POLITICAL PULSE: HHS Committee is Closely Divided on Bill to Require Notice/Consent of Prescriber for Substitution of Anti-epileptic Medication
HHS COMMITTEE DEBATES BILL ON SUBSTITUTION OF ANTI-EPILEPTIC MEDICATIONS
Last week, the HHS Committee held both a public hearing and work session on L.D. 1672, An Act to Require a Pharmacist to Provide Prior Notification to and Obtain Consent from the Prescribing Physician before Changing from One Formulation or Manufacturer of an Antiepileptic Drug to Another. Senator Peter Bowman (D-York) sponsored the bill at the request of Patricia Locuratolo, M.D., a neurologist from York, Maine who witnessed a number of her patients having adverse effects from a switch in medications under the state's generic substitution statute, even from a generic drug produced by one manufacturer to that same generic drug produced by another manufacturer.
At the public hearing last Tuesday afternoon, Dr. Locuratolo and a representative of the Epilepsy Foundation in New England testified in favor of the bill. Heidi Henninger, M.D., a neurologist specializing in epilepsy with Maine Neurology in Scarborough, submitted written comments in favor of the bill. DHHS, pharmacy benefit manager Medco, and generic manufacturer Mylan Labs testified in opposition to the bill. The MMA, Rite Aid, and the Maine Nurse Practitioners' Association testified "neither for nor against" the bill. In its testimony, the MMA talked about the substantial internal debate about the need for the bill and that the neurologists had persuaded their colleagues that the epilepsy patients present unique challenges in medication management and unique potential consequences for themselves and the public at large from medication failure. The MMA suggested that the Committee take some action to address this problem. DHHS estimated that the original draft of the bill could have a fiscal note of as much as $7 million because of increased costs for the MaineCare drug management program.
A key point of contention between the bill's proponents and opponents is whether prescribers have an adequate remedy for this problem under current law. The current generic substitution statute, 32 M.R.S.A. section 13781, permits a prescriber to write "dispense as written" on any prescription, but there is substantial uncertainty whether this could prevent a switch from one generic manufacturer to another of the same medication.
At the bill's work session last Thursday, the MMA offered a proposed amendment in an effort to mitigate the fiscal note and to address concern that the bill proposed a substantial departure from current law. Based upon the MMA draft, the committee analyst drafted the following amendment to the generic substitution statute.
A pharmacist shall contact the prescriber and obtain the consent of the prescriber prior to any substitution of a drug or a drug formulation when the prescriber has written "epilepsy/seizure risk" on the prescription form. This paragraph is repealed August 1, 2012.
The sunset provision was added because the FDA soon is expected to address issues of bioavailability that are at the root of this problem.
At the conclusion of the work session, the Committee split 6-5 with the majority voting "ought not to pass" (to kill the bill) and to send a letter to the MMA asking for some CME on this subject and the minority voting "ought to pass as amended" for the provision listed above. Unfortunately, the clinicians on the Committee split on the bill. House Chair Anne Perry (D-Calais), a nurse practitioner, voted with the majority while Linda Sanborn, M.D. (D-Gorham), a retired family practitioner spoke strongly in favor of the amendment and voted with the minority. By the end of the week, it was unclear whether Senator Peter Mills (R-Somerset) and Senator Lisa Marrache, M.D. (D-Kennebec) had registered their votes. Dr. Locuratolo had an opportunity to discuss the bill with Senator Marrache, but she seemed inclined to vote with the majority. DHHS officials agreed to withdraw the fiscal note from the amended version of the bill.
The majority included the following members:
- Senate Chair Joseph Brannigan (D-Cumberland)
- House Chair Anne Perry (D-Calais)
- Representative Mark Eves (D-North Berwick)
- Representative Sarah Lewin (R-Eliot)
- Representative Meredith Strang Burgess (R-Cumberland)
- Representative Henry Joy (R-Crystal)
The minority included the following members:
- Representative Linda Sanborn, M.D. (D-Gorham)
- Representative Pat Jones (D-Mount Vernon)
- Representative Matthew Peterson (D-Rumford)
- Representative Peter Stuckey (D-Portland)
- Representative James Campbell (U-Newfield)
Maine physicians will be interested to know that four lobbyists, two each for two out-of-state interests, Medco and the National Association of Chain Drug Stores (NACDS) spent most of the Thursday afternoon work session buttonholing members of the committee and appeared to have a substantial impact on those members who wound up in the majority.
Because of the close vote, L.D. 1672 should be the subject of a very interesting floor debate in both chambers. It is likely to be at least a week, if not more, before the bill comes out of the committee and it could be longer before caucuses take place on it so that it is prepared for debate. The only sure thing is that it will be debated before late March/early April. Dr. Locuratolo and the MMA are working on a set of talking points in support of the bill.
Until alerted to floor action on the bill, physicians who are interested in influencing the outcome, may do some or all of the following:
- Contact Senator Lisa Marrache, M.D. at 861-0154 or email@example.com
- Contact Senator Peter Mills at 474-3821 (H) or 474-3324 (W) or firstname.lastname@example.org (with regard to Senators Marrache and Mills, make contact ASAP in case they have not yet registered their votes on the bill)
- Contact your own Senator and Representative to alert them that this divided report will be coming to the floor and to advise them of your thoughts on it
- Contact any member of the HHS Committee, either to thank the member for a vote with the minority (and to help them prepare for the debate) or to continue education of the majority; you can find the HHS Committee members and their contact information on the web here: http://www.maine.gov/legis/house/jt_com/hum.htm.
For additional background on this issue:
HHS COMMITTEE ALSO HOLDS WORK SESSION ON MHDO/MHDPC BILL INCLUDING PROVISION ENCOURAGING SUBMISSION OF DATA IMPORTANT TO QUALITY INITIATIVES
On February 8th, the HHS Committee held a work session on L.D. 1544, An Act to Amend the Laws Governing the Maine Health Data Processing Center and the Maine Health Data Organization. While much of the bill is not controversial, two sections of the bill have been the subject of some debate. These provisions would permit health insurers to reject claims submitted without "all required fields filled with correct and complete information." In particular, the MHDO is concerned that the rendering or service provider, the billing provider, and the location where the service was performed are data fields frequently not filled out or filled out properly. Policymakers frequently ask the MHDO for this data to support various quality improvement initiatives. The MMA would be interested in hearing feedback from physicians and their billing staffs about the practical implications of the following language from this bill:
Sec. 8. 24-A MRSA §2436, sub-§2-A, as amended by PL 2003, c. 469, Pt. D, §4 and affected by
§9, is repealed and the following enacted in its place:
2-A. For a claim submitted by a health care provider or
health care facility with respect to a health plan as defined in section 4301A,
subsection 7, for purposes of this section, "undisputed claim" means
a timely claim for payment of covered health care expenses that is submitted to
a carrier in conformity with the following requirements.
A. The claim
must be submitted on one of the following claims forms:
(1) For a health care facility claim submitted
on paper, the standard claim form, using standards approved by a national
uniform billing committee;
(2) For a health care provider claim submitted
on paper, the standard claim form, using standards approved by a national
uniform claim committee; and
(3) For health care facility and health care
provider claims submitted electronically, an electronic form using standards
approved by an accredited standards committee of the American National
B. The claim
must use the most current published source codes with all required fields
filled with correct and complete information. All fields identifying the
rendering or service provider, the billing provider and the location where the
service was performed are considered to be required fields and must be filled
on all claims.
Sec. 9. 24-A MRSA §2436, sub-§2-B is enacted to read:
2-B. If a claim does not conform to the requirements
specified in subsection 2A and payment is denied to a health care provider or
health care facility by a carrier, the health care provider or health care
facility may not request payment from the insured or beneficiary and shall
attempt to rectify the deficiencies with the claim and resubmit the claim to
The HHS Committee will discuss these two sections of the bill again.
HHS & APPROPRIATIONS COMMITTEES CONTINUE SUPPLEMENTAL BUDGET DISCUSSIONS
The Appropriations Committee continues to deliberate L.D. 1671, the FY 2010-2011 supplemental budget, and continues to discuss problematic areas with the HHS Committee. On Friday, February 12th, the HHS Committee members met with the Appropriations Committee to discuss various issues and the discussion produced the following list of questions or information requests:
Questions from the February 12th
1. What is the detail on the fiscal note on LD 233, the bill that
provides MaineCare reimbursement for independent practice dental
hygienists? (Chris Nolan, OFPR)
2. Please provide a copy of the report from the Governor’s Office of
Health Policy and Finance to the Legislature on reducing the use of emergency
departments and reducing preventable admissions. (Jane Orbeton, OPLA)
3. Please provide information on the contract with Consumers for
Affordable Health Care, on the list of DHHS OMS fiscal agent related contracts
at $100,001 in federal funds in FY11.
4. Please provide information on the (Goold) GHS contract, on the
list of DHHS OMS fiscal agent related contracts at $3,839,1162.75 in GF (with
federal match) funds in FY11. (DHHS)
5. Please provide the list of smaller contracts with DHHS that were
listed by Beth Ashcroft in a discussion with the AFA Committee recently. (Jane Orbeton, OPLA)
6. Please provide information on whether there are possible savings
to DHHS/benefits to the ICF/MR’s from utilization of the LIHEAP program. (Maine
Association of Community Service Providers and DHHS)
7. Please provide information on the Change Package initiative with
regard to day habilitation services.
8. Please provide information on voluntary State or Legislature
memberships in organizations and from which accounts those memberships are
paid. (DAFS, DHHS, Executive Director
of Legislative Council)
9. Please provide information on whether with regard to long-term
care in the MaineCare program federal eligibility and estate recovery
requirements could/should be written into Maine law. (DHHS, Attorney General’s Office)
10. Please provide information on whether the initiatives with regard
to sheltering assets and estate recovery place the State at risk of violating
ARRA prohibitions on limiting eligibility for Medicaid benefits. (DHHS, Attorney General’s Office)
11. Please provide information on the services and accounts (MH and
MH/DD) that are included in the tax and match information. (DHHS)
12. Please provide information on the effect of the outpatient
hospital MH and SA rate cuts, including a comparison of the services and rates
provided by hospital-based providers and those provided by community
providers. (DHHS, Maine Hospital
Association, MAMHS, MASAP)
The HHS Committee has scheduled another budget work session for this Friday, February 19th at 9 a.m. The HHS Committee is scheduled for another meeting with the Appropriations Committee on February 24th at 2 p.m.
BRED COMMITTEE RECOMMENDS RESOLVE ON ADMINISTRATIVE LAW JUDGE BILL
At a work session last Thursday afternoon, the Business, Research & Economic Development Committee unanimously recommended the following language to replace L.D. 1608, An Act to Establish an Office of Administrative Law Judges for Licensing Boards.
Directing the Department of Professional and Financial Regulation to Study the
Complaint Resolution Process
1. Commissioner directed to study the
need for procedural changes in the processes used by professional and
occupational licensing boards within and affiliated with the Department to
resolve complaints against licensees.
Resolved: That the
Commissioner of the Department of Professional and Financial Regulation, in
consultation with interested parties including the Maine Regulatory Fairness
Board, shall conduct a study of the need to establish protocols for
occupational and professional licensing boards within and affiliated with the
Department with respect to the resolution of complaints; and be it further
2. Reporting date established. Resolved:
That the Commissioner of the Department of Professional
and Financial Regulation shall submit recommendations under section 1 to the
joint standing committee of the Legislature having jurisdiction over business,
research and economic development matters by February 15, 2011.
3. Legislation. The joint standing committee of the Legislature
having jurisdiction over business, research and economic development matters
may submit legislation regarding the establishment of protocols to resolve
complaints to the First Regular Session of the 125th Legislature.
INSURANCE COMMITTEE ADOPTS COMPROMISE LANGUAGE ON MEDICAL DEBT CREDIT REPORTING
The MMA, MHA, & the Thomas Agency all raised concerns about the original draft of L.D. 1676, An Act to Protect Maine Citizens' Credit, sponsored by Senator Phil Bartlett (D-Cumberland). Will Lund, the Superintendent of the Bureau of Consumer Credit Protection, and IFS Committee Analyst Colleen McCarthy-Reid collaborated to produce the following compromise language adopted by the Committee at a work session last week.
PROPOSED COMMITTEE AMENDMENT "." TO L.D. 1676, An Act to Protect Maine Citizens’ Credit
the bill by striking out everything after the enacting clause and
before the summary and inserting in its place the following:
Sec. 1. 9-A MRSA section 5-116-A is enacted to read:
Section 5-116-A. Debts owed to Health Care providers
Definition of health care provider. For purposes of this section,
“health care provider” means a physician, health care practitioner,
hospital, clinic, clinical laboratory, health care facility or other
person or facility that provides health care services and is licensed
or registered by the State.
2. Exclusion from definition of
“consumer credit transaction.” An agreement by a health care provider,
or by a debt collector on behalf of a health care provider, to accept
partial payments over time without assessment of interest from a
consumer on a debt for health care services is not considered a
“consumer credit transaction” as defined by section 1-310, subsection
3. Disclosure of available payment arrangements. A health
care provider shall notify a consumer of the availability of any
payment arrangements offered by the health care provider to satisfy a
debt for health care services.
4. Rehabilitation of defaulted
medical debt. Any payment arrangements offered pursuant to subsection 3
must provide the consumer the opportunity to reasonably rehabilitate,
cure or remedy a defaulted status of a debt for health care services
under terms and conditions established by the health care provider,
such as by making payment in full or by making six consecutive monthly
payments in a timely manner.
replaces the bill. It exempts from the definition of “consumer credit
transaction” an agreement to accept payments on debts for health care
services without interest over time, and requires that health care
providers disclose to consumers any available payment arrangements,
which, if offered, must enable consumers to rehabilitate defaulted
loans by meeting certain payment requirements.
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