• .7/15/08 We're Saved! Presidents veto of HR 6331 has been overridden by Congress!
• On July 15th, Congress overrode the President's veto of HR 6331, the "MEDICARE IMPROVEMENTS FOR PATIENTS AND PROVIDERS ACT OF 2008". This bill had seen a lot of action in just a short period of time since it was introduced into the House on June 20th, 2008 and redrafted 4 times in which to pass both Senate and House by July 10th only to have the President veto the bill on July 15th. Later that day, both the House and the Senate overrode the veto with 2/3rd majority. This was a major victory for pharmacy!
  
  With this bill as law, Physicians will actually get a 0.5% increase rather than a 10.6% decrease in reimbursement that was retroactive back to July 1, 2008.
  
  For Pharmacy:
  
  1. Requiring a 14-day reimbursement cycle for electronic Medicare Part D claims. Unfortunately this provision of the bill doesn't go into effect until 1/1/2010.
  
  2. A further delay to Oct. 1, 2009 in instituting AMP-based Medicaid generic drug reimbursement cuts.
  
  3. Postponement of the Medicare DME competitive bidding program for 18 to 24 months. CMS has clarified this as a postponement on implementation of Competitive Bidding Round 1, and a cancellation of accreditation deadlines for Competitive Bidding Round 2. CMS also clarifies that the deadline of September 30, 2009 that was previously established by which ALL DMEPOS suppliers must be accredited is still in effect.
  
  The DME Competitive Bidding areas for Round 1 now are NOT subject to implementation: (1) Charlotte-Gastonia-Concord, NC-SC, (2) Cincinnati-Middletown, OH-KY-IN, (3) Cleveland-Elyria-Mentor, OH, (4) Dallas-Fort Worth-Arlington, TX, (5) Kansas City, MO-KS, (6) Miami-Fort Lauderdale-Miami Beach, FL, (7) Orlando-Kissimmee, FL, (8) Pittsburgh, PA, (9) Riverside-San Bernardino-Ontario, CA, and (10) San Juan, PR.
  
  The votes were 383-41 in the House and 70 to 26 in the Senate, meeting the constitutional requirement for two-thirds margins to enact legislation without the president's signature. "The passage of this bill will guarantee community pharmacies the ability to help millions of patients and to compete on a level playing field," said Bruce T. Roberts, RPh, NCPA executive vice president and CEO.
  
  Please thank your Representatives.all of them were for passage of HR 6331 and they got the job done.this wasn't any easy task! Use this link for their contact information: www.grizrph.com/repcontact.htm

• 3/17/08 The need for Rehberg's co-sponsoring of H.R.3700...
  The NCPA/NACDS Federal Court injunction bought us some time (about 6 months to a year) until we are able to provide a fix for AMP (Average Manufacture Price).  This is the time we need to utilize our resources, pull together, and FIX AMP before it “fixes” us.  Even though we need to work towards the AMP FIX goal, it is unlikely that S.1951/ H.R.3700 will get pushed through Congress this year.  The physician Medicare fee cuts are coming up at the end of June and this is perhaps what we can “tie” another delay to.  I know it seems kind of cheesy to delay only to delay again, but the alternative is much worse.  Basically, if there isn’t time to fix AMP and find a large piece of legislation to “tie” it to in which to get through Congress (ie: Medicare package), then a delay is what we need for the time being.  We already have Baucus and Tester on board in our Senate, we must have Congressman Rehberg on board as well.  HR3700, the `Fair Medicaid Drug Payment Act of 2007' in the House of Representatives, is the exact same bill as Baucus’s S.1951 in the Senate.  By the way Senator/ Presidential Candidate Barack Obama [IL] is a co-sponsor of S.1951 and S.1954 since 12/03/07.

Rehberg has been a wonderful supporter of community pharmacy but we need his help now more that ever! Bring these points to his attention:

The devastating effects of AMP if implimented:

1. The Government Accountability Office (GAO) identified the reimbursement on average is 36% less than the acquisition costs for generic medications
2. Director of the PRIME Institute at the University of Minnesota, argued that with the 250% of AMP rule, as many as 10,000 to 12,000 pharmacies in rural and underserved urban communities would close, causing irrevocable harm
3. President Bush’s 2009 Fiscal Budget includes another 1.1 BILLION in cuts from pharmacy reimbursement which would equate to 150% of AMP not just 250% of AMP which would seal all our fates if ever enacted.
4. According to NCPA and CMS, community pharmacies would lose $5.5 million a day under the rule as written.

Why H.R.3700 and S.1951:

• Remove mail order transactions and certain other discounts, rebates, and price concessions from calculation of AMP
• Base pharmacy payment on average AMP, instead of the lowest AMP
•  Apply the AMP formula only when three or more alternatives are available, instead of two or more
• Raise Medicaid payment to 300% of AMP instead of 250%
•  Require prior authorization for brand name drugs that are more expensive than other biologically and therapeutically equivalent drug products
• Senator Baucus, the chair of US Senate Committee on Finance, and Representative Pallone,the chair of the Subcommittee on Health in the Energy and Commerce Committee, are in strong positions to move their respective legislation.
• Make sure to ask him to co-sponsor H.R.3700 as well as attach a delay to the June 30th physician Medicare cut bill.
• Don’t forget to thank him for his support on H.R.971, and H.R.1474

• Sample letter to Congressman Rehberg (HR 3700); Bag Stuffers for loyal customers; Contacts for Congressman Rehberg.

• 3/10/08 *Our TWO most important bills right now are S.1951 and H.R.3700; then followed by S.1954.

  A LIST OF CURRENT FEDERAL PHARMACY LEGISLATION
  As of 3/10/08
  Congressman Rehberg
  Bill	Supported Date	Total National Supporters
  HR 971	4/17/07	(180)
  HR 1474	6/12/07	(235)
  HR 3140	need HR3700 instead	(142)
  HR 3700	Please Call, Write, or Email	(44) Pallone's Bill
  Senator Baucus
  Bill	Supported Date	Total National Supporters
  S 1951	8/2/07	(42) (Obama 12/3/07)
  S 1954	8/2/07	(26) (Obama 12/3/07)
  Senator Tester
  Bill	Supported Date	Total National Supporters
  S 1951	9/24/07	(42) (Obama 12/3/07)
  S 1954	9/24/07	(26) (Obama 12/3/07)
  S 2161	3/4/08	(5)

• 2/20/08 'The government had until midnight last night to appeal the preliminary injunction against the AMP rule.  The deadline passed with no word from the government.  Therefore, the case remains with Judge Lamberth in the district court. The next deadline is for CMS to provide the administrative record by March 31st.  Eventually, Judge Lamberth will create a schedule for the parties to file motions that will lead to a final decision on the merits of the case'.

Thanks to Tobey Schule for providing this corespondance from David Schwartz.

• On February 4th President Bush released his 2009 fiscal budget asking for another 1.1 BILLION dollars to cut from pharmacies reimbursement from medicaid. This translates to 150% of AMP where as it was 250% AMP. Please remember that at 250% of AMP, The Government Accountability Office (GAO) identified the reimbursement on average is 36% less than the acquisition costs for generic medications. Remember also that the Director of the PRIME Institute at the University of Minnesota, argued that with the 250% of AMP rule, as many as 10,000 to 12,000 pharmacies in rural and underserved urban communities would close, causing irrevocable harm.
• Unless the Fair Medicaid Drug Payment Act passes, payments to pharmacies will be reduced by $8 billion over the next five years.  That is a 78% reduction in reimbursement.  These kinds of cuts could result in 10,000 to 12,000 pharmacy closures over the next few years.  That’s 20% of all pharmacies in the United States. If you weren't offended enough by the devastating effects of AMP before, I think this just might do it! Please join in the fight against AMP...the greater the numbers, the bigger the voice, the better the chance we have at saving our pharmacies and serving our communities.
• We need Pharmacists, Pharmacy owners, Technicians, and our loyal customers to help save us...please click on the following links to see how.Sample letter to Congressman Rehberg (HR 3700); Bag Stuffers for loyal customers; Contacts for Congressman Rehberg

• On December 19th Royce C. Lamberth, United States District Judge, signed Court Orders to POSTPONE AMP as well as to POSTPONE posting of AMP on a public website stating: "Defendents' (CMS) actions are likely to cause Plantiff's (NACDS and NCPA) to suffer irreparable harm for which no adequate remedy at law exists as Plantiff's members will not be able to recover from the Defendants if the AMP rule is implemented, and thousands of Plantiff's members pharmacies are expected to be forced to reduce hours and services, forced out of the Medicaid program, or forced to close." Please read the full 3 page Court Order. Special thanks to Tobey Schule, RPh for sharing this information with us.

• On November 14th the Montana Pharmacy Association (MPA) was at the ARM Hearing in Helena to explain to Montana Medicaid the importance of special packaging and current compounding regulations. Read ARM hearing proposal text here. (pgs: 1611-1618)
• The ARM amendment 37.86.1101 and 37.86.1105 pertains to Medicaid reimbursement for dispensing fees and outpatient, compound prescriptions. The pharmacy dispensing fee is based on the pharmacy’s average cost of filling prescriptions and whether the pharmacy dispenses a generic, preferred drug list or non-preferred drug. The average cost of filling a prescription will be based on the direct and indirect costs that can be allocated to the cost of the prescription department and that of filling a prescription, as determined from the Montana Dispensing Fee Questionnaire. The average statewide dispensing fee is estimated to be $8.75 for preferred drug list medications. You may call Montana Medicaid to see where your pharmacy dispensing fee falls between $6.16 to a maximum of $10 for brand and generic preferred drug list medications. A dispensing fee of $5.50 will be given for all non-preferred drug list medications.
• Unfortunately, the unit dosing fee of $0.75 per prescription will no longer be in effect after January 1st, 2008 when all this kicks in. CMS had tied the cost of unit dosing (special packaging), overhead costs, prescription volume, and personnel wages all into the dispensing fee. Since CMS will not allow for additional unit dosing fees, MPA suggested to give an additional 1$ dispensing fee for each medication to pharmacies who special package medications due to the additional costs of materials, extra “man” hours, delivering of the packages, etc.
• In addition, any new store would only be assigned a 6 month interim dispensing fee of $5.50. MPA suggested that the new store be assigned the average fee of $8.75 since the new stores have not built up volumes and costs would be high.
• Montana Medicaid’s proposed rule on compounding consists of using line item billing only (no more 00888 codes), and the use of compounding dispensing fees based on level of effort: $12.50, $17.50, $22.50. Any prescription over the level of effort of $12.50 dispensing fee would require a call the to the Prior Authorization unit to receive one of the higher dispensing fees. Another issue is that Medicaid had stated in the hearing notice that “the department encourages providers to explore rebatable or less costly excipients,” this would require extra inventory of rebate able products, and from what was explained by compounding pharmacists, PCCA has no or very few rebate able products and requires their new pharmacies to use their products, exclusively. In addition, reimbursement for mainly the rebate able ingredient still does not account for all the overhead costs associated with compounding. All three compounding pharmacists who spoke, said at these reimbursement rates, they would not be able to serve the Medicaid population. MPA’s position is to have no change in the current compounding program and to continue to use usual and customary fee, especially since compounding prescriptions is less than 1% of the Medicaid budget.
• Letter from MPA President Jim Seifert to Rhonda Lesofski, DPHHS, Office of Legal Affairs.
• Board Notice by Jim Seifert to MPA Board on ARM hearing.
  

• November 11, 2007, S.2161 was introduced into the Senate by Senator Johnny Isakson [GA] (introduced 10/15/2007). Bill Text here. This is a companion bill to H.R. 971. A bill to ensure and foster continued patient safety and quality of care by making the antitrust laws apply to negotiations between groups of independent pharmacies and health plans and health insurance issuers (including health plans under parts C and D of the Medicare Program) in the same manner as such laws apply to protected activities under the National Labor Relations Act.
• November 11, 2007 H.R. 971 Update: The House Judiciary Committee passed HR 971 by a unanimous voice vote on Wednesday, Nov. 7. Read ACPCN ALERT here.
• November 11, 2007 H.R. 1474 Update: The 'Fair and Speedy Treatment (FAST) of Medicare Prescription Drug Claims Act of 2007' has a whopping 229 co-sponsors and is being referred to the Subcommittee on Health.

• October 28th, 2007, H.R. 3700 was introduced into the House on September, 27th, 2007. H.R.3700, the `Fair Medicaid Drug Payment Act of 2007', is the bill will NEED to SAVE OUR HIDES before the implementation of the new AMP. Since H.R.3700 is the companion bill to Senator Baucus's S.1951, also known as the `Fair Medicaid Drug Payment Act of 2007' in the Senate, the two bills can be meshed easily and will keep our heads above water until we are able to tweak it later. Both S.1951 and H.R.3700 are easily implemented into Congress since they both deal with a percentage of AMP and we don’t need to bring out the calculator again and spend a bunch of time on calculations as we would with H.R.3140’s Retail Acquisition Costs. You can view the FULL BILL TEXT for H.R.3700 here.
  • H.R.3140 is a great bill and I would like to revisit this bill or another like this bill at a later date...but we are out of time and H.R.3700 is our best bet at this point in time to keep our heads above water.
• Representative Frank Pallone Jr. is the chair of the Subcommittee on Health in the Energy and Commerce Committee, in which has sole jurisdiction over Medicaid, the Food and Drug Administration (FDA), the National Institutes of Health (NIH) and the Centers for Disease Control (CDC), and shares jurisdiction of Medicare with the Ways and Means Committee. Representative Pallone is a very powerful Sponsor of this bill and we can expect this bill and S.1951 to merge and pass quickly saving pharmacy for the time being.
• At this time we need to focus on S.1951 and H.R.3700 and get them passed. To do this, we must have Congressman Rehberg on board. Please contact Congressman Rehberg to let him know we need his support on H.R.3700. When asking Congressman Rehberg to co-sponsor H.R.3700 please also thank him for co-sponsoring of H.R.971 (Medicare Pharmacy Negotiation Bill) and H.R.1474 ( Medicare Prompt Payment Legislation).
• "Representative Pallone and Senator Baucus are in strong positions to move their respective legislation, get into a conference, and send a single bill to the President before they adjourn" states Executive Director of MPA Jim Smith.

• October 28th, 2007. Update on H.R.971. PBM’s were finally forced to defend their abusive practices and were questioned on their withholding reimbursement payments from retail pharmacies that provide critical care for patients, the accepting of rebates from drug companies that are not disclosed to patients, and their hiding of profits from taxpayer-funded programs. As a result, The House Judiciary Committee antitrust task force held a public hearing on October 18th on H.R.971 where both ACP*CN and NCPA were there to defend independent pharmacies.
  H.R.971 creates a narrow exemption in the antitrust law that allows independent community pharmacists to aggregate their efforts in negotiating contracts with PBM’s. Currently, publicly-traded drug store chains negotiate favorable contract terms with the PBM’s, due to their size in the marketplace, while the independent community pharmacies are offered non-negotiable contracts. ‘In most instances independent community pharmacies are forced to accept these economically disadvantageous terms. The contracts are constructed in a way that greatly limits patient choices in their prescription drug coverage.’ (NCPA)
  ‘ Thousands of independent pharmacies across the nation demanded the hearing to explain how abusive PBM practices are intended to eliminate their competition with retail pharmacies by delayed payments, gouging of taxpayers dollars, and forcing patients into mail-order pharmacy programs. Pharmacists submitted case studies of specific examples where PBM’s are engaged in abusive practices that significantly undermine patient health care’. (ACP*CN)
  “It was President Theodore Roosevelt’s Sherman Antitrust Act that established rules to protect small business from big corporations,” said NCPA Executive Vice President and CEO Bruce Roberts, RPh. “One hundred years later, some provisions of the antitrust law need adjustment to assure protections for our nation’s small business owners. With the introduction of these bills, the community pharmacists will continue to be viable members of the community, and I applaud these members of Congress for coming to their aid.”
  ‘ The nation’s independent pharmacies got maximum results from the hearing. The next steps are for the committee to develop a narrow exclusion to antitrust law that will allow independents to negotiate together against PBM’s. They will then vote on the bill and send it to the full House for consideration.’ (ACP*CN)

  *(NCPA) National Community Pharmacists Association, www.ncpanet.org
  *(ACP*CN) Association of Community Pharmacists, www.acpcn.org
  

• October 5th, 2007, Senator Tester's response by e-mail in regards to co-sponsoring S.1951 and S.1954. Read here.
• On August 2nd 2007, Senator Max Baucus introduced two new bills to save pharmacies from the devastating affects that CMS has implement for pharmacies nationwide.
  • S.1951 is a bill labeled the "Fair Medicaid Drug Payment Act of 2007" (Read Summary). It is designed to change the AMP formula and improve reimbursement to pharmacies for dispensing generic drugs under Medicaid. Provisions include: (1) Remove mail order transactions and certain other discounts, rebates, and price concessions from calculation of AMP; (2) Base pharmacy payment on average AMP, instead of the lowest AMP; (3) Apply the AMP formula only when three or more alternatives are available, instead of two or more; (4) Raise Medicaid payment to 300% of AMP instead of 250%; (5) Require prior authorization for brand name drugs that are more expensive than other biologically and therapeutically equivalent drug products
  • S.1954 is a bill labeled the "Pharmacy Access Improvement (PhAIm) Act of 2007" (Read Summary). This bill would: (1)Require drug plans to reimburse pharmacies more quickly; (2) Require the establishment of information hotlines for pharmacists and physicians; (3) Restrict the practice of co-branding of Part D prescription drug cards; (4) Make it easier for pharmacies that serve a disproportionate number of low income patients to join drug plan networks, including 340B pharmacies;
    (5) Require CMS to establish standards with respect to access for enrollees who are residing in long-term care facilities to a long-term care network pharmacy;
    (6) Require Part D plans to disclose their list of MAC prices prior to contracting with a network pharmacy; and (7) Require HHS OIG to conduct a study of the cost of dispensing and submit a report by December 1, 2008.
  • please thank Thomas Clark and ASCP for their concise summary of the 2 bills above:
    • Thomas R. Clark, RPh, MHS
      Director of Policy & Advocacy
      American Society of Consultant Pharmacists
      TClark@ascp.com
      tel:703-739-1316, ext. 123
      fax:703-739-1321
    • http://www.ascp.com 1321 Duke Street, Alexandria, VA 22314
      America's Senior Care Pharmacists®
      Medicare Part D Resource:
      http://www.ascp.com/MedicareRx

• H.R 3140 “The Saving Our Community Pharmacies Act of 2007” rectifies the current pricing discrepancies and maintains patient- pharmacist relationship by:

  • Redefining the pharmacy reimbursement benchmark to accurately reflect pharmacy acquisition costs. Retail Acquisition Cost (RAC) is the median price for each drug based on a quarterly survey of actual invoices subject to audit from a 5% representative sample of pharmacies nationwide. A FUL based on RAC will allow states to pay pharmacies accurately and preserve patient access.
  • Excluding all sales to mail order facilities, as well as any pharmacy benefit manager (PBM) rebates and price concessions that are not available to retail pharmacies.
  • Properly defining the retail class of trade to only include retail community pharmacies.
  • Including provisions to drive generic utilization which would increase taxpayer and government savings.

  Read the H.R. 3140 Fact Sheet provided by NCPA.

  Read the H.R. 3140 Bill Text here

• Medicaid Cuts Are Final and Devastating

  The Centers for Medicare & Medicaid Services (CMS) have set their rules on July 6th 2007 and made them public on July 9th 2007 for viewing. Unfortunately, this rule still doesn’t provide a clear definition of Average Manufacturers Price (AMP), which is used in Medicaid’s reimbursement to pharmacies. Despite numerous attempts from pharmacists, and pharmacy organizations, Medicaid must use the new Federal Upper Limit (FUL), the maximum amount states can pay pharmacies for generic Medicaid drugs, that will be based on 250% of the lowest generic medications AMP.

  This rule is part of the Deficit Reduction Act of 2005, mandating CMS to reduce Federal and State Medicaid costs by 8.4 billion dollars over the next 5 years. “More than 90% of the cuts will be borne on the backs of community pharmacy as a result of the new AMP that cuts Medicaid reimbursement to pharmacies for generic drugs” as stated in an ACP*CN Media broadcast. In addition, this total does not include loss of bonuses and wages to hard working pharmacists and staff even though prescription numbers and total gross sales increase due to such a great loss in total profit.

  Studies have shown that the current AMP model is devastating to pharmacies. The Government Accountability Office (GAO) identified the reimbursement on average is 36% less than the acquisition costs for generic medications. In congruence, the Department of Health and Human Services Office of Inspector General (OIG) stated that the average pharmacy acquisition cost for 19 of 25 high-expenditure generics are higher than what Medicaid would have reimbursed the pharmacy posing a huge loss to the pharmacy.

  NCPA President John Tilley, RPh stated that “the new Medicaid AMP formula tells community pharmacies that fair and accurate reimbursement for helping economically disadvantaged patients is not a priority for the federal government.” Similarly, NCPA executive vice president and CEO Bruce Roberts, RPh stated “If the current policy is fully implemented, community pharmacies will be forced to make the impossible choice of turning their backs on vulnerable patients by dropping out of the Medicaid program or continuing in a program that threatens to bankrupt their businesses.”

  Other organizations such as ACP*CN are also concerned about the new ruling stating that “this ill-conceived rule issued by CMS leaves pharmacies in the dark about how under-reimbursed they will be for generic Medicaid Drugs” and that “patient access to their neighborhood pharmacist is under assault, as the country’s healthcare delivery system teeters on the edge of destruction.” In addition, APhA has addressed the same issues regarding CMS’s ruling on AMP stating that “Pharmacists across the country may be penalized for serving Medicaid patients by the Centers for Medicare and Medicaid Services’ (CMS) new regulation for pharmacy reimbursement in the Medicaid program.”

  You may view the 600 page pdf CMS ruling complete with comments from individuals and organizations and responses from CMS on GrizRPh News…they’re quite interesting. In addition please visit the following websites for additional information and full articles from: ACP*CN (http://www.acpcn.org/); NCPA (www.ncpanet.org/); and APhA (www.aphanet.org/). Please View this and more at GrizRPH.com (www.grizrph.com/).
  In addition, Please read the following full paged articles pertaining to CMS's AMP rulings:
  .
  " ACP*CN's Media Release: CMS Assaults Neighborhood Pharmacies with New rule Cutting Reimbursements for Generic Medicaid Drugs."
  .
  APhA proposed rule from February 2007 for Medicaid Cuts
  .
  APhA's comments on the New CMS Ruling
  .
  ACP*CN "Dispensing Fees Have Pharmacies On Offensive"
  

• H.R.1474 Prompt Payment Legislation: Late Medicare Part D payments have forced independent pharmacies to borrow tens of thousands of dollars every month to cover payroll, wholesaler bills, and other basic operating costs. HR1474 was just introduced to the the House by Congressman Berry (AR), Jones (NC), Herseth (SD), and Wicker (SD), which is the "Fair and Speedy Treatment (FAST) of Medicare Prescription Drug Claims Act of 2007". The plan calls for a 14 day turn around interval for payment (much like Medicaid) and would be very beneficial to ALL pharmacies!!!!!

• On April 9th, 2007, Faith Bremner from the Tribune Washington Bureau, made front page of the Great Falls Tribune for his concerns on how the new CMS ruling may affect rural independant pharmacies. Thank you Faith for your awareness and contribution! Great article! Click Here to read more.

• On March 13th 2007, Forty-six Senators had signed a document sent to the Centers of Medicare and Medicaid Services Acting Administrator Leslie V. Norwalk, expressing their concern that the new CMS ruling regarding pharmacy reimbursement would threaten existing retail pharmacies and restrict millions of medicare beneficiaries to access prescription drugs. Click Here to read more.

• On February 20th 2007, the NASMD (National Association of State Medicaid Directors) and APHSA (American Public Human Services Association) had proposed to CMS the regulation of AMP (Average Manufacture Price). Click Here to read more.