Existing law, the Knox-Keene Health Care Service Plan Act of 1975, provides for the licensure and regulation of health care service plans by the Department of Managed Health Care and makes a willful violation of that act a crime. Existing law also provides for the regulation of health insurers by the Department of Insurance. These provisions require specified services and drugs to be covered by the various plans.

This bill would, where an abuse-deterrent opioid analgesic drug product, as defined, is available, prohibit a health care service plan or insurer from requiring the use of opioid analgesic drug products without the abuse-deterrent properties in order to access abuse-deterrent opioid analgesic drug products. The bill would require a health care service plan or insurer to allow a provider to prescribe, and if otherwise covered, to provide coverage for, a less than 30-day supply of an opioid analgesic drug product. Because a willful violation of these requirements with respect to health care service plans would be a crime, this bill would impose a state-mandated local program.

Existing law, the Pharmacy Law, the knowing violation of which is a crime, provides for the licensing and regulation of pharmacists by the California State Board of Pharmacy. Existing regulations require a pharmacist to provide oral consultation to his or her patient or the patients agent in all care settings upon request or whenever the pharmacist deems it warranted.

This bill would require a pharmacist to inform a patient receiving an opioid analgesic drug product on proper storage and disposal of the drug, and authorizes this information to be included as part of the required oral consultation. would require the board to adopt regulations to implement that provision. Because a violation of this requirement would be a crime, the bill would impose a state-mandated local program.

The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.

This bill would provide that no reimbursement is required by this act for a specified reason.

Existing law, the Knox-Keene Health Care Service Plan Act of 1975, provides for the licensure and regulation of health care service plans by the Department of Managed Health Care and makes a willful violation of that act a crime. Existing law also provides for the regulation of health insurers by the Department of Insurance. These provisions require specified services and drugs to be covered by the various plans. The act prohibits specified health care service plan contracts that cover prescription drug benefits from limiting or excluding coverage for a drug for an enrollee under specified conditions, including if the drug previously had been approved for coverage by the plan for a medical condition of the enrollee.

Existing law, the Knox-Keene Health Care Service Plan Act of 1975, provides for the licensure and regulation of health care service plans by the Department of Managed Health Care and makes a willful violation of that act a crime. These provisions require specified services and drugs to be covered by the various plans. The act prohibits specified health care service plan contracts that cover prescription drug benefits from limiting or excluding coverage for a drug for an enrollee under specified conditions, including if the drug previously had been approved for coverage by the plan for a medical condition of the enrollee.

This bill would make technical, nonsubstantive changes to that provision. This bill would also state the intent of the Legislature to enact legislation to address the problem of prescription opioid pain reliever abuse and would make related findings and declarations.

Date of Hearing: May 27, 2015

ASSEMBLY COMMITTEE ON APPROPRIATIONS

Jimmy Gomez, Chair

ABPCA Bill Id:AB 623

Author:(Wood) – As Amended Ver:May 4, 2015

Urgency: No State Mandated Local Program: Yes Reimbursable: No

SUMMARY:

This bill addresses issues related to abuse of opioid analgesic drugs. Specifically, this bill:

1. Requires pharmacists to inform patients receiving an opioid analgesic drug product on proper storage and disposal of the drug,

2. Restricts the ability of health plans and insurers to limit access to abuse-deterrent forms of opioid analgesic drugs.

3. Requires a health plan or insurer to allow a provider to prescribe, and if otherwise covered, to provide coverage for, a less than 30-day supply of an opioid analgesic drug product.

FISCAL EFFECT:

1. According to the California Health Benefits Review Program (CHBRP):

   1. $4.4 million to Medi-Cal (GF/federal) and $135,000 to CalPERS for increased premiums.

2. Increased employer-funded premium costs in the private insurance market of approximately $1.2 million.

3. Increased premium expenditures by employees and individuals purchasing insurance of $1.6 million, and increased out-of-pocket expenses of $450,000.

2. Costs to the Board of Pharmacy to adopt regulations in the range of $50,000 (Pharmacy Board Contingent Fund).

3. Minor costs to the California Department of Insurance and the Department of Managed Health Care to verify plans and insurers comply with this requirement.

COMMENTS:

1. Purpose. The purpose of this bill is to address some aspects of opioid addiction. According to the author, given the availability of abuse-deterrent opioids, health care providers should be allowed to exercise their judgment in prescribing them without worrying about cost-related hurdles. Additionally, better education on storage and disposal would reduce the supply of opioids available for abuse.

2. Background. According to the federal Food and Drug Administration (FDA), opioid drugs provide significant benefit for patients when used properly for pain relief; however, opioids also carry a risk of misuse, abuse and death. Opioid products can be abused in a number of ways, including being swallowed whole; crushed in order to be swallowed, snorted, smoked; and, dissolved and injected. Abuse-deterrent drugs work correctly when taken as prescribed, but may be formulated in such a way that deters misuse and abuse, including making it difficult to snort or inject the drug for a more intense high.

The FDA released industry guidance on April 1, 2015 regarding the evaluation and labeling of abuse-deterrent opioids, citing the development of abuse-deterrent opioids as a potentially important step toward the goal of creating safer opioid analgesics. The FDA also noted that abuse-deterrent technologies developed to date have not yet proven successful at deterring the most common form of abuse – swallowing a number of intact capsules or tables to achieve a feeling of euphoria. Further, the FDA stated that the science of abuse deterrence is relatively new, and both the formulation technologies and the analytical, clinical, and statistical methods for evaluating the technologies are rapidly evolving.

3. CHBRP Analysis. Overall, CHBRP finds, based on a review of the medical literature, that the impact of abuse-deterrent opioids on abuse is ambiguous. Some studies find they reduce some forms of abuse, but other studies suggest they shift abuse to other drugs. CHBRP found the unit cost for opioid prescriptions would increase by 13% by increasing utilization of abuse-deterrent formulations by 38%, but that this bill is unlikely to have a material impact on public health. CHBRP states it would not affect affect the number of opioid analgesic overdoses, hospitalizations, and deaths for a number of reasons, including the fact that the most common form of abuse (swallowing pills) is not deterred by abuse-deterrent formulations and the potential for persons addicted to opioids to turn to heroin instead, or to simply swallow the pills instead of crushing or injecting them. CHBRP concludes further study is needed in order to ascertain effectiveness in preventing abuse.

4. Legislation in other states. At least 15 other bills expanding coverage and access to abuse-deterrent opioids have been introduced this year in other states.

5. Support. This bill is sponsored by Power of Pain Foundation and the U.S. Pain Foundation. It is supported by biotechnology industry groups, patient advocacy groups, pharmacists, law enforcement, and Partnership for Drug Free Kids. Supporters state that misuse and abuse of opioids is a growing public health problem, and abuse-deterrent opioids represent a significant opportunity to reduce misuse and abuse.

6. Opposition. Health plans and insurers, as well as pharmacy benefit managers, oppose this bill. The California Association of Health Plans (CAHP) writes that abuse-deterrent drugs are fairly new, costly, and have insufficient evidence about their efficacy in deterrence. The Pharmaceutical Care Management Association, a national association of pharmacy benefit managers states that this bill is part of a nationwide effort to force the use of abuse-deterrent opioids by disallowing generic substitutions, but abuse-deterrent formulations are not a quick fix for opioid abuse and will raise costs. Express Scripts, a pharmacy benefit manager, estimates that abuse-deterrent opioids cost about three times as much as non-abuse-deterrent agents.

Analysis Prepared by: Lisa Murawski / APPR. / (916) 319-2081

Date of Hearing: April 28, 2015

ASSEMBLY COMMITTEE ON BUSINESS AND PROFESSIONS

Susan Bonilla, Chair

ABPCA Bill Id:AB 623

Author:(Wood) – As Amended Ver:March 26, 2015

NOTE: This bill is double-referred, having been previously heard by the Assembly Committee on Health on April 21, 2015 and approved on a 15-4 vote.

SUBJECT: Abuse-deterrent opioid analgesic drug products.

SUMMARY: Prohibits a health care service plan (plan) or health insurer (insurer) from requiring the use of opioid drug products that have no abuse-deterrent properties in order to access abuse-deterrent opioid drug products; requires pharmacists to provide a patient receiving an opioid drug product information about proper storage and disposal of the drug; and, mandates that a plan and insurer may not prevent a provider from prescribing a less than 30-day supply of opioids analgesic drugs and to provide coverage, if otherwise covered, for the less than 30-day prescription.

EXISTING LAW:

1. Establishes the Knox-Keene Health Care Service Plan Act of 1975 (Knox-Keene Act), which provides for the licensure and regulation of health care service plans by the Department of Managed Health Care (DMHC), and provides for the regulation of health insurers by the California Department of Insurance (CDI). (Health and Safety Code (HSC) Sections 1340 et seq.)

2. Pursuant to DMHC regulations, states that a plan may require step therapy and requires a plan to have an expeditious process in place to authorize exceptions to step therapy when medically necessary. (California Code of Regulation (CCR) Title 28 Division 1 Section 1367.24(d)(2))

3. Requires plans and insurers to include information on cost-sharing tiers and utilization controls, including prior authorization or step therapy requirements, for each covered drug. (28 CCR Section 1367.24(d)(2))

4. Allows a plan to limit the amount of the drug dispensed at any one time to a 30-day supply or, if the treatment is for less than 30 days, for the medically necessary amount of the drug and allows for the imposition of a requirement that maintenance drugs be dispensed in a two months or greater supply. (28 CCR Section 1367.24(d)(3))

5. Prohibits health plans that cover prescription drugs from limiting or excluding coverage for a drug on the basis that the drug is prescribed for use different from that for which the drug has been approved by the federal Food and Drug Administration (FDA), provided that specified conditions have been met, including that the drug is prescribed by a participating licensed health care professional for the treatment of a chronic and seriously debilitating condition, the drug is medically necessary to treat that condition, and the drug is on the plan formulary. (HSC 1367.21)

6. Prohibits health plans that cover prescription drugs from limiting or excluding coverage for a drug for an enrollee if the drug was previously approved for coverage by the plan for a medical condition of the enrollee and the plan's prescribing provider continues to provide the drug for the medical condition, provided that it is safe and effective for treatment. (HSC 1367.22)

7. Provides for the licensure and regulation of pharmacists by the California Board of Pharmacy (BOP). (Business and Professions Code (BPC) Section 4000 et seq.)

8. Requires, under existing regulations, a pharmacist to provide oral consultation to a patient in all care settings under the following circumstances: (16 CCR 1707.2)

1. Upon request by the patient; or,

2. Whenever the pharmacist deems a consultation is warranted in the exercise of his or her professional judgment, and,

3. When the prescribed drug has not previously been dispensed to a patient; or,

4. When the prescription drug is dispensed that has not been previously dispensed to a patient in the same dosage, strengths, or with the same directions.

9. Gives the pharmacist the discretionary authority to provide information during oral consultation relating to any special directions for use and storage. (16 CCR 1707.2)

10. Allows a patient to waive the oral consultation with a pharmacist under specified conditions. (16 CCR 1707.2)

THIS BILL:

1. Requires a pharmacist to inform a patient receiving an opioid analgesic drug product on proper storage and disposal of the drug, and authorizes the information to be provided as part of an oral consultation, as specified.

2. Defines "opioid analgesic drug product" as a drug product in the opioid analgesic drug class that is prescribed to treat moderate to severe pain, or other conditions, whether in immediate release or extended release or long-acting form and whether or not combined with other drug substances to form a single drug product or dosage form.

3. Defines "abuse-deterrent opioid analgesic drug product" as a brand or generic opioid analgesic drug product approved by the FDA with abuse-deterrent labeling claims that indicate the drug product is expected to result in a meaningful reduction in abuse.

4. Prohibits, where an abuse-deterrent opioid analgesic drug product is available, a plan or insurer from requiring the use of opioid analgesic drug products without abuse-deterrent properties first before allowing access to abuse-deterrent opioid analgesic drug products.

5. Provides that this bill shall not be construed to prevent a plan or insurer from applying prior authorization requirements to abuse-deterrent opioid analgesic drug products, provided that those same requirements are applied to versions of those opioid analgesic drug products without the abuse-deterrent properties.

6. Mandates that a plan or insurer may not prevent a health care provider from prescribing a less than 30-day supply of an opioid analgesic drug product and requires the plan or insurer to cover a less-than 30-day supply if otherwise covered.

7. Makes legislative findings and declarations relating to opioid analgesic drug abuse.

FISCAL EFFECT: Unknown. This bill is keyed fiscal by the Legislative Counsel.

COMMENTS:

1. Purpose. This bill is sponsored by the American Chronic Pain Association, the Power of Pain Foundation, and the United States Pain Foundation. According to the author, "As a health care provider focused on the value of prevention, I believe that not enough is being done to curb the growth of opioid abuse. Health care providers and parents need tools to help guard against the abuse of medication by people who are not necessarily the patient. Curbing abuse will mean fewer unintentional overdoses. There is nowhere in the state that is immune to the problem of opioid abuse, particularly among young people. In Mendocino County, the problem is so acute that hospital admissions for narcotic overdoses are twice the state average. . . . Strategies like educating patients on the proper storage and disposal should help protect medications from being readily available and accessible for those wanting to abuse. Additionally, the development and availability of new drugs, abuse deterrent formula (ADF), which cannot be manipulated or crushed to intensify a high, should be encouraged. While it is estimated that these methods (crushing or dissolving) account for 30% of the abuse, this form of abuse is what results in the majority of ER visits, hospitalizations and deaths. . . . The pressures on cost in our health care system and huge and should not be ignored but there are times when it is obvious we either pay now for something or pay later. We are already paying the price for abuse. The more widespread ADF’s become the more positive an impact we can have on abuse. The increased availability and competition will also lead to reduced cost."

2. Background. Opioids are a class of narcotic drugs that include medications such as hydrocodone (e.g. Vicodin), oxycodone (e.g., OxyContin, Percocet), morphine (e.g., Kadian, Avinza) codeine, and other related drugs. Through the Controlled Substances Act of 1970 (CSA), the Drug Enforcement Administration (DEA) regulates the manufacture, distribution and dispensing of controlled substances. The CSA ranks into five schedules those drugs known to have potential for physical or psychological harm, based on three considerations: 1) their potential for abuse, 2) their accepted medical use, and 3) their accepted safety under medical supervision. Presently, the ADF formulations on the market and pending FDA approval are Schedule II drugs.

Schedule I controlled substances have a high potential for abuse and have no generally accepted medical, use such as heroin, ecstasy, and LSD.

Schedule II controlled substances have a currently accepted medical use in treatment, or a currently accepted medical use with severe restrictions, and have a high potential for abuse and psychological or physical dependence. Schedule II drugs can be narcotics or non-narcotic. Examples of Schedule II controlled substances include morphine, methadone, Ritalin, Demerol, Dilaudid, Percocet, Adderall, and Oxycontin. In October of 2014, the DEA as a response to the rising prescription drug abuse epidemic promulgated a rule rescheduling hydrocodone containing prescriptions (e.g., Vicodin) into this more tightly controlled category (21 Code of Federal Regulations 1308).

Schedule III and IV controlled substances have a currently accepted medical use in treatment, less potential for abuse but are known to be mixed in specific ways to achieve a narcotic-like end product. Examples include drugs include Tylenol with Codeine, Ambien, Xanax, and other anti-anxiety drugs.

Schedule V drugs have a low potential for abuse relative to substances listed in Schedule IV and consist primarily of preparations containing limited quantities of certain narcotics. Examples include Robitussin with Codeine and Lomotil.

Prescription Drug Abuse. According the Drug Abuse Warning Network, a division of the Substance Abuse and Mental Health Agency, prescription drug misuse and abuse is the intentional or unintentional use of medication without a prescription, in a way other than prescribed, or for the experience or feeling it causes. Results from the 2013 National Survey on Drug Use and Health indicate that about 15.3 million people aged 12 or older used prescription drugs non-medically in the past year, and 6.5 million did so in the past month. This issue is a growing national problem in the United States. Prescription drugs are abused and misused more often than any other drug, except marijuana and alcohol. This growth is fueled by misperceptions about their safety, increasing availability, and varied motivations for their use from countering anxiety and helping sleep problems to getting high. A 2011 analysis by the Centers for Disease Control and Prevention found that opioid analgesic sales increased nearly four-fold between 1999 and 2010; this was paralleled by an almost four-fold increase in opioid overdose deaths and substance abuse treatment admissions almost six times the rate during the same time period.

Abuse can stem from the fact that prescription drugs are legal and potentially more easily accessible, as they can be found at home in a medicine cabinet. Data shows that individuals who misuse prescription drugs, particularly teens, believe these substances are safer than illicit drugs because they are prescribed by a health care professional and thus are safe to take under any circumstances. The National Institute on Drug Abuse (NIDA) data indicates that in actuality, prescription drugs act directly or indirectly on the same brain systems affected by illicit drugs, thus, their abuse carries substantial addiction liability and can lead to a variety of other adverse health effects.

A 2008 report by the Coalition Against Insurance Fraud estimates that the abuse of opioid analgesics results in more than $72 billion in medical costs alone each year. This is comparable to costs related to other chronic diseases such as asthma and HIV.

The Senate Committee on Labor held a hearing on March 20^th, 2013 entitled Opioids and the Workers Compensation System: A Discussion on Mitigating Abuse and Ensuring Access during which the Committee reviewed a series of studies conducted by the California Workers’ Compensation Institute which highlighted a rise in opioid analgesic prescriptions by physicians in the state workers’ compensation system. The studies identified trends in widespread, potent use of Schedule II drugs by patients with low back pain; significant growth in the prescribing of all Schedule II drugs in the workers’ compensation system; and found that 6.7 percent of all prescriptions in the system for the first half of 2011 alone were for opioids.

Taken as prescribed, opioids analgesic can be used to manage pain safely and effectively. However, opioids may also produce other effects, and according to the NIDA, some individuals experience a euphoric response to opioid medications since these drugs affect the regions of the brain involving reward response.

The NIDA states that those who abuse opioids may seek to intensify their experience by taking the drug in ways other than those prescribed. For example, Oxycontin is an oral medication used to treat moderate to severe pain through a slow, steady release of the opioid. However, the NIDA states that people who abuse the drug may crush or dissolve the drug in order to snort or inject it, thereby increasing their risk for serious medical complications, including overdose. The NIDA states that when abused, even a single large dose of opioids can cause severe respiratory depression and death.

According to the California Department of Public Health (CDPH), in the past, prescription opioids were prescribed for relieving short-term, acute pain. However, today, they are increasingly being used for long-term (chronic) pain management. As a result, sales of opioid pain relievers quadrupled in the past 10 years. By 2010, enough opioid pain relievers were sold to medicate every American adult (about 240 million people) every four hours for an entire month. The CDPH states that in California, deaths involving opioid prescription medications have increased 16.5 percent since 2006. In 2012, there were more than 1,800 deaths from all types of opioids – 72 percent involved prescription opioids.

Abuse-deterrent opioids. According to the FDA, opioid products can be abused in a number of ways, including being swallowed whole; crushed in order to be swallowed, snorted, smoked; and, dissolved and injected. Opioids formulated with abuse-deterrent properties are designed to be more difficult to abuse, while retaining the same clinical effectiveness. For example, abuse-deterrent opioids may be formulated in ways that prevent chewing, crushing, grating, or grinding. Others may be formulated with agents that can make the drug resistant to dissolving by turning the drug into a gel-like substance when manipulated. Other formulations can reduce or defeat euphoria associated with the drug, or result in an unpleasant effect if the drug is manipulated.

The FDA released industry guidance on April 1, 2015 regarding the evaluation and labeling of abuse-deterrent opioids, citing the development of abuse-deterrent opioids as a potentially important step toward the goal of creating safer opioid analgesics, and considers the development of abuse-deterrent opioids a high public health priority. The FDA also noted that abuse-deterrent technologies developed to date have not yet proven successful at deterring the most common form of abuse – swallowing a number of intact capsules or tables to achieve a feeling of euphoria. Further, the FDA stated that the science of abuse deterrence is relatively new, and both the formulation technologies and the analytical, clinical, and statistical methods for evaluating the technologies are rapidly evolving.

Four opioids have been approved for abuse-deterrent labeling and there are a number of generic and brand opioid products with different types of abuse-deterrent technologies that seek labeling. One of the four currently approved is OxyContin, which, in 2010, was reformulated as an abuse-deterrent opioid. It was approved for ADF labeling in April 2013, indicating that the product has physical and chemical properties that are expected to make abuse via injection difficult and to reduce abuse via snorting. OxyContin’s manufacturer replaced the original OxyContin formulation in 2010 with its abuse-deterrent formulation, and upon approval of the labeling in 2013, the FDA stopped accepting applications for generics that rely upon the approval of original formulation of OxyContin.

Potential Public Health Impact. In terms of the public health impact of abuse-deterrent opioids, the author cites research published in April 2014 in the Journal of Medical Economics which estimated that abuse-deterrent formulation of OxyContin reduced overall health care costs by $430 million annually in the U.S., with an indirect cost savings of $605 million. Using health insurance claims data, government reports and literature, the study estimated that these savings represented 1.8percent of $58.4 billion in overall societal costs of prescription opioid abuse.

The author also cites a May 2105 study in Econostats that compared the financial impact between generic opioids without abuse-deterrent properties. The article cites, "That the average cost and most expensive cost for a one-month supply for patented opioids on the market as of July 2012 was $373 and $692, respectively.  The average cost and least expensive cost for a one-month supply of generic opioids on the market as of July 2012 was $233 and $48, respectively.  The price gap between the average patented cost and the average generic cost was $140." When looking at the overall costs of opioid abuse, "The current evidence shows that abuse-deterrent opioids will reduce the costs of opioid abuse per opioid patient by $4,568 to $4,645, depending upon the patient’s insurance status.  Accounting for the estimated additional cost of abuse-deterrent opioids (between $612 and $2,811), these medicines are associated with a net economic benefit between $1,757 and $4,033."

In a July 2012 article, the New England Journal of Medicine determined, "Interviews with patients who abused both formulations of OxyContin indicated a unanimous preference for the older version. Although 24 percent found a way to defeat the tamper-resistant properties of the abuse-deterrent formulation, 66 percent indicated a switch to another opioid, with “heroin” the most common response. These changes appear to be causally linked, as typified by one response: ‘Most people that I know don't use OxyContin to get high anymore. They have moved on to heroin [because] it is easier to use, much cheaper, and easily available.” It is important to note that there was no evidence that OxyContin abusers ceased their drug abuse as a result of the abuse-deterrent formulation. Rather, it appears that they simply shifted their drug of choice.’”

Step Therapy. According to the Centers for Medicare and Medicaid Services (CMS), step therapy is defined as: A health service plan or insurer may require you to first try one drug before they will cover another drug for that condition. For example, if Drug A and Drug B both treat your medical condition, a plan may require your doctor to prescribe Drug A first. If Drug A does not work for you, then the plan will cover Drug B. For example, before your insurance company will pay for a prescription of Hysingla (a brand name extended-release ADF formulation of hydrocodone (commonly known as Vicodin or Norco)), an insurer can currently require that your have tried regular hydrocodone formulation like Vicodin or Norco which have none of the ADF properties.

Other States. This year, at least fifteen other bills relating to abuse-deterrent opioids have been introduced in other states, including Colorado, Connecticut, Florida, Kansas, Maryland, Mississippi, Oklahoma, Rhode Island, Tennessee, Vermont, and Virginia. In 2014, legislation on this topic was introduced in New Jersey. The requirements of the bills vary across states, with some bills containing similar requirements as those proposed in this bill, but overall, the bills aim to expand coverage and access to abuse-deterrent opioids. Additionally, there is an abundance of legislation nationwide relating to various aspects of the prescription drug abuse epidemic including increasing access to naloxone (opioid overdose antidote), medication take-back programs, tighter regulations for identification requirements prior to dispensing opioids, and improving prescription monitoring programs.

Current Related Legislation. ACR 26 (Levine), Chapter 16, Statutes of 2015, proclaimed the month of March 2015 as Prescription Drug Abuse Awareness Month and encourages all citizens to actively participate in prevention programs and activities, and to safely store and dispose of their medications on a continual basis.

AB 73 (Waldron) of the current legislative session, provides that drugs in specified therapeutic drug classes that are prescribed by a Medi-Cal beneficiary's treating provider are covered Medi-Cal benefits and requires that a Medi-Cal managed care plan cover the drug upon demonstration by the provider that the drug is medically necessary and consistent with federal rules and regulations for labeling and use. (STATUS: This bill is pending in the Assembly Health Committee.)

Previous Related Legislation. AB 1535 (Bloom), Chapter 326, Statutes of 2014, authorizes a pharmacist to furnish naloxone hydrochloride (opioid overdose antidote) in accordance with standardized procedures or protocols developed and approved by both the BOP and the Medical Board of California.

AB 1814 (Waldron) of 2014, would have established that a prescriber’s reasonable professional judgment prevails over the policies and utilization controls of the Medi-Cal program, including the utilization controls of a Medi-Cal managed care plan, in prescribing a pharmaceutical from specified therapeutic drug classes. (NOTE: This bill was held in the Assembly Appropriations Committee.)

AB 831 (Bloom) of 2013, would have required, until January 1, 2016, the California Health and Human Services Agency (CHHSA) to convene a temporary working group to develop a state plan to reduce the rate of fatal drug overdoses and appropriates $500,000 from the General Fund to CHHSA to provide grants to local agencies to implement drug overdose prevention and response programs. (NOTE: This bill was held in the Assembly Appropriations Committee.)

AB 889 (Frazier) of 2013, would have prohibited a plan and insurer that provides coverage for medications pursuant to step therapy or fail first protocol from requiring an enrollee or insured to try and fail more than two medications before allowing the enrollee or insured access to the medication originally prescribed by their provider, and would have required plans and insurers to have an expeditious process in place for step therapy exceptions and that the duration of step therapy be consistent with up-to-date evidence-based outcomes and current published peer-reviewed medical and pharmaceutical literature. (NOTE: This bill was held in the Senate Appropriations Committee.)

AB 369 (Huffman) of 2012, would have prohibited plans and insurers that restrict medications for the treatment of pain from requiring a patient to try and fail on more than two pain medications before allowing the patient access to the pain medication, or its generic equivalent, prescribed by his or her physician. (NOTE: This bill was vetoed by Governor Brown with a veto message stating that a doctor's judgment and a health plan's clinical protocols have a role in ensuring prudent prescribing of pain medications, and any limitations on the practice of step therapy should better reflect a health plan or insurer's legitimate role in determining the allowable steps.)

AB 1826 (Huffman) of 2010, would have required a plan or insurer that covers prescription drug benefits to provide coverage for a drug that has been prescribed for the treatment of pain without first requiring the enrollee or insured to use an alternative drug or product. (NOTE: This bill was held in the Senate Appropriations Committee.)

AB 1144 (Price) of 2009, would have required plans and insurers to report to DMHC and CDI specified information related to chronic pain medication management, including when the plan or insurer requires an enroll to use of more than two formulary alternative medications prior to providing access to a pain medication prescribed by a provider, or to use pain medication other than what was prescribed for more than seven days prior to providing access to the prescribed pain medication. (NOTE: This bill was held in the Assembly Appropriations Committee.)

ARGUMENTS IN SUPPORT:

The US Pain Foundation (sponsor) writes a letter in support and notes, "Both the persistent lack of access to opioids by patients with legitimate, chronic pain and the rate of prescription opioid abuse exist side-by-side. Sadly, they also continue to rise. This is why abuse-deterrent formulations are needed – to help maintain access while reducing abuse risk."

The Power of Pain (co-sponsor) writes a letter in support and reports, "Opioids are an important and well-established component of pain management. However, misuse and abuse of opioids is a growing public health problem that is driving up healthcare, criminal justice, and workplace costs. We need to change our policies to develop a strong, lasting solution to this health crisis. To help combat the problem, a new approach has emerged with the development of opioids with technological advancements that either prevent physical alterations to the pills or inhibit the euphoric effects of opioids when abused. ADF technology represents a significant opportunity to reduce misuse and abuse of opioids."

The California Healthcare Institute writes a letter in support and highlights, "The innovative technology of Abuse Deterrent Formulations (ADFs) medications provide the same pain relief as conventional opioids but they contain physical or chemical properties that make crushing, cutting or dissolving for injection difficult. With these new breakthroughs, the FDA considers the development of these products a high public health priority."

Biocom writes a letter in supports and cites, "It is unconscionable that a plan could make a recovering addict or an individual at risk of becoming an addict take medication without the abuse deterrent to save a few dollars."

The Alliance for Patient Access writes a letter in support and notes, "Insurances policies should acknowledge physicians' judgment about which formulation a patient needs. Imposing prior authorization requirements or "fail first" policies to deter physicians from prescribing abuse-deterrent formulations does not serve patients' best interests."

The Partnership for Drug-Free Kids writes a letter in support and cites, "Many have suffered the ultimate tragedy [of misuse or abuse of prescription drugs], the loss of a daughter or son. While advancements like abuse deterrent formulations are not the only solution to solving the nation's prescription drug abuse problem, it is one common-sense approach to potentially help another family from losing a child to addiction."

The California Pharmacists Association writes a letter in support and notes, "Ensuring the pharmacists inform patients receiving opioid analgesics of the need to store them away from children, adolescents, and other at risk for diversion, and informing patients of the need to properly dispose of controlled substances, will help reduce the number of diverted drugs."

Healthy African American Families II writes a letter in support and states, "Having a greater share of the controlled substances in America's medicine cabinets formulated with abuse deterrent properties would be an important step forward to curbing prescription drug abuse while ensuring that these medicines remain available to those who need them for a legitimate medical purpose under a physician's care."

The Lupus Foundation of Southern California writes a letter in support and points out, "While AB 623 will not completely stop the abuse of prescription drugs, it does contain some important steps that will reduce it."

The California Hepatitis C Task Force writes a letter in support and claims, "AB 623 will prevent countless deaths from substance abuse alone which includes suicides and accidental overdoses but also consider the secondary impact from communicable, infectious and chronic diseases."

ARGUMENTS IN OPPOSITION:

California Retailers Association writes a letter in opposition and caution, "While we support innovations to prevent prescription drug abuse, we need to be cautious of mandating the dispensing of these drugs without consideration for efficacy and cost. Although technological innovations have been developed to prevent opioid medications such as Oxycontin from being crushed, dissolved, chewed, or cut, this does not entirely prevent abuse and potential overdose because an individual can still ingest opioids without limitation."

California Chamber of Commerce writes a letter in opposition and notes, ". . . even though AB 623 allows issuers [sic] to require pre-authorization and apply for other utilization review management protocols to opioids generally, this does not necessarily mean that the measure will not have negative consequences for purchasers and patients. For example, physicians may increase the rate at which they prescribe opioids over other types of pain medications if they know issuers [sic] are required to cover abuse-deterrent formulations."

California Association of Health Plans writes a letter in opposition and cites, "The New England Journal of Medicine concluded in its study of the issue that 'abuse-deterrent formulations may not be the 'magic bullets' that many had hoped they would be in solving the growing opioid problem.' As such, the overall value of abuse-deterrent drugs is still being evaluated by the FDA."

Pharmaceutical Management Association writes a letter in opposition and notes, "AB 623 is part of a nationwide effort to force the use of abuse-deterrent opioid analgesic drug products by disallowing generic substitution of existing opioid drug with an available generic. The fact is, Abuse Deterrent Formulations (ADFs) are not a quick fix for opioid abuse and will raises costs."

POLICY ISSUES FOR CONSIDERATION:

California Health Benefits Review Program (CHBRP) Review. The Assembly Health Committee referred this bill to the CHBRP for a comprehensive analysis of the overall impact of the bill. The committee submitted a request to CHBRP, housed within the University of California, to review this bill and perform an analysis of the clinical efficacy, cost-effectiveness, and public health impact of its provisions. CHBRP is established in state statute to assess legislation that proposes or repeals a mandated benefit or service for public health, medical and financial impact. CHBRP’s independent analysis will likely provide valuable information about the potential impact of this bill and inform the Legislature on key policy questions regarding the bill. For example, as a part of its role in determining the cost-effectiveness and public health impacts of the bill, the CHBRP analysis may estimate the cost implications of requiring brand name abuse-deterrent opioids over generic opioids without abuse-deterrent properties. Additionally, the bill would not require abuse-deterrent drugs to actually demonstrate reduced abuse in the community before requiring plans to cover them where available. As such, the CHBRP analysis may provide insight into the actual or potential public health impact of abuse-deterrent opioids in the community through an evaluation of a broader set of available evidence.

Pharmacist Education Provision. This bill would mandate a pharmacist provide to a patient receiving an opioid analgesic drug product information regarding proper storage and disposal of the drug. This provision provides that the pharmacist may include this information as part of the mandated oral consultation. However, the current regulations with limited exceptions allow the patient to waive the oral consultation. After discussion with the BOP, the language of this provision may not result in this information being distributed to every patient being prescribed these medications. For example, since this provision does not require that the information be placed in written materials, known as a Fact Sheet, a patient receiving a prescription for an opioid drug and who waives the oral consultation might not receive this important information. Because the BOP recognizes the prescription drug abuse epidemic, it is considering tightening regulations relating to consultation requirements relating to opioids. After discussions with the author and the sponsors, the committee recommends and the author agrees to amend this section directing the BOP to promulgate regulations so that this information is effectively distributed to targeted patients.

30-day Supply Provision. Currently there is no requirement in existing law that gives a plan or insurer the authority to require a health care provider to write for a certain amount of medication. The health care provider is free to prescribe a quantity as deemed medically necessary and within the standard of care. However, the DEA limits Schedule II controlled substances to less than a 90-day supply and requires a new prescription for continuation of the medication. Notably, there is a provision in the insurance regulations that gives a plan or insurer the authority to require a 60-day or more supply for maintenance medication. To be clear, this regulation does not prevent a health care provider from writing a prescription for any amount as deemed necessary for the condition being treated but could be grounds for denial of payment for a prescription for a maintenance opioid that is prescribe for less than sixty days. The language in the bill suggests that a plan or insurer has the ability to mandate the prescribing habits of health care providers. After several discussions with the author, the sponsors, the Medical Board of California, BOP, and the California Medical Association, the origin and intent of this section remains unclear and confusing. At this point, the author would appreciate more time to investigate the intent of this section and agrees to clarify the language or delete these sections as appropriate.

AMENDMENTS:

On page 3, line 15-17 strike out This information may be included as part of the oral consultation required under Section 1707.2 of Title 17 of the California Code of Regulations. and following the period after the word "drug" insert: The Board shall promulgate regulations to implement this section.

REGISTERED SUPPORT:

US Pain Foundation (sponsor)

Power of Pain (co-sponsor)

Biocom

Alliance for Patient Access

California Healthcare Institute

California Hepatitis C Task Force

California Pharmacists Association

California State Sheriffs’ Association

Healthy African American Families II

Lupus Foundation of Southern California

Partnership for Drug-Free Kids

REGISTERED OPPOSITION:

California Retailers Association

California Chamber of Commerce

California Association of Health Plans

Pharmaceutical Management Association

Analysis Prepared by: Vincent Chee / B. & P. / (916) 319-3301, Christian Jagusch / B. & P. / (916) 319-3301

Date of Hearing: April 21, 2015

ASSEMBLY COMMITTEE ON HEALTH

Rob Bonta, Chair

ABPCA Bill Id:AB 623

Author:(Wood) – As Amended Ver:March 26, 2015

SUBJECT: Abuse-deterrent opioid analgesic drug products.

SUMMARY: Prohibits a health care service plan (plan) or health insurer (insurer) from requiring the use of opioid drug products that have no abuse-deterrent properties in order to access abuse-deterrent opioid drug products; requires pharmacists to provide a patient receiving an opioid drug product information about proper storage and disposal of the drug; and, authorizes a provider to prescribe a less than 30-day supply of opioids analgesic drugs. Specifically, this bill:

1. Prohibits, where an abuse-deterrent opioid analgesic drug product is available, a plan or insurer from requiring the use of opioid analgesic drug products without abuse-deterrent properties first before allowing access abuse-deterrent opioid analgesic drug products.

2. Provides that this bill shall not be construed to prevent a plan or insurer from applying prior authorization requirements to abuse-deterrent opioid analgesic drug products, provided that those same requirements are applied to versions of those opioid analgesic drug products without the abuse-deterrent properties.

3. Defines "abuse-deterrent opioid analgesic drug product" as a brand or generic opioid analgesic drug product approved by the federal Food and Drug Administration (FDA) with abuse-deterrent labeling claims that indicate the drug product is expected to result in a meaningful reduction in abuse.

4. Defines "opioid analgesic drug product" as a drug product in the opioid analgesic drug class that is prescribed to treat moderate to severe pain, or other conditions, whether in immediate release or extended release or long-acting form and whether or not combined with other drug substances to form a single drug product or dosage form.

5. Authorizes a health care provider to prescribe a less than 30-day supply of an opioid analgesic drug product, and requires a plan or insurer to cover a less-than 30-day supply if otherwise covered.

6. Requires a pharmacist to inform a patient receiving an opioid analgesic drug product on proper storage and disposal of the drug, and authorizes the information to be provided as part of an oral consultation, as specified.

EXISTING LAW:

1. Establishes the Knox-Keene Health Care Service Plan Act of 1975 (Knox-Keene Act), which provides for the licensure and regulation of health care service plans by the Department of Managed Health Care, and provides for the regulation of health insurers by the California Department of Insurance (CDI).

2. Pursuant to DMHC regulations, states that a plan may require step therapy and requires a plan to have an expeditious process in place to authorize exceptions to step therapy when medically necessary.

3. Requires plans and insurers to include information on cost-sharing tiers and utilization controls, including prior authorization or step therapy requirements, for each covered drug.

4. Prohibits health plans that cover prescription drugs from limiting or excluding coverage for a drug on the basis that the drug is prescribed for use different from that for which the drug has been approved by the FDA, provided that specified conditions have been met, including that the drug is prescribed by a participating licensed health care professional for the treatment of a chronic and seriously debilitating condition, the drug is medically necessary to treat that condition, and the drug is on the plan formulary.

5. Prohibits health plans that cover prescription drugs from limiting or excluding coverage for a drug for an enrollee if the drug was previously approved for coverage by the plan for a medical condition of the enrollee and the plan's prescribing provider continues to provide the drug for the medical condition, provided that it is safe and effective for treatment.

6. Prohibits plans that cover prescription drugs from limiting or excluding coverage for a drug on the basis that the drug is prescribed for a use different from the use for which the drug has been approved by the federal FSA, provided that specified conditions have been met, including that the drug is prescribed by a participating licensed health care professional for the treatment of a chronic and seriously debilitating condition, the drug is medically necessary to treat that condition, and the drug is on the plan formulary.

7. Provides for the licensure and regulation of pharmacists by the California Board of Pharmacy.

8. Requires, under existing regulations, a pharmacist to provide oral consultation to a patient in all care settings under the following circumstances:

1. Upon request by the patient;

2. Whenever the pharmacist deems a consultation is warranted in the exercise of his or her professional judgment;

3. When the prescribed drug has not previously been dispensed to a patient; and,

4. When the prescription drug is dispensed that has not been previously dispensed to a patient in the same dosage, strengths, or with the same directions.

FISCAL EFFECT: This bill has not yet been analyzed by a fiscal committee.

COMMENTS:

1. PURPOSE OF THIS BILL. According to the author, not enough is being done to curb the growth of opioid abuse, and health care providers and parents need tools to help guard against the abuse of opioid medication. The author cites education for patients on the proper storage and disposal of opioids, as well as the development and availability of abuse-deterrent opioids, which are formulated to prevent manipulation of the drug for the purpose of misuse, as strategies that should be encouraged to combat opioid abuse. The author states that crushed or dissolved opioids account for 30% of opioid abuse, and this form of abuse is what results in the majority of emergency room visits, hospitalizations, and deaths. The author states that abuse-deterrent opioids are currently available on the market, that we should allow health care providers to exercise their judgment in prescribing abuse-deterrent opioids currently available on the market without worrying about cost-related hurdles. The author concludes by stating that the more widespread abuse-deterrent opioids become, the greater positive impact we can have on opioid abuse, and that increased availability of abuse-deterrent opioids and competition in the drug market will lead to reduced cost.

2. BACKGROUND.

   1. Opioids and opioid abuse. Opioids are a class of narcotic drugs that include medications such as hydrocodone (e.g. Vicodine), oxycodone (e.g., OxyContin, Percocet), morphine (e.g., Kadian, Avinza) codeine, and other related drugs. Taken as prescribed, opioids can be used to manage pain safely and effectively. However, opioids may also produce other effects, and according to the National Institute on Drug Abuse (NIDA), some individuals experience a euphoric response to opioid medications since these drugs affect the regions of the brain involving reward response.
      
      NIDA states that those who abuse opioids may seek to intensify their experience by taking the drug in ways other than those prescribed. For example, Oxycontin is an oral medication used to treat moderate to severe pain through a slow, steady release of the opioid. However, NIDA states that people who abuse the drug may crush or dissolve the drug in order snort or inject it, thereby increasing their risk for serious medical complications, including overdose. NIDA states that when abused, even a single large dose of opioids can cause severe respiratory depression and death.
      
      According to the California Department of Public Health (DPH), in the past, prescription opioids were prescribed for relieving short-term, acute pain. However, today, they are increasingly being used for long-term (chronic) pain management. As a result, sales of opioid pain relievers quadrupled in the past 10 years. By 2010, enough opioid pain relievers were sold to medicate every American adult (about 240 million people) every four hours for an entire month. DPH states that in California, deaths involving opioid prescription medications have increased 16.5% since 2006. In 2012, there were more than 1,800 deaths from all types of opioids – 72 percent involved prescription opioids.

   2. Abuse-deterrent opioids. According to the FDA, opioid products can be abused in a number of ways, including being swallowed whole; crushed in order to be swallowed, snorted, smoked; and, dissolved and injected. Opioids formulated with abuse-deterrent properties are designed to be more difficult to abuse, while retaining the same clinical effectiveness. For example, abuse-deterrent opioids may be formulated in ways that prevent chewing, crushing, grating, or grinding. Others may be formulated with agents that can make the drug resistant to dissolving by turning the drug into a gel-like substance when manipulated. Other formulations can reduce or defeat euphoria associated with the drug, or result in an unpleasant effect if the drug is manipulated.
      
      The FDA released industry guidance on April 1, 2015 regarding the evaluation and labeling of abuse-deterrent opioids, citing the development of abuse-deterrent opioids as a potentially important step toward the goal of creating safer opioid analgesics, and considers the development of abuse-deterrent opioids a high public health priority. The FDA also noted that abuse-deterrent technologies developed to date have not yet proven successful at deterring the most common form of abuse – swallowing a number of intact capsules or tables to achieve a feeling of euphoria. Further, the FDA stated that the science of abuse deterrence is relatively new, and both the formulation technologies and the analytical, clinical, and statistical methods for evaluating the technologies are rapidly evolving.
      
      In order for a drug to be approved as having an abuse-deterrent formulation, a drug manufacture must seek a label as such from the FDA. There are four general tiers of labeling claims available to describe the potential abuse-deterrent properties of a drug:

      1. Tier 1 – The drug is formulated with barriers to abuse.

      2. Tier 2 – The drug is expected to reduce or block the effect of the opioid when manipulated.

      3. Tier 3 - The drug is expected to result in a meaningful reduction in abuse.

      4. Tier 4 – The drug has demonstrated reduced abuse in the community.

According to the author, four opioids have been approved for abuse-deterrent labeling, each of which meet the requirements for Tier 3, and there are a number of generic and brand opioid products with different types of abuse-deterrent technologies that seek labeling. One of the four currently approved is OxyContin, which, in 2010, was reformulated as an abuse-deterrent opioid. It was approved for ADF labeling in April 2013, indicating that the product has physical and chemical properties that are expected to make abuse via injection difficult and to reduce abuse via snorting. OxyContin’s manufacturer replaced the original OxyContin formulation in 2010 with its abuse-deterrent formulation, and upon approval of the labeling in 2013, the FDA stopped accepting applications for generics that rely upon the approval of original formulation of OxyContin. Under this bill, plans would be required to cover abuse-deterrent opioids that meet Tier 3.

In terms of the public health impact of abuse-deterrent opioids, the author cites research published in 2014 in the journal “Pain Management” which estimated that abuse-deterrent formulation of OxyContin reduced overall health care costs by $430 million annually in the U.S., with an indirect cost savings of $605 million. The research study determined that these savings represented 1.8% of $58.4 billion in overall societal costs of prescription opioid abuse. The author also cites a study by Econostats that compared the cost between generic opioids without abuse-deterrent properties, and brand name abuse-deterrent opioids, finding that the price gap between the average patented cost of the brand name opioid and the average generic opioid cost was $140.

Other research has been conducted on abuse-deterrent opioids, including a study published in the New England Journal of Medicine in 2012 which found that abuse-deterrent formulations successfully reduced abuse of specific opioid, but resulted in increased use of heroin as a replacement for the drug, which could reduce societal cost savings.

3. Legislation in other states. At least 15 other bills regarding abuse-deterrent opioids have been introduced this year in other states, including Colorado, Connecticut, Florida, Kansas, Maryland, Mississippi, Oklahoma, Rhode Island, Tennessee, Vermont, and Virginia. In 2014, legislation on this topic was introduced in New Jersey. The requirements of the bills vary across states, with some bills containing similar requirements as those proposed in this bill, but overall, the bills aim to expand coverage and access to abuse-deterrent opioids.

4. Step Therapy. Step therapy is a utilization management technique sometimes applied to prescription drugs by a health plan or insurer. Health plans and insurers employ utilization management for a variety of reasons, including clinical considerations, and to control the cost of prescription drugs, particularly in therapeutic classes where generic version of the drugs exist. When implemented by a health plan or insurer, an enrollee may be required to first try an alternative medication (often a generic alternative) prior to receiving coverage for the final medication (often a brand-name medication).

1. SUPPORT. The Power of Pain Foundation (POPF), a co-sponsor of this bill, states that we must find a balance between the pain patients who truly need opioid medication for daily living, and those who are abusing the medication. POPF states that misuse and abuse of opioids is a growing public health problem that is driving up health care, criminal justice, and workplace costs, and that abuse-deterrent opioids represent a significant opportunity to reduce misuse and abuse. The Partnership for Drug-Free Kids (Partnership) writes that one in four teens reports having misused or abused a prescription drug, and nearly two-thirds of teens who have abused pain relievers say they get them from family members and friends. Partnership states that insurance coverage for abuse-deterrent opioids will lead to a larger share of abuse-deterrent medications in medicine cabinets, and also encourage companies to innovate in this direction.
   
   The California Academy of Physician Assistants and the California Academy of Eye Physicians and Surgeons state that this bill would prevent a plan or insurer from imposing barriers to access to abuse-deterrent opioids, if such drugs are deemed the most appropriate option by the prescriber. Law enforcement organizations state the abuse of prescription drugs continues to increase, particularly among minors who use medicine meant for therapeutic purposes for non-medical reasons. The organizations state that this bill represents a significant step forward in the effort to end potentially deadly prescription drug abuse by making meaningful changes to reduce opioid abuse through proper storage and disposal, allowing prescriptions for small quantities, and reducing barriers for doctors to prescribe opioids with abuse-deterrent formulations.

2. OPPOSITION. The California Association of Health Plans (CAHP) opposes this bill, stating that it is a coverage mandate for one form of drug, abuse-deterrent opioids, of which expensive brand drug manufacturers dominate the market. CAHP argues that the California Health Benefits Review Program (CHBRP) should analyze this bill before it is considered, and fiscal estimates of this proposal in other states have demonstrated increases in premiums. CAHP contends that the value of abuse-deterrent drugs is still being evaluated by the FDA, and while the bill attempts to allow prior authorization for abuse-deterrent products, it only does so if the same protocols apply to the non-abuse products which results in micromanagement of the formulary and could lead the prescriber to default to the more expensive abuse-deterrent option even though the effectiveness is still unproven and may be unnecessary. CAHP concludes by stating that plans must retain their ability to design drug benefits that are affordable and based on the evidence, particularly as drug costs continue to increase, and that abuse-deterrent drugs are fairly new, costly, and have insufficient evidence about their efficacy in deterrence.
   
   The Pharmaceutical Care Management Association, a national association of pharmacy benefit managers (PBM) states that this bill is part of a nationwide effort to force the use of abuse-deterrent opioids by disallowing generic substitutions, but that abuse-deterrent formulations are not a quick fix for opioid abuse and will raise costs. Express Scripts, a pharmacy benefit manager, estimates that abuse-deterrent opioids cost about three times as much as non-abuse-deterrent agents, and that the bill would restrict them from using step therapy to promote the use of lower cost, equally effective generics before more expensive brand medications.
   
   

3. RELATED LEGISLATION. AB 73 (Waldron) provides that drugs in specified therapeutic drug classes that are prescribed by a Medi-Cal beneficiary's treating provider are covered Medi-Cal benefits, and require that a Medi-Cal managed care plan cover the drug upon demonstration by the provider that the drug is medically necessary and consistent with federal rules and regulations for labeling and use. AB 73 is pending in the Assembly Health Committee.

6. PREVIOUS LEGISLATION.

   1. AB 1814 (Waldron) from 2014 would have established that a prescriber’s reasonable professional judgment prevails over the policies and utilization controls of the Medi-Cal program, including the utilization controls of a Medi-Cal managed care plan, in prescribing a pharmaceutical from specified therapeutic drug classes. This bill was held in the Assembly Appropriations Committee.
      
      

   2. AB 831 (Bloom) from 2013 would have required, until January 1, 2016, the California Health and Human Services Agency (CHHSA) to convene a temporary working group to develop a state plan to reduce the rate of fatal drug overdoses and appropriates $500,000 from the General Fund (GF) to CHHSA to provide grants to local agencies to implement drug overdose prevention and response programs. This bill was held in the Assembly Appropriations Committee.

   3. AB 889 (Frazier) of 2013 would have prohibited a plan and insurer that provides coverage for medications pursuant to step therapy or fail first protocol from requiring an enrollee or insured to try and fail more than two medications before allowing the enrollee or insured access to the medication originally prescribed by their provider, and would have required plans and insurers to have an expeditious process in place for step therapy exceptions and that the duration of step therapy be consistent with up-to-date evidence-based outcomes and current published peer-reviewed medical and pharmaceutical literature. This bill was held in the Senate Appropriations Committee.

   4. AB 369 (Huffman) of 2012 would have prohibited plans and insurers that restrict medications for the treatment of pain from requiring a patient to try and fail on more than two pain medications before allowing the patient access to the pain medication, or its generic equivalent, prescribed by his or her physician. This bill was vetoed with the Governor's veto message stating that a doctor's judgment and a health plan's clinical protocols have a role in ensuring prudent prescribing of pain medications, and any limitations on the practice of step therapy should better reflect a health plan or insurer's legitimate role in determining the allowable steps.

   5. AB 1826 (Huffman) of 2010 would have required a plan or insurer that covers prescription drug benefits to provide coverage for a drug that has been prescribed for the treatment of pain without first requiring the enrollee or insured to use an alternative drug or product. This bill was held in the Senate Appropriations Committee.

   6. AB 1144 (Price) of 2009 would have required plans and insurers to report to DMHC and CDI specified information related to chronic pain medication management, including when the plan or insurer requires an enroll to use of more than two formulary alternative medications prior to providing access to a pain medication prescribed by a provider, or to use pain medication other than what was prescribed for more than seven days prior to providing access to the prescribed pain medication. This bill was held in the Assembly Appropriations Committee.

7. POLICY COMMENTS.

   1. Bill will be reviewed by CHBRP. The committee submitted a request to CHBRP, housed within the University of California, to review this bill and perform an analysis of the clinical efficacy, cost-effectiveness, and public health impact of its provisions. CHBRP is established in state statute to assess legislation that proposes or repeals a mandated benefit or service for public health, medical and financial impact. Committee rules provide that the committee may not hear such bills until CHBRP's assessment is received and has been reviewed by committee staff. Since this bill does not propose a mandate for a new benefit, but rather would require plans and insurers to cover a different formulation of a drug that is already covered, this bill may be heard by the committee without the CHBRP analysis.
      
      CHBRP’s independent analysis will likely provide valuable information about the potential impact of this bill and inform the Legislature on key policy questions regarding the bill. For example, as a part of its role in determining the cost-effectiveness and public health impacts of the bill, the CHBRP analysis may estimate the cost implications of requiring brand name abuse-deterrent opioids over generic opioids without abuse-deterrent properties. Additionally, the bill would not require abuse-deterrent drugs to actually demonstrate reduced abuse in the community before requiring plans to cover them where available. As such, the CHBRP analysis may provide insight into the actual or potential public health impact of abuse-deterrent opioids in the community through an evaluation of a broader set of available evidence.

   2. Bill would impact Medi-Cal managed care plans. Most Medi-Cal managed care plans are Knox-Keene licensed, and, as such, will have to meet the requirements of this bill.

   3. Current law does not prohibit providers from prescribing a less than 30-day supply of opioids. This bill would authorize a provider to prescribe a less than 30-day supply of opioids. It does not appear that there are any provisions in statute that would prevent providers from doing this today.

8. DOUBLE REFERRED. This bill is double referred. Upon passage by this Committee, it will be referred to the Assembly Committee on Business and Professions.

REGISTERED SUPPORT / OPPOSITION:

Support

Power of Pain Foundation (sponsor)

U.S. Pain Foundation (sponsor)

Alliance for Patient Access

American GI Forum
Biocom

California Academy of Eye Physicians and Surgeons

California Academy of Physician Assistants

California Healthcare Institute

California Hepatitis C Task Force

California Pharmacists Association

California Police Chiefs Association

California State Sheriff's Association

Familia Unida

Neuropathy Action Foundation

Partnership for Drug Free Kids

Peace Officers Research Association of California

Opposition

California Association of Health Plans

California Chamber of Commerce

Express Scripts

Pharmaceutical Care Management Association

Analysis Prepared by: Kelly Green / HEALTH / (916) 319-2097