Recently in Compliance Category

November 23, 2015

Providers Likely To Face Higher Penalties For Fraud and Regulatory Violations

On November 2, 2015 the President signed The Bipartisan Budget Act of 2015, requiring that civil monetary penalties must be raised to account for inflation, followed by an annual review for further increases. Providers accused of False Claims Act (FCA) violations are likely to see an increase as high as 40% over the current penalty ranging from $5,500 to $11,000. Higher penalties may add up quickly in FCA cases, which generally involve hundreds of alleged tainted claims.

This could potentially have a negative impact on providers that have earmarked monies for quality of care improvement efforts who must now spend the money on paying higher penalties. The threat of higher penalties might also influence a provider's decision to settle FCA cases due to the risk of astronomical penalties that may be imposed.

Budget Deal Raises Stakes for False Claims, Civil Monetary Penalties [link]

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November 9, 2015

Investigations Mounting Against Widespread Pharmacy Fraud Claims to Military Health Program

The Wall Street Journal has reported that Federal prosecutors are investigating widespread fraud, in at least four states, by compounding pharmacies in claims submitted to TRICARE--the health-insurance program that insures over 9 million U.S. military members (active, guard/reserve and retired) and their families. Some of the allegations include: false billings, physicians writing prescriptions despite not meeting the beneficiaries in person, and improper kickbacks being received in exchange for referring business to a government agency.

"U.S. Targets Pharmacies Over Soaring Claims to Military Health Program" [link]

The major increase in spending on compounded drugs is believed to be the primary reason behind a $1.3 billion deficiency in the military's health-care budget earlier this year. As a result, funds had to be redirected from other programs to compensate for the shortage and Prosecutors are considering and pursuing civil and criminal charges against the pharmacies, physicians and drug marketers.

This action by Federal prosecutors is yet another example of the increased enforcement by federal authorities against the pharmaceutical industry seen in the last six months.

Continue reading "Investigations Mounting Against Widespread Pharmacy Fraud Claims to Military Health Program" »

November 4, 2015

Congress Considering Additional Legislation to Help Curb Medicare Prescription Drug Abuse

It was just released that Congress is contemplating whether Medicare will be able to restrict at-risk drug abuse beneficiaries to a limited number of pharmacies and providers when they seek narcotics. Currently, Medicaid and the Veterans Affairs (VA) are able to impose these restrictions, but Medicare is not.

If successful, this action will help prevent opioid abuse by averting doctor shopping and encouraging physicians and insurers to aid patients battling drug abuse.

"Congress Looks to Curb Medicare Prescription Drug Abuse"

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November 3, 2015

The U.S. Department of Health and Human Services Office of Inspector General has released their Work Plan for Fiscal Year 2016

The United States Department of Health and Human Services Office of Inspector General ("HHS-OIG") has released its Work Plan for Fiscal Year 2016. This plan summarizes new and continuing areas of review and activities that HHS-OIG plans to pursue as well as describing its primary objectives. The newest additions to the work plan are:

• Medical device credits for replaced medical devices
• Medicare payments during Medicare Severity Diagnosis Related Groups (MS-DRG) payment window
• Content Management System (CMS) validation of hospital-submitted quality reporting data
• Skilled nursing facility prospective payment system requirements
• Orthotic braces-reasonableness of Medicare payments compared to amounts paid by other payers
• Osteogenesis stimulators-lump-sum purchase versus rental
• Orthotic braces-supplier compliance with payment requirements
• Increased billing for ventilators
• Ambulatory surgical centers-quality oversight
• Physicians-referring/ordering Medicare services and supplies
• Anesthesia services-non covered services
• Physician home visits-reasonableness of services
• Prolonged (E & M) services-reasonableness of services
• Histocompatibility laboratories-supplier compliance with payment requirements
• Accountable Care Organizations: Strategies and Promising Practices
• Medicare payments for unlawfully present beneficiaries in the United States-mandated review
• Medicare payments for incarcerated beneficiaries-mandated review
• Content Management System (CMS) management of ICD-10 implementation
• Medicare Advantage organization practices in Puerto Rico
• Medicare Part D beneficiaries' exposure to inappropriate drug pairs
• Medicare Part D Eligibility Verification transactions
• Part D Pharmacy Enrollment
• Increase in prices for brand-name drugs under Part D
• Specialty drug pricing and reimbursement in Medicaid
• Express Lane Eligibility
• State agency verification of deficiency corrections
• Medical loss ratio-recoveries of MCO rebates from profit-limiting arrangements
• Review of States' methodologies for assigning Managed Care organization payments to different Medicaid FMAPs
• Managed long-term-care reimbursements
• Center for Disease Control (CDC)-oversight of the Select Agent Program
• Controls over networked medical devices at hospitals
• Food and Drug Administration (FDA)-tobacco establishment compliance with the Family Smoking Prevention and Tobacco Control Act
• Health Resources and Services Administration (HRSA)-compliance with Maternal, Infant, and Early Childhood Home Visiting (MIECHV) Requirements
• IHS-change card program review
• NIH-controls over subcontracting of NIH grant and contract work
• Controls over the preparation and receipt of select agent shipments
• Review of Office for Human Research Protections compliance evaluations to ensure human subject protection
• Foster Care-States' protocols for the use and monitoring of psychotropic medications for children in foster care
• States' implementation of guardian ad litem requirements
• Consumer Operated and Oriented Plan Loan Program-CO-OP compliance with requirements and CMS monitoring activities
• Allowability of contract expenditures
• Rollup of State-based marketplace eligibility determination audits and Content Management System (CMS) oversight
• Health Resources and Services Administration (HRSA)-compliance with Maternal, Infant, and Early Childhood Home Visiting (MIECHV) requirements

The U.S. Department of Health and Human Services Office of Inspector General has released their Work Plan for Fiscal Year 2016

The HHS-OIG expects significant recoveries in audit receivables, investigative receivables and non-HHS investigative receivables resulting from their Work Plan, as well as tremendous savings in legislative, regulatory, and/or administrative actions.

Continue reading "The U.S. Department of Health and Human Services Office of Inspector General has released their Work Plan for Fiscal Year 2016 " »

November 2, 2015

Significant Changes to Stark Regulations Finalized in 2016 Medicare Physician Fee Schedule

In July, we blogged about the major Stark Law provisions in the 2016 Proposed Medicare Physician Fee Schedule (the "Proposed Rule"). On October 29, 2015, the Centers for Medicare & Medicaid Services ("CMS") released the final 2016 Medicare Physician Fee Schedule (the "Final Rule") (available here), with few changes between the proposed rule and final rule as it related to the Stark provisions. The Final Rule will be published in the Federal Register on November 5, 2015. These are the first major changes to the Physician Self-Referral Rule (Stark Law) since 2009.

CMS stated that the Stark Law updates are meant to accommodate health care delivery/payment system reform, reduce burdens, facilitate compliance, clarify certain applications of the Stark Law, and issue new Stark exceptions. Below is a brief summary of the provisions adopted in the Final Rule:

(a) CMS adopted the proposed Stark exception for recruitment assistance and retention payments from hospitals, federally-qualified health centers (FQHCs), and rural hospital clinics (RHCs) to physicians to assist with employing non-physician practitioners (NPPs) in their geographical area. The only change from the Proposed Rule is the addition of a definition for the geographical area serviced by the FQHCs and RHCs, which is:

The "geographic area served" by a federally qualified health center or a rural health clinic is the area composed of the lowest number of contiguous or noncontiguous zip codes from which the federally qualified health center or rural health clinic draws at least 90 percent of its patients, as determined on an encounter basis. The geographic area served by the federally qualified health center or rural health clinic may include one or more zip codes from which the federally qualified health center or rural health clinic draws no patients, provided that such zip codes are entirely surrounded by zip codes in the geographic area described above from which the federally qualified health center or rural health clinic draws at least 90 percent of its patients.

(b) CMS standardized the various terms used for the principle of "takes into account" referrals (e.g., variations include "based on" or "without regard to"). CMS settled on standardizing the language to "takes into account" the volume or value of referrals.

(c) CMS clarified that the regulations in 42 CFR 411.357(t) regarding retention payments in underserved areas is correct. The Final Rule clarifies that the retention payment must not exceed the lesser of an amount equal to 25 percent of the physician's current annual income averaged over the previous 24 months.

(d) CMS clarified that the Stark exception requiring that a lease arrangement be set out in writing does not require a single formal contract, but a collection of documents may satisfy the "writing" requirement. CMS did so by replacing the term "agreement" with the term "lease arrangement" throughout the regulation.

(e) CMS extended the "holdover" lease arrangement provision from six months to indefinitely (as opposed to a definite, but longer than six-month period as contemplated in the Proposed Rule). The new holdover lease language is applicable so long as the lease arrangement met the conditions of the exception prior to its expiration, the holdover is on the same terms and conditions as the immediately preceding arrangement, and that the holdover continues to satisfy the requirements of the exception.

(f) CMS revised the language of the exception to the definition of "remuneration" for items/devices/supplies that are used solely for one or more of the six purposes (i.e., collection, transportation, processing, storing, ordering, or communicating the specimen/results). The revision clarifies that the item can be used for more than one of the six purposes, so long as it is used solely for one or more of those purposes.

(g) CMS adopted the language in the Proposed Rule with regard to the clarification that employees or independent contractors do not "stand in the shoes" of their physician organization's arrangements "unless they voluntarily stand in the shoes of the physician organization as permitted under 42 CFR 411.354(c)(1)(iii) or (c)(2)(iv)(B).

(h) CMS expanded the exception for ownership of publicly traded securities with the language from the Proposed Rule to include protection for "trading on an electronic stock market or over-the-counter quotation system in which quotations are published on a daily basis and trades are standardized and publicly transparent."

(i) CMS added a new exception for timeshare lease arrangements between a physician and a hospital or unrelated physician organization for the use of premises, equipment, personnel, items, supplies, or services if certain conditions are met. The exception does not apply to advanced imaging, radiation therapy, or clinical/pathology laboratory equipment (other than equipment used to perform CLIA-waived laboratory testing).

(j) CMS added language to clarify that the physician-owned hospital disclosure requirements are not met by posting the ownership interest disclosure on a social media website, electronic patient payment portal, electronic patient care portal, or an electronic health information exchange.

Continue reading "Significant Changes to Stark Regulations Finalized in 2016 Medicare Physician Fee Schedule" »

October 23, 2015

President Obama Announces New Steps to Fight Opioid Abuse Epidemic

On October 21, 2015, President Obama announced new initiatives to fight the nation's opioid abuse epidemic. The President discussed several plans for doing so, such as: expanding access to drug treatment, increasing the number of physicians who can prescribe a drug used to treat opiate addiction, doubling the number of providers that can prescribe a drug to reverse the effects of an opioid overdose, and directing the Centers for Disease Control and Prevention to invest $8.5 million in opioid addiction prevention.


In Michigan and New York, prescription drug abuse has become a high priority for law enforcement officials including enforcement actions directly targeting physicians, dentists and other prescribers as well as dispensers such as pharmacies and pharmacists. Such health care providers are well advised to take appropriate care to prevent the abuse and misuse of controlled substances and to maintain proper documentation of the medical necessity and legitimacy of such prescriptions.

Continue reading "President Obama Announces New Steps to Fight Opioid Abuse Epidemic" »

July 9, 2015

OCR Announces Consolidation of Kansas City and Chicago Branches

On April 20, 2015, the Department of Health and Human Services' Office of Inspector General, in partnership with the American Health Lawyers Association and the Association of Healthcare Internal Auditors, published Practical Guidance for Health Care Governing Boards on Compliance Oversight, which describes the OIG's expectations of the compliance oversight role healthcare governing boards (e.g., Board of Directors of a hospital) should play in a healthcare organization. For a summary of this guidance, please visit:

Continue reading "OCR Announces Consolidation of Kansas City and Chicago Branches" »

May 22, 2015


Recently, pharmacies (specifically compounding pharmacies) across the country have begun receiving letters from the U.S. Department of Justice (DOJ) notifying them that the pharmacy is being investigated for fraud under the False Claims Act for knowingly billing for drugs that were not medically necessary. Industry insiders have reported that, just yesterday (on 5/21/2015), at least four pharmacies received these investigation notices from the DOJ. The industry insiders also reported that the letters were hand-delivered on Thursday, May 21, 2015, by U.S. Navy CIS agents, were signed by the U.S. Attorney General, and demanded that the pharmacies respond to the billing fraud allegations within twenty (20) days.

Further, pharmacies are being investigated and receiving DOJ letters specifically related to their contacts with patients, and allegations of impropriety regarding the same. These actions/letters are, of course, somewhat related to major recent developments related to Tricare's scrutiny of compounding pharmacies. For more information, please see the Enhanced Compound Ingredient Screening Notice issued by the Department of Defense's Pharmacy Operations Division on May 11, 2015, which is available here.

Letters from the DOJ alleging billing fraud, False Claims Act violations, or referencing a DOJ investigation are extremely time-sensitive. False Claims Act fines and penalties can be crippling for a pharmacy. A pharmacy that receives such a letter must act quickly to engage experienced healthcare legal counsel to defend it against these allegations and to represent them during the investigation.

The Health Law Partners, P.C. (HLP), is a full-service healthcare law firm representing pharmacies and other healthcare entities across the country. Healthcare regulatory matters are extremely complex and frequently evolving, and healthcare investigations require representation by attorneys experienced in such matters. The attorneys at HLP specialize in healthcare fraud and abuse matters, including government investigations. HLP has experience defending pharmacies in DOJ investigations and understands the defenses available to fight allegations of billing fraud and False Claims Act violations.

If you received a letter from the DOJ regarding an investigation, or for more information, please contact Adrienne Dresevic, Esq.,, or Clinton Mikel, Esq.,, at (248) 996-8510.

February 4, 2015

Outpatient "Observation" Battle Continues

On January 22, 2015, in the case of Barrows v. Burwell, No. 3:11-cv-1703, 2015 WL 264727 (2nd Cir., January 22, 2015), the United States Court of Appeals for the Second Circuit ruled that Medicare beneficiaries be granted the opportunity to demonstrate a Constitutionally-protected property interest to challenge their patient status designations as hospital outpatients rather than inpatients.

Continue reading "Outpatient "Observation" Battle Continues" »

August 29, 2014

BCBSM Places Limits on Quantity of Highly Abused Narcotics

With the fight against prescription drug abuse reaching an all-time high, health insurance plans are now taking a proactive role in attempting to reduce the quantity of some of the most abused drugs in the marketplace. As of September 2, 2014, Blue Cross Blue Shield of Michigan (BCBSM) commercial plans (non-Medicare) will implement new quantity limits for Oxycodone immediate release tablets and capsules (sold under the brand names of Roxicodone an OxyIR) and Oxymorphone immediate release tablets (sold under the brand name of Opana) of 180 per 30 days. These new limits apply to all strengths of the generic and brand-name versions of these drugs. Some pain management physicians have expressed concern that such limitations are an attempt by the health insurance companies to usurp the medical judgment of treating physicians due to cost containment measures while others believe that such limitations are helpful in reducing the potential for unsupervised use, misuse or abuse of prescription painkillers that can lead to addiction, hospitalization and even death. BCBSM will entertain a written request from a prescriber for an override of the limitation that includes documentation that the amount prescribed is medically necessary. A quantity limit override form is available from BCBSM on its website.
The attorneys at The Health Law Partners have a significant amount of experience in the defense of health care fraud investigations and pharmacy legal matters. For more information regarding such matters, please contact Robert S. Iwrey, Esq. at (248) 996-8510 or

August 14, 2014

OIG Posts New Guidance for Submitting a Contractor Self-Disclosure

On August 12, 2014, the Office of Inspector General ("OIG") posted new guidance for contractors self-disclosing violations of federal criminal law involving fraud, conflict of interest, bribery, or gratuity violations or violations of the civil False Claims Act in connection with U.S. Department of Health and Human Services contracts or subcontracts. The Federal Acquisition Regulation ("FAR") requires federal contractors with contracts valued over $5 million to disclose to the OIG when they have credible evidence of one of these violations. The FAR contractor self-disclosure rule provides, in part:

(3)(i) The Contractor shall timely disclose, in writing, to the agency Office of the Inspector General (OIG), with a copy to the Contracting Officer, whenever, in connection with the award, performance, or closeout of this contract or any subcontract thereunder, the Contractor has credible evidence that a principal, employee, agent, or subcontractor of the Contractor has committed-- (A) A violation of Federal criminal law involving fraud, conflict of interest, bribery, or gratuity violations found in Title 18 of the United States Code; or (B) A violation of the civil False Claims Act (31 U.S.C. 3729-3733). (See, 48 CFR 52.203-13(b)(3)(i).)

The newly posted guidance instructs that self-disclosure made under the rule "are made with no advance agreement regarding possible OIG resolution of the matter and with no promises regarding potential civil or criminal actions by the U.S. Department of Justice." However, the guidance states that prompt disclosure, along with full cooperation, completed access to necessary records, restitution, and adequate corrective actions indicate an attitude of integrity even when self-disclosing potential criminal conduct.

The Guidance for Submitting a Contractor Self-Disclosure, the Contractor Self-Disclosure Form, and Frequently Asked Questions regarding the self-disclosure program are available on the OIG's website at

Continue reading "OIG Posts New Guidance for Submitting a Contractor Self-Disclosure" »

August 13, 2013

HLP Publishes Client Alert on 2014 IPPS Final Rule

On August 2, 2013, the Centers for Medicare & Medicaid Services ("CMS") published its highly anticipated 2014 Inpatient Prospective Payment System ("IPPS") Final Rule (the "2014 IPPS Final Rule"). The 2014 IPPS Final Rule will be effective on October 1, 2013. There are two main aspects of the 2014 IPPS Final Rule that will significantly affect the day-to-day operations of hospitals nationwide: First, the 2014 IPPS Final Rule finalizes CMS' proposal to revise its "Payment Denial Policy" and allow billing of many services under Part B following a determination that a Part A inpatient claim will be denied as not medically necessary. Second, the IPPS Final Rule changes the criteria for coverage of Part A of inpatient hospital claims.

The HLP has prepared a Client Alert outlining key provisions of this important rule.

Continue reading "HLP Publishes Client Alert on 2014 IPPS Final Rule" »

August 6, 2013

New Inpatient Admission Requirements, Part B Inpatient Rebilling Policy Finalized

On August 2, 2013, the Centers for Medicare & Medicaid Services ("CMS") issued its highly anticipated 2014 inpatient prospective payment system ("IPPS") Final Rule (the "Final Rule"). Within this Final Rule, CMS finalized (1) its new requirements for Medicare Part A coverage of inpatient hospital admissions; and (2) its Part B inpatient rebilling policies.

Medicare Part A Coverage of Inpatient Hospital Admissions

Under the Final Rule, CMS adopts its proposal to presume that "inpatient hospital claims with lengths of stay greater than 2 midnights after the formal admission following the order will be presumed generally appropriate for Part A payment and will not be the focus of medical review efforts absent evidence of systematic gaming, abuse, or delays in the provision of care in an attempt to qualify for the 2-midnight presumption." See Final Rule at 1842.

This is a policy shift on the part of CMS. Under its previous policy, physicians admitting beneficiaries to inpatient status were instructed to use a 24-hour period as a benchmark (i.e., admitting physicians were instructed that they "should order admission for patients who are expected to need hospital care for 24 hours or more, and treat other patients on an outpatient basis"). See Medicare Benefit Policy Manual (CMS Internet-Only Publication 100-02), Chapter 1, Section 10. However, there was no presumption of coverage tied to meeting this 24 hour benchmark.

Note that although a length of stay crossing 2 midnights could mean a 24 hour and 2 minute hospital stay, a length of stay crossing 2 midnights also could mean a 71 hour and 58 minute hospital stay.

The Final Rule also adopts CMS' proposal to require a physician's order to inpatient status before payment will be made for an inpatient claim. See Final Rule at 1789 et seq.

Part B Inpatient Rebilling

Under the Final Rule, CMS adopts its proposal to allow rebilling under Part B (following a denial of a Part A inpatient hospital claim) for many services (with certain notable exceptions, such as observation services). See Final Rule at 1653 et seq. The Final Rule retains many aspects of the Proposed Rule, including the following:

• Eventually rebilling will be limited to claims that are within 1 year of the date of service at issue; However, CMS is permitting hospitals to rebill under the timeframes set forth in Ruling 1455-R for claims eligible under the Ruling, as well as for services provided before October 1, 2013 that are denied after September 30, 2013;

• Certain services will be excluded from the opportunity to rebill, i.e. ED visits and observation services; However the Final Rule deviates from CMS' proposal in that it will allow hospitals to rebill physical therapy, occupational therapy and speech therapy services; and

• Administrative law judge jurisdiction remains limited to whether the Part A claim at issue was medically necessary.

The American Hospital Association ("AHA") has expressed its disappointment with the Final Rule as it relates to Part B inpatient rebilling and indicated its intent to proceed with its pending lawsuit against CMS related to this issue.

A more comprehensive summary will be forthcoming by way of HLP client alert. Please contact Jessica L. Gustafson, Esq. or Abby Pendleton, Esq. at (248) 996-8510 with any questions.

March 15, 2013

CMS Speaks: The Future for Payment of Part B Services Post-RAC Denial - CMS' Long-Term Solution Too Limiting!

On March 13, 2013, the Centers for Medicare and Medicaid Services ("CMS") concurrently issued Ruling CMS-1455-NR (the "Ruling") and a proposed rule for revising Medicare Part B billing policies in the event of Part A payment denials (the "Proposed Rule").


Since the conclusion of the Recovery Audit Contractor ("RAC") demonstration program and prior to March 13, 2013, CMS has taken the position that following a contractor's denial of a Part A inpatient hospital claim, hospitals were permitted to bill Medicare Part B for only a very limited portion of the denied services (i.e., the "ancillary services"). Moreover, these ancillary services could only be billed under Part B if such services were provided during the prior year under existing timely filing rules. Compounding the litany of financial problems created for hospitals from RAC denials, the RACs have denied an extraordinary number of short stay inpatient claims, in many cases many years following the dates of service, leaving hospitals with zero payment for services fully rendered, which the hospitals believe were reasonable and necessary under Part A. Although in many cases the RACs have determined that the services were reasonable and necessary as outpatient services, the RACs failed to provide Part B offset.

Accordingly, hospitals have had no choice but to vigorously pursue relief through the Medicare appeals process. In many cases, hospitals have argued that the inpatient services were medically necessary. Moreover, as an alternative, hospitals have argued that they are at least entitled to an offset under Part B (e.g., payment for outpatient observation services, payment for the procedure as if the patient had been an outpatient, etc.). Notably, some Administrative Law Judges ("ALJs") have agreed that to the extent the Part A denial is upheld, the hospital is entitled to Part B payment (not limited to ancillary services) and have ordered same ("Partially Favorable Decisions"). The Medicare Appeals Council likewise agrees and has issued many decisions to this effect. Although CMS has been vocal in its disagreement on this issue, in July of 2012, CMS issued a memorandum to its contractors providing instructions as to how to effectuate the Partially Favorable ALJ and MAC decisions. For the past few months, many ALJs have also started to remand cases back to the Qualified Independent Contractor ("QIC") stage of appeal as the QICs have ignored the hospitals' arguments related to the Part B offset issue. Amazingly, despite the remand orders, the QICs have been reissuing the exact same decisions made in the first instance, in essence failing to comply with the ALJ's orders and refusing to address the Part B offset issue.

CMS' position, as adopted by its contractors, has led to a significant financial impact on hospitals as well as resulted in the unnecessary unburdening of the Medicare appeals process.


Given pressures asserted by the hospital community, including the recent litigation over the above issues filed by the American Hospital Association and five (5) health systems, on March 13, 2013, CMS announced a new Ruling in conjunction with the release of a proposed rule to define Part B billing policies when a Part A claim for a hospital inpatient admission is denied as not medically reasonable and necessary. While this Ruling provides significant relief, CMS' continued position that outpatient observation services cannot be billed is troubling. Moreover, CMS proposed long term solution as set forth below is not palatable for the hospital community.



Ruling 1455-NR (the "Ruling") became effective immediately on March 13, 2013. The Ruling is the interim guideline until CMS finalizes the proposed rule on the issue, establishing a permanent policy. The Ruling reiterates CMS' position that the MAC and ALJ decisions discussed above are contrary to longstanding CMS policy that only allows billing for Part B ancillary services within a specified time from the dates of service (following a finding of Part A overpayment). The Ruling acknowledges that CMS is "acquiescing" to the ALJ and MAC decisions discussed above, and is applicable to all denials made (1) while the Ruling is in effect, (2) prior to the effective date of the Ruling where appeal rights have not expired, and (3) prior to the effective date for which an appeal is pending.

Summary of Billable Services under Ruling

When a Part A claim for inpatient services is denied by a Medicare contractor (not self-audit determinations or utilization review determinations) as not reasonable and necessary, the hospital may do the following:

1. Submit a Part B inpatient claim for more than just ancillary services. The hospital is entitled to bill a Part B inpatient claim for the Part B services that would have been payable had the beneficiary originally been treated as an outpatient rather than admitted as inpatient. However, CMS states that the hospital may NOT bill for those services that specifically require an outpatient status (e.g., outpatient visits, ED visits, and outpatient observation services). CMS' decision to not permit observation services is particularly problematic as many of the cases at issue involve admissions from the ER where observation services would be applicable.

2. Submit a Part B outpatient claim for reasonable and necessary services for the outpatient services furnished during the 3-day payment window prior to the original inpatient window, including ED visits and observation services.

No Duplicate Claims

In order to rebill the claims, a hospital cannot have an outstanding appeal for payment under Part A. In other words, a hospital must withdraw the pending Part A appeal or wait for an appeal decision to become final or binding before rebilling is allowed. Once a claim for Part B reimbursement is submitted, the hospital will no longer be able to pursue an appeal for the Part A claim.

Timeframe for Rebilling

While the Ruling is in effect, a hospital will have 180 days from the date of determination or dismissal of a Part A appeal to rebill under Part B. The Ruling retains the presumed date of receipt: 5 days from the date of the notice/decision unless there is evidence to the contrary.

Treatment of Current ALJ Remands

Cases that have been remanded by an ALJ will be returned to the ALJ level and adjudicated according to the new scope defined by this Ruling - namely, the ALJ may only decide if Part A inpatient billing was appropriate because the services provided were reasonable and medically necessary. According to the Ruling, it is CMS' position that the ALJ may not order Part B payment. Rather, the hospital must either withdraw the appeal from the ALJ or wait for a determination before rebilling for Part B services. This statement is particularly problematic, raising questions as to whether CMS has such authority via a memorandum ruling to essentially take away a provider's due process appeal rights. Hospitals who seek outpatient observation payment as an alternative are well advised to continue making arguments in the appeals process as such issues may need to be preserved for potential federal court cases. Patient Status (copayments, deductibles, etc.)

Under the Ruling, because a patient's status (inpatient vs. outpatient) cannot be changed after discharge, the patient will be considered an inpatient for Part B inpatient services billed, and an outpatient for Part B outpatient services billed.

Part A/B Rebilling Demonstration Terminated

The Ruling noted that the demonstration program for Part A to Part B billing, an experiment targeted at solving the problem of excessive lengths of observation care stays, is terminated since the Ruling and the permanent rule to follow are the perceived resolution to the problem.


The Ruling is only the interim solution. Also on March 13, 2013, CMS released a proposed rule to be published in the Federal Register on March 18, 2013, which would supersede the Ruling once issued as a final rule. The Proposed Rule would retain the right for hospitals to rebill under Part B for inpatient hospital services deemed not to be reasonable and medically necessary within the same scope as defined in the Ruling, but significantly narrows the circumstances for doing so. In fact, CMS readily admits that the Proposed Rule will "greatly limit the capacity in which a hospital could rebill," thus offsetting the cost to the Medicare program. The additional limitations not present in the Ruling, but introduced in the Proposed Rule are described below.

As detailed below, CMS's proposed long term solution is not a fair remedy for hospitals and must be challenged. Hospitals must take advantage of the comment period as well as continue to pursue legal recourse if necessary.

One Year from Service Limitation

The most significant problem with the proposed rule is CMS' position that Part B claims may only be filed within one (1) year of the beginning date of service, irrespective of any audit or decision on appeal. This severely restricts the availability of CMS' solution and casts doubt as to its real intention behind the Proposed Rule. If a determination is not made within one year of the beginning date of service (which will be the circumstances in most audit determinations outside of pre-payment review), a hospital will not be able to avail itself of Part B billing in the event that Part A services are found by an auditor to be not reasonable and medically necessary. CMS treats the billing as an original claim, and not as an adjustment.

Hospitals May "Self-Audit" and Rebill

Unlike the interim solution under the Ruling discussed above, the Proposed Rule would allow hospitals that discover inpatient hospital admissions to be not medically necessary in the course of utilization reviews to rebill these claims as Part B if the other requirements of the Proposed Rule are met. CMS anticipates that hospitals will increase "self-audits" and rebill under Part B, saving the Medicare program money by reducing the number of Part A claims. CMS also anticipates lower appeal volumes.

Patient Requirement and Treatment

For a hospital to be allowed to rebill services under Part B, the subject patient must be enrolled in Medicare Part B. The Proposed Rule also requires that any Part A payment collected from the patient be refunded. Additionally, the Proposed Rule contemplates requiring prior notice to patients about possible changes in deductible and cost sharing if Part A payment is denied. Patients would continue to be liable for Part B copayments, the full cost of drugs that are usually self-administered, and Part D coverage (the patient may pursue Part D reimbursement).
A patient's right to appeal a Part A inpatient admission denial is not extinguished by a hospital's submission of a Part B claim. If a patient has a pending Part A claim, the hospital may not file a concurrent Part B claim. If the patient's appeal is not decided within 12 months of the date of service, hospital will not be able to rebill under Part B.


While CMS purports to address the problem of increasing lengths of outpatient hospitalizations and resolve the piecemeal solution of MACs and ALJs ordering payment as if outpatient services were performed when it is determined that inpatient hospital services are not reasonable and medically necessary, in reality the Proposed Rule will not likely result in these solutions.

First, as noted above, in permitting hospitals to rebill claims as Part B claims if an inpatient hospital claim is denied as not medically necessary under Part A, CMS has expressly created an exception for rebilling observation services; this is not permitted. Therefore, as it is clear that RACs are continuing to aggressively deny hospital "short stay" cases, there is very little incentive for hospitals not to admit beneficiaries as outpatients and order observation services for the first 24-48 hours of each hospitalization, in cases where there beneficiary will require services that can be provided both to "outpatient observation" patients and inpatients (i.e., ongoing monitoring and assessment). This result decreases reimbursement to the hospitals, and increases costs passed along to beneficiaries and does not ensure "accurate" reimbursement.

Moreover, creating a result that ALJs are purportedly stripped of authority to issue "partially favorable" decisions raises significant due process concerns.

The one-year claims filing limitation included in the Proposed Rule would put a hospital between a rock and a hard place - it must decide whether to preemptively accept reduced payment when in fact it is very likely that an ALJ or MAC may find that inpatient hospital services were indeed medically necessary, or to risk losing all payment for medically necessary services rendered to the Medicare patient.

For the reasons described above, the Proposed Rule does not create a meaningful solution for hospitals, and will not result in more "accurate" payments being made to hospitals.

The HLP intends to submit comments to this Proposed Rule. For more information on the information addressed herein, including RACs, the Ruling or Proposed Rule, please contact Abby Pendleton or Jessica Gustafson at (248) 996-8510.

March 7, 2013

Abby Pendleton, Esq to Speak at The American Academy of Orthopaedic Surgeons Annual Meeting

Abby Pendleton, Esq. will be co-speaking with Jack Bert, M.D. and Ranjan Sachdev, M.D. MBA, CHC on March 19, 2013 at the American Academy of Orthopaedic Surgeons Annual Meeting in Chicago. They will be presenting on the topic "Compliance 2013- What You Need to Know".

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