Wachler & Associates Health Law Blog

Published on: June 17, 2016

CMS Holds Open-Door Forum on its Upcoming HHA Pre-Claim Review Demonstration

On June 14, 2016 between 2 and 3pm EST, CMS had a special open-door forum (ODF) regarding its pre-claim review demonstration for home health services (the “Demonstration”) which will take place in Illinois, Florida, Texas, Michigan and Massachusetts (listed chronologically by implementation date; see our prior blog post on the Demonstration for more information regarding the details of CMS’ pre-claim review process). During the ODF, home health agencies (HHAs) had the opportunity to learn more about the Demonstration and to ask CMS questions regarding pre-claim reviews. In addition to the questions, some HHAs took the opportunity to raise concerns they had regarding the Demonstration.

CMS started by addressing the basics of the program, specifically that HHAs will be required to submit a pre-claim review request prior to submitting the final bill for payment. CMS then restated that the Demonstration’s goal is to assure that HHA services are medically necessary and reasonable; to determine this, the Medicare Administrative Contractors (MACs) reviewing the pre-claim review requests will evaluate the submitted documentation to assure that the beneficiary: 1) is confined to home at time of service; 2) is under a physician’s care; 3) receives care pursuant to a plan of care approved by the physician; 4) is in need of skilled services; and 5) has had a face-to-face encounter with his or her certifying physician and the physician’s observations support the certification for home health services.

The statements from the ODF’s participants varied from logistical questions to expressions of concern over the impending Demonstration. On the logistical side, after CMS stated that a unique tracking number (UTN) would be provided once a pre-claim review was approved, participants requested guidance on where to place the UTN on the final bill. CMS explained that an operational guide for the Demonstration would be released within “the next few weeks.” The guide is to include information on what fields to put certain information (including UTNs) into, along with other procedural and administrative guidance for the Demonstration’s roll-out. CMS also answered a question on whether there would be specific forms provided for HHAs to fill out when filing the pre-claim review request: CMS stated that while no document was available yet, one would be made available in the future, and that the forms themselves would generally be furnished by the individual MACs in each region, rather than CMS itself.

Published on: June 16, 2016

Government Accountability Office Releases Critique of Medicare Appeals Process

by Wachler & Associates, P.C.

On June 9, 2016, the Government Accountability Office (GAO) publicly released its report on the Medicare system, highlighting the deficiencies within the Medicare audit and appeals process; a bill currently in the Senate would address many of these problems by reforming CMS’ procedures.

The GAO report, titled “Opportunities Remain to Improve Appeals Process,” focuses on the rising amount of Medicare appeals in recent years and the strain it has put on the system. The increase has been almost unprecedented—between the fiscal years (FYs) 2010 and 2014, the number of ALJ hearings ballooned from 41,733 to 432,534, or a 936% increase. Further, while the statutory time frame for an ALJ hearing to be completed is 90-days, GAO found that in FY 2014 96% of ALJ appeals were not completed within the 90-day limit.

GAO also reported on the insufficiency of data collected by CMS during the Medicare appeals process. The data currently being collected does not report on the reasoning for the appeals, or the amount of money over which the appeals are being made. GAO found this to interfere with the observation and documentation of trends within the appeals system, leading to inconsistencies with Federal regulations. The lack of data has also led to repetitive appeals, with CMS arguing the same issues over and over, with nearly identical appeals remaining separate all the way to the 3^rd and 4^th levels of appeals.

Published on: June 10, 2016

CMS Implements HHA Pre-Claim Review Demonstration

by Wachler & Associates, P.C.

On June 8, 2016, CMS finalized its plan for the implementation of a 3-year “demonstration” of Medicare pre-claim review for home health services. The trial will be carried out in 5 states: Florida, Illinois, Massachusetts, Michigan and Texas—all of which CMS terms as having “high incidences of fraud and improper payments” with regard to home health services. When CMS released the plan proposal in February, it was met with negative feedback from providers and Congress during the comment period, but CMS decided to go forward regardless, and it is important for home health agencies (HHAs) to adapt to the new requirements or else risk penalties or denial of payments.

According to the Department of Health and Human Services, 59% of home health service payments in 2015 were improper, up 41.7% from 2013’s improper payment rate of 17.3%. CMS hopes that pre-claim reviews will cut down on incorrect payments, not only caused by fraud, but also due to more prevalent causes such as insufficient documentation to support the medical necessity of the services, which is cited by CMS as the largest cause of erroneous funding.

The demonstration will require HHAs to submit pre-claim review requests to Medicare Administrative Contractors (MACs). These requests will include the same documentation normally provided to prove that the billed services meet the standards of Medicare reasonability and medical necessity, only submitted prior to the filing of the final claim. The HHA should begin treatment of the patient while awaiting a determination on the pre-claim filing. The HHA should submit the pre-claim review request after the Request for Anticipated Payment (RAP) is processed and within thirty (30) days of the first treatment provided to the patient, and the request should be submitted before the final claim is submitted for payment. According to CMS, MACs “will make every effort” to issue a decision on a pre-claim review request within ten (10) business days for an initial request and twenty (20) business days for a resubmitted request following a non-affirmative decision. When a pre-claim request is approved, the HHA will be given a unique pre-claim tracking number which the HHA must submit with the claim itself to assure full and proper reimbursement.

Published on: April 22, 2016

Chicago-Area Doctor Convicted of Violating Federal Anti-Kickback Statute

by Wachler & Associates, P.C.

In March, a federal jury convicted a Chicago-area physician on ten counts related to violations of the federal anti-kickback statute (AKS). According to a release by the United States Department of Justice (DOJ), Dr. Venkateswara Kuchipudi is the tenth defendant convicted as a result of a multi-year investigation into Sacred Heart Hospital on Chicago’s West Side. The investigation was executed by the Medicare Fraud Strike Force, a part of the Health Care Fraud Prevention & Enforcement Team (HEAT), and resulted in closure of the hospital.

The AKS prohibits healthcare providers from providing or receiving any form of remuneration in return for the referral of Medicare, Medicaid or other federal healthcare program business. The AKS is a criminal statute and interpreted broadly, and a violation of the AKS has significant implications on health care providers and suppliers. Violation of the statute constitutes a felony punishable by a maximum fine of $25,000, imprisonment up to 5 years, or both, and a conviction will also lead to exclusion from Federal health care programs, including Medicare and Medicaid.

According to the DOJ, Dr. Kuchipudi provided extensive referrals to Sacred Heart Hospital. The trial also revealed that Dr. Kuchipudi engaged in a scheme to ensure that his nursing home patients were transported to Sacred Heart Hospital for treatment even when there were better hospitals closer to the nursing homes at which Dr. Kuchipudi had privileges. In return, Sacred Heart Hospital provided physician assistants and nurse practitioners to Dr. Kuchipudi in the hospital and in Chicago-area nursing homes where Dr. Kuchipudi’s patients resided. The physician assistants and nurse practitioners were paid by the hospital, however Dr. Kuchipudi billed Medicare and Medicaid for their services as if he employed them himself.

Published on: April 18, 2016

CMS Releases Final Rule on Reporting and Returning Medicare Overpayments

by Wachler & Associates, P.C.

On February 12, 2016, the Centers for Medicare and Medicaid Services (CMS) released its long-awaited Final Rule regarding the reporting and returning of Medicare overpayments. The Final Rule requires providers and suppliers receiving funds under the Medicare program to report and return overpayments by the later of (1) 60 days after the date on which the overpayment was “identified” or (2) the date any corresponding cost report is due, if applicable.

The first major provision contained in the Final Rule concerns the definition of “identified” for purposes of starting the 60-day clock for reporting and returning the overpayment. As set forth in the Final Rule, a person has identified an overpayment when the person has or should have, through reasonable diligence, determined that the person has received an overpayment and quantified overpayment amount. According to CMS, the 60-day time period to report and return begins whether either the reasonable diligence is completed, or on the day the person received creditable information of a potential overpayment if the person failed to conduct reasonable diligence and the person in fact received an overpayment. Furthermore, absent extraordinary circumstances, CMS chose a six-month period as the benchmark for completing timely investigations, which would give providers a total of eight month to resolve its overpayment issues (six months for timely investigation and two months for reporting and returning).

The second major provision contained in the Final Rule is in regards to the applicable lookback period for reporting and returning identified overpayments. In its 2012 proposed rule, CMS proposed a 10-year lookback period, which many in the provider community found to be overly burdensome. However, CMS reduced its proposed 10-year look back period in the Final Rule to a 6-year lookback period. The 6-year lookback is measured from the date the person identifies the overpayment.

Published on: March 1, 2016

HHS Modifies HIPAA to Allow for Easier Firearm Background Checks

by Wachler & Associates, P.C.

In January, the Office for Civil Rights (OCR) of the Department of Health and Human Services (HHS) published a final rule, which modifies HIPAA privacy rules to allow for easier sharing between certain HIPAA covered entities and the National Instant Criminal Background Check System (NICS). Specifically, the final rule allows certain HIPAA covered entities to share with NICS the identities of individuals prohibited under federal law from legally owning a firearm.

The Gun Control Act of 1968 prohibits categories of individuals from engaging in the shipment, transport, receipt or possession of firearms. The Department of Justice (DOJ) issued regulations applying the prohibition to those that have been involuntarily committed to a mental institution, those found to be incompetent to stand trial or found not guilty by reason of insanity are prohibited from owning a firearm, or otherwise determined by a court, board, commission, or other lawful authority to be a danger to themselves or others or unable to manage their own affairs as a result of marked subnormal intelligence, or mental illness, incompetency, condition, or disease. This prohibition is referred to as the “mental health prohibitor.” The January final rule provides that only covered entities which already have lawful authority to render adjudication decisions which subject individuals to the mental health prohibitor may disclose those individuals’ identities to the NICS. The final rule does not allow for clinical or medical information to be disclosed; only demographic information about individuals subject to the prohibitor may be disclosed.

In the text and analysis of the Final Rule, the OCR explains the very limited and narrow exception to HIPAA privacy rules as a balance between patient privacy and public safety goals. The Final Rule cited the American Medical Association’s (AMA’s) support for the Final Rule stating that the AMA “…Code of Ethics supports strong protections for patient privacy and, in most cases, requires physicians to keep patient medical records strictly confidential. If there must be a breach in confidentiality, such as for public health or safety reasons, the disclosures must be as narrow in scope as possible.” In addition, OCR cited uniformity as a justification for the Final Rule. OCR explained that some states have not established reporting rules for this type of disclosure to the NICS. Thus, this rule will allow for more uniform reporting standards throughout all fifty states.

Published on: February 29, 2016

CMS Releases Proposed Rule Changing Benchmarking Methodology for ACOs

by Wachler & Associates, P.C.

Under the Medicare Shared Savings Program, providers and suppliers paid under Medicare Parts A and B who participate in an ACO may be eligible to receive “shared savings payments” if the ACO meets certain cost savings and quality benchmarks. On February 3, 2016, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule that in addition to other changes to the Medicare Shared Savings Program, would modify the savings and quality benchmarking methodology through which ACOs’ benchmarks are updated and reset at the end of each three year ACO agreement period.

Specifically, CMS proposes the incorporation of regional expenditures when updating and resetting ACO benchmarks. CMS believes that incorporating regional fee for service (FFS) expenditures will more accurately reflect FFS spending in an ACO’s region and thereby make benchmark goals more independent of historical benchmarks and encourage greater participation in the ACO program. Additionally, CMS proposes to account for the health status of an ACO’s assigned population in relation to FFS beneficiaries in the ACO’s region when calculating risk adjustment. Also, CMS seeks to include changes in ACO participant composition as a factor when adjusting ACO benchmarks.

In addition to revising the benchmarking methodology, the proposed rule modifies other key provisions of the Shared Savings Program, such as defining circumstances under which CMS could reopen payment determinations and adding a participation agreement renewal option. There are currently over four hundred ACOs participating in the Shared Savings Program. However, as Wachler & Associates previously posted, less than fifty percent of participating ACOs qualified for shared savings payments in calendar year 2014. The proposed changes are expected to increase overall participation in ACOs and save approximately $120 million for the Shared Savings Program in calendar years 2017 through 2019. The public comment period for this proposed rule will close on March 28, 2016.

Published on: February 25, 2016

OMHA Expands the Settlement Conference Facilitation Pilot to Part A Claim Appeals

by Wachler & Associates, P.C.

The Office of Medicare Hearings and Appeals (OMHA) recently announced its Phase III expansion of the Settlement Conference Facilitation (SCF) pilot program. The SCF pilot was originally launched in July 2014 to provide an alternative dispute resolution process for eligible Medicare providers to settle appealed Medicare claim denials pending at the Administrative Law Judge (ALJ) level of the Medicare appeals process. Under the SCF pilot, Medicare providers have the opportunity to enter into open settlement discussions with the Centers for Medicare & Medicaid Service (CMS) with the goal of coming to a mutually agreed upon resolution for the pending ALJ claims. Initially, the program was limited to Part B claims that met specific eligibility criteria. In October 2015, OMHA implemented Phase II of the SCF pilot, which expanded the eligibility requirements for Part B claims. Recently, OMHA announced that it will open Phase III of the SCF pilot, expanding the program to Part A claim appeals. Much like the previous phases, OMHA has provided eligibility requirements for participating in the SCF pilot, which include:

The appellant must be a Medicare provider (for the purposes of this pilot, “appellant” is defined as a Medicare provider that has been assigned a National Provider Identifier (NPI) number);
A request for hearing must appeal a Medicare Part A Qualified Independent Contractor (QIC) reconsideration decision;

Published on: February 23, 2016

OIG Advisory Opinion Examines Radiology Arrangement Regarding Transcription Fees Paid to Third Party

by Wachler & Associates, P.C.

The Department of Health and Human Services’ Office of Inspector General (“OIG”) recently released OIG Advisory Opinion No. 15-15, in which the OIG determined that an arrangement involving an acute care hospital (“Hospital”), radiology practice and family medicine clinic (“Clinic”) would not generate prohibited remuneration under section 1129B(b) of the Social Security Act, the Federal anti-kickback statute (“AKS”).

Under the arrangement, the Clinic refers patients and certain diagnostic tests to the Hospital, and thus the Clinic’s physicians are referral sources for the Hospital. The radiology practice contracts with the Hospital to supervise radiology services and provide professional interpretations of all radiologic imaging taken at the Hospital, and members of the radiology practice can influence referrals to the Hospital. The Clinic includes technologists who provide radiologic imaging services for the Clinic’s patients, and the Clinic transmits the resulting images to the radiology practice to interpret the images and is thus a referral source for the radiology practice. The radiology practice’s radiologists interpret the images and dictate reports, but send the dictated reports to the Hospital and the Hospital’s employees transcribe the reports on behalf of the radiologists, who send the final reports back to the Clinic. The radiology practice pays the Hospital a “flat rate per line of transcription” fee that is fair market value for the service, and the Clinic pays no portion of any transcription cost. The Clinic bills third-party payors, including Medicare and Medicaid, for the technical component, and the radiology practice bills these payors for the professional component of the radiology services. The OIG also noted that the Hospital is located in a sparsely populated region, the Clinic is in a rural community in that region, and that the radiology practice is the only radiology practice within a 100-mile radius of the Clinic or Hospital.

Crucial to the OIG’s finding, the Centers for Medicare & Medicaid Services’ (“CMS”) Medicare Claims Processing Manual provides that with regards to the professional component of a radiology service, the interpretation of the diagnostic procedure includes a written report. Further, CMS advised the OIG that transcription costs are considered indirect expenses under the methodology establishing resource-based practice expense relative value units (RVUs), meaning that such costs are not separately identified but are included in both the professional and technical components for each service. As such, CMS’ position is that when the technical component and professional component are provided and billed by different entities, the two providers may determine who will pay for transcription costs.

Published on: February 16, 2016

OCR Releases New HIPAA Guidance for Health App Developers

by Wachler & Associates, P.C.

On February 11, 2016, the Department of Health and Human Services, Office for Civil Rights (“OCR”), released important guidance on its Developer Portal to address the application of the Health Insurance Portability and Accountability Act (“HIPAA”) regulations to developers of mobile health apps. Whether a mobile app developer is directly employed by a covered entity (i.e., health plans, health care clearing houses, and most health care providers) or a business associate of a covered entity (or one of the covered entity’s contractors), reasonable safeguards must be applied when the developer creates, receives, maintains or transmits protected health information (“PHI”) on behalf of a covered entity or other business associate.

The OCR guidance provides “Key Questions” for app developers in determining whether or not they may be a business associate of a covered entity. In addition, the OCR guidance provides several factual scenarios to further assist app developers in determining whether they are considered a business associate. Below are two of the scenarios included in the OCR guidance, one in which the developer would not be considered a business associate and one where the developer would be considered a business associate.

Scenario: Consumer downloads a health app to her smartphone. She populates it with her own information. For example, the consumer inputs blood glucose levels and blood pressure readings she obtained herself using home health equipment.