2013 FPA LEGISLATIVE REPORT

Michael Jackson, BPharm, Executive Vice President and CEO
Updated October 28, 2013

It seems that every legislative session has its own unique personality with many challenges as well as opportunities. We can say for sure that given the limited resources available to the FPA we were successful in getting a number of favorable issues advanced and stopping others from becoming law as recommended by both FPA leadership and you as pharmacy stakeholders. We identified over 900 bills in the Florida House and nearly 1,000 bills filed in the Florida Senate. A little over 200 bills made it through the complex process and are either on their way to the governor’s desk or are being signed as we go to press with this report. This is not unusual as it generally is difficult to revise Florida laws and is designed purposefully to be that way. This report contains a review of the issues discussed by the legislature that may be of interest to the members. Some have been signed into law by the governor while other bills are being reviewed for Governor Scott’s signature. A final report will be provided at the FPA annual meeting July 7 – 14, 2013. Some of the issues we have been monitoring that have been approved by the Florida House and Senate are as follows:

Substitution of Biological Drugs (HB365) – This legislation allows for the interchangeable of biosimilar and biological drugs under the following conditions:

  • The FDA has determined that the substitute biological product is biosimilar to and interchangeable for the prescribed biological product
  • Adds biologicals, biosimilars and biosimilar interchangeables to hospital formulary lists
  • The prescribing health care provider does not express a preference against substitution in writing, verbally, or electronically and
  • The pharmacist notifies the person presenting the prescription of the substitution in the same manner as provided in existing laws (465.025) and
  • The pharmacist maintains a written record of the substitution for at least 2 years.
  • Hospital pharmacists can comply with patient notification by noting in the patient’s medical record.
  • The Board of Pharmacy must maintain a web site list of interchangeable biologicals and biosimilars drugs
  • Signed into Law by Governor Scott

What does this mean for FPA members? – Currently the FDA has not defined how biological and biosimilar drugs can be interchanged. This law appears to create a way for pharmacists to do that similar to how generic drugs are interchanged today. There are few if any biosimilar drugs on the market here in the US however the FPA understands that there are some in the development pipeline.

Medicaid Fraud (HB939) – Certain provisions of Florida Medicaid laws have been revised to do the following:

  • Requires a Medicaid provider to report a change in any principal of the provider to the Agency for Health Care Administration (AHCA) within 30 days after the change occurs;
  • Provides a definition for “administrative fines” for purposes of liability for payment of such fines in the event of a change of ownership;
  • Authorizes, rather than requires, the AHCA to perform an onsite inspection of a provider before entering a provider agreement to ensure that the entity complies with the Medicaid program and professional regulations;
  • Modifies provider’s surety bond requirements to provide that the amount of the bond need not exceed $50,000, if the physician or group of physicians licensed under ch. 458, ch. 459 or ch. 460, F.S., has a 50 percent or greater ownership interest in the provider or if the provider is an assisted living facility under ch. 429, F.S.;
  • Provides a definition for principals of a provider with a controlling interest for hospitals and nursing homes, for purposes of conducting criminal background checks to be consistent with the definition for licensure;
  • Removes exceptions to the background screenings requirements for hospices or assisted living facilities that are Medicaid providers;
  • Permits enrollment of an out-of-state provider if the provider is located within 50 miles of the state line; the provider is a physician actively licensed in the state and interprets diagnostic testing results through telecommunications and information technology from a distance; or the AHCA determines a need for that provider type to ensure adequate access to care;
  • Amends the Medicaid Third Party Liability Act with respect to procedures for challenging certain recovered medical expenses to ensure compliance with federal law;
  • Expands the list of criminal offenses for which the AHCA may terminate the participation of a Medicaid provider;
  • Requires the AHCA to impose the sanction of termination for cause against providers that voluntarily relinquish their Medicaid provider numbers after being notified that an audit, survey, or inspection that could result in the sanction of suspension or termination is underway or has been conducted;
  • Requires that when the AHCA determines that an overpayment has been made, the AHCA must base its determination solely on the information available before the issuance of an audit report and upon contemporaneous records. The AHCA may consider addenda and modifications to a note made contemporaneously with the patient care episode if the addenda is germane to the care;
  • Requires overpayments or fines to be paid to the AHCA within 30 days after the date of the final order;
  • Clarifies the scope of immunity from civil liability for persons who report fraudulent acts or suspected fraudulent acts;
  • Amends the membership of the Medicaid and Public Assistance Fraud Strike Force to allow members to utilize designees and repeals the Strike Force effective June 30, 2014; and,
  • Repeals s. 624.352, F.S., relating to interagency agreements to detect and deter Medicaid and public assistance fraud effective June 30, 2014.
  • Signed into law by Governor Scott

What does this mean for FPA members? – This change in Florida laws related to Medicaid gives the Agency for Health Care Administration additional authority over provider behavior. Members will have to continue their efforts to maintain good records regarding the care of Medicaid recipients. Members will also need to make sure that any changes in prescription department managers are reported promptly.

Workers Compensation (SB662) – This legislation seeks to further define reimbursement for prescription medications for workers compensation patients. If signed into law by Governor Scott this bill:

  • Attempts to clarify pricing of repackaged drugs for workers compensation prescriptions
  • Sets reimbursement rates of dispensing MDs to 112.5% of AWP and an $8.00 dispensing fee for repackaged drugs
  • Requires use original manufacturer’s NDC code for repackaged drugs
  • Would disallow dispensing practitioners from possessing drugs billed to workers compensation that has not been paid for within 60 days of dispensing.
  • Signed into law by Governor Scott

What does this mean for FPA members? – Prescription drugs for workers compensation patients dispensed by physicians are higher in costs than those dispensed by pharmacies. Florida’s workers compensation prescription costs are higher than many states. This again could be contributed to physician dispensing. This bill seeks to define reimbursement workers compensation prescriptions dispensed by dispensing practitioners. Though the bill does not level the playing field between pharmacy and physician dispensing practitioners it does establish a reimbursement ceiling that was not present before.

Payment Systems for Hospitals (SB1520)

  • Creates a DRG based payment systems for hospitals
  • Rates are to be recalculated annually
  • Agency to set outpatient reimbursement services rates
  • Funds a statewide Medicaid residency program for primary care providers using Medicaid per diems
  • Funding allocated for Medical residents
  • Signed into law by Governor Scott

What does this mean for FPA members? – DRGs or “diagnostic related groups” is not a new concept in payment for hospital services. DRG is a type of prospective payment system for reimbursing hospitals. DRGs classify an inpatient stay into a group based on a patient’s diagnoses, gender, age, and other factors, which can include hospital case mix and overall wellness or acuity of the hospital’s overall patient population. Groups of related diagnoses are designed to provide a stable and fairly predictable indication of the resources needed for treating a particular patient. This type of system is used in the federal Medicare program and seeks to tailor reimbursement more closely to actual costs of treatment for each individual patient. Hospitals with a significant Medicaid census may see their reimbursement change. This could affect health care support services such as inpatient pharmacy budgets.

Impaired Practitioner Consultant (SB604) – This bill was originally filed to give the Department of Health contracted impaired practitioner consultant access to the PDMP program database however that bill was amended to now only allow expansion the Department of Health’s ability to defend the impaired practitioner consultant if there is a claim.

What does this mean for FPA members? – This issue will likely have little bearing on FPA members as it is primarily a bill to address Department of Health internal policies.

Physician Assistant Ordering of Medications (SB398)

  • Clarifies that a PA can order medications in a hospital under the direction of a physician
  • The House version that appeared to clarify that the PA can dispense as an agent of the physician had that section removed
  • Signed into law by Governor Scott

What does this mean for FPA members? – Currently physician assistants have been ordering medications in hospitals based upon authority granted to them by the facilities policies and procedures. This practice has been called into question by some facility risk managers indicating the vague language in the PA practice act. This bill clarifies physician assistant authority for issuing orders in licensed hospitals. Members should not see any changes in those facilities.

Public and Private Schools and Epinephrine (SB284)

  • Allows public schools to order and maintain epinephrine auto-injectors for their students
  • Epinephrine must be maintained in a locked location
  • School district must adopt protocol with licensed MDs
  • Can be administered by trained school personnel or by the student authorized to self administer
  • School district employees and physician who signed the standing protocol not liable under certain circumstances
  • Signed into law by Governor Scott

What does this mean for FPA members? – This bill will have little to no impact on FPA members however it would be a good idea for pharmacists to connect with public and private school districts and stress the importance of proper storage and maintenance of these medications. Members could educate school administrators on issues such as expiration dating, recalls or other similar matters.

Florida Controlled Substance Act (SB294)

  • Revises the list of controlled substances in schedule I (addition of some 20 or more items)
  • Adds synthetic cannabinoids, cathinones and phenethylamines
  • Unlawful acts related to these substances subject to arrest and prosecution
  • Signed onto law by Governor Scott

What does this mean for FPA members? – This legislation came about by the need to address emerging chemical changes with abused substances by adding to the list of Florida schedule I controlled substances. Members will need to make sure that any chemicals in their pharmacies that are added to schedule I are handled according to this new revision to Florida law. You can see the list of new chemicals that have been added by going to Senate bill 294 passed during the 2013 legislative session.

Optometrist Prescribing (HB239)

  • Expands optometrist prescribing authority to include oral and topical ophthalmic agents
  • Creates a certification training program jointly provided by the Florida Medical Association and the Florida Osteopathic Medical Association
  • Restricts the prescribing or administration of controlled substances to only III, IV or V
  • Allows optometrists to administer schedule III, IV or V oral analgesics for the relief of pain due to conditions or the eye or its appendages.
  • Adverse incidences required to be reported
  • Signed into law by Governor Scott

What does this mean for FPA members? – Pharmacists may now dispense from an expanded list of medications prescribed by certified optometrists. This includes not only topical drugs used to treat and diagnosis the eye by optometrists but also oral drugs that are used for the same purpose. Members may need to be aware that optometrists will need to be credentialed to have this new prescribing authority. It is unknown whether or not there is an obligation on the pharmacist to verify this new prescribing authority prior to dispensing.

Waiver of Licensure Fees for Veterans (SB160)

  • Exempts initial licensure fees for honorably discharged veterans
  • Veteran must apply within 24 months of discharge
  • May have an insignificant negative fiscal impact on DOH
  • 1.6 million veterans living in Florida
  • Signed into law by Governor Scott

What does this mean for FPA members? – FPA member pharmacists and technicians generally already have a Florida license and as such this bill will have an insignificant impact. Pharmacists and pharmacy technicians who have been recently discharged honorably and are eligible for licensure within 24 months of that discharge will not have to pay their initial fees. Unfortunately this may not help recent discharged veterans who must begin their 6 years of pharmacy school training. It possibly could help pharmacy technicians who complete their Board approved training program within the 24 month period. Discharged veterans who are pharmacists and are transferring their licenses to Florida may be eligible for this waiver of licensure fees.

Revision of Accreditation Standards (HB1071)

  • Removes a number of references to “Joint Commission” in several sections of Florida laws
  • May allow for alternative accreditation organizations for facilities and services
  • Accreditation organizations must incorporate licensure regulations required by Florida
  • Passed Florida House and Senate
  • Signed into law by Governor Scott

What does this mean for FPA members? – The Joint Commission (TJC), formerly the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) and previous to that the Joint Commission on Accreditation of Hospitals (JCAH) is a United States-based nonprofit tax-exempt 501(c) organization that accredits more than 19,000 health care organizations and programs in the United States. A majority of state governments have come to recognize Joint Commission accreditation as a condition of licensure and the receipt of Medicaid reimbursement. Surveys (inspections) typically follow a triennial cycle, with findings made available to the public in an accreditation quality report on web site. Pharmacists working in hospitals or similar facilities could see alternate accreditation entities surveying their facilities rather than Joint Commission.

Volunteer Health Services (HB1093)

  • Allows health care providers to receive continuing education credits (up to 8 hours) for pro bono services
  • Pro bono services should be performed for a state agency under a government contractor
  • Services should be provided to the indigent
  • Signed into law by Governor Scott

What does this mean for FPA members? – On occasion, governmental contractors may solicit the services of health care providers to provide volunteer and uncompensated health care services to low-income individuals. It is possible that pharmacists providing these services could qualify for this continuing education credit.

State Employee Mail Order Program (SB1500 – State Budget)

  • Mail order language found on page 390, paragraph item #6
  • Appears to be renewing the current state employee mail order program
  • SB1802 has softened the sting of this provision perhaps by setting the conditions under which this mail order program can proceed
  • Signed into law by Governor Scott

What does this mean for FPA members? – For the past several years the Florida legislature inserted in the budget language that required state employees to get their maintenance medications processed through the state’s contracted mail order provider after the 3rd fill. It is possible that though the mail order language is still listed in the budget, SB1802 or other similar legislation which also passed the House and Senate may provide some relief to the language in the budget and the mail order requirement may end for this fiscal year.  More on this will be shared at the 2013 annual meeting and convention this summer.

Medical Malpractice Insurance (SB468)

  • Attempts to deregulate malpractice insurance rate setting
  • Malpractice insurance carriers would not be subject to rate reviews by the office of insurance regulations
  • Exemption for physicians
  • Pharmacists and technicians added later in the session
  • Signed into law by Governor Scott

What does this mean for FPA members? – Some insurance providers are exempted from having to file with the Office of Insurance Regulations (OIR) for changes to their premium rates. This means that insurance carriers that are exempted could have more flexibility to change their premium rates at will. This bill was designed to add malpractice insurance carriers as entities who would not have to have their rates reviewed by OIR. Removed from this deregulation of malpractice carriers included licensed dentists, physicians, osteopathic physicians, chiropractic physicians and podiatric physicians. This means that pharmacist liability insurance carriers could change their rates at will without any intervention from the Office of Insurance Regulation. The FPA was successful in adding in pharmacists and pharmacy technicians to this bill which would require insurance carriers to have their rates reviewed prior to implementation.

Cancer Treatment Fairness Act (HB1159)

  • Requires insurance coverage of oral cancer medications
  • Cost sharing requirements for oral cancer medications must not be less favorable than cost sharing requirements for IV or injectable medications
  • Does not allow the insurance plan or HMO to modify their policies to avoid compliance on the effective date of this bill
  • Does not allow for the plan or HMO to offer incentives or penalize patients for accepting less protection required by this bill
  • Does not allow an insurance plan or HMO to penalize a health care practitioner for recommending or providing care required by this bill
  • Does not allow the insurance plan or HMO to provide incentives to practitioners to provide care that is not in compliance with this bill
  • Will not allow for the change in classification of IV or injectable cancer treatment or increase the amount of the cost share in effect on the effective date of the bill
  • Signed into law by Governor Scott

What does this mean for FPA Members? – The Association was amazed to learn that copays or cost shares paid by patients for oral cancer medications were in some cases higher than what patients had to pay for IV or injectable therapy. Additional language was included in the bill that removed things like patient or provider penalties or incentives to steer therapy based upon coverage for cancer patients. Members treating patients on cancer medications may see changes in patients’ copays or cost shares.

Funding of the PDMP Program (HB1159) – Senate bill 1192 and House bill 831 were filed to address a number of issues related to Florida’s prescription drug monitoring program (PDMP). This program can only be funded with voluntary contributions to a foundation authorized by the Florida legislature. No manufacturer grants or state funds were allowed to support the PDMP program. SB1192 and HB831 were published to allow state and or manufacturer funding. Neither bill was able to get to the governor’s desk for signing into law. An amendment however was inserted into House bill 1159 related to cancer treatment that provided $500,000 in funding for the PDMP for fiscal year 2013-2014. Absent this allocation by the legislature the PDMP would have to wind down its operations. The FPA reached out to members of the Florida legislature and asked for their support. Association leadership even initiated a fundraising campaign at our law conference in Tampa on April 20, 2013.

What does this mean for FPA Members? – Had this program not received this funding from the legislature there would likely be a requirement for pharmacies to report data to a prescription drug monitoring program database that would be unfunded and have no resources to operate. Members may also find that they would have been unable to query the database for patients’ dispensing history should the PDMP program stop operating. The Association has learned that the PDMP program had only about a month or so of operating funds. This budget allocation will keep things going until the legislature implements its 2014 budget.

BILLS OF INTEREST NOT ADOPTED BY THE FLORIDA LEGISLATURE

As mentioned earlier slightly over 10% of all filed bills ever get to the Governor’s desk. Some of those may be victim of the veto pen which means that many of the issues debated by Florida’s policymakers ever get through a very complex process. A sampling of some of the many issues that the FPA was monitoring that did not pass includes the following:

Disposable and Reusable Bags (SB722, HB957)

  • Would have facilitated uniform local ordinance rules on disposable bags for merchants
  • Optional for charging a fee for reusable bags
  • Required a fee to be charged for recyclable bags
  • 50% of fees collected go to school districts
  • Merchant could have kept up to the other 50% of the fees
  • Reports would have been required to be filed with the state

“Who Can Be Called Doctor” (SB612, HB805)

· Created grounds for disciplinary action for a licensee under F.S. 464 to use the “Dr.” designation when providing or advertising health care services.

  • Penalty would have been a third degree felony
  • Not applicable to pharmacists

Needle and Syringe Exchange Program (SB808, HB735)

  • Created a free needle and hypodermic syringe and needle exchange pilot program in Miami Dade
  • Program to be housed within the Department of Health
  • User would get one needle and syringe for each one exchanged
  • Department of Health would have to provide educational materials on HIV AIDS
  • Possession of needles and syringes under this program would not have been a violation
  • Program would have ended July 1, 2018

Audits of Pharmacy Records (HB791, SB1358)

  • Attempted to expand existing auditing standards for Medicaid and make them applicable to all third party programs
  • Was supposed to revise F.S. 465.188
  • Found favorable in Senate Health Policy

Medical Cannabis (SB1250, H1139, S1214)

  • Labeled the Cathy Jordan Medical Cannabis Act
  • 133 page bill would have defined the medical use of cannabis
  • The Department of Business and Professional Regulation would have been the designated agency that regulates medical cannabis farms
  • Bill described a “dispensary” as being a facility licensed under Florida Statutes 499

Required Coverage for Telemedicine Services (SB898, HB499)

  • Would have required health insurers, corporations, and health maintenance organizations issuing certain health policies to provide coverage for telemedicine services
  • Would have prohibited the exclusion of telemedicine cost coverage solely because the services were not provided face to face
  • Would have prohibited the imposition of certain dollar and durational coverage limitations or copayments, coinsurance, or deductibles on telemedicine services unless imposed equally
  • Would have provided coverage under the state plan or a waiver for health home services provided to eligible individuals with chronic conditions

Changes to Licensing Requirements (SB1334)

  • Would have removed the requirement for the Department of Health to issue wallet and wall ID cards
  • Would have relocated CE tracking language to a different section of Florida law
  • Would have required the Department of Health to integrate the CE tracking and licensing systems
  • Would have required licensees to provide current email address
  • Mailed and emailed notices from the DOH would be considered sufficient notice

 

Adding Growth Hormones to Schedule III

 

  • Proposed legislation would have added human chorionic gonadotropin and other similar growth hormone drugs to Florida’s schedule III controlled substance list.

Change of Pharmacy Technician Ratio (HB671, SB818)

  • Would have significantly raised the number of technicians that a pharmacist could supervise beyond the current Florida law limit of three.
  • Would have allowed the supervision of more than six technicians if permitted by guidelines adopted by the Board of Pharmacy
  • Opposed by the FPA and FSHP
  • Passed by House but stalled in the Senate

FPA IS ON THE MOVE

We hope that you found this report informative and a synopsis of the investment that each of you have made in maintaining your membership in the Florida Pharmacy Association. There will continue to be no shortage of issues pending that need to be dealt with. The FPA has a wealth of student, technician and pharmacist volunteers that have graciously given of their time and talents to fulfill the mission of the FPA. It is no secret that this profession is in transformation. It will evolve into a practice model that can be of tremendous benefit to consumers but to do that we must continue the revolution against policies that harm patient access and devalues what our industry can bring to the health care table. We are all gladiators in a fight to ensure the viability of this profession for years to come. Thank you for your commitment and your support.