REGULATIONS, NOTICES, & GUIDANCE:

  • January 5, 2016: The Centers for Medicare & Medicaid Services (CMS) submitted a final rule titled Covered Outpatient Drugs (CMS-2345-F) to the Office of Management and Budget (OMB). The OMB previously reviewed and released the rule on December 11, 2015.
  • January 4, 2016: The Office for Civil Rights (OCR) of the Department of Health and Human Services (HHS) delivered a final rule—known as the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule and the National Instant Criminal Background Check System (NICS)—that would allow certain entities covered by HIPAA to release information to the NICS pertaining to individuals under a Federal “mental health prohibitor,” which disqualifies them from owning, receiving, transporting, or shipping a firearm. Under the rule, which went into effect on February 5, 2016, no personal diagnostic or clinical data aside from the indication of the prohibitor will be revealed.
  • January 8, 2016: HHS made public the deadline extension that would allow entities to submit an Essential Community Provider (ECP) Petition, pertaining to data corrections and additions from qualified providers to be considered for the 2017 ECP list, through January 15, 2016.CMS released the ECP Petition to gather more complete data from qualifying ECP providers who wanted to be considered for inclusion on the ECP list for the 2017 benefit year.
  • January 8, 2016:, By issuing the notice Over-the-Counter Sunscreens – Safety and Effectiveness Data, the Food and Drug Administration extended the comment period for the notice “Over-the-Counter Sunscreens: Safety and Effectiveness Data; Draft Guidance for Industry; Availability,” which appeared in the Federal Register on November 23, 2015 (80 FR 72975). This extension notice made known the availability of industry draft guidance, requesting that comments be submitted by January 22, 2016. In response to an extension request, the FDA extended the comment period of the draft guidance by 30 days, which made the new comment period valid until February 22, 2016.
  • January 5, 2016:In an issued proposal rule known as Copayments for Medications Beginning January 1, 2017, the Department of Veterans Affairs (VA) proposed to amend its regulations pertaining to copayments for outpatient medications and medications for non-service conditions. Current VA charges for non-exempt veterans total $8 to $9 for medication supplies of 30 days or less. Current regulations require future year copayments to be calculated based on the Medical Consumer Index prescription drug component. The proposed rule would abolish this formula, instead basing future payment rates on a three-tier medication system, which would be more specifically defined through the rulemaking process. With certain exceptions, Tier 1, Tier 2, and Tier 3 medications would be distinguished based on medication availability under the new rule, which would go into effect January 1, 2017. New copayment amounts for 30-day or less supplies would be fixed at $5, $8, and $11 for Tiers 1, 2, and 3, respectively. The comment period closed on March 7, 2016.
  • January 4, 2016: The FDA issued two (2) final orders: Effective Date of Requirement for Premarket approval for Surgical Mesh for Transvaginal Pelvic Organ Prolapse Repair, which would require a premarket approval application (PMA) or a notice of completion for a product development protocol (PDP) be filed for said treatment; and Obstetrical and Gynecological Devices; Reclassification of Surgical Mesh for Transvaginal Pelvic Organ Prolapse Repair, which would reclassify from class II to class III said treatment. The FDA’s reclassification of said devices is based on its determination that general and special controls together are insufficient reasonable safety and effectiveness assurances for the devices, and therefore, these devices pose a potential for unreasonable risk of illness or injury. These changes are of the FDA’s own initiative because new information has been presented.
  • January 5, 2016:The FDA issued a final order, effective since January 6, 2017, entitled Obstetrical and Gynecological Devices; Classification of the Intravaginal Culture System, which classifies the intravaginal culture system into the special controls class, or class II. The special controls that will be applicable to said device will be included in the codified language for classification of the intravaginal culture system and are identified in this order. This reclassification is intended to provide for the reasonable assurance of safety and effectiveness of the device. The classification was applicable on November 2, 2015.
  • January 8, 2016:The availability of the draft document known as Use of Nucleic Acid Tests to Reduce the Risk of Transmission of Hepatitis B Virus from Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidance for Industry, announced by the FDA, makes donor eligibility determinations pertaining to donors of human cells, tissues, and tissue-based products (HCT/Ps) from establishments provided by said document. The document also contains recommendations concerning FDA-licensed nucleic acid tests (NAT) in the testing of donor deoxyribonucleic acid (DNA) for hepatitis B virus (HBV). When finalized, the draft guidance will supplement previous recommendations by the FDA to HCT/P establishments for hepatitis B surface antigen (HBsAg) and total antibody to hepatitis B core antigen (anti-HBc) testing of donor materials. The prior establishments can be found in the August 2007 document “Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps).”
  • January 6, 2016: The report released by HHS Office of Inspector General (OIG) entitled CMS Could Not Effectively Ensure That Advance Premium Tax Credit Payments Made Under the Affordable Care Act Were Only for Enrollees Who Paid Their Premiums (A-02-14-02025) showed that the OIG determined CMS could not guarantee that advance premium tax credit (APTC) payments toward qualified health plans (QHP) issuers pertained only to enrollees who had paid their premiums. The OIG found that CMS (1) did not have a process deployed that would ensure APTC payments only for premium-paying enrollees; rather, CMS used information gathered from each QHP issuer to determine which enrollees paid monthly premiums and to ensure the accuracy of APTC payments reported to CMS; and (2) had sole responsibility for ensuring that only enrollees who paid their monthly premiums received APTC payments and did not share enrollee data with the IRS. OIG recommended that CMS (1) create and establish procedures and policies for the calculation of APTC payments that would not require sole reliance on QHP issuers’ data and attestations of enrollee payments, and (2) once these payment policies and procedures are implemented to consult with the IRS concerning sharing APTC payment data throughout the year to allow for verification of data with each enrollee’s Form 1095-A at tax filing time. CMS concurred with recommendation (1) and did not respond in either agreement or disagreement to recommendation (2).
  • January 6, 2016: Concerning the dissemination of grants from charitable nonprofit organizations to financially-needy individuals suffering from specific life-threatening and chronic conditions and diseases, OIG released a Modification of Advisory Opinion 04-15, which modifies Advisory Opinion 04-15. These grants are intended to contribute to the costs of prescription drug therapies; its first modification at Modification of Advisory Opinion 04-15, is to reflect guidance issued in the Supplemental Special Advisory Bulletin on May 21regarding Independent Charity Patient Assistance Programs.
  • January 4, 2016: The proposedrule,received by OMB from CMS, known asHospital and Critical Access Hospital (CAH) Changes to Promote Innovation, Flexibility, and Improvement in Patient Care (CMS-3295-P)would update the requirements that hospitals and Critical Access Hospitals (CAHs) need to meet to participate in Medicare and Medicaid programs. The intended purpose of these proposals is to adapt the requirements to current practice standards as well as support quality of care improvements, minimize barriers to care, and diminish issues that may exacerbate workforce shortage concerns.
  • January 4, 2016: OIG issued these Advisory Opinions 15-17 and 15-16 which are respectively regarding: “a non-profit, tax-exempt, charitable organization’s proposal to provide financial assistance with copayment obligations, health insurance premiums, and insurance deductibles to patients, including Medicare and Medicaid beneficiaries, receiving treatment for [disease state redacted]”; and “a nonprofit, tax-exempt, charitable organization’s proposal to provide assistance with out-of-pocket expenses for outpatient prescription drugs to financially needy insured patients, including, but not limited to, Medicare and Medicaid beneficiaries.”
  • January 5, 2016: CMS issued the updatesR3431CP, R3432CP, R3433CP, R217BP, and R3435CP. Update R3431CP pertains to Fiscal Year (FY) 2016 Inpatient Prospective Payment System (IPPS) and Long Term Care Hospital (LTCH) PPS Changes. Update R3432CP pertains to 2016 Durable Medical Equipment Prosthetics, Orthotics, and Supplies Healthcare Common Procedure Coding System (HCPCS) Code Jurisdiction List. Update R3433CP pertains to Clinical Laboratory Fee Schedule – Medicare Travel Allowance Fees for Collection of Specimens. Update R217BP pertains to Rural Health Clinic and Federally Qualified Health Center – Medicare Benefit Policy Manual Update. Update R3435CP pertains to Clarification on Patient’s Reason for Visit Necessary to Capture HIPAA Compliant Fields.
  • January 6, 2016: The FDA reopened the comment period for “Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products”in a notice entitled Guidance: Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products.The previous comment period for the draft guidance was recorded in the Federal Register of November 7, 2013. The FDA reopened the comment period to receive any new or updated comments that have bearing on the issue. Stakeholders were recommended to submit comments by May 6, 2016 before the FDA began drafting the final version of the guidance. Stakeholders can comment at any time, though timely comment submissions during comment periods are given priority.The FDA also announced a public workshop that was held on April 21, 2016 from 8:30 a.m. to 5 p.m. on Streamlining Regulations for Good Manufacturing Practices for Hearing Aids. Electronic and written comments on the workshop were to be submitted by May 19, 2016.
  • HRSA posted the December 2015 Update 340B Price Unavailability – How to Report to HRSA. Under the 340B statute, Medicaid participating manufacturers must enter into agreement with the Secretary. The agreement requires that, when selling covered outpatient drugs to particular covered entities that are listed in the statute, manufacturers charge a price no more than the amount determined under a statutory formula (“the 340B ceiling price”). If unable to purchase a covered drug at the 340B price, the covered entity should contact the manufacturer and/or wholesaler to conclude why the drug is not available at the 340B price. If the issue remains unresolved at this stage, covered entities should notify the HRSA of such occurrences.
  • January 7, 2016: The Substance Abuse and Mental Health Services Administration (SAMHSA) submitted a rule proposal to the OMB, known as Increase Number of Patients to which Drug Addiction Treatment Act (DATA)-Waived Physicians Can Prescribe Buprenorphine. The intention of this rule was to improve the national response to the increase in heroin use and prescribed opioid misuse. The rule linked morbidity and mortality with its approach to wider access to buprenorphine treatment and diversion protection.The use of buprenorphine during Medication assisted treatment (MAT), combined with counseling and other support services, is an important tool that improves opioid addiction treatment.SAMHSA’s proposal addresses restrictions imposed on buprenorphine by the Drug Addiction Treatment ACT (DATA 2000).

III. REPORTS, STUDIES, & ANALYSES:

  • January 8, 2016: CBO released the December 2015 Monthly Budget Review. CBO estimates that the deficit for the federal budget was $212 billion for the first three months of the 2016 fiscal year. This deficit was larger by $36 billion than the deficit recorded during the same period the previous year. Receipts and outlays were higher by 4 and 7 percent, respectively, than the previous year’s amounts. The three-month deficit would have been (if not for changes in the timing of somepayments, which otherwise would have occurred on a weekend or on New Year’s Day), 9 billion larger than it was the previous year.
  • January 5, 2016: Issued by the Government Accountability Office (GAO), a report entitled DOD and VA Health Care: Actions Needed to Help Ensure Appropriate Medication Continuation and Prescribing Practices (GAO-16-158) found that DOD relies on each military service branch to review its providers’ medication prescribing practices. The report also found that the Army does not monitor the medication prescriptionsthat treat PTSD on a continual basis. Without this monitoring, the Army may not be able to identify and resolve practices that are not within the guidelines. Federal standards of internal control require such agencies to have control activities to establish measures of performance,oversee and implement ongoing monitoring to gauge performance, and ensure that the any review findings are quickly resolved. DOD and VHA agreed with GAO’s recommendations that the Army monitor the prescribing practices of medications that are discouraged under the PTSD guideline and that VHA clarify its current policy on medication continuation.
  • January 6, 2016: the Urban Institute revealed in an analysis that affordability is the primary reason uninsured parents remain uninsured.About 65 percent of uninsured parents said they couldn’t afford insurance, according to the analysis. Other frequently discussed reasons for being uninsured included transition between coverage types (13.7 percent), difficulty finding information about coverage options (7.1 percent), and not wanting insurance (13.0 percent).
  • According to a study in an issue of Health Affairs, titled Premium-Based Financial Incentives Did Not Promote Workplace Weight Loss In A 2013–15 Study, workplace wellness programs that use financial incentives to promote weight loss are ineffective. In the study, researchers at the University of Pennsylvania observed nearly 200 obese wellness program participants, giving them a goal of losing 5 percent of their body weight. To see which would be most successful, the study assigned each subjecteither no incentive, a premium-based incentive, or a separate monetary incentive. The researchers found at twelve months that no statistically significant differences had taken place in mean weight loss between the groups.