HHS Actually Takes Action to LOWER the Penalties For One Of Its Enforcement Laws

On April 29, 2019, the United States Department of Health and Human Services (“HHS”) announced in the Federal Register through a Notification of Enforcement Discretion that effective immediately, it would be exercising its discretion regarding the application of HHS regulations concerning the assessment of Civil Monetary Penalties (“CMPs”) under the Health Insurance Portability and Accountability Act (“HIPAA”) and the Health Information Technology for Economic and Clinical Health (“HITECH”) Act. Specifically, HHS has changed its uniform cumulative annual CMP limit across the four categories of culpability and replaced it with tiered annual CMP limits increasing as the categories of culpability increase in severity.

In 2009, HITECH established four tiers of culpability with increasing penalties based on increasing severity. Those categories included: (1) the person did not know (and, by exercising reasonable diligence, would not have known) that the person violated the provision; (2) the violation was due to reasonable cause, and not willful neglect; (3) the violation was due to willful neglect that is timely corrected; and (4) the violation was due to willful neglect that is not timely corrected.

At the time of enactment of the HITECH Act, discrepancies were identified in the descriptions of the penalty ranges and uncertainty existed surrounding whether the $1,500,000 annual cap on CMPs should be applied to all of the categories of culpability. In the final regulations implementing HITECH that were adopted by HHS in 2013, the $1,500,000 annual cap was confirmed by HHS to apply to all categories. And, ever since then, HHS has been issuing penalties under the following framework:

Culpability Min. Penalty per Violation Max. Penalty Per Violation Annual Limit
No Knowledge $100 $50,000 $1,500,000
Reasonable Cause $1,000 $50,000 $1,500,000
Willful Neglect  – Corrected $10,000 $50,000 $1,500,000
Willful Neglect – Not Corrected $50,000 $50,000 $1,500,000

However, in a sudden change of position, HHS’ guidance this past week states that upon further review of the statute, it believes a better reading of the statute is to provide a tiered annual limit. Thus, under HHS’ new interpretation, there are new maximum annual limits to HIPAA enforcement actions as follows:

Culpability Min. Penalty per Violation Max. Penalty Per Violation Annual Limit
No Knowledge $100 $50,000 $25,000
Reasonable Cause $1,000 $50,000 $100,000
Willful Neglect  – Corrected $10,000 $50,000 $250,000
Willful Neglect – Not Corrected $50,000 $50,000 $1,500,000

It is unclear how the “No Knowledge” category will work given that the maximum penalty per violation remains at $50,000 while the annual limit is only $25,000. A review of the Federal Register entry from HHS confirms these to be the numbers published by HHS, and thus, until HHS offers further guidance or begins applying these new figures to specific cases, there remains some uncertainty for this category of culpability.

Nevertheless, these changes should come as welcome news to providers and business associates trusted with protected health information (“PHI”) as a penalty for a HIPAA violation can add up quickly. Thus, these new annual limits will help to curb the financial sting of a violation, especially when the provider or business associate either is genuinely unaware of the violation or takes appropriate action in response to a violation. Only time will tell whether HHS’ clarification of its reading of the statute to require lesser annual CMP penalty caps marks a general shift toward lower penalties or fewer enforcement actions overall.

In the meantime, it would be wise for providers and business associates to continue demonstrating good faith compliance efforts to try and minimize the tier of culpability within which a particular penalty falls. Only through ongoing reviews, audits and assessments of privacy policies and procedures and general compliance programs will providers and business associates remain prepared and help to mitigate the penalty of a potential HIPAA violation.  Certainly with these new tiered annual CMP caps, those that handle PHI have an even greater incentive to remain focused on effective compliance efforts.

HHS Seeks Input From the Provider Community On Possible Changes to the Federal Anti-Kickback Statute and the Beneficiary Inducement Civil Monetary Penalty Law

On August 27, 2018, the Department of Health and Human Services (“HHS”), Office of Inspector General (“OIG”) published a request for information (“RFI”) seeking input from the public on how it might change the Federal Anti-Kickback Statute (“AKS”) and beneficiary inducement civil monetary penalty law (“CMP Law”) to eliminate barriers to coordinated care and value-based care. Any comments must be submitted by October 26, 2018 at 5:00 p.m.

The OIG’s request states that HHS is “working to transform the health care system into one that better pays for value.” Removing unnecessary government obstacles to care coordination has been identified by HHS as a key priority to accomplishing better care coordination. Accordingly, as part of its “Regulatory Sprint to Coordinated Care”, HHS is looking to identify regulatory provisions that act as barriers, assess whether they are unnecessary obstacles and either issuing guidance or revising regulations to remove the obstacles. The ultimate goal is “to encourage and incentivize coordinated care while protecting against harms caused by fraud and abuse.”

Part of this process is a review by the OIG to identify either new safe harbors that can be created under the AKS or new exceptions to the definition of “remuneration” under the CMP Law. The OIG has identified both of these laws as having a broad reach and a potential significant impediment to beneficial arrangements that would advance coordinated care. The AKS provides criminal penalties for individuals or entities that knowingly and willfully offer, pay, solicit or receive remuneration to induce or reward the referral of business that is reimbursable under Federal health care programs. (Section 1128B(b) of the Social Security Act). The CMP Law provides for the imposition of civil monetary penalties against any person who offers or transfers remuneration to a Medicare or State health care program beneficiary that the benefactor knows or should know is likely to influence the beneficiary’s selection of a particular provider, practitioner, or supplier of any item or service for which payment may be made, in whole or in part, by Medicare or a State health care program. (Section 1128A(a)(5) of the Social Security Act).

In addition, the OIG is looking for input on “[t]he structure of arrangements between parties that participate in alternative payment models or other novel financial arrangements designed to promote care coordination and value” and “terminology related to alternative payment models, value-based arrangements, and care coordination” to better assess where and how to make improvements. The goal is to identify and understand potential beneficial new ways of delivering health care so that appropriate safe guards can be put in place to avoid potential violations of the AKS and the CMP Law.

Another area of interest to the OIG is engagements with beneficiaries, whether through incentives or elimination of cost sharing obligations. The OIG has requested input on the types of incentives the industry would be interested in providing along with explanations of the type of incentive, how it is believed it would improve quality of care and what, if any, restrictions or guidance would be necessary. Similarly, the OIG seems willing to consider possible relief or elimination of beneficiary cost-sharing obligations and has requested input on how this might improve care and what the risks and safeguards should be if modifications were permitted.

Finally, the OIG has asked for input regarding (1) the current use of fraud and abuse waivers for testing delivery models, (2) possibly allowing donations or subsidies for cybersecurity related items or services, (3) accountable care organization beneficiary incentive programs and (4) options for further telehealth expansion.

It remains to be seen what, if any, changes will come about as a result of this RFI. However, it is a step in the right direction that the OIG is acknowledging the impediments of these laws and is beginning a dialogue on how to improve the system.

CMS Proposes Simplifying E/M Documentation Requirements to Reduce Clinician Burden While Simultaneously Seeking to Cut E/M Reimbursement Rates

The Centers for Medicare and Medicaid Services (“CMS”) recently released its notice of proposed rulemaking titled “Revisions to Payment Policies under the Physician Fee Schedule and Other Revisions to Part B for CY 2019.” Buried therein were proposed changes to the way in which evaluation and management (“E/M”) visits are documented and paid. While CMS has touted its proposal as a “historic change[] that would increase the amount of time that doctors and other clinicians can spend with their patients by reducing the burden of paperwork,” it has also slipped in a cut in reimbursement for many E/M visits, especially those coded at Level 4 or Level 5. Consequently, many specialists who historically code at these higher level visits due to the complexity of the patients they typically treat may face significant reductions in revenue for the services they provide.

E/M services have historically been categorized in the outpatient setting as Level 1 to Level 5 with visits being distinguished based on the level of complexity, site of service and whether the patient is new or established. Moreover, the coding takes into account such key components as the history of present illness, the physical examination and the medical decision making of the clinician. In its most basic sense, the greater the time and complexity required, the higher the level of visit and the greater the payment rate.

CMS has proposed to simplify the documentation for these services by (1) eliminating the need to document medical necessity of a home visit made in lieu of an office or outpatient visit, (2) eliminating the prohibition of documenting multiple visits with the same practitioner, or by practitioners in the same or very similar specialties within a group practice, on the same day as another E/M service, and (3) allowing practitioners to choose, as an alternative to the current framework specified under 1995 or 1997 guidelines, either medical decision making or time (regardless of whether 50% is spent on counseling or care coordination) as a basis to determine the appropriate level of an E/M visit. CMS has stated in its press release, which was issued following the proposals, that it believes these changes will “fundamentally improve the nation’s healthcare system and help restore the doctor-patient relationship by empowering clinicians to use their electronic health records (EHRs) to document clinically meaningful information, instead of information that is only for billing purposes” and therefore “puts patients over paperwork.” As a result of this, CMS has suggested that clinicians will see a savings of thousands of hours and millions of dollars in reduced administrative costs in CY 2019.

Absent from the CMS press release is any real discussion of the corresponding cut in reimbursement that is also included in the proposal and which accompanies this reduction in necessary documentation. A review of the notice reveals CMS is attempting to sell its changes on reimbursement as a proposal to “simplify” the payments and “eliminate the increasingly outdated distinction between the kinds of visits” reflected in the current levels. In actuality, as the below chart demonstrates, specialists that are required to expend the greater amounts of time and address the cases with greater complexity (i.e. Level 4 and 5 visits) will be reimbursed significantly less per visit while those general practitioners and others that have historically treated less complex cases (i.e. Levels 2 and 3) will suddenly be compensated more than they have historically and exactly the same as the most complex Level 4 and Level 5 cases.

New Patient 2018 Rate, National Avg 2019 Rate, Proposed, National Avg
99201 $45 $44
99202 $76 $135
99203 $110 $135
99204 $167 $135
99205 $211 $135
Established Patient 2018 Rate, National Avg 2019 Rate, Proposed, National Avg
99211 $22 $24
99212 $45 $93
99213 $74 $93
99214 $109 $93
99215 $148 $93

 

CMS has attempted to rectify the inherent inequity in creating a uniform rate for Levels 2 through 5 by creating new Healthcare Common Procedure Coding System G-code add-ons for factors such as inherent visit complexity and additional prolonged face-to-face services. With these additional codes, additional work Relative Value Units can be added to a visit. Nevertheless, CMS acknowledges in its proposal that there will nevertheless be a number of specialties that see a decrease in overall reimbursement for providing the exact same services they are providing today. Included in that list are such specialties as dermatology, rheumatology, oncology, neurology and hematology, which are each estimated to see decreases in overall reimbursement.

CMS is currently seeking comments, which are due by September 10, 2018, regarding not only whether such implementations should be made, but also whether a delay in implementation, such as to January 1, 2020 rather than January 1, 2019, would be warranted given the breadth of changes being proposed.

The OCR Reminds Businesses that Consequences for HIPAA Violations Do Not Vanish When the Business Closes

The U.S. Department of Health and Human Services (“HHS”), Office of Civil Rights (“OCR”), issued a press release recently to make the point that just because a business closes during an OCR investigation does not mean that is the end of the business’ potential liability under the Health Insurance Portability and Accountability Act’s (“HIPAA”) Privacy Rule.

For those unaware, the OCR enforces the Federal standards that govern the privacy of individually identifiable health information (45 C.F.R. Part 160 and Subparts A and E of Part 164, the “Privacy Rule”), the Federal standards that govern the security of electronic individually identifiable health information (45 C.F.R. Part 160 and Subparts A and C of Part 164, the “Security Rule”), and the Federal standards for notification in the case of breach of unsecured protected health information (45 C.F.R. Part 160 and Subparts A and D of 45 C.F.R. Part 164, the “Breach Notification Rule”). HHS has the authority to conduct compliance reviews and investigations of complaints alleging violations of the Privacy, Security, and Breach Notification Rules by covered entities and business associates, and covered entities and business associates must cooperate with HHS compliance reviews and investigations. See 45 C.F.R. §§ 160.306(c), 160.308, and 160.310(b).

To highlight its point, OCR identified in its press release a recent settlement it reached with an Illinois business that provided for storage, maintenance and delivery of medical records for covered entities. An investigation of the entity began in February 2015, following an anonymous complaint of improper disposal and disclosure of the protected health information (“PHI”) of 2,150 individuals. Specifically, the allegations included that PHI was left in unlocked trucks and that access was given to unauthorized personnel to remove PHI from the company’s facility.

Prior to resolution of the investigation, the company went out of business resulting in a receiver being appointed by a court in 2016 to liquidate all assets for distribution to creditors and others. Despite this fact, OCR continued to pursue the case and ultimately the receiver entered into a settlement and corrective action plan that included both a monetary penalty and an agreement by the company to properly store and dispose of the remaining PHI in its possession in accordance with HIPAA.

Thus, the OCR made clear with this matter and its reaffirming press release that those entrusted with PHI will not be able to simply walk away from the corresponding responsibilities simply because the business ceases operations. Accordingly, such businesses must ensure proper transition or disposal of all PHI in its possession prior to concluding operations to avoid significant penalties from the OCR. By reinforcing these responsibilities, the OCR reemphasizes the importance of covered entities and business associates avoiding placing PHI at risk of disclosure and also avoiding putting covered entities in a potential breach situation when the business associate it entrusts with PHI suddenly goes out of business.

Beware CMS’ Ability to Preemptively Suspend or Revoke a Provider’s License

Most providers primarily worry about the financial impact of fraud and abuse and other compliance issues. However, as occurred recently in Dallas Texas, federal and state agencies can also come for a provider’s license either via a limitation, suspension or revocation causing far greater long-term and permanent damage to the institution. And, what is most troubling, is that the authority to take such action does not necessarily require the right of the provider to receive a hearing or even an opportunity to refute the allegations.

On August 18th a Dallas laboratory filed suit against federal and state officials and agencies seeking to temporarily restrain them from suspending or revoking the company’s federal laboratory licenses. This lawsuit was prompted as a result of federal inspectors allegedly finding regulatory violations in the way the laboratory operated and conducted business. It is believed that the federal and state investigations came as a result of a lawsuit filed by the private insurer, UnitedHealthcare, against the laboratory. In that lawsuit UnitedHealthcare claims that there were bribes and kickbacks to doctors and other providers during a five year period for overpriced and unnecessary drug and genetic tests.

According to a letter sent on May 10th from CMS to the laboratory’s officials, there were “systemic and pervasive problems throughout the laboratory which [] led to the findings of immediate jeopardy.” A finding of immediate jeopardy provides CMS with the authority under federal law to suspend, limit or even revoke a laboratory’s license to operate arguably without any right to a hearing or opportunity for the laboratory to refute the allegations.

These events demonstrate the broad authority held by CMS to pull licenses if it is believed that the ongoing actions are likely to cause patients injury, harm, impairment or death. This further underscores the critical importance of maintaining an effective compliance program and having proper protocols in place to perform internal audits/investigations and to respond to and remediate any outside audits/investigations. Furthermore, this laboratory is just the latest example of situations where claims and disputes with a private payer can quickly pivot to investigations and claims by the federal or state governments. Providers must be diligent in addressing the allegations of private payers and always be mindful of how those allegations may impact on federal or state health care programs. Failing to do so can place a provider in a detrimental position. And, for most providers, having their licenses suspended or revoked, even if just for the period of time the investigation is occurring, can be catastrophic to their business.

New Proposed Legislation Seeks To Restore Tax Exempt Status to Non-Profit Acute Care Hospitals In New Jersey and Implement Instead a Community Service Contribution Payment

In the wake of the 2015 court case challenging the tax exempt status of a nonprofit hospital here in New Jersey, the fight continues over this issue with many of the non-profit hospitals in New Jersey currently engaged in litigation before the Tax Courts and various bills having been proposed and debated in the Legislature. This past week a bill (A4985) was introduced in the Assembly of the New Jersey Legislature that seeks to restore the property tax exemption for nonprofit hospitals that operate with on-site for-profit providers. The bill was sponsored by Assemblyman Troy Singleton. The Statement to the bill makes clear that the bill “would establish a clear and predictable system in which nonprofit hospitals make a reasonable contribution to their host communities.”

In addition to restoring the tax exempt status, the proposed bill requires these hospitals to pay community service contributions to host municipalities and it establishes a Nonprofit Hospital Community Service Contribution Study Commission.

With regard to the contribution, the community service contribution would be equal to $2.50 a day for each licensed bed at the exempt acute care hospital property except in the case of a satellite emergency care facility in which case the contribution would be equal to $250 a day. Following 2018, and for each subsequent tax year, the per day amount utilized for the calculation will be increased by two percent over the prior tax year.

Up to 75% of that annual community service contribution can be reduced by the amount of payments remitted to the municipality in which the acute care hospital or satellite emergency care facility is located pursuant to a voluntary agreement operative in the prior tax year to compensate for public safety services.  Similarly, up to 25% of the annual community service contribution can be reduced pursuant to any agreement to provide compensation for the provision of affordable housing in the municipality.

The municipalities will be required to utilize a portion of these contribution funds for police or fire protection; first aid, emergency, rescue, or ambulance services; any other public safety purpose; or to reduce the property tax levy and the remainder for affordable housing.

Acute care hospitals are permitted to apply to the New Jersey Health Care Facilities Financing Authority in the Department of Health for a certificate of exemption for a given tax year in the event the hospital is either in financial distress or at risk of being in financial distress. Such an application would require significant information including audited financial records. A response from the government will be promptly required within 60 days of receipt of the records.

Beyond the financial requirement, the bill also proposes the creation of the Nonprofit Hospital Community Service Contribution Study Commission. The Commission would consist of nine members made up of agency heads, members of the Senate and Assembly, mayors of municipalities and chief executive officers of nonprofit hospitals. The Commission will be tasked with studying the implementation of this bill and reporting on its financial impact on both nonprofit hospitals and the municipalities receiving the contributions. The report shall also include any recommendations to improve the administration, equity or other aspect of the nonprofit community service contribution system including the adequacy of the amount of the contribution.

Finally, the bill contemplates having exemptions for a large number of properties including buildings used for colleges, schools, academies, public libraries, asylums or schools for those with developmental disabilities, religious sites and many others.

While this bill will not eliminate the financial obligation nonprofit acute care hospitals are now faced with following the 2015 ruling, this legislation appears to at least help to alleviate the amount that will need to be remitted by these hospitals and provides oversight on how the money will be utilized by the municipalities. Time will tell whether this newest legislative effort will have more success than its predecessors and whether the Tax Courts will act prior to it having a chance to work its way through the Legislature.

The Office of Inspector General and the Health Care Compliance Association Collaborate to Provide Guidance on Effective Compliance Programs

On March 27, 2017 the Department of Health and Human Services Office of Inspector General (“OIG”) and the Health Care Compliance Association (“HCCA”) released a document called Measuring Compliance Program Effectiveness: A Resource Guide (the “Guide”). The Guide is the collaboration of forty compliance professionals and OIG staff that met in January 2017 to discuss ways to measure the effectiveness of a compliance program. Given the historically limited information provided by the OIG regarding compliance programs this document provides important insight to the industry regarding how to assess the effectiveness of a compliance program.

The Guide takes the basic seven elements of a compliance program and provides lists of individual compliance program metrics to consider in implementing each item. The areas addressed in the Guide including the following:

  1. Standards, Policies and Procedures, including policy/procedure access, accountability for their update and the quality of their content
  2. Compliance Program Administration, including the roles of those responsible, the culture fostered by the compliance personnel, incentives, evaluations and risk assessment based on staffing/knowledge base
  3. Screening and Evaluation of Employees, Physicians, Vendors and other Agents, including accountability, potential conflicts of interest, disclosures and proper screening protocols
  4. Communication, Education and Training on Compliance Issues, including proper training, communication and accountability
  5. Monitoring, Auditing and Internal Reporting Systems, including proper processes, risk assessments, proper monitoring and auditing and timely corrective action plans/remediation
  6. Discipline for Non-Compliance, including consistency, awareness and documentation
  7. Investigations and Remedial Measures, including proper guidelines, consistency, quality, process, documentation, timeliness, communication and competency

The Guide is cautious to point out that it is not a “checklist” of required items to be applied wholesale in assessing the effectiveness of a compliance program. Rather, the items are intended to serve as broad ideas of metrics for health care organizations to choose based upon which best fit their needs. The Guide even states that an attempt to use all or even a large number of the items in the Guide would be impractical and is not recommended. Thus, it is important for health care organizations to consult with their compliance department and legal counsel to assess which best fit their needs and assist in advancing the effectiveness of their compliance program. Factors such as the organization’s risk areas, size, resources, industry segment, etc. are all critical to the analysis of which items to utilize.

The 2017 OIG Work Plan – Areas of New Focus In the New Year

On November 10, 2016 the Department of Health and Human Services Office of Inspector General released its 2017 Work Plan. The Work Plan, which is updated annually, furnishes key guidance to providers, suppliers, and others doing business in the health care industry regarding audit and enforcement activities that will be focused upon by the agency in the upcoming year. Providers should therefore be diligent in ensuring that their compliance programs and scheduled audit activities encompass these areas of focus. The following is a summary of some of the key new areas of focus identified in the Work Plan for Part A and Part B Medicare services. Unlike in some prior years, there does not appear to be one new area of emphasis by the OIG but rather the identification of a few select focused new items of interest that it has added to its Work Plan. In addition to these new areas, the OIG has maintained in its Work Plan several other areas of focus that it will continue to work this year.

Hospitals

  1. Hyperbaric Oxygen Therapy Services – Hyperbaric oxygen (HBO) therapy involves giving a beneficiary high concentration of oxygen within a pressurized chamber. Given that HBO therapy is primarily an adjunctive treatment for the management of select nonhealing wounds, CMS Publication 100-03, National Coverage Determinations Manual, Ch. 20, § 20.29(A) requires a beneficiary meet 1 of 15 covered conditions for providers to receive reimbursement. In the past the OIG has reviewed such claims for medical appropriateness, sufficient documentation and noncovered conditions. The OIG intends to reemphasize its efforts in assessing whether reimbursement was in accordance with Federal requirements.
  2. Incorrect Medical Assistance Days Claimed by Hospitals – The OIG will be reviewing Medicaid patient days to determine whether the Medicare administrative contractors have properly settlement Medicare cost reports for disproportionate share hospitals (DSH) that have received Medicare DSH payments to ensure compliance with all Federal requirements.
  3. Inpatient Psychiatric Facility Outlier Payments – From FY 2014 to FY 2015 the number of claims with outlier payments increased by 28 percent for Inpatient Psychiatric Facilities providing active psychiatric treatment to meet the urgent needs of those experiencing an acute mental health crisis, which may involve mental illness or alcohol- or drug-related problems. In terms of Medicare payments for such stays, the total outlier payments have increased from $450.2 million to $534.6 million. OIG intends to determine whether these facilities have complied with Medicare documentation, coverage and coding requirements for stays resulting in outlier payments.
  4. Case Review of Inpatient Rehabilitation Hospital Patients Not Suited for Intensive Therapy – In a separate medical review seeking to identify adverse events in inpatient rehabilitation hospitals, physician reviewers found a small number of cases in which patients appeared to be unsuited for intensive rehabilitation therapy. This study will assess a sample of rehabilitation hospital admissions to determine whether the patients participated in and benefited from intensive rehabilitation therapy for their illness, injury or surgery. For those identified as not suitable candidates, the reviewers will identify reasons why.

Nursing Homes

  1. Nursing Home Complaint Investigation Data Brief – The OIG will be reviewing the diligence with which State agencies are investigating complaints categorized as “immediate jeopardy” or “actual harm” within the applicable timeframes called for under the law at nursing homes.
  2. Skilled Nursing Facilities – Unreported Incidents of Potential Abuse and Neglect – The OIG will be assessing whether there are incidences of abuse and neglect at Skilled Nursing Facilities that are going unreported. The OIG will be looking for evidence that incidents were properly reported and investigated per Federal and State requirements.
  3. Skilled Nursing Facility Reimbursement – Skilled Nursing Facilities must periodically assess their patients using the tool called the Minimum Data Set to classify each patient into a resource utilization group for payment. Medicare reimbursement is tied to the activities of daily living and therapy received by each beneficiary and reported on the Minimum Data Set. The OIG will be reviewing documentation at selected SNFs to determine if the requirements for each particular resource utilization group is accurate.
  4. Skilled Nursing Facility Adverse Event Screening Tool – The OIG will be assisting in rolling out the Adverse Event Screening Tool in coordination with the Institute for Healthcare Improvement. The goal of the product is to disseminate practical information about the tool for use by those involved with the skilled nursing industry.

Hospices

  1. Medicare Hospice Benefit Vulnerabilities and Recommendations for Improvement – The OIG has identified vulnerabilities in payment, compliance and oversight as well as quality-of-care concerns that directly impact beneficiaries of these services. The OIG will be making recommendations for protecting beneficiaries and improving the program.
  2. Review of Hospices’ Compliance with Medicare Requirements – A review of hospice medical records and billing documentation will be conducted to determine whether Medicare payments for hospice services were made in accordance with Medicare requirements.
  3. Hospice Home Care – Frequency of Nurse On-Site Visits to Assess Quality of Care and Services – A review will be conducted to determine if hospice nurses were performing the requirements on-site visits to the homes of Medicare beneficiaries receiving hospice care at least once every 14 days to assess quality of care and services provided by the aid.

Home Health Services

  1. Comparing HHA Survey Documents to Medicare Claims Data – The OIG is concerned with identifying potentially unqualified or fraudulent providers. Home Health Agencies are required to supply patient information to State agencies and thus a determination will be made as to whether HHAs are accurately providing patient information to State agencies for recertification surveys.

Medical Equipment and Supplies

  1. Part B Services During Non-Part A Nursing Home Stays: Durable Medical Equipment – If a beneficiary resides at a SNF after 100 days, Medicare Part B may provide coverage for certain therapy and supplies (non-Part A stay). However, a 2009 OIG report found that Medicare Part B allowed inappropriate payments of $30 million in 2006 for durable medical equipment, prosthetics, orthotics and supplies during non-Part A stays in SNFs. This new study will determine the extent of inappropriate Medicare Part B payments for such items during non-Part A stays in 2015.
  2. Medicare Market Share of Mail-Order Diabetic Testing Strips – The OIG will be releasing its required reporting on the market share of diabetic testing strips in anticipation of the next round of the competitive bidding program.
  3. Positive Airway Pressure Device Supplies – Beneficiaries routinely receive replacements of continuous positive airway pressure or respiratory assist device therapy (PAP) when they wear out or are exhausted. Previously the OIG had discovered that equipment was being shipped when no physician order for refills were in effect. The OIG will be investigating whether claims for frequent replaced PAP device supplies were properly documented as medically necessary along with ensuring frequency of replace and other Medicare requirements are being met.

Prescription Drugs

  1. Drug Waste of Single-Use Vial Drugs – The FDA approves vial sizes for single use submitted by manufacturers but does not control the vial sizes submitted for approval. A study will be conducted to determine if savings might be realized if smaller single use vial sizes were utilized here in the United States as is done in other countries.
  2. Potential Savings from Inflation-Based Rebates in Medicare Part B – Each year statutorily mandated rebates enable Medicaid to recoup substantial portions of the billions spent on prescription drugs. In contrast, Medicare Part B similarly spends billions annually but has no similar rebate. The OIG will perform a sample study to calculate how much the Federal Government could potentially collect from pharmaceutical manufacturers if similar rebates were required for Part B.

The Work Plan also contains new endeavors relating to other Providers and Suppliers such as Diagnostic Laboratories, Transitional or Chronic Care Management and Ambulance Services.

In addition to Medicare Part A and Part B, the OIG will be implementing new focuses for Part C and Part D services as well. They include the following new initiatives:

Part C – Medicare Advantage

  1. Medicare Part C Payments for Service Dates After Individual’s Date of Death – CMS pays MA organizations for Part C benefits prospectively. A prior OIG review determined that Medicare improperly made $23 million in payments in 2011 for deceased beneficiaries of which $20 million was directly related to Part C payments. The OIG will therefore be examining if payments made after a beneficiaries’ date of death were in accordance with Medicare requirements.
  2. Extent of Denied Care in Medicare Advantage and CMS Oversight – Capitated payments, as used by CMS to pay MA plans, can result in financial incentives for plans to underserve beneficiaries. A review will be conducted to assess the extent to which inappropriate denials are occurring.

Part D – Prescription Drug Program

  1. Medicare Part D Rebates Related to Drugs Dispensed by 340B Pharmacies – The OIG will assess potential savings if pharmaceutical manufacturers paid rebates for drugs dispensed through the Medicare Part D program but at 340B covered entities and contract pharmacies.
  2. Questionable Billing for Compounded Topical Drugs in Part D – Part D spending for compounded topical drugs grew by more than 3,400 percent between 2006 and 2015. The OIG will be investigating the potential fraud risk given this sharp increase in spending and identifying pharmacies with questionable Part D billing for these drugs and any associated prescribers.

A review of the full Work Plan identifies a number of other areas to be reviewed by the OIG including review of the States’ operations of their Medicaid programs and the activities within the Health Insurance Marketplaces.

Not surprisingly, it will be another busy year for the OIG and its various audit, investigation and review bodies.

Appellate Division Enforces The Self-Critical Analysis Privilege Protections of the Patient Safety Act

On February 6, 2017, the New Jersey Appellate Division reversed a trial court ruling by holding that a hospital’s failure to notify regulators of a treatment error does not mean that the hospital loses the privilege and confidentiality afforded to its internal self-critical analysis under the Patient Safety Act.

The matter of Brugaletta v. Chilton Memorial Hospital, et al. concerned a claim of medical malpractice by a patient, Ms. Brugaletta. During discovery she sought the hospital’s internal self-critical analysis of her care. The trial judge initially ruled the documentation should be produced claiming that Ms. Brugaletta had suffered a “serious preventable adverse event” (“SPAE”) and that the hospital had failed to report the event to the New Jersey Department of Health or Ms. Brugaletta in violation of the Patient Safety Act. The hospital appealed that determination disputing that Ms. Brugaletta suffered an SPAE and that it had any reporting obligation to the Department or Ms. Brugaletta.

The Patient Safety Act (N.J.S.A. 26:2H-12.23, et al.) creates an absolute privilege over certain documents that a hospital develops as part of a self-critical analysis. In analyzing the Patient Safety Act, the Appellate Division held that the only statutory precondition of the self-critical analysis privilege is compliance with the statutory requirement that hospitals develop and implement a patient safety plan in accordance with the requirements established by the commissioner by regulation. Thus, as long as the proper procedure is followed as set forth in the hospital’s safety plan, then the self-critical analysis is protected by the privilege.

The Appellate Division rejected any interpretation whereby the self-critical analysis privilege was conditioned on a hospital meeting its reporting obligations. Rather, it viewed those as a separate and distinct obligation under the Patient Safety Act. The Appellate Division also disagreed with the trial court’s finding that an SPAE had occurred as the trial court failed to identify record evidence to make such a conclusion, specifically with regard to causation. 

Thus, the Appellate Division found the trial court had erred in compelling the hospital to disclose the self-critical analysis and in finding that the hospital failed to report an alleged SPAE to the Department and Ms. Brugaletta.

This case and decision are just the most recent example of the continuing efforts by patients to challenge the protections of the Patient Safety Act and the courts’ efforts at determining the legislature’s intended purpose of the statute’s language. History suggestions this will not be the last such case.

 

The Future Is Uncertain For the Patient Protection and Affordable Care Act

With the election of Donald Trump to the office of President of the United States, Republicans and their supporters began implementing plans for the repeal and replacement of President Obama’s signature legislation, the Patient Protection and Affordable Care Act (“ACA”). President-Elect Trump’s selection of Representative Tom Price (R-GA) to the position of Secretary of Health and Human Services signaled the next step in those efforts.

Dr. Price, an orthopedic surgeon, has been a regular voice in opposition to the ACA and many in Congress and the media see this selection as confirmation that every effort will be made to replace the ACA. Several Democrats have already come forth indicating they plan to challenge Dr. Price’s selection as they see any threat to the ACA as a threat to thousands of patients that have only received insurance as a result of the ACA.

While a repeal of the ACA is still not guaranteed and many are already challenging whether it could even be effectuated without significant impacts on the health insurance industry and millions of Americans, it is nevertheless important to understand what a replacement program might look like. Dr. Price has previously submitted one of the more detailed Republican plans to replace the ACA. His previously proposed legislation is known as the Empowering Patients First Act.

Unlike the ACA, Dr. Price’s legislation seeks to minimize government’s role in health care. The following are five key elements of Dr. Price’s prior proposal:

  1. Fixed tax credits that rise with age so that patients can purchase their own insurance on the private market, including across state lines. The tax credits would not fluctuate based on income.
  2. Expand health savings accounts to further incentivize patients to contribute to such accounts to pay co-pays and deductibles.
  3. Preexisting conditions would continue to be excluded as a basis to deny coverage but only if the patient has had continuous insurance for eighteen months prior to selecting a new policy. If not, coverage might be denied for up to eighteen months under the new policy.
  4. Limiting the amount of money companies can deduct from their taxes for employee health insurance expenses.
  5. States would be paid federal funds to set up high risk pools to assist those with preexisting conditions that cannot afford insurance on the private market.

While Dr. Price has indicated his willingness to negotiate and compromise on what the ultimate replacement looks like, it remains to be seen how flexible he and the Republicans will be on a substitute for the ACA. Regardless of the final form, one cannot forget that as Secretary of HHS, Dr. Price would ultimately control the authoring of the enabling regulations to implement the new legislation.

It is anticipated that during President-Elect Trump’s first 100 days in office this issue will be addressed.