DEA Requirement Update:
1. Biennial Inventory: Pharmacy will need to audit all controlled substances including expired drugs. Audit reports for CII drugs separated from report for CIII through C-V drugs. Use separator sheet between CII and all other drugs. Place a third sheet at the end of CIII - C-V drugs. Keystone/PARD office has examples for your use. Must be done every 2 years, can be done sooner BUT not later than 2 years from the previous audit. Must be started and completed on the same day either at start of day or at end of day and properly shown on first page of audit.
Power of Attorney for ordering CII - Each person (other than the DEA Registrant) given the right to order CII must have a Power of Attorney on file at the facility. No sharing user name & password for CSOS - $10,000 per incident fine. We have the Power of Attorney form in house for your use. Just call.
NCPA Advocacy Center Update
Week Ending May 12th, 2012
NCPA Annual Legislative Conference: The 44th Annual Legislative Conference concluded this week with panel briefings from congressional health policy advisers, top federal officials from Medicare and Medicaid, and antitrust lawyers from the Senate, the Federal Trade Commission, and private practice. Some of community pharmacy's strongest advocates and champions attended this year's rally including Senator Mark Pryor (D-AR)—original sponsor of the Pharmacy Competition and Consumer Choice Act (S. 1058); Representative Tom Marino (R-PA)—original sponsor of the Preserving Our Hometown Independent Pharmacies Act (H.R. 1946); Representative Peter Welch (D-VT)—original sponsor of the Medicare Access to Diabetes Supplies Act (H.R. 1936); Senator Roger Wicker (R-MS); Representative Judy Chu (D-CA), and Representative Ruben Hinojosa (D-TX).
In addition, these Members of Congress spoke to our general sessions about the public policy issues of most importance to community pharmacy: Ways and Means Committee Chairman Dave Camp (R-MI), House Energy and Commerce Health Subcommittee Ranking Member Frank Pallone (D-NJ), Congressman Aaron Schock (R-IL); Senators Jerry Moran (R-KS), Al Franken (D-MN), and Sherrod Brown (D-OH). In addition, these government officials and experts spoke: Jonathan Blum, Deputy Administrator and Director, Center for Medicare, Centers for Medicare and Medicaid Services; Barbara Edwards, Deputy Director, Centers for Medicaid and CHIP Services, and Colonel George E. Jones, Jr. PharmD, Deputy Chief, Pharmaceutical Operations Directorate, TRICARE Management Activity.
NCPA Members had more than 500 hill visits with their Members of Congress on Tuesday and Wednesday of this past week and many more participated from home by contacting their Members of Congress on the key issues. Thanks to all NCPA members who participated in NCPA Legislative Conference activities this past week – either by coming to Washington or participating from back home!
Congress Making Changes to DOD TRICARE Pharmacy Program: This week the House Armed Service Committee approved the 2013 National Defense Authorization Act. In it, the Committee supported a number of changes which affect beneficiaries and the pharmacy benefit. The Committee endorsed changes to the co-payment for pharmacy benefits (but did not endorse the drastic changes proposed by the Obama Administration that would have significantly incentivized the use of mail order).
This proposal would establish the cost-sharing rates under the TRICARE pharmacy benefits program as $5 for generic medications, $17 for formulary medications and $44 for non-formulary medications obtained through retail pharmacies (all 30 day supplies), and $0 for generic medications, $13 for formulary medications and $43 for non-formulary medications obtained through the TRICARE mail order pharmacy (at 90 day fills). This section would also limit any annual increase in cost-sharing rates under the TRICARE pharmacy program to the amount equal to the percentage increase by which retiree pay is increased beginning October 1, 2013.
We greatly appreciate that after meeting with Mississippi independent pharmacy representatives, Congressman Steve Palazzo (R-MS) offered an amendment--which was agreed to--that requires the Department of Defense to study the effects of offering incentives for mail order pharmacy use on independent and community pharmacies.
Further, the legislation includes a pilot program for refills of maintenance medications for TRICARE for Life Beneficiaries through the TRICARE mail-order pharmacy program. The Secretary of Defense will conduct a pilot program for 5 years that would require TRICARE for Life eligible beneficiaries to obtain refill prescriptions for maintenance medication from the TRICARE mail order pharmacy. The section would allow beneficiaries to opt out of the mail order program after 1 year and would authorize the Secretary of Defense to waive the mail order requirement on an individual basis if the Secretary deems it appropriate. NCPA will work with the Congress to try and delete this mail order requirement by showing them the many pictures of mail order waste that have been sent to us by our members.
Congress Holds DME Competitive Bidding Hearing: The Subcommittee on Health in the House Ways and Means committee held a hearing focused on the impact of the DMEPOS competitive bidding program on beneficiaries, suppliers, and Medicare expenditures and the implications for program expansion.
CMS’ testimony focused on the positive findings of the competitive bidding program, while GAO made several statements in their testimony to bring light to the fact that the data analyzed for the report was very limited at this time. Specifically, GAO stated in its introduction that, “our findings on the first year of the round 1 rebid are based on the limited evidence available at the time we did our work.” In addition, GAO stated that, “although the first year of the CBP round 1 rebid has been completed, it is too soon to determine its full effects on Medicare beneficiaries and DME suppliers.”
Members of Congress expressed their concerns with the competitive bidding process in their questions to the representatives from CMS and the GAO. Congressman Jim Gerlach (R-PA) also weighed in and stated that he was very concerned that under the program, community pharmacists would not be reimbursed for home delivery of diabetic testing strips. Rep. Gerlach stated that this is a patient access issue and needs to be addressed before moving forward.
Track and Trace for Prescription Drugs: The House Energy and Commerce Committee finally approved major Food and Drug Administration legislation (H.R. 5651) on Thursday, setting up a floor vote as soon as next week. The legislation passed without a single vote in opposition (46-0). The House bill includes provisions that would address the issue of drug shortages, especially with respect to the DEA increasing manufacturer quotas for controlled substance production if they are in short supply. There are no new downstream supply chain security provisions in the House bill, such as requirements for pharmacists to track and trace prescription drugs.
The Senate could take up the FDA user fee legislation as early as next week as well. NCPA is working very closely with the supply chain stakeholder coalition and key Senate HELP committee staff to evaluate ways to make the pharmaceutical distribution system safer, while protecting the interests of independent pharmacies by ensuring that new burdens are not imposed on small business pharmacies with respect to tracking and tracing of prescription drugs.
CMS Shares Important Part D Information at NCPDP Annual Meeting: NCPA staff participated in NCPDP workgroup meetings and the Annual Conference this week. Several key topics discussed include:
- NPI Requirement: beginning January 1, 2013, all Medicare Part D prescription drug events (PDEs) must contain active and valid individual prescriber NPIs. Sponsors will be required to engage in point-of-sale NPI validation communication with pharmacies, and if this communication does not produce an active and valid NPI, sponsors will be required to pay the claim and research the NPI. Sponsors will only be able to recoup payment from a network pharmacy if the sponsor has engaged in the POS communication and the pharmacy contract permits recoupment. NCPDP is working on a series of communication codes as the pharmacy and sponsor work to validate an NPI. Pharmacies need to be aware of these requirements, and closely scrutinize their contracts for recoupment policies.
- LTC Unused Drug Reporting: CMS confirmed that it will not require unused drug reporting when short-cycle dispensing requirements begin on January 1. Based on industry feedback, CMS agreed this would be a burdensome process and has determined other data elements it can utilize to compile these reports. There will be new PDE fields and submission clarification codes to capture dispensing methodology, patient residence and pharmacy type. CMS was unable to comment on the ‘lack of incentive’ this creates for facilities that were choosing to dispense in seven-day-or-less increments to be exempt from previously proposed reporting requirements.
- CMS Addresses NCPA Concerns: CMS addressed several areas of concern in the Part D program which NCPA has been extremely vocal about: preferred networks, violation of model transfer, and excessive pharmacy audit recoupments. CMS acknowledged that the marketing of preferred network plans need to be explicitly clear in all marketing materials (i.e. every page of materials) of the differential cost-share among different pharmacies. CMS also stated that contractual language between plans and pharmacies must also clearly state whether a pharmacy is a preferred pharmacy vs. a non-preferred pharmacy. CMS is also exploring the possibility of modifying terminology since the terms preferred vs. non-preferred has created confusion when the industry has also been using terms such as in-network and out-of-network. CMS also shared that it has received complaints of inappropriate transfers to mail order without the patient’s consent. This appears to be occurring more frequently after a physician approval of a prior authorization, and the plan automatically fills the medication through its mail order program. Related to audits, CMS said they are seeing a significant number of complaints regarding pharmacy audits, including instances where plans recoup the entire claim for administrative/clerical errors. There are concerns that plans are not reporting the recovered amount from the pharmacy correctly. NCPA appreciates the attention CMS is bringing to these issues and will continue to work with the Part D program to ensure beneficiaries are not misled and their access is not hindered.
NCPA Responds to OIG Report on Questionable Part D Pharmacy Billing: OIG released a report on questionable retail pharmacy billing practices in the Part D program in 2009. OIG found that 10.7% percent of independent pharmacies had questionable billing, compared to just over 1% of chain pharmacies. Although independent pharmacies made up 34 percent of all retail pharmacies that billed Part D, they accounted for 80 percent of the pharmacies with questionable billing. Of the 2,637 pharmacies with questionable billing, 2,120 were independent. In geographic areas with high questionable billing practices, 93% of the pharmacies with questionable billing in were independent pharmacies.
NCPA responded through the media and to members of Congress. We emphasized that none of the measures that OIG analyzed confirm that a particular pharmacy is engaging in fraudulent or abusive practices. Some pharmacies may be billing extremely high amounts for legitimate reasons. We pointed out that the heavy presence of independent community pharmacies in rural and urban areas, near teaching hospitals and the independent community pharmacies with LTC/retail combo shops possibly result in high, but legitimate billing rates compared to mail order or chain drug stores. Congress is likely to review these findings more in depth and determine whether there is a need for more aggressive oversight of pharmacies by Part D plans.
CMS Releases Important Information Regarding Part D FWA Training: CMS noted that Part B suppliers are deemed to have met the Part D FWA training requirements, but that each individual supplier location or pharmacy location must be enrolled in Medicare Part A or Part B to be “deemed”. CMS added that the deeming exception for FWA training and education does not apply to the Medicare Parts C and D compliance training and education requirement. In terms of demonstrating compliance with the FWA training requirements, CMS recommended that pharmacies keep all training documentation at each individual site. CMS has developed a web-based training module that can be used to satisfy the FWA training and education requirements. Using CMS’ training and education module is optional and an organization that uses another method may continue to use that method. To take a web-based training course, go to http://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/index.html?redirect=/MLNProducts. Under “Related Links”, at the bottom of the page, click on “Web-Based Training (WBT) Courses”. Click on Medicare Parts C and D Fraud, Waste and Abuse Training, not the icon next to it.
GAO Report On Round 1 Rebid of Comp Bidding Program Raises Important Questions: The GAO released a report and provided congressional testimony on the results of the Round 1 Rebid for competitive bidding for DME. The highlights of GAO’s report include:
· CMS’s beneficiary satisfaction survey had limitations. If a beneficiary’s access problems resulted in his not receiving DME, that beneficiary would not be included in the survey.
· Although CMS reported no changes in health outcomes for beneficiaries living in competitive bidding areas in 2011, these measures do not show directly whether beneficiaries received the DME they needed on time, or whether health outcomes were caused by problems accessing CBP-covered DME.
· Although CBP-covered beneficiaries pay less for their diabetic testing supplies if they choose a CBP mail-order contract supplier, CMS has determined that some CBP-covered beneficiaries who had been receiving their supplies by mail-order in 2010 have been switching to non-mail-order sources in 2011. This switching would decrease both CBP’s mail-order utilization and its anticipated Medicare savings.
Of note, at NCPA’s Legislative Conference this week, Jonathan Blum from CMS stated that CMS believes that Part B beneficiaries should have a choice between mail order and retail diabetic test strips. He further stated that CMS does not want to steer patients in a particular direction, toward mail order or retail pharmacy.
NCPA Comments on FDA Nonprescription Drug Class Proposal: NCPA’s comments focused on the ability of a nonprescription class of drugs to increase public access to affordable health care. A nonprescription class of drugs class may benefit patients seeking immediate symptomatic relief for acute conditions and will reduce the burden on emergency rooms and other health care providers by utilizing clinically-trained medication experts – pharmacists. NCPA seeks to have the following concerns addressed:
Pharmacy Comments on EHR Incentive Program: The Collaborative is very supportive of the proposed measures and objectives for the EHR Incentive program; however, our concern is that the proposed measures and objectives will become unfunded mandates. Pharmacists are ineligible for EHR incentives, though they will need to exchange information with EHR systems to connect to and ensure needed bidirectional communication with eligible professionals. As implementation of Stage 2 moves forward; especially with regard to the certification criteria for EHR technology, it should not create additional or financial burdens on pharmacists, such as becoming an unfunded mandate. Also, the Collaborative recommends that CMS consider allowing pharmacists to become eligible professionals in the EHR Incentive Program.
NCPA Political Events: NCPA hosted two political events in conjunction with the NCPA Legislative Conference in Washington, DC this past week.
· A fundraising reception was held on Monday, May 7th for Senator Jon Tester (D-MT). Sen. Tester co-founded the Senate Community Pharmacy Caucus with Sen. Moran of Kansas and has been very active on many issues affecting independent community pharmacy. Thank you to all the NCPA members who contributed to Senator Tester’s campaign!
· The Annual Sal D’Angelo NCPA PAC breakfast was held on Tuesday, May 8th and featured Political Analyst and Strategist for CNN, Alex Castellanos and Chairman of the Democratic Congressional Campaign Committee, Representative Steve Israel (D-NY). Thank you to all the NCPA members who contribute to the NCPA PAC!
In addition to the events held during the legislative conference, NCPA members and/or staff participated in political events this week for:
· Sen. John Cornyn (R-TX): Senate Finance Committee Member and Chairman of the National Republican Senatorial Committee;
· Sen. Mark Pryor (D-AR): NCPA Chairman Mark Riley attended a luncheon for Sen. Pryor who is the lead sponsor of the Pharmacy Competition and Consumer Choice Act (S. 1058)
· Democratic Senatorial Campaign Committee: NCPA Member Mark Kinney and NCPA Sr. VP of Government Affairs John Coster attended a DSCC breakfast with Sen. Michael Bennet (D-CO) and Rep. Chris Murphy (D-CT) who is the leading democratic candidate for the U.S. Senate seat being vacated by Sen. Lieberman (I-CT);
· Rep. Joe Barton (R-TX): NCPA Past President Joe Harmison attended a luncheon for Rep. Barton who serves on the House Energy and Commerce Committee, the event was hosted by Chairman of the Energy and Commerce Committee, Rep. Fred Upton (R-MI);
· Speaker of the House, Rep. John Boehner (R-OH): NCPA member Tom Whiston and Ernie Boyd with the Ohio Pharmacists Association attended a reception for Speaker Boehner;
· Rep. Charles Boustany (R-LA): NCPA members Kerry and Diane Milano attended a reception for Rep. Boustany who serves on the House Ways and Means Committee, the event was also attended by Republican members of the House Ways and Means Committee;
· Rep. Jim Gerlach (R-PA): NCPA member Robert Frankil and Carl Marrara with the Pennsylvania Pharmacists Association attended a reception for Rep. Gerlach who serves on the House Ways and Means Subcommittee on Health and is a co-sponsor of the Preserving Our Hometown Independent Pharmacies Act of 2011 (H.R. 1946);
· Rep. Chris Gibson (R-NY): NCPA PAC Committee member Nasir Mahmood attended a reception for Rep. Gibson who serves on the House Armed Services Committee, the event was hosted by Majority Leader Rep. Eric Cantor (R-VA);
· Rep. Brett Guthrie (R-KY): House Energy and Commerce Subcommittee on Health
· Rep. Kathy Hochul (D-NY): NCPA PAC Chairman Steve Giroux attended a reception for Rep. Hochul who serves on the House Armed Services Committee, the event was hosted by Democratic Whip, Rep. Steny Hoyer (D-MD);
· Rep. Lynn Jenkins (R-KS): NCPA Officer Brian Caswell along with NCPA members Sam Boyajian, Jim Coast, Van Coble, Dared Price and Mike Larkin with the Kansas Pharmacists Association attended a breakfast for Rep. Jenkins who serves on the House Ways and Means Committee and is a co-sponsor of the Medicare Access to Diabetes Supplies Act (H.R. 1936)
· Rep. Kristi Noem (R-SD): House Education and the Workforce Committee;
· Rep. Lee Terry (R-NE): House Energy and Commerce Committee and co-sponsor of the Medicare Access to Diabetes Supplies Act (H.R. 1936) and the Pharmacy Competition and Consumer Choice Act (H.R. 1971).
NCPA Advocacy Center Update
Week Ending May 5th, 2012
Congress Returns Next Week: Congress was in recess this week. Both House and Senate come back next week in a run-up to the Memorial Day recess. The elections are fast approaching, which means less and less gets done in Washington. Nevertheless, NCPA was active this week in Congress, meeting with Congressional staff on key issues that will have to be addressed this year by Congress.
DOD TRICARE: NCPA and NACDS send a joint letter to both the House and Senate Armed Services Committee this week, urging that the Committees reject the President’s proposals to sharply increase the copays for prescriptions obtained through retail pharmacies as compared to the TRICARE mail order pharmacy. We urged that they allow community pharmacies to work with TRICARE patients to optimize the use of generics, and avoid the expensive waste that is generated thorough mail order outlets.
Track and Trace for Prescription Drugs: NCPA continues to participate in a supply chain stakeholder group evaluating ways to make the pharmaceutical distribution system safer. Congress is considering a proposal from the group to serialize all individual prescription bottles to assist in a recall or to identify counterfeit products. NCPA is working to make sure that small pharmacies are not imposed with new burdens with respect to tracking and tracing of prescription drugs. We also continue to talk with Congressional staff about our ideas on how to address drug shortages and pharmacy crime.
NCPA Responds to Criticism of HR 1971: This week NCPA drafted a response letter to Americans for Tax Reform’s (ATR) letter which criticized H.R. 1971, The Pharmacy Competition and Consumer Choice Act of 2011. This bill imposes audit fairness and audit transparency on PBMs. ATR opposes the bill as adding costly regulatory burdens to PBMs, being anti-competitive and promoting fraud, waste and abuse within the pharmacy industry. In response, NCPA argued that the bill continues to allow for cracking down on fraud, waste and abuse, but regulates abusive auditing of clerical errors. We also noted that the bill promotes competition by opening up restricted PBM networks to any willing pharmacy. Finally, we pointed out that audit transparency and regulations are necessary to ensure that audit recoveries go toward patient savings and not padding PBM profits. A copy of the letter can be found on the NCPA Advocacy Center Website.
Important LTC Pharmacy Updates from CMS:
· NCPA has learned from CMS that they will not be proposing any data collection on unused medications for short-cycle dispensing which they had been considering for the 2013 Part D Reporting Requirements. In January, CMS issued a request for comments regarding changes to the Part D reporting requirements for CY2013, including requirements which focused on reporting of unused drugs as a result of short-cycle dispensing that will begin in 2013. NCPA had serious concerns with the reporting requirements and shared our concerns in our comments to the agency. CMS has taken our comments into account and determined that they will take a “different approach to quantifying unused drugs.” CMS will be issuing guidance on the reporting of Prescription Drug Event (PDE) fields and will be analyzing unused drugs through data reported to CMS from various sources.
· This week NCPA participated with CMS on a call regarding current LTC pharmacy issues. In terms of opioid overuse in the LTC setting, CMS is pushing hard for more education and outreach to providers, pharmacies, facilities, patients and their families to look to alternatives to drugs in dealing with dementia patients. With regard to CMS’ new requirement that a standard paper notice be provided to Part D patients whose drug claims are rejected by their Part D plan, CMS stated, with regard to the LTC setting that:
o The standard notice must be sent out with 72 hours of the pharmacy’s receipt of the transaction response that the medication cannot be filled.
o The pharmacy can be send the notice, in order of preference, to the enrollee, enrollee’s representative, the prescriber or staff at the LTC facility.
o Note that pharmacists must be prepared to distribute the standardized notice for Part D patient coverage denials starting no later than July 1, 2012.
NCPA Meets with CMS Pharmacy Team on AMP, RSP, NADAC and AAC: NCPA met with the CMS Medicaid pharmacy team to discuss the current status of the agency’s implementation of several new Medicaid pharmacy reimbursement initiatives. CMS plans to publish a final rule regarding Federal Upper Limits for generics sometime next year, but may finalize the draft lists that they have been publishing this year. The FULs will be based on weighted average AMP. These lists have consistently shown that small independent pharmacies would be significantly under reimbursed for many Medicaid prescription drugs. In addition, CMS will soon be asking pharmacies to send invoice data to their contractor (Myers and Stauffer) so a single NADAC amount can be published for each Medicaid covered drug. NADAC is the National Average Drug Acquisition Cost, and is designed to help states set their pharmacy reimbursement. Finally, CMS will be publishing a Retail Survey Price (RSP), which is the “out the door” amount the pharmacy receives on average for a prescription, reflecting a blend of third party, Medicaid, and cash.
NCPA Presents to CMS Educational Advisory Panel: NCPA shared our concerns this week with CMS’ Advisory Panel on Outreach and Education (APOE). The panel makes recommendations to the Secretary of HHS and the Administrator of CMS on how to better inform beneficiaries about their Medicare health plan choices. NCPA felt it was important to educate these panel members on the confusion surrounding Part D preferred networks, including Medicare plan finder issues, the CMS complaint line, aggressive marketing tactics and the differences between “network” and “preferred” pharmacies.
NCPA Comments on Medication Adherence to Surgeon General: The Office of the Surgeon General is seeking information about causes, impact and potential “real life” solutions for medication non-adherence associated with chronic conditions. NCPA provided community pharmacy’s perspective and practical solutions that promote better adherence. In our comments, NCPA stressed the need for proper alignment of interests from payers, providers, and patients focused on improving care while reducing waste and lowering health care costs. The measures surrounding adherence must be tied to clinical outcomes, and not based solely on refill ratios or automatic refills facilitated by mail order. NCPA also shared the concept behind Simplify My Meds as a practical solution that addresses several barriers to medication adherence, promotes adherence and improves care quality.
DEA Holds Fourth National Prescription Drug Take Back Day: this past week, DEA and its local law enforcement and community partners held the fourth nationwide medication take back day and collected 552,161of unused or expired medications for disposal. These take back events are complementary to NCPA’s Dispose My Meds program, which is typically offered year-round, except for controlled substances are currently prohibited from collection and disposal in pharmacies. That may change depending on the regulations DEA is drafting to implement the Secure and Responsible Drug Disposal Act of 2010, which amends the Controlled Substances Act to allow an “ultimate user” of controlled substance medications to dispose of them by delivering them to entities authorized by the Attorney General to accept them. The Act also allows the Attorney General to authorize long term care facilities to dispose of their residents’ controlled substances in certain instances. DEA Administrator Michele M. Leonhart, indicated that, “While a uniform system for prescription drug disposal is being finalized, we will continue to sponsor these important take-back opportunities as a service to our communities.” If pharmacies participated in these events have pictures please send them in to us. NCPA has created the Waste Not, Want Not photo album highlighting the tremendous amounts of waste coming back from mail order. Pharmacies are strongly encouraged to send in examples of mail order waste to disposemymeds@ncpanet.org. Please remove all identifiable patient information, and if possible include the PBM/payer involved and an estimated dollar amount of waste incurred.
In the States:
· In a unanimous vote on Wednesday afternoon, the Alabama House of Representatives passed SB383 – Fair Pharmacy Audit legislation and sent it to the Governor for signature. This means the legislation now only awaits the Governor’s signature to become law. There were no negative votes in committee or on the floor for this legislation. The House floor vote was 95-0 and Senate floor vote 28-0.
· The Mississippi Independent Pharmacists Association has successfully advanced a concurrent resolution encouraging CMS to recognize pharmacists as healthcare providers and as in integral component of the healthcare delivery system and important component of patient care and contributors to electronic health records
NCPA Advocacy Center Update
Week Ending April 28, 2012.
Congress to Act on FDA Legislation: Both the House and Senate are in the process of marking up FDA legislation which, in addition to reauthorizing manufacturer user fees, could include new provisions relating to supply chain security, drug shortages, providing prescription information to the blind and visually impaired, and further regulation of illegal online pharmacies.
This week, NCPA worked closely working with Senate Health, Education, Labor and Pension Committee staff on all these issues to protect the interests of community pharmacies. HELP Committee held their markup of the legislation and although the track and trace legislation was not added as an amendment, it is expected to be added before the full Senate considers the reauthorization. NCPA is opposed to new requirements for pharmacies to track and trace every prescription drug that comes into the pharmacy. The current track and trace language currently under consideration by Congress would only require pharmacies to track at the lot level, but the requirements could become more onerous as the process moves forward.
The House Energy and Committee Subcommittee on Health is scheduled to markup the FDA legislation on May 8th. We will continue working to make sure none of the potential provisions negatively impact community pharmacy, and that any track and trace legislation excludes unit level tracking for pharmacies.
National Defense Authorization Act Proceeds: Over the next few months, the National Defense Authorization Act for fiscal year 2013 will be considered by the Senate and House Armed Services Committees in preparation for consideration by both full chambers of Congress. In anticipation of this development, NCPA has been working throughout the year with other stakeholders including NACDS and the beneficiary groups to make it clear to Congress that we oppose additional increases in retail pharmacy copayments and new proposals to push beneficiaries into Mail Order in TRICARE.
This week we met with committee staff of the Senate Armed Services Committee - as well as staff from the House Armed Services Committee. We will vigorously oppose any drastic increases and unfair proposals in TRICARE which would harm our pharmacies and the active family and retired military beneficiaries that we serve daily.
NCPA Responds to CMS Study on Competitive Bidding Savings: NCPA responded to a CMS report released last week that claims that significant savings were achieved from mail order Medicare competitive bidding for diabetes supplies. The response is included in the link below. Bottom line: The CMS report actually confirms what NCPA has been saying all along: that mail order produces waste, and that Medicare beneficiaries prefer to obtain their health care services from their community pharmacist face to face than from a mail order outlet.
Mail Order Waste Confirmed in Medicare Competitive Bidding Program is available at http://ncpanet.wordpress.com/2012/04/26/mail-order-waste-confirmed-in-medicare-competitive-bidding-program/
GAO Reports on CMS’ Implementation of new FWA Screening Requirements: As NCPA has reported previously, the new FWA requirements will impact independent community pharmacy. Highlights of the report include:
· CMS expects to have contractors to do criminal background checks and fingerprint screening by the end of 2012. Note that this level of screening is reserved for High Risk Suppliers, which include newly enrolled DME suppliers and new DME supplier locations.
· CMS officials said the agency was developing and reviewing regulations to address the requirement that providers and suppliers disclose any current or previous affiliation with another provider or supplier that has uncollected debt; has been subject to payment suspension; has been excluded from Medicare, Medicaid, or CHIP; or has had its billing privileges denied or revoked. CMS is not certain when the regulation will be published.
· CMS officials said that the agency was studying criteria found in HHS OIG model plans as it worked to address the health care reform law’s requirement that Medicare providers establish compliance programs. CMS does not have a projected target date for implementation.
CMS Releases Final PECOS Rule: The purpose of the rule is to ensure that only identifiable providers and suppliers can order or certify certain medical services, equipment and supplies for Medicare beneficiaries. PECOS supports the Medicare provider and supplier enrollment process by capturing provider/supplier information from the CMS-855 family of forms. The system manages, tracks, and validates enrollment data collected in both paper form and electronically via the Internet. A complete summary is available on the “NCPA Members” section of the NCPA website.
Dispose My Meds Celebrates Earth Week… Please Send Us Pictures of Mail Order Waste: Dispose My Meds is now entering its fourth year as an NCPA member benefit, and the program has achieved nationwide recognition from groups outside of pharmacy as well. Over 1,500 pharmacies are participating and have collected more than 70,000 lbs. of unused, or expired non-controlled medications. Through this program, NCPA has created the Waste Not, Want Not photo album highlighting the tremendous amounts of waste coming back from mail order. Also new this year, NCPA created letters to the editors and press releases highlighting mail order waste and pharmacists are encouraged to share in their local publications. As the NCPA Advocacy Center continues its full court press on Capitol Hill to fight PBM and mail order abuses, we would like to provide these graphic displays of mail order waste to members of Congress and their staff. NCPA has a goal of collecting 100 images for the album, pharmacies are strongly encouraged to send in examples of mail order waste to: disposemymeds@ncpanet.org. Please remove all identifiable patient information, and if possible include the PBM/payer involved and an estimated dollar amount of waste incurred.
CMS Releases 2013 MTM Program Guidance: A CMS-approved MTM program is required in the development of a Part D sponsor’s annual bid. Sponsors will be required to have information on their website about their MTM program, including at a minimum: plan eligibility requirements, a contact for more information, and a high level summary of services offered as part of the MTM program. Sponsors must enroll targeted beneficiaries using an opt-out method of enrollment. This means sponsors must auto-enroll the targeted beneficiaries when they meet the plan’s eligibility criteria, unless the beneficiary declines. Sponsors are expected to use more than one approach when possible to reach all eligible targeted beneficiaries to offer MTM services, not just reaching out through passive offers. Targeted beneficiaries for the plan’s MTM program are those who meet all three criteria:
1. Having multiple chronic diseases – minimum threshold: 2-3. Sponsors cannot require more than 3 chronic diseases as the minimum number that a beneficiary must have to be eligible. For 2013, CMS is designating two additional core chronic diseases for MTM targeting: Alzheimer’s disease and End Stage Renal Disease (ESRD).
2. Taking multiple Part D drugs – minimum threshold: 2-8. Sponsors cannot require more than 8 Part D drugs as the minimum that a beneficiary has filled to be eligible.
3. Likely to incur annual drug costs greater than $3,144 for CY2013
Part D sponsors must also begin using the new standardized format for Comprehensive Medication Review (CMR) action plan and written summary no later than 1/1/2013. Examples of the standardized format are available on the Advocacy Center’s Medicare webpage. Beginning in 2013, sponsors must offer an annual comprehensive medication review to all beneficiaries enrolled in the MTM program in long-term care settings.
In the States:
· Minnesota Governor Dayton (D) formally signed fair and uniform pharmacy audit legislation into law this week. NCPA congratulates the many independent pharmacists and pharmacy organizations in Minnesota who worked tirelessly to ultimately make this legislation a success.
· Mississippi Governor Bryant (R) formally signed fair and uniform pharmacy audit legislation, which strengthens Mississippi’s existing act, into law this week. NCPA congratulates the many independent pharmacists and pharmacy organizations in Mississippi who worked tirelessly to ultimately strengthen their existing fair audit provisions and make this legislative sessions legislation a success.
NCPA Political Events: NCPA attended political events this week for: Sen. Chuck Schumer (D-NY): Senate Finance Committee; Rep. Xavier Becerra (D-CA): House Ways and Means Committee; Rep. Blake Farenthold (R-TX): House Homeland Security Committee with special guest Majority Whip Rep. Kevin McCarthy (R-CA); Rep. Martha Roby (R-AL): House Armed Services Committee.
Reminder: Effective May 1 - Reporting of Controlled Substance Schedule II
The Pennsylvania Office of Attorney General will be contacting any pharmacy that is either delinquent or non-compliant with the electronic Schedule II Controlled Substances reporting. This reporting is to be done on a monthly basis. Agents of the Bureau of Narcotics Investigation will be contacting by letter, email or personal visit any pharmacy not meeting this requirement. Starting July 1, any chronic offenders will be reported to the Bureau of Enforcement and Investigation and possible action by the State Board of Pharmacy.