Security Income (SSI) and Spousal Impoverishment Standards.
• On June 7, 2017, CMS issued an informational bulletin entitled, Strategies to Streamline Transitions for Medicaid-eligible Beneficiaries Who Newly Qualify for Medicare. The informational bulletin provides strategies to streamline transitions for Medicaid-eligible beneficiaries who are newly qualify for Medicare.

V. ACA Repeal News

• On June 5, 2017, White House Legislative Affairs Director Marc Short said Senate staff is close to finishing its draft version of an Affordable Care Act overhaul and, despite senators' vow to start from square one, the bill likely will be similar to the House legislation, including in its treatment of preexisting conditions.