A&B Healthcare Week in Review, August 19, 2016

I. Regulations, Notices, & Guidance

• On August 16, 2016, the Department of Health and Human Services (HHS) issued a Notice of Proposed Rulemaking entitled World Trade Center Health Program.  In 2011 and 2012, the Secretary of HHS promulgated regulations designed to govern the World Trade Center (WTC) Health Program, including the processes by which eligible responders and survivors may apply for enrollment in the Program, obtain health monitoring and treatment for WTC-related health conditions, and appeal enrollment and treatment decisions, as well as a process to add new conditions to the List of WTC-Related Health Conditions. The Administrator of the WTC Health Program has identified potential improvements to certain existing provisions, including, but not limited to, appeals of enrollment, certification, and treatment decisions, as well as the procedures for the addition of health conditions for WTC Health Program coverage. Comments must be received by September 16, 2016. 
• On August 16, 2016, the Food and Drug Administration (FDA) issued a notice announcing the availability of Guidance for Industry: Classification of Pharmaceutical Co-Crystals. This guidance provides applicants planning to submit new drug applications (NDAs) and abbreviated new drug applications (ANDAs) with information on the appropriate regulatory classification of pharmaceutical co-crystal solid-state forms. This guidance also provides information about the data that applicants should submit to support the appropriate classification of a co-crystal as well as the regulatory implications of the classification. This draft guidance revises the guidance for industry entitled "Regulatory Classification of Pharmaceutical Co-Crystals" issued in April 2013. Comments on the draft guidance are requested by October 17, 2016.
• On August 15, 2016, the FDA issued a Final Guidance entitled Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery. FDA has developed this guidance document to assist industry in preparing premarket notification (510(k)) submissions for electrosurgical devices intended for use in general surgery. These devices are designed to cut and/or remove tissue and control bleeding through the use of high-frequency electrical current. For the purpose of this guidance, electrosurgical devices also may be called radiofrequency (RF) devices or high-frequency (HF) devices. Public comments may be submitted at any time for Agency consideration to http://www.regulations.gov. 
• On August 15, 2016, the FDA issued a Final Guidance entitled Premarket Notification (510(k)) Submissions for Bipolar Electrosurgical Vessel Sealers for General Surgery.  FDA has developed this guidance document to assist industry in preparing premarket notification (510(k)) submissions for bipolar electrosurgical vessel sealers intended for use in general surgery. These devices are designed to seal isolated blood and lymphatic vessels for hemostasis (as an alternative to ties) through the use of high-frequency electrical current between two electrodes in close proximity. Public comments may be submitted at any time for Agency consideration to http://www.regulations.gov.
• On August 16, 2016, the Office of Management and Budget (OMB) received the following final rules for review: 
  • A Department of Health and Human Services (HHS) final rule entitled Reform of Requirement for Long-Term Care Facilities. According to OMB, this final rule revises the requirements that long-term care facilities must meet to participate in the Medicare and Medicaid programs. OMB also notes that the rule is an integral part of Centers for Medicare & Medicaid Services (CMS) efforts to achieve broad-based improvements both in the quality of health care furnished through federal programs, and in patient safety, while at the same time reducing procedural burdens on providers
  • An HHS final rule entitled Medicare and State Health Care Programs: Fraud and Abuse; Revisions to the Office of the Inspector General's Civil Monetary Penalty Rules. According to OMB, this rule makes changes to the Civil Monetary Penalty (CMP) regulations to implement authorities under the Affordable Care Act (ACA) and other statutes. The ACA provides for CMPs, assessments, and exclusions for: (1) failure to grant timely access to the Office of Inspector General (OIG) for audits, investigations, etc.; (2) ordering and prescribing while excluded; (3) making false statements, omissions or misrepresentations in an enrollment application; (4) failure to return an overpayment; and (5) making or using a false record or statement that is material to a false or fraudulent claim. The rule also will finalize an alternate methodology for calculating certain penalties and assessments. 
  • An HHS final rule entitled Medicare and State Health Care Programs: Fraud and Abuse; Revisions to Safe Harbors Under the Anti-Kickback Statute, and Civil Monetary Penalty Rules Regarding Beneficiary Inducements and Gainsharing. According to OMB, this final rule amends the safe harbors to the anti-kickback statute and the civil monetary penalty rules under the authority of the OIG. The final rule adds new safe harbors, some of which codify statutory changes set forth in the Medicare Prescription Drug Improvement and Modernization Act of 2003 (MMA) and the ACA designed to protect certain payment practices and business arrangements from criminal prosecution and civil sanctions under the anti-kickback provisions of the statute. OIG also codifies ACA's revised definition of "remuneration" and adds a gainsharing civil monetary penalty provision
  • A Department of Defense (DOD) final rule entitled TRICARE: Refills of Maintenance Medications Through Military Treatment Facility Pharmacies or National Mail Order Pharmacy Program. According to OMB, this interim final rule implements section 702 (c) of the Carl Levin and Howard P. Buck McKeon National Defense Authorization Act for Fiscal Year 2015, which states that beginning October 1, 2015, the pharmacy benefits program shall require eligible covered beneficiaries generally to refill non-generic prescription maintenance medications through military treatment facility pharmacies or the national mail-order pharmacy program. This interim rule includes procedures to assist beneficiaries in transferring covered prescriptions to the mail order pharmacy program. 

Event Notices

• August 30, 2016: HHS will hold a meeting of the Technical Advisory Panel on Medicare Trustee Reports. The Panel will discuss the long-term rate of change in health spending and may make recommendations to the Secretary on how the Medicare Trustees might estimate health spending more accurately in the short and long run.
• September 8-9, 2016: The Medicare Payment Advisory Commission (MedPAC) will hold its next meeting September 8-9, 2016.  An agenda and additional information will be posted here one week prior to the meeting. 
• September 12, 2016: CMS will hold a meeting of the Advisory Panel on Clinical Diagnostic Laboratory Tests. The agenda for the September 12, 2016, meeting will provide for discussion and comment on specified CLFS issues relevant to the final rule entitled, “Medicare Program; Medicare Clinical Diagnostic Laboratory Tests Payment System,” which are designated in the Panel’s charter. Specifically, the Panel will discuss the following issues: payment for routine chemistry tests that are paid currently as ATPs following implementation of the new payment system for clinical diagnostic laboratory tests on January 1, 2018; and the application process for ADLTs. A detailed agenda will be posted approximately 2 weeks before the meeting here.
• September 14, 2016: The FDA will hold a meeting of the public advisory committee of the Pediatric Advisory Committee (PAC).  The Committee will discuss a number of specific products and provide an update of their additional ongoing analysis of a possible safety signal regarding the use of the drug product Exjade (deferasirox) in children with fever and dehydration that was discussed at the September 2015 PAC meeting. For the products to be discussed at the PAC meeting, FDA intends to make background material available to the public no later than 2 business days before the meeting, here. 
• September 16, 2016: The Physician-Focused Payment Model Technical Advisory Committee (PTAC) will hold its next meeting on September 16, 2016. Though previously announced, the PTAC now formally has noticed this meeting in the Federal Register.
• September 19, 2016: HHS will hold a meeting of the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria.  The September public meeting will be dedicated to the topics of Prevention and Stewardship. The meeting agenda will be posted on the Advisory Council website when it has been finalized. Pre-registration for attending the meeting in person is required to be completed no later than September 14, 2016; public attendance at the meeting is limited to the available space. 
• September 26, 2016: HHS will hold a meeting of the Presidential Advisory Council on HIV/AIDS.  The agenda for the upcoming meeting will be posted on the AIDS.gov website at aids.gov/pacha when available.

II. Congressional Legislation & Committee Action

U.S. Senate

• The Senate has adjourned and will reconvene on Tuesday, September 6, 2016.

House of Representatives

• The House has adjourned and will reconvene on Tuesday, September 6, 2016.

III. Reports, Studies, & Analyses 

• On August 16, 2016, CMS issued an MLN Matters Article entitled Next Generation Accountable Care Organizations - Implementation, to provide information on the Next Generation Accountable Care Organizations Model’s benefit enhancement waiver initiatives and supplemental claims processing direction. 
• On August 18, 2016, the OIG issued a report entitled The Department Of Health And Human Services Security Management Practices For Computer Systems With Access To Personally Identifiable Information.  The OIG found that HHS and its operating divisions use a variety of tools to monitor and detect exfiltration and other threats. All entities, including contractors that provide services to HHS, are required to follow HHS information security management practices for all covered systems.
• On August 18, 2016, OIG issued a report entitled Texas Did Not Always Comply with Federal Requirements and Its Cost Allocation Plan When It Claimed Medicaid Administrative Costs. The OIG found that, in FY 2014, the Texas Department of Health and Human Services Commission improperly charged Medicaid $55,000 for co-located warehouse costs included in the miscellaneous regional cost pool. 
• On August 17, 2016, the OIG issued a report entitled Wireless Penetration Test of Centers for Medicare & Medicaid Services’ Data Centers.  The OIG performed a wireless penetration test of select CMS Data Centers and facilities to determine whether CMS’s security controls over its wireless networks were effective. The OIG recommended that CMS improve its security controls to address identified wireless network vulnerabilities.
• On August 15, 2016, the OIG issued a report entitled Colorado Received Millions in Unallowable Bonus Payments. The report found that some of the bonus payments that Colorado received for FYs 2010 through 2013 were not allowable in accordance with Federal requirements. Most of the data used in Colorado's bonus payment calculations were in accordance with Federal requirements. OIG recommended that the State agency refund $38.3 million to the Federal Government. The State agency did not concur with the findings or recommendation. 

IV. Other Health Policy News

• On August 18, 2016, CMS released a Request for Information (RFI), entitled Inappropriate Steering of Individuals Eligible for or Receiving Medicare and Medicaid Benefits to Individual Market Plans. According to CMS, this RFI seeks public comment regarding concerns about health care providers and provider-affiliated organizations steering people eligible for or receiving Medicare and/or Medicaid benefits to an individual market plan for the purpose of obtaining higher payment rates. CMS is concerned about reports of this practice and is requesting comments on the frequency and impact of this issue from the public. CMS believes this practice not only could raise overall health system costs, but potentially could be harmful to patient care and service coordination because of changes to provider networks and drug formularies, result in higher out-of-pocket costs for enrollees, and have a negative impact on the individual market single risk pool (or the combined risk pool in states that have chosen to merge their risk pools). CMS is seeking input from stakeholders and the public regarding the frequency and impact of this practice, and options to limit this practice. Comments must be received no later than 5 p.m. on September 22, 2016.
• On August 18, 2016, CMS made available its second annual release of data that details information on the prescription drugs that were prescribed by individual physicians and other health care providers and paid for under the Medicare Part D Prescription Drug Program. Specifically, the data is in regards to privacy-protected data on the prescription drugs that were paid for under the Medicare Part D Prescription Drug Program in 2014.  The new 2014 dataset describes the specific medications paid for under the Medicare Part D program and statistics on their utilization and costs for 38 million beneficiaries enrolled in a Medicare Part D plan, who represent 70 percent of all Medicare beneficiaries. CMS provides data on more than one million distinct health care providers who collectively prescribed $121 billion in prescription drugs under the Part D program. New in the 2014 data are distinct beneficiary counts, prescription drug event counts, and total drug costs aggregated by drug category for opioids, antibiotics, antipsychotics, and high-risk medications among the elderly. In addition, a prescriber enrollment status field has been added to indicate whether the prescriber is enrolled, not enrolled, or opted out of the Medicare program. 
• On August 18, 2016, the Health Resources and Services Administration (HRSA) released the Office of Pharmacy Affairs August Update – Contract Pharmacy: Important Tips. The August Update addresses contract pharmacy selection, contract pharmacy eligibility and registration, contract pharmacy oversight, and Medicaid and contract pharmacy.
• On August 16, 2016, CMS released a New IMPACT Act Frequently Asked Questions Document. The FAQs address frequently asked IMPACT Act related questions that were received by CMS and is intended to provide guidance on related questions. 
• On August 16, 2016, Aetna announced that it will withdraw from participation in 11 Exchanges next year. Aetna will maintain a presence in Delaware, Iowa, Nebraska and Virginia. Aetna CEO, Mark Bertolini said in a statement, “More than 40 payers of various sizes have similarly chosen to stop selling plans in one more rating areas in the individual public exchanges over the 2015 and 2016 plan years.” Mr. Bertolini added, “As a strong supporter of public exchanges as a means to meet the needs of the uninsured, we regret having to make this decision.”
• At an August meeting, the National Conference of State Legislators released a report that indicates state legislators in a least 25 states filed bills during the 2015-2016 legislative sessions that aim to increase transparency around prescription drug costs by imposing new requirements on drug manufacturers, health insurers, and/or pharmaceutical benefit managers. 
• On August 15, 2016, America’s Health Insurance Plans (AHIP) released a study entitled Orphan Drug Utilization and Price Changes (2012-2014), which found a correlation between orphan drug price increases and orphan drugs that are used to treat common conditions. The study, which looked at 46 of the 80 drugs that had orphan drug exclusivity between 2012 and 2014, found that the average wholesale price of the drugs increased by 26 percent during that time frame. Drugs with mostly non-orphan uses had the greatest average price increases (37 percent); price jumps were lowest for drugs prescribed almost exclusively for their rare disease indications (12 percent).