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Federal Regulatory, Legislative and Reimbursement Report – October-November-December 2015


  • Antipsychotic Medication Use in Nursing Facilities Continues to Drop Nationally
    • The National Partnership to Improve Dementia Care in Nursing Homes has released data indicating that antipsychotic use in skilled nursing facilities has dropped 21.7% over the past four years. Data compiled through the first quarter of 2015 indicate that nationally, 18.7% of nursing home residents receive an antipsychotic. In the fourth quarter of 2011, national use in nursing facilities was 23.9%. There is a goal to reduce usage 25% by the end of 2015, and 30% by the end of 2016.
  • CMS Survey and Certification Letter: 16-04-NH Focused Dementia Care Survey Tools
  • CMS Survey and Certification Letter: 16-05-ALL Infection Control Pilot Project
    • Centers for Medicare and Medicaid Services released a Survey and Center Letter on December 23, 2015:
    • CMS has begun a three-year pilot project to improve assessment of infection control and prevention regulations in nursing homes, hospitals, and during transitions of care.
    • Please click here for more information.
  • CMS Issues Guidance on Any Willing Pharmacy AWP Requirements
    • CMS issued a guidance to Medicare Part D plans to make available terms of participation to pharmacies. “CMS expects Part D sponsors to have standard contracting terms and conditions readily available for requesting pharmacies no later than September 15 of each year for the immediately succeeding benefit year.”
  • CMS Medicare and Medicaid Programs; Reform of Requirements for Long Term Care Facilities (Mega Rule)
    • The proposed rule would revise the requirements that long-term care facilities must meet to participate in the Medicare and Medicaid programs. These proposed changes are necessary to reflect the substantial advances that have been made over the past several years in the theory and practice of service delivery and safety.
    • Highlights include:
      • New section: 483.21 Comprehensive Person-Center Care Planning
      • Gradual dose reduction includes goal to eliminate medication.
      • New definition of an unnecessary medication; CMS proposes to define all agents that affect the brain (cross blood brain barrier) as psychotropic agents.
      • Training requirements related to dementia and abuse prevention.
      • Implementation of Quality Assurance and Performance Improvement program. (QAPI)
      • Implementation of Infection Control-Institute Infection Prevention and Control Programs in LTCF.
      • Compliance and ethics programs
      • Reporting of suspicion of a crime
      • Control Programs in LTCF.
      • Compliance and ethics programs
      • Reporting of suspicion of a crime
    • https://www.federalregister.gov/articles/2015/07/16/2015-17207/medicare-and-medicaid-programs-reform-of-requirements-for-long-term-care-facilities
  • 2016 Medicare Advantage (Part C) and D Final Rule
    • Key provisions of the Final Rule include:
      • Clarifying Various Program Participation Requirements
      • Enrollment Eligibility for Individuals Not Lawfully Present in the U.S
      • Part D Notice of Changes
      • Business Continuity for MA and Part D Plans
      • Transfer of TrOOP Between PDP Sponsors Due to Enrollment Changes
      • MA-PD Coordination Requirements for Drugs Covered Under Parts A, B, and D
      • Good Cause Processes
      • MA Organizations’ Extension of Adjudication Timeframes for Organization Determinations and Reconsiderations
    • Key pharmacy provisions include:
      • Efficient Dispensing in Long-Term Care Facilities
      • New Categories or Classes
      • Medication Therapy Management Program
      • Prescription Drug Pricing Standards and Maximum Allowable Cost Section
      • Any Willing Pharmacy Terms and Conditions Section
      • Enrollment Requirements for the Prescribers of Part D Covered Drugs
    • https://www.ascp.com/sites/default/files/CMS%202016%20Final%20Rule.pdf
  • Revised Appendix PP of the State Operations Manual, Guidance to Surveyors for LTCF
    •  CMS issued revision to Appendix PP, Guidance to Surveyors for LTCF of the SOM on 11/26/14
      • Key revisions include:
        • F-Tag 222: Restraints 483.13 (a)
        • F-Tag 281: Professional Standards of Quality 483.20 (k)(3)
        • F-Tag 332/333: Medication Errors 483.25 (m)(1)(2)
        • F-Tag 332/333: Medication Errors 483.25 (m)(1)(2)
        • F-Tag 425: Pharmacy Services 483.60 (a) & (b)(1)
        • F-Tag 428: Drug Regimen Review 483.60 (c)(1)(2)
        • F-Tag 431: Consultant Pharmacist Services (483.60) (b)(2)(3)(d)(e)
        • F-Tag 441: Infection Control 483.65
      • https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/som107ap_pp_guidelines_ltcf.pdf


  • E-prescribing of controlled drugs now legal in all states
    • Vermont recently became the 50th state to approve e-prescribing for controlled substances, marking the practice legal across all states. (Health Data Management)

Legislative Update

  • Medication Therapy Management (MTM) Expansion
    • Senator Roberts (R-KS) introduced an expansion of MTM services as part of Medicare. The Medication Therapy Management Empowerment Act of 2015 (s.776) expands access to MTM services to include Medicare beneficiaries with one chronic condition. This bill does not have a companion in the House, but does have a number of bipartisan cosponsors.
  • Part D Enhanced Medication Therapy Management Model
    • The Part D Enhanced Medication Therapy Management Model will test whether providing Part D sponsors with additional payment incentives and regulatory flexibilities will engender enhancements in the MTM program, leading to improved therapeutic outcomes, while reducing net Medicare expenditures. The model is an opportunity for stand-alone basic Part D plans to right-size their investments in MTM services, identify and implement innovative strategies to optimize medication use, improve care coordination, and strengthen system
  • Congress Passes NOTICE Act
    • Approved unanimously by House and Senate, the Notice of Observation Treatment and Implication for Care Eligibility (NOTICE) Act. NOTICE Act
    • The purpose of the law is to advise Medicare beneficiaries when they are in hospitals under “observation” status and inform them of the implications of this status if they are admitted to skilled nursing facilities.
    • Hospitals often keep beneficiaries in observation status, rather than admitting them, which does not allow the beneficiary to qualify for Medicare Part A admission to a SNF because the 72-hour requirement has not been met. This legislation, while not fixing the problem, requires the beneficiary to be notified of their status.
    • President Obama has signed the legislation into law.
  • HRSA Publishes Proposed 340B Rule
    • The Health Resources and Services Administration published 340B Drug Pricing Program Omnibus Guidance in the Federal Register on August 28. The program requires manufacturers to supply drugs to eligible entities at substantial discounts. Manufacturers complain that significant amounts of these drugs are dispensed to ineligible recipients. click here for more information.
  • Pharmacy Lock-in
    • Pharmacy lock-in, the idea that a Part D beneficiary must get their controlled substances from an approved provider (they are locked into one pharmacy for their controlled substances), is a reoccurring theme on the Hill to prevent drug diversion. The current pharmacy lock-in bill is Stopping Medication Abuse and Protecting Seniors Act of 2015. SB1913 was introduced right before August recess and has yet to gain many cosponsors.
    • SB1913 exempts LTC facilities that contract with one pharmacy.

Reimbursement Update

  • CMS Publishes 2016 SNF Rule
    • CMS the final payment and policy rule for fiscal year 2016 for Medicare skilled nursing facility prospective payment system.
    • The rule increases nursing home payments by 1.2 percent, or approximately 430 million beginning October 1.
    • The rule also begins implementation of the value-based purchasing initiative and will require SNFs to begin transmitting staffing data in July, 2016. See the CMS Fact Sheet.
  • CMS Lowers Market Basket Increase
    •  In the April 27, 2015, Members Only, the Association referenced that in the PPS Notice of Proposed Rulemaking (NPRM), a net market basket growth rate of 1.4% had been proposed. Now, CMS has announced that skilled nursing facilities would get a net 1.2% pay increase — totaling $430 million — in fiscal 2016 under a final rule issued by the Centers for Medicare & Medicaid Services late Thursday. The increase reflects a 2.3% market basket increase, reduced by a 0.6% “forecast error adjustment” and 0.5% for the “multifactor productivity adjustment”. The announcement was made at the close of the business day late last week.
  • MedPAC Releases 2015 Data Book
    • The Medicare Payment Advisory Commission (MedPAC) has released its annual report on health spending in the Medicare program. The volume is a treasury of facts about demographic spending, including differences in expenditures by venue (hospitals, outpatient, nursing facilities, etc.). This has become the definitive source for data on all things. Click here for more information.
  • Medicare Drug Spending Dashboard
    • Today, CMS is releasing a new online dashboard to provide information on Medicare spending on prescription drugs, for both Part B (drugs administered in doctors’ offices and other outpatient settings) and Part D (drugs patients administer themselves) to provide additional information and increase transparency. Having this information available to the public in an accessible format should inform health care decisions, policy considerations and encourage collective problem solving around these important issues.
    • click here for more information

Government Accountability Office

  • Nursing Home Quality: CMS Should Continue to Improve Data and Oversight
    • The Government Accountability Office (GAO) recently released a new report:
      • Nursing Home Quality: CMS Should Continue to Improve Data and Oversight
      • Please Click here for more information.
  • Social Security Administration
    • 2016 Medicare Parts A & B Premiums and Deductibles Announced
      • As the Social Security Administration previously announced, there will be no Social Security cost of living increase for 2016. As a result, by law, most people with Medicare Part B will be “held harmless” from any increase in premiums in 2016 and will pay the same monthly premium as last year, which is $104.90.
      • Please click here for more information.
  • The American Geriatric Society
    • Beers Criteria for Inappropriate Medication Use in Older Adults Updated
      • For the first time since 2012, The American Geriatric Society (AGS) Beers Criteria has been updated. The 2015 Beers Criteria includes updated lists including but not limited to: medications and types of medications that are potentially inappropriate for older people, medications that are potentially inappropriate for older adults with certain common health problems, and types of medications that should be used with caution in older adults.
      • Please click here for more information.

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