January 4, 2010
BLEEDING DISORDER LEGISLATION IN OTHER STATES
By: John Kasprak, Senior Attorney
Nicole Dube, Legislative Analyst II
You asked for information on bleeding disorder legislation in Massachusetts, Missouri, New Jersey, and Pennsylvania, including provisions on a standard of care, health insurance coverage, pharmacy services, medical screenings, and other related issues.
To date, New Jersey is the only state that has passed legislation establishing a “standard of care” for the treatment of bleeding disorders. That law, originally passed in 2000 and fully implemented in 2004, was designed to address problems with the quality of hemophilia care provided by certain home care companies. Under this law, all insurance carriers providing coverage for the home treatment of hemophilia must contract with home care providers that comply with certain minimum standards of care developed by the state's Department of Health and Senior Services.
These standards include prohibitions on substitution of blood products without prior approval of the patient's physician, ability to provide all brands of clotting factor products and needed ancillary supplies, demonstrated knowledge and experience concerning bleeding disorders, ability to deliver prescribed blood products in a timely manner in emergency situations, and demonstrated record keeping ability. The law requires the department to compile a list of providers meeting the minimum standards and make it available to insurers and their policy holders. Also, it requires insurers to pay for laboratory services at all hemophilia treatment centers regardless of whether the lab is a participating provider with the insurer.
The other three states (Massachusetts, Missouri, and Pennsylvania) have considered legislative proposals addressing standards of care for treatment of bleeding disorders and other related provisions. None have passed to date. Two similar pieces of legislation in Massachusetts (1) establish qualifications and standards for pharmacies from whom people with bleeding disorders receive care, (2) institute measures to detect cases of von Willebrand disease and other bleeding disorders, (3) ensure access to comprehensive treatment, including specialized labs, and (4) guarantee insurance coverage of needed services. Existing Massachusetts law requires its Public Health Department to establish a program for the care and treatment of hemophilia.
Missouri's bill establishes a standard of care and requires the state pharmacy board to establish rules governing the standard, adds blood clotting product-related services to those covered under its Medicaid program, and requires all health benefit plans to cover home nursing services associated with bleeding disorders. The bill did not pass in the 2009 session.
Finally, Pennsylvania's proposal is similar to the bills introduced in Massachusetts and Missouri.
In 2004, the New Jersey Department of Health and Senior Services (DHSS) completed implementation of the “Standards of Care in Hemophilia Homecare Law” that was passed in 2000 (SB 786; New Jersey Statutes, Chap. 26:2S-10.1 to 10.3). The new standards resulted from problems with the quality of hemophilia care being provided by certain home care companies (HCCs) in the state. Some of these problems were:
1. limitations on choice of hemophilia therapy and the amount of clotting factor that an individual with hemophilia was allowed to store at home;
2. lack of availability of ancillary supplies (i.e., needles and syringes);
3. factor therapies not provided in a timely manner;
4. no provision for medically necessary preventive devices, disposal of medical waste, or nursing care; and
5. lack of trained staff to help clients with third party reimbursement issues.
Standards of Care
The New Jersey law specifies that a carrier offering a managed care plan providing benefits or health care services for the home treatment of bleeding episodes associated with hemophilia, including the purchase of blood products and home infusion equipment, must comply with the law.
For purposes of providing home treatment services for bleeding episodes associated with hemophilia, the carrier must contract with, and exclusively use, providers that comply with standards adopted by DHSS in consultation with the Hemophilia Association of New Jersey. At a minimum, these standards must require that each provider:
1. fill prescriptions from the covered person's attending physician and not substitute blood products without that physician's prior approval;
2. provide all brands of clotting factor products in low, medium, and high-assay range levels to execute treatment regimens as prescribed by the attending physician, and all needed ancillary supplies for the treatment or prevention of bleeding episodes, including needles, syringes, and cold compression packs;
3. be able to deliver prescribed blood products, medications, and nursing services within three hours after receiving a prescription for an emergent situation, and maintain 24-hour on-call service to accommodate this requirement;
4. demonstrate experience with and knowledge of bleeding disorders and their management;
5. demonstrate the ability for appropriate and necessary record keeping and documentation, including the ability to expedite product recall or notification systems and assist covered persons in obtaining third party reimbursement;
6. provide for proper removal and disposal of hazardous waste according to state and federal law;
7. provide covered persons with a written copy of the agency's policy regarding discontinuation of services related to loss of health benefits plan coverage or inability to pay; and
8. provide covered persons, upon request, with information about the expected costs for medications and services provided by the agency that are not otherwise covered by the person's health benefits plan.
DHSS must compile a list of providers who meet these minimum standards and make it available to carriers and covered persons, upon request.
As used above, “blood product” includes, but is not limited to, Factor VIII, Factor IX, and cryoprecipitate, and “blood infusion equipment” includes, but is not limited to, syringes and needles.
Clinical Laboratory Services
Under the New Jersey law, a insurance carrier must pay for services provided by the clinical laboratory at a hospital with a state-recognized hemophilia care center if the covered person's attending physician determines that using this laboratory is necessary because:
1. test results are medically necessary immediately or sooner than the normal return time for a carrier's participating lab, or
2. accurate test results need to be determined by closely supervised procedures in venipuncture and lab techniques in a controlled environment that cannot be adequately achieved by the carrier's participating lab.
The carrier must pay the hospital's clinical laboratory for the lab services at the same rate it would pay a participating clinical lab for comparable services. The carrier retains the right to review all services provided for medical necessity.
Recently Proposed Legislation
Two similar pieces of legislation (S1864 and A2704) were considered by the 2008-09 New Jersey Legislature, but have not passed to date. These bills would create a “Bleeding Disorders Treatment Fund,” administered by DHSS and funded by an assessment on manufacturers and home health care companies that sell clotting factor to patients with bleeding disorders in New Jersey. Under these proposals, at least 60% of the monies in the fund in any calendar year must be used to fund the operating expenses of hemophilia treatment centers, with the balance used to support the purchase of insurance policies and patient-related services provided by the Hemophilia Association of New Jersey.
These bills were referred to the Senate and Assembly's respective appropriations committees; they have not been reported out to date.
Existing Law—Hemophilia Advisory Committee
The Massachusetts Department of Public Health (DPH) must establish a program for the care and treatment of people suffering from hemophilia. Hemophilia, under the law, means a bleeding tendency resulting from a genetically determined deficiency of a clotting factor in the blood. This program must assist persons who require continuing treatment with blood and blood derivatives to avoid crippling, extensive hospitalization, and other effects associated with this condition, but who are unable to pay for the entire cost of such services on a continuing basis.
The public health commissioner must appoint a Hemophilia Advisory Committee to consult with the department in the administration of this act. The committee has five members representing hospitals, the Massachusetts Blood Bank Association, voluntary agencies interested in hemophilia, medical specialists in hemophilia patient care, and the general public.
The commissioner appoints one member as chairman. Each member holds office for a term of four years. The committee meets as frequently as the chairman deems necessary, but not less than once each year.
Committee members serve without compensation but are reimbursed for actual expenses incurred in carrying out their official duties (Massachusetts General Laws, Chap. 111, § 6A).
1. with the advice of the committee, develop standards for determining program eligibility and treatment;
2. extend financial assistance to people with hemophilia in obtaining blood, blood derivatives and concentrates, and other agents for treatment of hemophilia in hospitals, medical and dental facilities, and at home;
3. assist in the development and expansion of programs for the care and treatment of people with hemophilia, including self-administration, prevention, home care, and other medical and dental procedures and techniques designed to provide maximum control over bleeding episodes typical of this condition;
4. conduct educational programs among physicians, dentists, hospitals, public health departments, and the public concerning hemophilia, including disseminating information and conducting educational programs on methods of care and treatment; and
5. establish all rules and regulations necessary to effect the law's purposes (Mass. General Laws, Chapter 111, § 6C).
Legislation was introduced during the 2009-2010 session to assist individuals with bleeding disorders. Two bills are currently under consideration: HB 915, An Act Relative to Insurance Coverage and Standards of Treatment of Persons With Bleeding Disorders, and SB 567, An Act Relative to the Hemophilia Advisory Committee.
This bill (1) establishes qualifications and standards for specialty pharmacies from whom people with bleeding disorders receive care, (2) institutes measures to detect undiagnosed cases of von Willebrand disease, (3) ensures access to comprehensive hemophilia treatment facilities and specialized diagnostic labs, and (4) guarantees coverage of needed services by third party payers.
Insurance Provisions. The bill requires insurers to contract with any pharmacy, 340B pharmacy program, or other dispensing pharmacy licensed by the state to provide blood clotting products and ancillary infusion equipment and supplies. (These entities must satisfy pharmacy standards established under the bill.) Insurers must cover physician and medically necessary clinical laboratory services at a hospital with a comprehensive hemophilia care center. (The “340B” program, created under federal law, requires drug manufacturers to provide outpatient drugs to eligible healthcare centers, clinics and hospitals at a reduced price.)
Insurers must also cover all Food and Drug Administration (FDA)-approved brands or blood clotting products, ancillary infusion equipment, and supplies prescribed by the individual's physician. These clotting products must also be included in the insurer's drug formulary. Insurers cannot require pharmacies to make substitutions for these products unless the individual's physician approves. Any prior authorization required by an insurer for blood clotting products must be completed within the latter of 24 hours or 1 business day; prior authorization may be waived if the treating physician deems it to be an emergency.
von Willebrand Disease Screenings. The bill requires licensed physicians who provide obstetrical and gynecological services to screen for von Willebrand disease and other bleeding disorders before advising a person to undergo an invasive uterine surgical procedure for menorrhagia. (von Willebrand disease is a bleeding disorder caused by a defect or deficiency of a blood clotting protein, called von Willebrand Factor. Menorrhagia refers to heavy menstrual bleeding.)
Standards of Care. Under the bill, pharmacies must:
1. be open and staffed at a minimum from 9:00 a.m. until 8:00 p.m. Monday through Friday, excluding holidays, have a pharmacist available to fill blood clotting product prescriptions, and make on-call arrangements for emergencies that occur when it is closed;
2. have 24-hour access to multi-lingual interpreters;
3. when dispensing blood clotting products, furnish ancillary infusion equipment and supplies prescribed by the treating physician;
4. provide all prescribed blood clotting products and not make substitutions without the treating physician's prior approval;
5. supply all FDA-approved brands or blood clotting products in multiple assay ranges, including products manufactured from human plasma and those made with recombinant biotechnology techniques;
6. provide directly or through a reliable third-party agency, home nursing services when the treating physician deems it necessary;
7. correctly fill and deliver prescriptions for blood clotting products and ancillary infusion equipment and supplies to the insured within 48 hours of receiving the order;
8. after consulting with the treating physician, create a plan to provide patients in an emergency situation with access to prescribed products, equipment, and supplies within three hours and notify the treating physician whenever it is contacted about an emergency situation;
9. provide all appropriate and necessary recordkeeping and documentation;
10. provide administrative assistance to help the insured obtain payment for blood clotting products, ancillary infusion equipment and supplies, and home nursing services;
11. explain patient deductibles, coinsurance payment responsibilities, and lifetime cap limits clearly when the first order is placed, upon request, whenever an insurance change occurs, and annually when updating insurance information;
12. participate in the National Patient Notification System and provide patient notification of recalls and withdrawals of blood clotting products and ancillary infusion equipment and supplies;
13. provide sharp containers or the equivalent for medical waste removal and disposal; and
14. be certified biannually by DPH to meet these standards of care.
In November 2009, the Senate referred the bill to the Joint Committee on Public Health for consideration during the 2010 legislative session.
Senate Bill 567
This bill makes changes to DPH's Hemophilia Advisory Committee. It requires the DPH commissioner to coordinate with the insurance commissioner to reorganize the committee to review the impact of legislation and administrative actions preserving the treatment and care of hemophilia and other inherited bleeding and clotting disorders. The committee must also advise on the establishment of 14 programs for public awareness, reporting, and treatment of hemophilia and other blood disorders.
Committee Duties. The bill expands the committee's duties, requiring it to advise the public health and insurance commissioners on:
1. legislation and administrative changes to policies and programs integral to the health and wellness of people with hemophilia and other bleeding and clotting disorders;
2. coordination with other state agencies and private organizations to help develop community-based initiatives to increase awareness of care and treatment for people with bleeding and clotting disorders, including hemophilia;
3. dissemination of information on initiatives to constituency groups;
4. standards of care and treatment for people with bleeding and clotting disorders, taking into consideration the federal and state standards of care guidelines developed by state and national organizations including the Medical and Scientific Advisory Council of the National Hemophilia Foundation;
5. protection and promotion of open access to treatment for hemophilia and other bleeding and clotting disorders that adheres to the standards of care described above;
6. help people living with hemophilia and other bleeding and clotting disorders need to access appropriate public and private health insurance coverage; and
7. development of care and treatment programs for people with hemophilia and other bleeding and clotting disorders, including self administration, home care, medical and dental procedures, and techniques designed to provide maximum control over bleeding episodes.
DPH Duties. The bill specifies that DPH can provide services to people with hemophilia and other bleeding and clotting disorders through cooperative agreements with hemophilia treatment centers, medical facilities and schools, and nonprofit organizations. It may also provide services to facilitate linkages for people with hemophilia or other bleeding and clotting disorders.
Reporting. The bill requires the commissioners of public health and insurance to submit annual reports to the governor and legislative leaders starting December 31, 2010 on the status of care and treatment for people living with hemophilia and other related bleeding disorders. These must include how the state assisted in protecting these individuals' rights.
Committee Membership. The bill increases the hemophilia advisory committee's membership from five to eleven members. It adds the commissioners of public health and insurance, or their designees as co-chairs and non-voting members. (The DPH commissioner appoints one of the members as committee chair.) The bill requires the governor to appoint the remaining nine members as follows:
1. one licensed, practicing registered nurse currently treating people with hemophilia or related bleeding disorders;
2. one licensed, practicing social worker currently treating people with hemophilia or other related bleeding disorders;
3. one representative of a state-based, federally funded hemophilia treatment center;
4. one representative of an organization established under state law for the purpose of providing health insurance;
5. one representative of a voluntary health organization that currently services the hemophilia and related bleeding disorders community;
6. one person or caregiver of a person living with hemophilia;
7. one person or caregiver of a person living with a bleeding disorder other than hemophilia;
8. one person or caregiver of a person living with a clotting disorder; and
9. one licensed, practicing, board certified physician currently treating people with hemophilia or other related bleeding disorders.
Under the bill, members continue to serve without compensation, but are reimbursed for expenses incurred while carrying out their duties.
The bill is currently under consideration by the Joint Committee on Health Care Financing.
Missouri HB 839, introduced in 2009, would have (1) established a standard of care for people with bleeding disorders and required the State Board of Pharmacy to establish rules governing the standard of care, (2) added blood clotting product-related services to the list of covered services under the Missouri HealthNet Program (Medicaid), and (3) required all health benefit plans delivered, issued, continued, or renewed on or after a certain date to cover for home nursing services associated with chronic bleeding disorders reliant on blood clotting products.
The bill did not pass.
Standard of Care
The bill directed the State Board of Pharmacy (which is within the Department of Insurance, Financial Institutions and Professional Registration) to establish rules governing the standard of care for individuals needing plasma protein therapies. These rules, when feasible, were to
include the standards established by the medical advisory committees of the patient groups representing the hemophilia and von Willebrand diseases. They had to include safeguards to ensure that the pharmacy provided:
1. all brands of FDA-approved blood clotting products in all available assays and vial sizes;
2. the shipment of prescribed blood clotting products to the patient within two business days or less for established patients and three business days or less for new patients in nonemergency situations;
3. patients with blood clotting products within three hours of notification of the patient's need for the plasma protein therapy product;
4. all necessary ancillary infusion equipment and supplies for administration of plasma protein therapy products;
5. a pharmacist available 24 hours a day, seven days a week, every day of the year, either onsite or on call, to fill prescriptions for blood clotting products;
6. coordinated pharmacy and home nursing services when the latter are deemed necessary by the treating physician;
7. patients who receive blood clotting products with a designated contact telephone number for reporting problems with a delivery or product;
8. patients with notification of recalls and withdrawals of blood clotting products and ancillary fusion equipment within 24 hours of receipt of the notification;
9. containers for the disposal of hazardous waste, and the proper collection;
10. removal, and disposal of hazardous waste under state and federal law; and
11. administrative assistance to patients in obtaining payment for blood clotting products, ancillary fusion equipment, and home nursing services.
The bill also required a pharmacy to dispense all prescriptions of blood clotting products as written by the prescribing physician. No changes or substitutions could be made without that physician's prior approval. If the prescription did not indicate a specific brand name of product, the provider had to contact the prescribing physician to determine the product to be dispensed.
Also, the blood clotting product and infusion technique could not be changed without the consent of the treating physician and the patient.
Missouri HealthNet (Medicaid)
The Missouri HealthNet Division is responsible for the administration of Title XIX (Medicaid).
The proposed legislation added blood clotting-related products to the list of covered services under Missouri's Medicaid program. Such services included (1) home delivery of blood clotting products and ancillary infusion equipment and supplies, including emergency delivery when medically necessary; (2) medically necessary ancillary infusion equipment and supplies required to administer the blood clotting products; and (3) in-home assessments conducted by a pharmacist, nurse, or local home health care agency trained in bleeding disorders when deemed necessary by the recipient's treating physician.
Health Benefit Plans
Under the bill, all health benefit plans delivered, issued for delivery, continued, or renewed after August 28, 2009 had to provide coverage for home nursing services associated with chronic bleeding disorders reliant on blood clotting products. The bill defined “bleeding disorder” as a medical condition characterized by a severe deficiency or absence of one or more essential blood clotting proteins in the human blood, including all forms of hemophilia, von Willebrand's disease, and other bleeding disorders that result in uncontrollable bleeding or abnormal blood clotting.
It defined “home nursing services” as specialized nursing care provided in the home setting to assist a patient in the reconstitution and administration of blood clotting products.
The bill defined “blood clotting product” as medicine manufactured from human plasma or recombinant biotechnology techniques approved for distribution by the FDA that is used for the treatment and prevention of symptoms associated with bleeding disorders. Plasma protein therapy products include recombinant factor VII, recombinant-activated factor VIIa, factor VIII, and factor IX products; von Willebrand factor products; bypass products for patients with inhibitors; prothrombin complex concentrates; and activated prothrombin complex concentrates.
Pharmacies. Under the bill, if a benefit plan has a drug formulary, it must include all FDA-approved blood clotting products. Also, if a plan requires preauthorization or preapproval before a blood clotting product can be dispensed, the preapproval or preauthorization must be completed within 24 hours or one business day, whichever is later. The bill also requires a plan to provide an enrollee diagnosed with a bleeding disorder reliant on blood clotting products with a choice of pharmacies.
Clinical Laboratory Services. A health benefit plan must, under the bill, cover clinical laboratory services provided at a hospital hemophilia program, regardless of whether the hospital's laboratory participates in the plan's provider network, if the enrollee's treating physician determines that its use is medically necessary because: (1) the laboratory test results are required sooner than the normal turnaround time for results from a participating clinical laboratory or (2) accurate test results must be determined by closely supervised venipuncture procedures and laboratory techniques in a controlled environment, which cannot be provided by the participating laboratory. The benefit plan must reimburse the laboratory for all laboratory services according to the lab's usual and customary fee schedule.
Required Medical Screening. Under the bill, if a health benefit plan requires a physician to perform a medical screening for von Willebrand's disease and other bleeding disorders before providing coverage for an invasive uterine surgical procedure for menorrhagia, the requirement must be in accordance with established guidelines of the National Heart, Lung, and Blood Institute of the National Institutes of Health. The health benefit plan must cover the required medical screening, including physician's fees and clinical lab services.
On August 5, 2009, the Pennsylvania House of Representatives unanimously passed H.B. 620, the “Hemophilia Standards of Care Act.” The bill was then referred to the Pennsylvania Senate Public Health and Welfare Committee where it awaits action. Under the bill, health insurance policies, contracts, or managed care plans issued by all health insurers must provide benefits and health care services for patients with severe bleeding disorders. The bill does not subject the state's Medicaid program to these provisions. A
health insurer must provide coverage for services outlined in the bill to patients with bleeding disorders delivered by a state-recognized hemophilia program.
The bill requires health insurers to contract with pharmacies to provide blood clotting products a treating physician. Also, a pharmacy must supply enough ancillary infusion equipment to prepare and infuse the quantity of the blood clotting product being dispensed. An insurer must also provide a covered person with a choice of at least three full-service home care pharmacies. The state Department of Health must compile and distribute, upon request, a list of full-service home care pharmacies that comply with the bill's provisions. In addition, a patient may obtain blood clotting products and ancillary infusion equipment from any other participating pharmacy and from the 340B program affiliated with the patient's state-recognized hemophilia program (there are eight such programs in the state).
Substitutions cannot be made without the prior approval of the patient's physician. All FDA-approved blood clotting products must be included in the insurer's formulary, if applicable. An insurer that requires preapproval or preauthorization of a prescription must complete it within 24 hours or one business day, unless the physician deems the circumstances urgent.
Health Insurance Coverage
Under the bill, a health insurer must pay for all FDA-approved brands of blood clotting products in multiple assay ranges. It also must pay for blood clotting products as prescribed by the treating physician for in-patient care, out-patient care, and the home treatment of bleeding disorders.
Finally, the bill requires an OB-GYN to request a medical screening for von Willebrand disease and other bleeding disorders before advising an individual that an invasive uterine surgical procedure is the most appropriate treatment for menorrhagia (heavy menstrual bleeding). A health insurer must provide coverage for this screening.