CMS Releases 2016 Proposed Call Letter
On February 20th, CMS released proposed updates to the Medicare Advantage and Part D programs through the 2016 Advance Notice and Draft Call Letter. Sean Cavanaugh, Deputy Administrator of CMS and the Director of the Center for Medicare, held a conference call in which he expressed CMS’s hope that these changes continue to move the Medicare program toward paying providers based on the quality of care, rather than the number of patients they serve. Some of the issues raised in the call letter include:
The Advance Notice and draft Call Letter may be viewed by clicking here  and selecting “Announcements and Documents.” Comments on the proposed Advance Notice and Draft Call Letter are invited from the industry and the public and must be submitted by March 6, 2015. The final 2016 Rate Announcement and Call Letter, including the final Medicare Advantage and FFS growth percentage and final benchmarks will be published on Monday, April 6, 2015. Comments can be emailed to: AdvanceNotice2016@cms.hhs.gov .
CMS Releases Final Medicare Part D Rule
On Friday, February 6, the Centers for Medicare and Medicaid Services released a pre-published version of a Final Medicare Part D Rule  for plan year 2016. The rule, likely to be published in the Federal Register on Thursday, February 12, seeks to finalize several of the provisions from last year’s controversial proposed rule that weren’t addressed in the plan year 2015 final rule (released last spring). After doing a preliminary review of the rule, ASCP staff has found that only a few key provisions are being finalized, specifically, the business continuity for MA organizations and PDP sponsors and the efficient dispensing in long term care (LTC) facilities and other changes. The first provision would require MA organizations and PDP sponsors to have a plan in place to restore essential services within 72 hours of a system failure. The second provision stipulates that, beginning in 2016, plans would be prohibited from reimbursing LTC pharmacies in a manner that would discourage efficient dispensing (i.e. prorated dispensing fees). The provisions we saw in the plan year 2015 proposed rule that aren’t being finalized include the expansion of the medication therapy management (MTM) beneficiary pool and the exceptions to drug categories or classes of clinical concern (six protected classes). While it doesn’t appear to be controversial, ASCP staff will continue to review the rule in an effort to seek out any other provisions that may have an impact on LTC pharmacies.
Provider Status Bills Introduced in Both House and Senate
Provider status legislation, key ASCP-supported bills, were reintroduced January 28-29, 2015 in the House and Senate. The bill’s original sponsor, Rep. Brett Guthrie (R-KY) and the two original cosponsors, Rep. G.K. Butterfield (D-NC) and Rep. Todd Young (R-IN) were joined by Rep. Ron Kind (D-WI) to reintroduce the bill in the House. At the end of the 113th Congress, the bill had 123 cosponsors, and we will likely see most of those members signing-on in support of the bill this session as well.
A provider status bill was also introduced into the U.S. Senate, which has identical language to the House bill. S. 314, the Pharmacy and Medically Underserved Areas Enhancement Act, was introduced by Senators Chuck Grassley (R-IA), Robert Casey (D-PA), Mark Kirk (R-IL), and Sherrod Brown (D-OH).
The legislative language remains unchanged from last session; the only difference is the new bill numbers, H.R. 592 and S. 314. Both bills aim to provide patients in medically underserved communities access to pharmacists' services under Medicare Part B.
CMS Releases Revised Appendix PP of the SOM
On November 26, CMS issued a revision to Appendix PP, “Guidance to Surveyors for Long Term Care Facilities”  of the SOM. This document represents a compilation of revisions made to Appendix PP and issued beginning in 2003 through May 2014. Although the November 26 document includes updates that have already been incorporated into standard operating procedures for long-term care providers, previously unpublished updates are included in multiple F Tags. Sections of the SOM that contain revisions that impact medication use in nursing facilities include:
ASCP staff and leadership are in the process of examining the finer details of these changes. A comprehensive summary of the revisions previously unknown prior to the November 26 release of this update will be made available to ASCP members as soon as possible.
USP Republishes Proposed New General Chapter <800> Hazardous Drugs
The U.S. Pharmacopeia’s (USP’s) Compounding Expert Committee is again soliciting comments on the proposed new chapter, “General Chapter <800> Hazardous Drugs – Handling in Healthcare Settings.”  The expert committee previously published in May 2014 a proposed new general chapter, which received broad opposition from multiple stakeholders. The proposed new general chapter would establish a new standard to protect personnel and the environment when handling hazardous drugs. ASCP Policy & Advocacy staff are reviewing the proposal and plan to submit comments. Members who wish to provide feedback in support of ASCP’s comments should subscribe to the Grassroots Network (members only). The final revised general chapter is set to be published in the March 2015 Pharmacopeial Forum (PF). The draft is being published in advance to allow additional stakeholder input prior to being finalized.
Seeking Feedback - STAMP Out Prescription Misuse and Abuse Campaign
On September 17, ASCP hosted a continuing pharmacy education (CPE) webinar featuring the STAMP Out Prescription Drug Misuse and Abuse  campaign. This educational session explained how to recognize and reduce prescription drug misuse and abuse in the older adult population, and encouraged pharmacists to educate the community about this extremely pertinent topic. During the webinar, we asked members to participate by providing educational sessions in the community utilizing the STAMP Out toolkit. We want to hear from members who were successful in delivering these educational sessions and how their sessions were received by those audiences. Click here  to participate in a very short survey to provide feedback on the campaign. If you have any questions regarding the toolkit, the webinar, or how you can get involved, please email us at email@example.com .
E-Prescribing Final Rule Implementation Deadline – November 1, 2014
Since 2005, CMS has had regulations in place which mandate the use of the National Council for Prescription Drug Programs (NCPDP) SCRIPT Standard for all electronic prescriptions payable under Medicare Part D. However, within this rule were several exemptions, including an exemption for long-term care. This exemption allowed long-term care prescribers, pharmacies, and facilities to utilize legacy systems using HL7 standards for the electronic transmission of prescriptions. This exemption sunsets as of November 1, and all long-term care entities will have to utilize the NCPDP SCRIPT standard for all e-prescribing. Advanced Pharmacy created a brief summary  to explain what this November 1 deadline entails. While this rule requires the use of the NCPDP SCRIPT standard for all entities who choose to electronically transmit prescriptions, the rule does not mandate the use of e-prescribing in the long-term care setting. Manual faxing of paper prescriptions will continue to be allowed.
Stand Up, Stand Out: ASCP’s 2014 Summer Grassroots Advocacy Initiative
Legislators listen to constituents because they decide who stays in office. Lawmakers care what you think. Members who actively advocate for the value of consultant and senior care pharmacists make a difference. Summer is a great time to reach out to legislators when they are in their home districts. This year’s initiative focuses on getting patient access to and coverage for pharmacists’ clinical services. You can get involved by organizing a regional or chapter fundraiser, visiting your legislators’ district offices, inviting your legislator on a site walk, or writing a letter to the local editor. For more information about how to get involved this summer and to get regular updates, subscribe to our Grassroots Network  (members only).
DEA Issues Final Rule on Disposal of Controlled Substances
On Monday, September 8 the Drug Enforcement Administration (DEA) released their final rule regarding the disposal of controlled substances. ASCP’s Policy and Advocacy (P&A) staff have been anticipating this final rule (PDF) since the publishing of a notice of proposed rulemaking on December 21, 2012. ASCP submitted comments  (PDF) opposing the proposal citing potential new avenues for diversion and the logistical impracticality of applying the regulations. P&A staff are reviewing the details of the final rule to determine the impact it will have on the long-term care setting and will make an analysis available as soon as possible. Continue to check our Advocacy Center  for updates.
DEA Issues Final Rule on Hydrocodone Combination Products
The Drug Enforcement Administration (DEA) released on August 22, 2014 its long-anticipated final rule  rescheduling hydrocodone combination products to Schedule II of the Controlled Substances Act (CSA). The new regulation will go into effect October 6, 2014, 45 days after its publication in the Federal Register. ASCP submitted comments to the DEA docket in April 2014 opposing the proposed regulation, citing increased pain medication access barriers for patients residing in post-acute and long-term care facilities. ASCP’s leadership is currently evaluating the details of the regulation outlined in the Federal Register notice to determine next steps. ASCP members who want to stay informed on this issue should subscribe to the Grassroots Network .
Advocacy for Hospice Enrollee Medication Access Continues
ASCP has met with officials from the Centers for Medicare & Medicaid Services (CMS), as well as representatives from the Senate Finance and House Ways & Means committees, to address ongoing problems related to the CMS hospice drug-coverage guidelines published March 10, 2014. CMS officials have signaled a willingness to consider further clarification of their guidance or a complete withdrawal in favor of an interim replacement policy. ASCP is working closely with other stakeholder organizations such as the National Hospice and Palliative Care Organization and the Pharmaceutical Care Management Association. In addition, ASCP submitted comments  (PDF) July 1, 2014 in to CMS. ASCP used the opportunity to document prior authorization processing and medication access barriers observed in the field as a result of the current guidance. The Society reiterated its request to suspend the guidance until a more appropriate policy can be established.
ASCP Joins "Any Willing Pharmacy" Coalition
ASCP has joined the National Community Pharmacists Association in a coalition effort to support the "any willing pharmacy" initiative to improve pharmacy access to Medicare Part D preferred networks. The "Any Willing Pharmacy" Coalition will organize lobbying efforts for all interested parties seeking to advance H.R. 4577  (PDF), the "Ensuring Seniors Access to Local Pharmacies Act of 2014." The proposed legislation would require prescription drug plans to extend to any pharmacy an opportunity to meet the terms and conditions needed to be included in a plan's preferred network. ASCP also recently signed onto a pharmacy stakeholder letter  (PDF) to Congress in support of the legislation.
Tramadol is Now a Schedule IV Controlled Drug
Effective August 18, 2014, Tramadol is now regulated as a Schedule IV controlled drug under the CSA. DEA published the proposed rule November 2013 and ASCP submitted comments  (PDF) opposing its addition to Schedule IV citing potential patient access barriers. Prior to the publication of the final rule at least 10 states, most recently Ohio, passed legislation to recognize Tramadol as a Schedule IV drug.
ASCP anticipates that DEA will soon finalize a regulation rescheduling hydrocodone combination products from Schedule III to Schedule II of the CSA. We will keep you informed as updates become available.
USP Proposed New General Chapter <800> Hazardous Drugs
The U.S. Pharmacopeia (USP) is soliciting comments on a proposed new chapter to its USP-NF compendia. The proposed new chapter, “General Chapter <800> Hazardous Drugs – Handling in Healthcare Settings ,” would establish a new standard to protect personnel and the environment when handling hazardous drugs. ASCP Policy & Advocacy staff are reviewing the proposal and plans to submit comments. Members who wish to provide feedback in support of ASCP’s comments should subscribe to the Grassroots Network  (members only).