ASSEMBLY STATE GOVERNMENT COMMITTEE EXPLORES RAMIFICATIONS OF THE PROPOSED ESI - MEDCO MERGER

 

Yesterday, the Assembly State Government Committee held a hearing exploring the potential ramifications of an ESI Medco Merger on the State of New Jersey where Medco is headquartered and holds the prescription drug contract for the New Jersey State Health Benefits Plan.

This effort was championed by Committee, Chair, Assemblywoman Linda Stender (D-Union).  In addition, it was greatly encouraging to note the “pharmacy friendly”, supportive statements of committee members, Vice-Chairman, Dr. Assemblyman Herb Conaway (D-Burlington), and Assemblyman Gary Schaer (D-Passaic).

As a result of the testimony presented, it looks likely that we will see the introduction of a resolution in the New Jersey General Assembly encouraging the New Jersey Attorney General to join the 33 other state attorney generals requesting enhanced investigations of the proposed merger.  In addition, The Chair and members of the committee set the stage for our new push for PBM Regulation in New Jersey by virtue of the public statements made during the hearing.

Testimony was presented by the CWA (State’s Largest Employee Union) representative that echoed all of our sentiments and called for legislative oversight of the State’s Medco Contract.

David Schwed, R.Ph. provided outstanding testimony as a retired pharmacy owner.  Matt Diloreto of NCPA was also vocal in providing data to support our claims that the merger would have a deleterious effect on the marketplace, and did a wonderful job of informing the committee about what is occurring in Congress. GSPO Attorney David Balto was superb as the Anti-Trust Expert.

Stay tuned for more information.  We expect the announcement of more hearings in the New Year.

CONGRATULATIONS TO NY ON SIGNING OF AMMO LEGISLATION

We are very happy to report that Governor Andrew Cuomo (D-NY) signed NY’s long awaited Anti-Mandatory Mail Order legislation (A.5502-B) into law Monday evening.  Congratulations to Craig Burridge and the membership of PSSNY as well as may other pharmacy organizations who worked on this effort. This new law is similar to our own New Jersey Any Willing Provider Law.

Our law Chapter 395 of 1999:

(1)  Permits the subscriber, at the time of issuance, amendment or renewal, to select benefit coverage allowing the subscriber to choose a pharmacy or pharmacist for the provision of prescription drugs or pharmacy services, provided that any pharmacist or pharmacy selected by the subscriber is registered pursuant to R.S.45:14-1 et seq.;

(2)  Provides that no pharmacy or pharmacist shall be denied the right to participate as a preferred provider or as a contracting provider, under the same terms and conditions currently applicable to all other preferred or contracting providers, if the contract provides for coverage by contracted or preferred providers for pharmaceutical services, provided the pharmacy or pharmacist is registered pursuant to R.S.45:14-1 et seq., and accepts the terms and conditions of the contract;

(3)  Provides that no copayment, fee, or other condition shall be imposed upon a subscriber selecting a participating or contracting pharmacist or pharmacy that is not also equally imposed upon all subscribers selecting a participating or contracting pharmacist or pharmacy;

(4)  (a)  Provides that no subscriber shall be required to obtain pharmacy services and prescription drugs from a mail service pharmacy;

(b)  Provides for no differential in any copayment applicable to any prescription drug of the same strength, quantity and days' supply, whether obtained from a mail service pharmacy or a non-mail service pharmacy, provided that the non-mail service pharmacy agrees to the same terms, conditions, price and services applicable to the mail service pharmacy; and

(c) Provides that the limit on days' supply is the same whether the prescription drug is obtained from a mail service pharmacy or a non-mail service pharmacy, and that the limit shall not be less than 90 days; (partial text of law))

Violations of this law are enforced by the NJ Department of Banking and Insurance.  However, as in the case of NY, the law is not applicable to ERISA plans or the NJ State Health Benefits Plan.

In early 2012, we are proposing to take our current law to the next level to bring PBMs under the purview of state government with a new legislative proposal that will encompass ALL plans including Medicaid HMOS and the NJ State Health Benefits Plan.  We hope you will join our grassroots effort to make this a reality!  Thank you for all of you past support.

 

 

RULE PROPOSAL
VOLUME 43, ISSUE 21
ISSUE DATE:NOVEMBER 7, 2011
LAW AND PUBLIC SAFETY
DIVISION OF CONSUMER AFFAIRS 
STATE BOARD OF PHARMACY

Pre-Proposed New Rule: N.J.A.C. 13:39-4.22
Notice of Pre-Proposal
Remote Processing of Prescriptions

Authorized By: State Board of Pharmacy, Edward G. McGinley, R.Ph, President.
Authority: N.J.S.A. 45:14-47 and 48.

Pre-proposal Number: PPR 2011-002.

Take notice that the State Board of Pharmacy (Board) is considering proposing a new rule to permit pharmacists and pharmacy technicians to perform certain pharmaceutical functions at locations that are not permitted as New Jersey pharmacies. The Board believes that the pre-proposed new rule will provide pharmacies greater flexibility in managing prescription processing operations. The pre-proposed new rule will also help ensure that any prescription processing functions performed remotely, or outside of a permitted pharmacy, are performed by qualified and appropriately trained individuals pursuant to safeguards designed to protect the confidentiality of prescription and patient information.

Comments on the pre-proposed new rule should be sent by January 6, 2012 to:
Lawrence DeMarzo, Deputy Director
Division of Consumer Affairs
P.O. Box 45013
Newark, New Jersey, 07101

Full text of the pre-proposed new rule follows:

13:39-4.22   Remote processing of prescriptions

(a) For purposes of this section, the following words shall have the following meanings, unless the context clearly indicates otherwise:

"Remote location" means a location in New Jersey that is not a New Jersey permitted pharmacy, or a location in another state, territory or possession of the United States, where pharmaceutical functions are performed.

"Remote processing of prescriptions" means the performance of pharmaceutical functions at a location other than a New Jersey permitted pharmacy.

(b) A New Jersey permitted pharmacy may permit a pharmacist at a remote location to perform the following pharmaceutical functions only:

1. Receipt, interpretation and clarification of prescription orders;

2. Data entry of prescription medication information;

3. Prospective drug review;

4. Refill authorizations;

5. Interventions;

6. Patient counseling;

7. Claims submission; and

8. Claims resolution and adjudication.

(c) A New Jersey permitted pharmacy engaging in the remote processing of prescriptions at a remote location in New Jersey shall ensure that a pharmacist performing pharmaceutical functions at the remote location holds an active New Jersey pharmacist license in good standing. A New Jersey permitted pharmacy engaging in the remote processing of prescriptions at a remote location outside of New Jersey shall ensure that a pharmacist performing pharmaceutical functions at the remote location holds an active pharmacist license or registration in good standing in that jurisdiction, and that the pharmacist is authorized to engage in the remote processing of prescriptions under the pharmacy laws and regulations of that jurisdiction.

(d) A pharmacist performing pharmaceutical functions for a New Jersey permitted pharmacy at a remote location in New Jersey or in another state, territory or possession of the United States shall be an employee of the pharmacy.

(e) A New Jersey permitted pharmacy may permit a New Jersey registered pharmacy technician to perform the pharmaceutical functions set forth in (b) above at a remote location in New Jersey, consistent with the requirements of N.J.A.C. 13:39-6.15. A New Jersey permitted pharmacy engaging in the remote processing of prescriptions at a location outside of New Jersey may permit a pharmacy technician at such location to perform the pharmaceutical functions set forth in (b) above, provided the technician is authorized to perform such functions under the pharmacy laws and regulations of that jurisdiction.

(f) The pharmacist-in-charge shall ensure that all pharmacy technicians engaging in the remote processing of prescriptions have received adequate training relevant to performing pharmaceutical functions at a remote location. All pharmaceutical functions performed by a pharmacy technician at a remote location shall be supervised by a licensed pharmacist.

(g) The pharmacist-in-charge shall ensure that the pharmacist or pharmacy technician performing pharmaceutical functions at a remote location has access to the pharmacy's electronic prescription files and that adequate security controls are in place to ensure the confidentiality of all patient information. Security controls shall include at least two factor positive authentication of the authorized user, encryption of all data exchanged between the equipment located at the remote processing site and the remote processing pharmacy, and measures designed to prevent unauthorized storage or transfer of patient information.

(h) All pharmacists and pharmacy technicians participating in the remote processing of prescriptions shall ensure the confidentiality of patient information in compliance with all Federal and State laws, rules and regulations, including the Federal Health Insurance Portability and Accountability Act of 1996, PL 104-191.

(i) A pharmacy engaging in the remote processing of prescriptions shall maintain an audit trail that records and documents all pharmaceutical functions performed by a pharmacist or pharmacy technician at a remote location, consistent with the requirements of N.J.A.C. 13:39-7.6.

(j) The pharmacist-in-charge shall be responsible for all pharmaceutical functions performed in connection with the remote processing of prescriptions.

(k) The remote location shall be considered part of the permitted pharmacy. The remote location and any equipment and/or devices used in connection with the remote processing of prescriptions shall be subject to Board inspection.

(l) No medications shall be stored at, or dispensed from, a remote location.

(m) An out-of-State pharmacy registered with the Board pursuant to N.J.A.C. 13:39-4.20 may engage in the remote processing of prescriptions that are to be shipped, mailed, distributed or delivered into New Jersey, provided that the remote processing of prescriptions is authorized under the pharmacy laws and regulations in the jurisdiction where the out-of-State pharmacy is located, and provided that such functions are performed by licensed or registered pharmacists or pharmacy technicians that have been adequately trained.

(n) A New Jersey permitted pharmacy or a registered out-of-State pharmacy may engage in the remote processing of prescriptions in conjunction with another pharmacy provided the pharmacies are parties to a central prescription handling arrangement for which they have obtained Board approval pursuant to N.J.A.C. 13:39-4.19.

New Jersey State Legislative Update

By Laurie A. Clark

NJPhA Legislative Counsel

August 11, 2011

 

NEW JESEY STATE BUDGET

 

“Summary of changes affecting pharmacy programs”:

 

NJ MEDICAID:  MEDICARE PART D COPAYS NOW IN EFFECT FOR DUAL ELIGIBLES

The July 1, budgetary changes that were implemented for New Jersey Medicaid Beneficiaries consisted of the original proposals contained in the Governor’s Budget.  The Legislative Budget bill that was sent to the Governor’s desk contained positive changes for Medicaid ABD patients such as the reinstatement of the Medicare Part D copayment wraparound, and the elimination of the transfer of more beneficiaries into Medicaid Managed Care.  Unfortunately, those items were subject to the Governor’s Line Item Veto .  This was frustrating to say to the least.  We must continue to work with NJ Medicaid in order to get contract reform, access and adequate payment under these plans.

 

In specific, New Jersey Medicaid will no longer pay for the co-payments for Medicare Part D – Dual Eligibles.  Keep in mind that these are Medicare Part D co-payments and are the responsibility of the patient.  Pharmacies are NOT required to fill the prescription unless the patient pays the copayments.  Because Medicare Part D rules apply, pharmacies may select to waive these copayments on a “case by case” basis only.

 

In addition, these beneficiaries are recipients of the LIS (Low Income Subsidy), and therefore are not subject to the “donut hole”.  Except for benzodiazepines, the NJ Family Care/Medicaid program no longer covers barbiturates, smoking cessation products and legend vitamins.

 

PAAD, SENIOR GOLD AND ADDP

The co-payment structure for the PAAD and Senior Gold Programs remains the same.

However, except for benzodiazepines and barbiturates, drugs not covered by Medicare Part D, are not covered by the Pharmaceutical Assistance to the Aged and Disabled Program, the Senior Gold Prescription Drug Discount Program, the Aids Drug Distribution Program.

HISTORIC PENSION AND HEALTH BENEFITS REFORM PACKAGE SIGNED BY THE GOVERNOR * Updated

On June 28, Governor Christie signed historic legislation S- 2937 sponsored by Senate President, Stephen Sweeney (D-Cumberland) and Senator Joseph Pennachio (R-Morris) and A-4143 sponsored by Assemblymen Louis Greenwald (D-Camden) and Declan O’Scanlon (R-Monmouth) The bi-partisan, landmark law is intended to preserve the future viability of New Jersey’s publicly funded pension system.  Of major significance is the fact that the new law will change the traditional way the state provides health benefits coverage for all state employees.

 

With respect to the pension system, the new statute increases the funding ratio of the system to 88%. These reforms protect the pension system for retirees, increasing the funded ratio of the combined state and local systems from the current 62% to more than 88% over the next thirty years. By 2041, this will reduce total pension underfunding to $37 billion. Without these critical reforms, the unfunded liability across the pension systems would have skyrocketed to $183 billion, resulting in a massive impact on state and local budgets.

 

In terms of health benefit coverage, the most significant change is the fact that plan design and coverage will no longer be negotiated through unions but will be decided by the various plan design committees, which are established for each pension system. These changes are intended to create choices and lower costs.

 

The Health Plan Benefit Design Committees are responsible for providing plans with at least three levels of coverage, featuring varying levels out-of-pocket costs. The Committees have sole discretion to set the amounts for maximums, co-pays, deductibles, and other such participant costs for each plan.  The Committees must also provide for a high deductible health plan.

 

It is envisioned that these reforms will modernize the State employee health benefits plans by bringing the current system more in line with the private sector and federal government.

 

In terms of cost savings, it is projected that these reforms will substantially lower health benefits costs for local governments, including those at the county, school and municipal levels, representing another major step forward in providing real, long-term property tax relief. At present, New Jersey spends $4.4 billion annually on public employees and retiree health care costs, with the cost of health benefits making up 9% of the State's budget today.

 

The new law takes effect immediately with changes becoming effective upon contract renewal.

 

GOVERNOR APPOINTS MEMBERS OF PLAN DESIGN COMMITTEES

Governor Christie has named appointees to both the State Health Benefits Plan Design Committee and the School Employees' Health Benefits Plan Design Committee. Once again, the committees have sole discretion to set the amounts for maximums, co-pays, deductibles, and other such participant costs for each plan.

 

STATE HEALTH BENEFITS PLAN DESIGN COMMITTEE

Governor Appointees

Appoint Kenneth E. Kobylowski (Shrewsbury, Monmouth)

Appoint Richard E. Constable, III (Orange, Essex)

Appoint Matthew P. McDermott (Cranford, Union)

Appoint Regina M. Egea (New Vernon, Morris)

Appoint Marc D. Larkins, Esq. (Irvington, Essex)

Appoint John Hutchison (Lawrenceville, Mercer)

May 27, 2010
FDA MedWatch Mobile Pilot - In an effort to improve patient safety and health outcomes, the FDA is beginning a 6-month pilot to evaluate the effectiveness of text messaging in disseminating MedWatch Safety Alerts. 

If you would like to participate in this pilot and receive these concise alerts - generally no more than 2 or 3 messages per week - please go to: http://www.fda.gov/aboutfda/contactfda/stayinformed/ucm193168.htm
If you would like to sign-up for standard e-mail MedWatch Safety Alerts, you can sign-up at: http://www.fda.gov/aboutfda/contactfda/stayinformed/ucm193168.htm
There are no charges from the FDA for these services, but standard messaging charges from your wireless provider may apply.

Governor Christie Reverses Cuts in PAAD and Senior Gold Programs CMS: Medicare Beneficiary Savings - The Centers for Medicare & Medicaid Services (CMS) issued new guidance to Part D plan sponsors to guarantee that Medicare beneficiaries enrolled in Part D prescription drug plans will see 50 percent savings on their brand name and some authorized generic drugs when they enter the coverage gap, or donut hole, during 2011. 

CMS also issued the draft model agreement that drug manufacturers of applicable Part D drugs will sign in order to participate in the discount program. Discounts will apply when the beneficiary reaches the coverage gap. Eligible beneficiaries will see the discount when they buy their drugs at their local pharmacy counter. 

Press Release: http://www.cms.gov/apps/media/press_releases.asp

Recommendations for Prescription Container Labeling - To promote the establishment of universal standards for prescription medication labels, and to address the widespread problem of patient misinterpretation of medication instructions, a USP Advisory Panel has issued recommendations to bring consistency to labeling on dispensed prescription packaging. The recommendations can be found at http://www.usp.org/USPNF/compendialNotices/recommendContainerLabeling.html. Please note that these are only recommendations and no labeling requirement regulations have been passed in New Jersey as of yet.

Drug Safety Labeling Changes - 

The FDA has made revisions to the safety labeling, including boxed warning, contraindications, warnings, precautions, adverse reactions, or patient package insert, of certain drug products. Please view the following table for those updates: http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm209165.htm

DME Accreditation Exemption and Competitive Bidding - H.R. 5235, the Medicare Access to Diabetes Supplies Act: This legislation would exclude diabetic supplies provided by small pharmacies from DME competitive bidding. The bill defines small pharmacies using the SBA definition of $7 million or less in annual sales. Excluding these supplies from competitive bidding is important for small pharmacies because they will unlikely be able to effectively participate in the competitive bidding program. This is will reduce beneficiaries' access to diabetes testing supplies. It is believed that CMS will issue guidance on the pharmacy DME accreditation exemption sometime within the next several weeks. This will clarify how CMS will implement the pharmacy exemption, which was enacted as part of the health care reform law.

PBM Reform: The Next Steps - 

H.R. 5234, the PBM Audit Reform and Transparency Act of 2010: This legislation expands the new PBM transparency requirements included in the health care reform bill to all plans both public and private plans. It is also the first federal legislation to try and reform PBM's abusive auditing practices. This bill: 
- Requires PBMs to curb abusive pharmacy audits; 
- Prevents PBMs from mandating covered individuals use of a specific pharmacy (retail, mail, specialty) if the PBM has ownership interest in that pharmacy; 
- Prohibits a PBM from transmitting personally identifiable utilization/claims data to a pharmacy owned by the PBM unless the patient has chosen to fill that particular prescription at the PBM-owned pharmacy.

Electronic Prescribing of Controlled Substances - Starting June 1, 2010, the Drug Enforcement Administration (DEA) will permit electronic prescriptions of Schedule 2 through 5 controlled substances. Both the physician and the pharmacy must be certified by a third party provider who will certify that the physician or the pharmacy has met all the requirements set by the new regulation. For more information, go to the DEA Diversion website www.deadiversion.usdoj.gov and read the "Q&A for pharmacies" article under the "What's New" Section. If the State requirements are more stringent than the DEA regulations, the State law would supersede any less stringent DEA provision.

May 20, 2010:  Governor Christie Reverses Cuts in PAAD and Senior Gold Programs
April 19, 2010:  Health Care Reform Passes – What to do now if you are not accredited and “stepped down”
April 19, 2010:  Pharmacists Play a Vital Role in Providing Immunizations in Their Communities
April 19, 2010:  Summary of CMS Final Rule: Medicare Program:  Policy and Technical Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Program
March 23, 2010:  Health Care Reform Alert:  Summary of Bill’s Provisions on Community Pharmacy
March 17, 2010:  Medicare Part D Company Ejected From Program for First Time
March 2,2010:  Contact members of the Assembly Health Committee in opposition to Assembly Bill A-1995
February 19, 2010:  New Law Governing CDS Prescriptions will take effect on March1, 2010
February 15, 2010:  New Medco Contract for New Jersey State Employees
February 15, 2010:  Additional Budget Cuts for Current FY 2010 Budget
December 20, 2009:  Influenza, H1N1 website www.flu.gov
December 20, 2009:  Medicare Part B DMEPOS Accreditation
December 20, 2009:  Physician and Practitioner Enrollment Records
October 15, 2009:  FDA Authorizes the use of Expired Tamiflu
August 6, 2009:  New Prescription Labeling Requirement Effective January 29, 2010
June 16, 2009:  FDA Issues Public Health Advisory Regarding Stolen Levemir Insulin
May 27, 2009:  CDC Guidance on Antiviral Treatment of Patients with Confirme,d Probable, or Suspected Cases of Novel Influenza A (H1N1)
April 27, 2009:  Information That You Need to Know About the Swine Influenza Pandemic
April 9, 2009:  Immunization Regulation Summary
March 17, 2009:  Court Approves First DataBank-Medi-Span Final Settlements
March 17, 2009:  Appropriations Committee Advances Bill to Regulate Pharmacy Benefit Management Companies
February 12, 2009:  Pharmacy Groups Announce Principles to Improve Patient Care, Access to Medications, Promote Technology to Enhance Health Care Delivery