July Legislative Update: HB 1 OH Budget, Tech Rules, Zoster, SB 119, Federal Health Care Reform
HB 1: Budget
Things are getting very tense down at the Statehouse because tax revenue figures are dropping, and jobless claims and the Medicaid population are growing - three things that you do not want to happen at the same time. Agency budgets are being cut and programs are being slashed. We have several items in the State's biennial budget that we are keeping a close eye on.
HB1 is currently in Conference Committee. Because the fiscal year began July 1, 2009, the State of Ohio has had to pass two one week budgets so that the State can continue to operate while the Conference committee tries to come to a resolution.
Medicaid Fee Cut Proposed. At the time of writing, the Governor has proposed that the Medicaid fee be reduced from $3.70 down to $1.80. OPA will keep you informed.
Ohio's Best Rx Program, the state prescription drug discount program created in 2003, will be eliminated effective January 1, 2010. The Department of Aging, which administers the program, will spend this year transitioning program participants into other programs currently in existence. The program was never able to become self-sustainable, and it will be a welcome relief to have it lifted from the shoulders of pharmacists across Ohio.
The Governor's Executive Budget proposal "carves out" the Medicaid pharmacy benefit from managed care and returns its administration to ODJFS. This is expected to generate $5.2 million in savings and cost avoidance in fiscal year 2010, and $235.5 million in fiscal year 2011. This does not need to be done through statute. It is a contractual issue which will be done internally or through the rules process. There is an effort by the managed care companies to have language inserted into the budget that would mandate them (managed care) to provide the pharmacy benefit, but as of now they have not been successful. We continue to keep a close eye on this issue.
In a meeting with Medicaid, we were told that the carve-out could be done two different ways.
1. The pharmacy benefit would go completely back to fee-for-service, the way it was before being handed over to managed care.
2. The managed care companies could continue to manage the pharmacy benefit, but ODJFS would set one formulary and the prior authorizations, thereby allowing the State to collect the rebates from manufacturers.
At the time of this printing, it is unclear how ODJFS plans to handle the proposed Medicaid pharmacy carve-out. It is a matter of great concern, however, considering that the Governor is also proposing a drastic cut in the Medicaid pharmacy dispensing fee. The Governor has proposed to partially fill the growing budget hole by slashing the pharmacy dispensing fee from the current $3.70 to $1.80. We urge every pharmacist to contact the Governor and their State Legislators immediately and let them know how this will affect your pharmacy.
OPA continues to keep a very close eye on these developments and is actively participating in discussions at every level on this issue.
Pharmacy Technician Rules Revision
Rules for the implementation of the Pharmacy Technician law have been finalized by the Board of Pharmacy. The effective date for all of the rules, except the rule regarding Board-approved examinations for qualified technicians (Rule 4729-4-02), was June 21, 2009.
Rule 4729-4-02, Board approved examination for qualified technicians, was pulled from the JCARR (Joint Commission on Agency Rule Review) hearing calendar and revised to include a statement that all employer tests must be approved by the Board of Pharmacy before they can be administered to employees. The rule will now go back to JCARR at the end of June, and will be presented to the Board of Pharmacy for final approval at their July board meeting. The effective date for 4729-4-02 is expected to be July 26, 2009.
Because the rule on employer testing has been delayed, it became necessary to push back the timeframes for having pharmacy technicians "qualified" as well. Language was inserted in the Budget Bill that will give you more time to have your pharmacy technicians pass the competency test. Assuming the budget bill passes with this language, you will now have 12 months from the date of hire for new hires to pass the exam, and 18 months for employees hired prior to the April 8, 2009 effective date of the legislation.
Do You Know the Pharmacy Technician Requirements?
Qualified pharmacy technician means a person whom, under the direct supervision of a pharmacist, all of the following apply:
- The person is 18 years of age or older
- Possesses a high school diploma or GED
- Passes a criminal records' check (has no felony convictions) that is submitted to the employer. Be sure you are running background checks on new hires and those technicians who have NOT worked for you for more than five years.
- Passes a competency exam
Exam can be either
- An employer test approved by the Ohio Board of Pharmacy (BOP).
- One of the national certifying exams (certification program must be accredited by National Commission for Certifying Agencies). Information on this will be posted on the Board's website in July.
What can a "qualified pharmacy technician" do?
In a pharmacy or while performing a function of the pharmacy and under the direct supervision of a pharmacist, only a qualified pharmacy technician may do any of the following:
- engage in the compounding of any drugs;
- package or label any medication;
- prepare or mix any intravenous medication to be injected into a human being.
Please go to the "What's New" section of the Board of Pharmacy website (www.pharmacy.ohio.gov/)and familiarize yourself with the rules regarding pharmacy technicians. Remember there are criminal penalties involved with noncompliance with sections of this law!
Zoster Vaccine Rules Finalized by the Board of Pharmacy
The zoster vaccine rules were finalized by the Board in June. The effective date is June 21, 2009. Below is the text of the new rule.
4729-5-38 Immunization Administration. In addition to the immunizations and medications listed in section 4729.41 of the Ohio Revised Code and pursuant to the requirements noted in section 4729.41 of the Revised Code and rules 4729-5-36 and 4729-5-37 of the Ohio Administrative Code, a pharmacist may administer the zoster vaccine according to the following requirements:
(A) The pharmacist must receive a patient specific prescription prior to administration of the drug;
(B) The vaccine must be administered within thirty days of the issuance of the prescription;
(C) The patient must meet the age criteria specified in the F.D.A. approved labeling; and
(D) The pharmacist must be able to document meeting the training criteria required by Rule 4729-5-36.
Approved Herpes Zoster Home Study Available
At the June meeting of the Ohio State Board of Pharmacy, the Board approved Immunizations for Herpes Zoster as a supplemental course for pharmacists who have completed a board-approved immunization training program. This one contact-hour (0.1 CEU) home study lesson, developed by the Ohio Pharmacists Foundation, provides information on advances in herpes zoster immunizations and a working knowledge of the live, attenuated zoster vaccine.
Information on purchasing this supplemental course may be found on OPA's website www.ohiopharmacists.org. The course expires June 18, 2012.
SB 119: Mandated Error Reporting
SB 119, introduced by Sen. Grendell, would require pharmacists, pharmacy interns, and qualified pharmacy technicians to report suspected dispensing errors to the State Board of Pharmacy. It would require the Board to investigate all such reports, to pursue disciplinary action when warranted, and to specify criminal penalties for failure to comply with the reporting requirements.
This bill is of grave concern to OPA. We feel the best way to deal with and prevent pharmacy errors would be through a non-punitive peer review process, much the same as that of physicians.
OARRS Reporting Update
As of July 1, 2009, all pharmacies that are required to report prescription data to Ohio's Prescription Monitoring Program (OARRS) will be submitting it directly to the State Board, rather than the previous outside vendor. As of September 1, 2009, the data must be submitted weekly, instead of twice a month. Direct any questions to email@example.com or 614.466.4143.
Health Care Reform
The Affordable Health Choices Act has been proposed by Senator Edward Kennedy (D-MA). Language in the Affordable Health Choices Act expands access to pharmacist-delivered medication therapy management (MTM) services. The legislation recognizes MTM services provided by pharmacists as a vital component of coordinated care delivered by community health teams. Additionally, the bill establishes a pioneering grant program to implement MTM for the treatment of chronic diseases. This is an important step toward further integrating MTM into healthcare delivery to improve outcomes and reduce costs.
July 1, 2009 Compliance Date for FDA Adverse Events Reporting
Pharmacists and other authorized dispensers must distribute the 1-800 number side effects statement to consumers with prescription medications, as of July 1, 2009. The prescription labeling must include the statement, "Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088." See December 2008 Legislative Update in the Ohio Pharmacist journal for details.