Kusserow on Compliance: OIG 2017 work plan highlights

As compliance officers prepare their work plans for 2017, it is worth remembering those matters of current interest to the HHS Office of Inspector General (OIG) that are reflected in its 2017 Work Plan. The OIG’s plan outlines new and ongoing reviews of HHS programs and operations and timeframes for completion.  The OIG reviews various providers, including hospitals, nursing homes, and home health services.  Items in the Work Plan of particular significance include the following:

  • incorrect medical assistance days claimed by hospitals (addressing risk of overpayment under the Medicare disproportionate share hospital payments);
  • case review of inpatient rehabilitation hospital patients, not suited for intensive therapy;
  • inpatient psychiatric facility outlier payments;
  • Medicare costs associated with defective medical devices;
  • unreported incidents of abuse and neglect in skilled nursing facilities;
  • skilled nursing facility reimbursement;
  • review of hospice compliance with Medicare requirements;
  • Medicare payments for transitional and chronic care management;
  • Medicare Payments for Service Dates After Individuals’ Date of Death;
  • Centers for Medicare & Medicaid Services (CMS)’ implementation of the Quality Payment Program;
  • Medicare Part D rebates for drugs dispensed by 340B pharmacies;
  • Medicaid overpayment reporting and collections; and
  • CMS oversight and issuer compliance in ensuring data integrity for the Affordable Care Act (ACA) Risk Adjustment Program.

Tom Herrmann, J.D., a retired OIG executive who was intimately involved in past OIG Work Plan development, advises compliance officers to closely review the entire OIG Work Plan, as it telegraphs issues that have come to the OIG’s attention as potential problem areas warranting close examination. The results of such reviews often lead to proposed legal and regulatory changes.  They also may trigger additional audits, evaluations, and investigations. Examining the Work Plan items that may relate to their organizations in detail is an opportunity for compliance officers to get ahead of the power curve, rather than behind it.  The fact is that one of the purposes of publishing the OIG Work Plan is to encourage health care entities to engage in such self-examination and program improvement.

Richard P. Kusserow served as DHHS Inspector General for 11 years. He currently is CEO of Strategic Management Services, LLC (SM), a firm that has assisted more than 3,000 organizations and entities with compliance related matters. The SM sister company, CRC, provides a wide range of compliance tools including sanction-screening.

Connect with Richard Kusserow on Google+ or LinkedIn.

Subscribe to the Kusserow on Compliance Newsletter

Copyright © 2016 Strategic Management Services, LLC. Published with permission.

MA and Part D benefit administration not always straightforward

Although the idea that private insurers can be more efficient than the government in offering health plans may be a matter of opinion, over 17 million Medicare beneficiaries have taken “advantage” of the option by enrolling in Medicare Advantage (MA). At the American Health Lawyers Association (AHLA) Fundamentals of Health Law conference, Thomas Barker, partner at Foley Hoag LLP, noted that MA enrollment has steadily increased over the past 10 years. Medicare Part D coverage is also an important benefit for those taking outpatient medications. Despite beneficiaries’ reliance on these programs, administration of the benefits still has some kinks.

Medicare Advantage

MA plans are available to those entitled to Part A or eligible to enroll in Part B. MA plans are required to offer all original Medicare benefits, but may implement their own cost-sharing and benefit designs as long as they are actuarially equivalent to original Medicare. For example, original Medicare only covers skilled nursing care under Part A if the beneficiary has been in an inpatient hospital for three days prior to nursing facility admission. Most MA plans do not impose this rule.

MA plans are required to implement the same cost sharing for four particular categories: chemotherapy administration, renal dialysis, skilled nursing care, and “other benefits specified by CMS” (of which there are none to date). Congress reasoned that this would provide for predictability in benefit design.

Local and national coverage decisions

Original Medicare may not pay for items and services that are not reasonable and necessary for diagnosis or treatment. CMS issues national coverage decisions on reasonableness and necessity of certain therapies and technologies, which apply to MA plans. If a national coverage decision has not been issued for a certain item or service, local CMS contractors have the power to issue their own decisions. Barker explained that this is when MA plan design starts to get complicated.

If an MA plan is only operating in a regional market, it must apply the local coverage decisions. However, if multiple markets are covered, the MA plan has the option of applying the coverage decision even to enrollees who are outside of the decision’s jurisdiction. In cases where no decision has been issued, nationally or locally, MA plans have some discretion. Although CMS has not clarified its position, Barker interprets the available information to mean that MA enrollees are entitled to the same benefits as original Medicare beneficiaries living in their area. Yet at the same time, CMS seems to give MA plans some discretion to use the medical necessity criteria of other local plans or develop their own evidence-based criteria.

Part D

Medicare Part D is completely offered through private plans, which are extremely competitive (compared to MA plans’ requirement to bid against an established benchmark). Part D operation also differs from MA due to the increased flexibility in benefit design. Although there is a statutorily established design, fewer than 10 percent of Part D enrollees are in such a plan. Almost all plans offer a different coverage design that is actuarially equivalent to the standard benefit. Most commonly, these plans have no deductible and have a three-tiered cost-sharing amount as opposed to coinsurance.

Beneficiaries who choose to enroll in Part D are entitled to “coverage of covered Part D drugs.” Although the definition is basic, some challenges have emerged. The drug must be FDA approved and only dispensed pursuant to a prescription, can be a vaccine and insulin, can be used for a “medically-accepted indication,” and must not be expressly excluded from coverage or covered by Parts A or B. Although Part B covers some drugs, such as those that are physician-administered, CMS contractors can make differing determinations over whether a Part B-covered drug is usually self-administered. This results in some drugs covered under Part B in some jurisdictions and under Part D in others.

The “medically-accepted indication” phrase in the statute has also presented some challenges. Barker noted that this entire issue turns on grammar as much as it does administrative law. After establishing that the drug must be prescribed and FDA approved, it says “and such term includes…any use of a covered Part D drug for a medically accepted indication.” In a relevant lawsuit, a physician prescribed a drug approved as a fertility drug to treat a rare form of ovarian cancer. Although there was compendia support, it would not have met the “medically accepted indication” definition and the Part D plan denied coverage. The court rejected the government’s argument that the phrase “and includes” is definitional, finding that reading the phrase as illustrative was more logical. Therefore, according to the court, a Part D drug does not have to be prescribed for a medically accepted indication in order to be covered.

Kusserow on Compliance: Medicare parts A and B among OIG’s top management challenges

Annually, the HHS Office of Inspector General (OIG) prepares a summary of the most significant management and performance challenges facing HHS and its progress toward addressing them. Among them are issues relating to Medicare Parts A and B.  The programs are expected to continue increasing significantly due to the growth in the number of beneficiaries and the increase in per capita health care costs. The Annual Report by Medicare’s Board of Trustees estimates that the Trust Fund for Part A will be depleted by 2028, and that the Part B spending growth of almost 7 percent over the next five years will be higher than growth rate for the U.S. economy. Part B is undergoing substantial changes through the Medicare Access and CHIP Reauthorization Act of 2015 and other reforms. The following were the key challenges identified in these programs.

Reducing improper payments. In FY 2015, CMS reported an improper payment rate of 12.1 percent, corresponding to $43.3 billion, for Medicare fee-for-service (Parts A and B). These measures include payments that were paid at an incorrect amount (including both overpayments and underpayments), as well as payments for unnecessary services, services not rendered, billing or coding errors, and claims that did not meet documentation or other Medicare coverage requirements. The OIG found vulnerabilities in hospital billings and returning improper payments to the Medicare Trust Fund. Special focus is needed on improper payments in home health and hospice care vulnerabilities.  Many improper payments have been identified across a number of risk areas, such as insufficient documentation, medical necessity, and homebound determinations.  One-third of stays for hospice general inpatient care have been found as not meeting Medicare requirements, costing $268 million.   There have been findings, as well, of improper payments (some exceeding 50 percent) to Part B providers, such as chiropractors, physical therapists, and certain durable medical equipment (DME) suppliers.

Preventing, detecting, and responding to fraud. The OIG has found that program areas susceptible to widespread fraud include home health and hospice services and DME, including billing for unnecessary services or services not provided; kickbacks to recruiters and patients; aggressive and illegal DME telemarketing; and social targeting of Medicare beneficiaries that put them at risk of medical identity theft.  CMS lacks accurate information about the individuals and entities with which it does business and must take appropriate steps to avoid doing business with, and exposing beneficiaries to, those who are untrustworthy.  There is a need to fully and effectively deploy all available program integrity tools, including those provided under the Patient Protection and Affordable Care Act (ACA) (P.L. 111-148), such as enhanced screening of provider enrollments.  Weaknesses have been found in contractors’ administration of provider enrollments that could leave Medicare vulnerable to billing by ineligible providers and beneficiaries. Weaknesses included gaps in the verification of key information, inconsistencies in site visit procedures, and failures to use site visit results for enrollment decisions. CMS’s Provider Enrollment, Chain and Ownership System (PECOS) is incomplete and, in some cases, inaccurate. It was intended to aid in tracking enrollment and revalidation trends and to help determine whether contractors are meeting requirements.

Fostering prudent payment policies.  Medicare pays significantly different amounts for the same services provided to similar patients in different settings.   The OIG estimated swing-bed services provided up to 90 percent of the critical access hospital (CAH) services that they reviewed, which could have been provided at other nearby facilities that are paid under the Skilled Nursing Facility (SNF) Prospective Payment System.  Medicare could have saved $4.1 billion over 6 years if payments for swing-bed services at CAHs were made to other facilities at SNF rates. Medicare and beneficiaries also typically pay more for a physician service provided in a “provider-based facility” (i.e., one owned by a hospital) than for the same service provided in an independent facility.  CMS is implementing a significant overhaul of the payment system for clinical laboratory tests pursuant to the Protecting Access to Medicare Act of 2014 and the new system seeks to better align Medicare reimbursement for lab tests with market rates (taking effect on January 1, 2018).  Concerns continue about risks to payment accuracy on the basis of CMS’s plans to rely on labs to self-identify whether they meet the criteria for reporting private payer data and they plan to rely on reporting labs’ self-attestations of the data’s completeness and accuracy.  Some payment systems create financial incentives that may negatively affect patient care and drive up Medicare costs, such as payment policies for SNFs that give facilities incentives to bill for higher levels of therapy than beneficiaries need.  Some SNFs have been billing for the highest level of therapy at increasing rates that were not supported by patient needs.  Many hospices have been found providing care much longer and received much higher Medicare payments for beneficiaries in inpatient assisted-living facilities than for beneficiaries in other settings, creating incentives for hospices to target these patients, doubling hospice care cost in the last 5 years.

Progress reported by CMS/HHS in addressing the challenges

  • Substantial strides in fighting fraud, waste, and abuse in Medicare and Medicaid have been made through the Health Care Fraud and Abuse Control Program, recovering stolen and misspent funds at a return of $6.10 for every $1 invested.
  • Many OIG recommendations are being implement to implement additional program integrity tools.
  • Prior authorization models and demonstrations are being implemented in certain areas to help ensure items and services are provided in compliance with Medicare coverage, coding, and payment rules.
  • Prior authorization processes are being implemented in certain locations for power mobility devices, repetitive scheduled non-emergent ambulance transport, and certain durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS).
  • A demonstration project has begun in five states, requiring home health agencies to submit required documentation for pre-claim review to help reduce and prevent improper payments.
  • There have been reductions in Medicare billing and payments for certain services and geographic areas known for fraud risks.
  • Steps have been taken to improve provider enrollment safeguards and protection for the Medicare program.
  • Expansion of temporary provider enrollment moratoria for home health agencies has been extended in certain geographic locations known for significant fraud.
  • New regulations have been proposed that would use provider and supplier information more effectively to keep out or remove providers who pose risks to Medicare and its beneficiaries.
  •  Enhanced address verification software in PECOS has been reported to better detect vacant or invalid addresses or commercial mailing reporting agencies.
  • Improvements have been reported in oversight and measurement of contractors’ performance and agency corrective actions regarding improper payment vulnerabilities that contractors identify.
  • For laboratory services, reports have been made of significant progress in several key areas, including promulgating regulations, establishing the Advisory Panel, publishing most of the sub-regulatory guidance, and building the data collection system.
  • New legislation is being proposed that would restrict the higher payment rates for provider-based facilities to “on-campus” facilities and to “off-campus” facilities that were designated as such before November 2, 2015.

What OIG states still needs to be done

  • Continued improvement of oversight of the performance of contractors in implementing Medicare provider enrollment safeguards is needed to ensure payment accuracy and identify and recover overpayments in a timely manner.
  • Need to improve the completeness, accuracy, and timeliness of its provider ownership data (maintained in PECOS) to support effective oversight.
  • HHS should continue to address and resolve program integrity weaknesses identified.
  • Numerous actions remain to be acted upon and implemented to reduce improper payments for specific services.
  • Need to increase oversight of hospice general inpatient claims, ensure that a physician is involved in the decision to use proper level of care, and conduct prepayment reviews for lengthy stays.
  • Safeguards need strengthening to ensure that Medicare pays for home health services only when the beneficiary meets the applicable homebound requirement and the home health agency has provided reasonable and necessary skilled services that are supported by and documented in the physician’s certification plan.
  • Changes are needed (some requiring legislation) to promote more prudent payment policies, including payments to hospital outpatient departments and ambulatory surgical centers, SNFs, and hospices.
  • Need to act upon a number of pending recommendations within existing authorities to mitigate the financial and quality of care risks under the current systems, such as CMS analyzing billing data to identify SNFs that appear to be overbilling for therapy and expand its oversight reviews of those SNFs.
  • For laboratory tests, maintain focus on key remaining tasks, including completing the data collection system, ensuring completeness and accuracy of reported data, and establishing new Medicare payment rates after labs report data in 2017.
  • Monitor labs’ reporting to ensure report data are accurate and complete.

Richard P. Kusserow served as DHHS Inspector General for 11 years. He currently is CEO of Strategic Management Services, LLC (SM), a firm that has assisted more than 3,000 organizations and entities with compliance related matters. The SM sister company, CRC, provides a wide range of compliance tools including sanction-screening.

Connect with Richard Kusserow on Google+ or LinkedIn.

Subscribe to the Kusserow on Compliance Newsletter

Copyright © 2016 Strategic Management Services, LLC. Published with permission.

CMS updates its Medicare and Medicaid drug spending dashboards

As part of its effort to provide additional information on, and increase transparency in the cost of prescription drugs, CMS has updated both its Medicare and Medicaid drug spending dashboards to include information from 2015. According to a CMS press release, the medications presented as part of the 2015 Medicare Drug Spending Dashboard represents a very large proportion of Medicare spending, including 34 percent of all Part D spending and 69 percent of Part B drug spending, which was similar to the 2014 drug dashboard. A second, contemporaneous CMS press release notes that the medications presented as part of the 2015 Medicaid Drug Spending Dashboard represent approximately 41 percent of Medicaid covered outpatient drug spending in 2017.

Total program spending

For total program spending, the Medicare dashboard shows five drugs with the highest Part D and Part B drug spending, respectively, in 2015 compared to their spending in 2014. For example, the dashboard shows that Lantus (insulin) was a top-five drug in terms of costs in Medicare Part D between 2014 and 2015, as was Havroni, a new drug to treat Hepatitis C.

The Medicaid dashboard also shows the trend in total drug spending for the five drugs with the highest aggregate drug spending in 2015. Of the top five, Harvoni and Abilify (aripiprazole, a brand name anti-psychotic drug) had total drug spending greater than $2 billion in 2015, with annual total program spending for Abilify greater than $1.7 billion for each of the past five years. Also, spending for Lantus/Lantus Solostar (insulin glargine, a brand name diabetes drug) was $1.4 billion and spending for Vyvanse (lisdexamfetamine dimesylate, a brand name attention deficit hyperactivity disorder drug) and Humira/Humira pen (adalimumab, a brand name drug used for rheumatoid arthritis) was approximately $800 million each.

Highest total spending (Part D)

The Medicare dashboard shows that the five Part D drugs with highest total spending in 2015 were:

  • Spiriva (tiotropium bromide, a brand name chronic obstructive pulmonary disease treatment);
  • Advair Diskus (fluticasone/salmeterol, a brand name asthma and chronic obstructive pulmonary disease treatment);
  • Crestor (rosuvastatin calcium, a brand name cholesterol drug)
  • Lantus/Lantus Solostar (insulin glargine, a brand name diabetes drug); and
  • Harvoni (ledipasvir/sofosbuvir; a brand name Hepatitis C virus treatment).

Advair Diskus and Crestor were also among the top five drugs with the highest Part D spending in 2014, but Spiriva, Lantus, and Harvoni were not. Harvoni was introduced in October 2014 and in 2015 had just over $7 billion in spending. Sovaldi (sofosbuvir), another drug for treating Hepatitis C, had the highest spending in 2014, but was not among the top five drugs in 2015, with $1.3 billion in spending.

Highest total spending (Part B)

The Medicare dashboard shows the top five Part B drugs with highest total spending were:

  • Lucentis (ranibizumab, a brand name drug for wet age-related macular degeneration);
  • Remicade (infliximab, a brand name rheumatoid arthritis drug);
  • Neulasta (pegfilgrastim, a brand name white blood cell stimulator for use with cancer treatments);
  • Rituxan (rituximab, a brand name cancer treatment); and
  • Eylea (aflibercept, a brand name drug for wet age-related macular degeneration).

These were the same five drugs with the highest Part B spending in 2014. Each of these drugs contributed more than $1 billion in spending for the Medicare Part B program.

Unit cost

The Medicare dashboard lists the top five drugs with the largest increases in average cost per unit from 2014 to 2015 in the Part B and D programs. Glumetza (metformin HCl, a diabetes treatment) had the largest increase in cost per unit at over 380 percent and had total spending increases from $34.3 million to $153 million. All five of these Part D drugs had increases in cost per unit of more than 100 percent. Among Part B drugs, mitomycin (a generic chemotherapy agent), had the largest increase in average Part B cost per unit at 163 percent and had total spending increases from $5.9 million to $15.8 million. The other four Part B drugs had smaller, but still significant increases, approximately 25 to 40 percent.

The Medicaid dashboard shows the top five drugs with the largest increases in average cost per unit from 2014 to 2015. Ativan (lorazepam, a brand name drug used for anxiety) had the largest increase in cost per unit at 1,264 percent and a spending increase from $1.7 million to $5.3 million. All five of the drugs had increases in cost per unit of more than 400 percent.

High cost per prescription fill

The Medicaid dashboard shows the top five drugs selected for high costs per prescription fill (i.e., greater than or equal to $1,000) in 2015. Advate (antihemophilic factor [recombinant], a brand name hemophilia treatment) had an average cost per fill of $20,828 and was associated with total program spending of $354 million. In comparison, Prezista (darunavir ethanolate, a brand name HIV antiviral) had an average cost per fill of $1,259 and total program spending of $335 million. NovoSeven RT (coagulation factor VIIa [recombinant], a brand name hemophilia treatment) had the highest average cost per fill at $67,098 and $298 million in program spending.