The Food and Drug Administration (FDA) on June 30th announced in new guidance that they do not intend to enforce the track-and-trace requirements until November 1, 2015. Previously, the FDA deadline for compliance was July 1, 2015; however, after feedback from stakeholders, the FDA decided to delay enforcement of track-and-trace until November 1, 2015. This means that the FDA does not intend to take action before November 1, 2015 against dispensers who accept ownership of a product without obtaining the product tracing information. This policy does not extend to the requirements that manufacturers, wholesale distributors, or repackagers provide product tracing information to dispensers. In addition, it is still required that the dispenser provide the subsequent owner with the product tracing information, including transaction history. The FDA encourages dispensers to work with the previous owner to obtain the tracing information if that information is not received by the dispenser.
The legislation authorizing this requirement, the Drug Supply Chain Security Act (DSCSA), outlines the steps necessary to create an electronic, interoperable system that “will identify and trace certain prescription drugs as they are distributed within the United States” by November 27, 2023. The purpose of the DSCSA is to enhance the FDA’s ability to detect potentially harmful drug products and trace their distribution, allowing them to remove the harmful product from the pharmaceutical distribution supply chain.
It is important to note that although the FDA does not intend to enforce the regulations until November 1, 2015, pharmacies should begin their documentation requirements by the original July 1st deadline. It is necessary to retain all documentation in paper or electronic format, as per the requirements laid out in the DSCSA. Guidance on how to remain compliant is available here .
ASCP submitted comments on the second draft of USP Chapter <800>:Hazardous Drugs - Handling in Healthcare Settings on May 31st. As a standards-setting organization, USP has authority to create and update certain documents that serve as best practice guidance or have regulatory significance. USP Chapters below 1000 are regulatory and are enforceable by FDA. The first draft proposal of Chapter 800 originally was released last summer. At that time, ASCP submitted a four page letter with comments as well as signed onto a joint letter to USP with 5 other pharmacy organization in July 2014. The current draft chapter has been revised in response to comments from interested parties on the initial draft. It imposes restrictions on workers handling dangerous drugs, but these restrictions include situations where a dosage form has to be manipulated, including tablet splitting and crushing tablets or opening capsules. The revision also references coming changes to USP Chapter 797 (Pharmaceutical Compounding – Sterile Preparations) to harmonize the Chapter 800 content. In effect, a pharmacy or a SNF would have to build a negative pressure room in order to manipulate a tablet or capsule considered Hazardous as included on the NIOSH list of Antineoplastic and other hazardous drugs in healthcare setting, 2014.
ASCP's submitted comments outlined issues for LTC in both pharmacies and facilities. These included recommendations to not apply one standard for Hazardous drugs to all healthcare settings and to not impede patient care with regulations that are not realistically attainable, especially in the LTC setting. ASCP also signed onto a joint letter to USP from a stakeholders group that included seven pharmacy organizations as well as the American Medical Association (AMA) and described the issues from both a pharmacist and physician perspective.
On May 20, 2015, a joint letter was submitted to the U S Food and Drug Administration (FDA) with comments in response to "Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities.” As stated in the letter, “the delivery of pharmacy services to residents of nursing homes and other long-term care facilities is a specialized pharmacy category whose methods of operation have evolved over the past 25 years in order to facilitate the appropriate care of these residents. The draft repackaging guidance directly conflicts with these operational standards and would result in severe disruption to the industry, as well as create a potential reduction in patient safety and quality of care for nursing home residents unless FDA makes modifications to this guidance.” Read the full press release here.
On April 22, ASCP was featured on “A Call to Action: Raising Awareness for Reducing Adverse Events in Nursing Homes,” a quarterly CMS coalition teleconference comprised of long term care stakeholder groups. During the call, ASCP’s Director of Education and Clinical Affairs, Joan Baird, PharmD, CGP, FASCP, discussed the critical role of the consultant pharmacist in long term care facilities. She briefly explained the regulatory guidance under which consultants practice, and pointed out the changing long term care landscape and challenges. Dr. Baird asked that coalition leadership work together to ensure consultants have access to the full medical record both on and offsite, and that consultants be contacted immediately when a fall occurs or there is a change in a resident’s condition.”
The National Council on Aging invited ASCP to the 2015 Falls Prevention Summit, a White House Conference on Aging event held on April 30, 2015. The purpose of the event was to update the 2005 "Falls Free National Action Plan," and engage key stakeholders in committing to implement recommendations of the revised National Action Plan. ASCP had the opportunity to educate other clinicians on the role that consultant pharmacists can play in fall prevention, and suggest incorporating new recommendations to enlist the expertise of a long-term care pharmacist in the updated edition of the Action Plan.
The long-term care pharmacy industry is one of many pharmacy segments concerned over the Food and Drug Administration (FDA) repackaging guidelines and compounding guidelines. ASCP joined other pharmacy stakeholder organizations to attend a Listening Session meeting at FDA headquarters on April 30th to discuss these guidances. The session was moderated by Jane Axelrad, Associate Director for Policy, CDER-FDA. ASCP expressed concerns with both documents and their possible effects on long term care practices. As currently drafted, the guidelines would prohibit repackaging medicines unless they are prescribed for a specific patient. This would make it difficult for long-term care pharmacies to maintain emergency kits and remote dispensing equipment. The compounding guidelines could have implications for pharmacies near a state border that service facilities in more than one state. Other industries have expressed concern over this draft and are working to persuade FDA to amend the guidelines. ASCP is working with other groups and companies to respond to the proposed guidelines by the May 17 comment deadline.
CMS released the final 2016 Rate Announcement and Call Letter on Monday. Although the Call Letter did not contain any surprises, we are encouraged that CMS shares our concern over important issues such as medication therapy management, the adequacy of PDP pharmacy networks and the accuracy of the PDP network listings. We believe the Call Letter gives us the opportunity to continue to engage CMS on these issues in the coming months. Areas of interest in the document include the CMR completion rate as a component of the plan Star Ratings, Audit & Oversight, and MAC Pricing. For more information, see the highlights document which also includes links to the Call Letter as well as a CMS Fact Sheet.
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.
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 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.
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.
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.
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.
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.
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).
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.
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.
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 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.
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.
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).