Highlight on Wisconsin: As opioid overdose and deaths rise, state seeks $15.7 million in SAMHSA support

The rate of opioid overdose deaths in Wisconsin has risen approximately 81 percent from 2006 through 2015, according to a new Wisconsin Department of Health Services (DHS) report, titled “Select Opioid-Related Morbidity and Mortality Data for Wisconsin.” In response, the Wisconsin DHS has submitted an application for up to $15.7 million in federal funding to boost the state’s response to the growing misuse and abuse of opioids from the Substance Abuse and Mental Health Services Administration (SAMHSA). The amount of the grant is based on the unmet need for opioid-related treatment and the number of opioid-related deaths in the state. Wisconsin is eligible to receive up to $7,636,938 each year for the next two years under the 21st Century Cures Act.

The DHS report provides statewide and county-level data on opioid-related deaths and hospital visits, neonatal abstinence syndrome (NAS) (in which an infant is born with withdrawal symptoms from substances taken by the mother), and data on ambulance runs in which naloxone (a medication used to reverse opioid overdose) was administered. The report includes these data highlights:

  • The rate of opioid overdose deaths increased from 5.9 deaths/100,000 residents in 2006 to 10.7 deaths/100,000 in 2015.
  • Rates of drug overdose deaths involving opioids were higher among counties in the southeastern region of the state (Milwaukee area), and higher among men compared with women.
  • Drug overdose deaths involving opioids were highest among young men aged 25-34, and among women aged 35-54.
  • Hospital visits involving opioid acute poisoning (including overdose) increased from 25.3 to 52.0 per 100,000 between 2006 and 2014.
  • The rate of ambulance runs in which naloxone was administered rose from 51.2 to 67 per 100,000 from 2011 to 2015.
  • The rate of NAS increased from 2.0 to 8.7 per 1,000 live births from 2006 to 2014, a rate increase of 335 percent.

In 2016, DHS issued a Public Health Advisory due to the opioid epidemic. In 2017, Governor Scott Walker called for a special session of the legislature to consider recommendations presented by the Governor’s Task Force on Opioid Abuse. New legislative proposals will build on efforts already underway under the HOPE (Heroin, Opioid Prevention and Education) agenda, which includes 17 bills aimed at prevention and treatment of opioid addiction and overdose.

Pending approval from SAMHSA, the funds will be used to:

  • Support community coalitions focused on reducing the nonmedical use of opioids among people age 12 to 25.
  • Establish a hotline to provide information on treatment services and recovery supports.
  • Expand access to treatment for uninsured and underinsured individuals.
  • Establish new opioid-specific treatment programs to reduce the distance people have to travel for these services.
  • Establish a network of individuals in long-term recovery from the misuse and abuse of opioids trained to coach people through the treatment and recovery process.
  • Develop training for professionals on proven intervention and treatment strategies for opioid misuse and abuse.

 

Compliance advice offered to providers in the orthotic and prosthetic arena

There are high clinical documentation standards for orthotic and prosthetic (O&P) providers. Non-compliance with these documentation requirements can result in numerous adverse consequences for O&P providers, including: audits; recoupment of payments already received; loss of contracting and provider privileges; civil money penalties; loss of credentialing, certification, or licensure; the risk of getting on the Zone Program Integrity Contractor (ZPIC) radar, and exclusion from participation with any physician that accepts government funding, such as Medicare or Medicaid.

Understanding and applying compliance requirements in the O&P arena was the focus of a Health Care Compliance Association (HCCA) webinar offered by Tonja Wise, CHC, Corporate Compliance Manager, O&P Compliance Officer, Shriners Hospitals for Children International.

Wise’s presentation began by explaining why the O&P provider needs compliance and how O&P is different from other specialties. She then discussed the O&P provider’s obligations in the areas of documentation, provider notes, coding, and billing. Wise also noted the importance of the prescribing physician, who shares some of the documentation responsibility with the O&P provider. A summary of Wise’s major points of these topics include the following:

  • As a result of recent fraudulent activity and increased payment recoveries, O&P has become the new durable medical equipment (DME) when it comes to audits and scrutiny by the Office of Inspector General (OIG).
  • O&P suppliers that intend to bill Medicare (and Medicaid in most states) must be accredited. The Board of Certification/Accreditation (BOC) and the Association of Boards of Certification (ABC) both offer this service. Going through accreditation is good practice for ensuring that the organization meets the Medicare Supplier Standards and the accreditation standards.
  • Medical documentation must corroborate the O&P provider’s chart and justify the order written and device supplied. Documentation of the orders, delivery, use and care instructions, and safety are very specific.
  • Documentation requirements include a signed HIPAA acknowledgement; consents for treatment; a valid dispensing order prior to delivery; a signed, detailed written order prior to billing; a detailed delivery receipt; complete, comprehensive O&P provider notes; safety checks completed; and proof of patient care and instructions.
  • Provider notes should be complete, comprehensive, and compliant. This means each patient visit should have an independent, detailed note. The initial evaluation and the delivery visits are the most involved and will be the most important to the payor or auditor. These notes must outline all of the information necessary to support medical necessity.
  • It is the responsibility of the certified O&P provider to ensure that the appropriate Healthcare Common Procedure Coding System (HCPCS) codes are selected.
  • Know the federal requirements for the warranty period for O&P devices. CMS requires a 90-day warranty for all new devices. State Medicaid warranty periods may differ. The O&P provider does not need a new prescription for repairs if the provider delivered the device, unless major components are being replaced.
  • All bills should be reviewed for accuracy and consistency prior to submission. Confirm that diagnostic codes on all orders are consistent with the claim. Ensure all modifiers are included with the claim and are accurate.
  • Prescribing physicians are responsible for providing orders that meet CMS criteria for all O&P devices, documenting all medical necessity for the device being ordered, providing accurate diagnosis data (O&P providers cannot diagnose), and supplying any medical documentation necessary to support the O&P provider’s claim.

Conclusion

Wise believes that the best protection for an O&P provider is to have a robust compliance program in place to monitor coding, billing, medical necessity, and documentation. To ensure this compliance, she suggests that the O&P provider do the following:

  • Conduct annual compliance education.
  • Utilize access to O&P resources for guidance.
  • Be knowledgeable of federal, state and local requirements.
  • Be educated on payor requirements.
  • Read and understand the local coverage decisions (LCDs) and reference them frequently.
  • Be a self-auditor and audit frequently.
  • Ensure that any regulatory updates or major changes to O&P are communicated throughout the organization.

State views, even in GOP states, not fully aligned with current repeal initiatives

An issue brief from the Kaiser Family Foundation (KFF) summarizes input and recommendations from governors and insurance commissioners in 35 states regarding health care reform, including their view on repeal and replacement of the Patient Protection and Affordable Care Act (ACA) (P.L. 111-148) and changes Congress is considering to the structure and financing of Medicaid. KFF’s analysis in its issue brief shows that state leaders have varied views on ACA repeal and replacement and potential changes to Medicaid. While many of their views fall along party lines, some views are shared across parties and those who support and oppose repeal.

On December 2, 2016, Republican House leaders sent a letter to state governors and insurance commissioners seeking input and recommendations based on their experience overseeing the health insurance markets and Medicaid programs within their respective states. Responses were due by January 6, 2017.

The respondents included a mix of governors and insurance commissioners in 34 states and the Mayor of the District of Columbia. Among the 35 responding states, 18 had a Republican governor at the time of the response and 17 had a Democratic governor. Three-fourths (26 of 35) of the states had adopted the ACA Medicaid expansion (ACA, section 2001) to low-income adults.

ACA repeal

The KFF analysis found that 23 of 35 responses cited some positive effects of the ACA. This group included all respondents from Democratic-led states and six of the 18 respondents from Republican-led states. The respondents pointed to several positive effects, including gains in coverage, reduced uninsured rates, increased affordability for subsidized consumers, increased access and utilization of care, and reductions to uncompensated care for hospitals.

Challenges with the ACA were cited in 21 of the 35 responses. All 18 respondents from states with Republican governors cited challenges, as well as respondents from three states with Democratic governors. Respondents pointed out several issues, including the following:

  • the ACA has shifted too much control of health insurance to the federal government and that greater authority and flexibility should be given back to states to regulate their insurance markets;
  • the ACA has caused insurers to leave the individual market leading to more limited access and choice for consumers;
  • continuing premium increases;
  • the prevalence of narrow network plans that limit access to providers; and
  • the sustainability of Medicaid due to the significant growth in enrollment under the ACA Medicaid expansion.

Across both parties, 29 of 35 respondents were concerned about repealing the ACA. All 17 responses from states with a Democratic governor noted concerns, as did 12 of the 18 responses from states with a Republican governor. The concerns included potential coverage losses for individuals covered through the marketplaces or Medicaid expansion, marketplace instability caused by repeal, the loss of federal funding, the shift of cost to the states, disruption of delivery and payment reform initiatives, and increased administrative costs.

Medicaid financing structure

The Trump administration and Republican Congressional plans have called for Medicaid to be financed through block grants or per capita caps. In exchange for caps, the states would get increased flexibility to administer their programs.

The KFF analysis found that 18 of 35 of the responses included comments on Medicaid financing, particularly the move to a block grant or per capita cap financing structure. Twelve of the 18 respondents indicated concerns about a capped financing structure. Ten of the 12 respondents expressing concerns were from states with a Democratic governor.

Respondents in six of the 18 Republican states indicated general support for capped financing, but most included suggestions on how a cap should be structured. Their suggestions included:

  • limiting cap financing to only certain parts of the Medicaid population (e.g., excluding seniors and people with disabilities);
  • having the cap allow for enhanced funding during economic downturns;
  • reviewing the cap annually; and
  • ensuring that the cap does not disadvantage states that have not taken up certain program options, like the Medicaid expansion.

Medicaid flexibility

Fourteen of the 35 responses, most from Republican states, indicated an interest in increased state Medicaid flexibility.The suggested areas for increased flexibility included premiums and cost sharing, benefits, eligibility (including enrollment caps, work requirements, income standards), provider payments, and delivery systems.

Section 1115 waivers

Republican respondents in 10 of the 35 states cited interest in increased flexibility and streamlined processes to make changes under Social Security Act §1115 (Section 1115 waivers). These comments included providing a pathway for waivers to become permanent, eliminating or reducing renewal requirements for waivers, allowing other states to replicate waiver changes approved for other states, providing expedited and streamlined approval processes for waivers and state plan amendments, and reductions in regulatory requirements and state reporting requirements.

Section 1332 waivers

Most respondents (20 of the 35) did not provide comments on ACA section 1332 waivers for state innovation. Seven respondents indicated they are or would potentially consider pursuing a 1332 waiver or that they supported maintaining the 1332 waiver authority. Eight respondents indicated that they are not planning to utilize this authority. Several respondents indicated that the current rules related to 1332 waivers are too restrictive, limiting their interest in pursuing a waiver.

Four VA facilities weak on controlled substance diversion protections

In recent years, diversion of controlled substances has occurred at several Veterans Affairs (VA) medical facilities. In fact, in a 2009 and 2014 report, the VA Office of the Inspector General (OIG) identified a number of weaknesses in VA medical facilities’ implementation of controlled substance inspection programs. For example, the VA OIG found that some VA medical facilities had not conducted the required monthly inspections, and when facilities did conduct the monthly inspections, the inspections were sometimes incomplete because they did not follow all of the required Veterans Health Administration (VHA) procedures.

GAO review

As a result of these deficiencies, Congress requested that the Government Accountability Office (GAO) report on VHA’s processes to reduce the risk of diversion of controlled substances at its medical facilities and VHA’s oversight of these processes. The report examined: (1) the extent to which selected VA medical facilities have implemented controlled substance inspection programs as required by VHA policies, and (2) VHA’s oversight of these programs at selected VA medical facilities.

Implementation of inspections

The GAO found weaknesses in the way four VA medical facilities were implementing their controlled substance inspection programs. Two of the four facilities did not conduct monthly inspections of controlled substances as required by the VHA. Between January 2015 and February 2016, one facility missed 43 percent of monthly inspections in critical patient care areas and the pharmacy. Further, inspections that three of the four facilities performed did not include or follow three or more of the nine VHA requirements. At two of the three facilities, inspectors did not properly verify that controlled substances had been transferred from VA pharmacies to patient care areas; nor did inspectors ensure that all controlled substances on hold for destruction were properly documented.

Contributing factors

GAO discovered that several factors contributed to the failure to adhere to VHA policy. First, the two facilities that missed inspections lacked an additional control procedure (such as the use of an alternate controlled substance coordinator) to help prevent missed inspections when inspectors could not conduct them due to professional or other personal responsibilities. Second, three of the four facilities did not ensure their written procedures included the nine VHA program requirements. Third, while the VHA relies on coordinators at the facilities to ensure that the inspections are completed appropriately, the GAO found that VHA’s training course for the coordinators does not focus on its required inspection procedures.

Inconsistent oversight

The GAO also found inconsistent oversight at the selected facilities of their controlled substance inspection programs by facility directors and the Veterans Integrated Service Networks to which the facilities report. Directors at two of the four selected VA medical facilities had not implemented corrective actions to address missed inspections identified in the monthly inspection reports. In addition, two of the four selected networks did not review their facilities’ quarterly trend reports, as required by VHA. One network that had reviewed the trend reports failed to follow up with a facility to ensure it had submitted missed trend reports. The GAO concluded that without effective oversight of the inspection programs by directors and networks, VHA lacks reasonable assurance that its programs are being implemented as required to prevent and identify diversion of controlled substances.

Recommendations

The GAO recommended that the Secretary of the VA direct the Under Secretary for Health to:

  • ensure that VA medical facilities have established an additional control procedure, such as an alternate controlled substance coordinator or additional inspectors, to help coordinators meet their responsibilities and prevent missed inspections;
  • ensure that VA medical facilities have established a process where coordinators, in conjunction with pharmacy officials, periodically compare facility inspection procedures to VHA’s policy requirements and modify facility inspection procedures as appropriate;
  • improve the training of VA medical facility controlled substance coordinators by ensuring the training includes the inspection procedures that VHA requires;
  • ensure that medical facility directors have designed and implemented a process to address nonadherence with program requirements, including documenting the nonadherence and the corrective actions taken to remediate nonadherence or the actions that demonstrate why no remediation is necessary; and
  • ensure that networks review their facilities’ quarterly trend reports and ensure facilities take corrective actions when nonadherence is identified.

The VA concurred with the GAO’s recommendations.