Recently in Health Law News Category

September 19, 2014

DOJ to Scrutinize False Claims Act Investigations and Lawsuits for Criminal Conduct

The Department of Justice's ("DOJ") Criminal Division announced, through its Assistant Attorney General, Leslie R. Caldwell, that the DOJ is closely scrutinizing civil False Claims Act investigations and lawsuits for criminal conduct. Speaking at the Taxpayers Against Fraud Education Fund's annual conference in Washington D.C., Ms. Caldwell asked attorneys contemplating filing qui tam lawsuits to reach out to criminal authorities, just as they would reach out to the civil counterparts in the DOJ and U.S. Attorney's Offices. Ms. Caldwell emphasized that there are resources available to the DOJ's Criminal Division that aren't available to other agencies, such as search warrants, wiretaps, consensual recordings, undercover operations, confidential informants, and legal assistance requests to foreign governments for evidence in other countries.

The DOJ's practice of combing through civil False Claims Act cases in the healthcare arena is not new. However, through this announcement, the DOJ clearly intends to expedite and streamline its internal referral process and the examination of cases for criminal conduct. Ms. Caldwell explained that "experienced prosecutors in the Fraud Section are immediately reviewing the qui tam cases" upon arrival to determine whether to pursue criminal charges.

In summary, those facing civil exposure under the False Claims Act should be aware that the DOJ may be using a fine-tooth comb to sift through the qui tam complaint for criminal conduct. If the DOJ finds criminal conduct, the negotiations will likely shift from avoiding or reducing fines to avoiding criminal charges. Therefore, the DOJ may use the threat of criminal charges as leverage to negotiate larger fines.

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September 11, 2014

DEA ELEVATES HYDROCODONE-COMBINATION PRODUCTS TO THE MORE RESTRICTIVE CATEGORY OF SCHEDULE II DRUGS

In an attempt to combat prescription drug abuse, on August 22, 2014, the U.S. Drug Enforcement Administration ("DEA") published a final rule (here) elevating Hydrocodone-combination products ("HCPs") to the more restrictive schedule II category of drugs under the Controlled Substances Act ("CSA"). Since the enactment of the CSA in 1971, HCPs have been classified as schedule III drugs. Under the final rule, effective October 6, 2014, DEA registrants are required to adhere to more stringent prescribing, dispensing, security, and recordkeeping requirements with respect to HCPs. The final rule applies to "all pharmaceuticals containing hydrocodone currently on the market in the United States," which includes, but is not limited to, Vicodin, Lortab, Hycodan, and Tussionex.

How Will The New Rule Affect Prescribers?

Under the final rule, prescribers may no longer authorize refills for HCP prescriptions. Previously, authorized prescribers could prescribe a 30-day supply of HCPs with up to five refills. Under the final rule, practitioners may issue multiple prescriptions authorizing patients to receive up to a 90-day supply of HCPs, provided certain regulatory requirements are met. However, the DEA will allow pharmacists to refill legitimate HCP prescriptions until April 8, 2015, if the prescription allows refills and was issued prior to October 6, 2014. Additionally, like other schedule II controlled substances, prescribers will no longer be able to "call in" or "fax in" HCP prescriptions to a pharmacy absent an emergency.

Moreover, prescribers must prepare for a potential increase in the need for physician office visits for patients using HCPs and should expect greater regulatory scrutiny concerning the prescribing of HCPs. In fact, the DEA cautioned that prescribers must determine whether multiple prescriptions (i.e., up to the allowed 90-day supply of HCPs) are appropriate for a particular patient, and they must base their decision "on sound medical judgment and in accordance with established medical standards."

How Will The New Rule Affect Manufacturers, Distributors, and Pharmacies?

Under the final rule, manufacturers, distributors, and pharmacies must meet heightened security and recordkeeping standards. More specifically, manufacturers that repackage or re-label HCPs must obtain a quota in order to repackage or re-label HCPs. However, the DEA will allow repackaging and re-labeling without meeting the quota requirement until December 8, 2014.

For distributors, the primary change is that they must physically store HCPs in a vault that meets certain requirements. For pharmacies, the final rule requires them to use a DEA Form 222 in order to obtain HCPs from a distributor. Pharmacies will also be required to keep HCP records separate or readily retrievable. In addition, pharmacies should move quickly to update ordering systems with new National Drug Code numbers.

Conclusion.

The DEA published the final rule merely 45 days prior to the effective date, and health care entities and professionals must move quickly to implement the more stringent schedule II requirements. Furthermore, it is important to remember that each state has its own rules regarding controlled substance prescribing that must be followed as well. Prescribers and dispensers of controlled substances are well advised to follow the more restrictive/conservative requirements when there is a conflict between federal and state law. E.g., under the subject final rule, any legitimate prescription for HCPs that are issued before October 6, 2014 that authorizes refills may be dispensed by a pharmacy if such dispensing occurs before April 8, 2015; however, under Michigan's Administrative Rules, a prescription for a controlled substance listed in schedule II shall not be refilled. Thus, in Michigan, as of October 6, 2014, prescribers should not write prescriptions with refills for HCPs and dispensers should not dispense HCPs pursuant to a prescription refill. Additionally, health care entities and professionals should review any state specific legal or regulatory requirements that emerge as a result of this final rule. For example, the Ohio Board of Pharmacy issued a companion publication (here) addressing Ohio-specific compliance issues related to the final rule. While the rescheduling is not without opposition, the change is here and the October 6, 2014, effective date is right around the corner.

Continue reading "DEA ELEVATES HYDROCODONE-COMBINATION PRODUCTS TO THE MORE RESTRICTIVE CATEGORY OF SCHEDULE II DRUGS" »

September 9, 2014

Modifications to the Electronic Health Record Meaningful Use Incentive Program

On September 4, 2014, the Department of Health & Human Services, Centers for Medicare & Medicaid Services ("CMS"), published a final rule (See, 79 FR 52910) modifying the Medicare and Medicaid Electronic Health Record Meaningful Use Incentive Program ("EHR Meaningful Use Incentive Program"). The reason for the modification is that health care providers were unable to upgrade to the 2014 certified electronic health record technology ("CEHRT") due to product delays and availability. The final rule allows more flexibility in how providers use CEHRT to meet meaningful use for an EHR Meaningful Use Incentive Program for the 2014 reporting period. CMS reports that this flexibility will allow more providers "to participate and meet important meaningful use objectives like drug interaction and drug allergy checks, providing clinical summaries to patients, electronic prescribing, reporting on key public health data, and reporting on quality measures."

The final rule states that CMS will allow providers to use 2011 CEHRT to meet Stage 1 objectives or a combination of 2011 and 2014 CEHRT to meet Stage 1 or Stage 2 objectives. However, providers still using 2011 CEHRT must attest to the failure to implement 2014 CEHRT due to delays beyond their control. Additionally, all eligible providers will be required to use 2014 CEHRT beginning in 2015. The final rule also finalizes the extension of Stage 2 through 2016 for certain providers, and extends the Stage 3 start date from January 1, 2016, to January 1, 2017, for providers who first became meaningful users in 2011 or 2012.

The final rule is effective October 1, 2014.

Continue reading "Modifications to the Electronic Health Record Meaningful Use Incentive Program" »

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 riwrey@thehlp.com.

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 https://oig.hhs.gov/compliance/self-disclosure-info/contractor.asp.

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July 16, 2014

Halifax Health to Pay $1M Settlement in False Claims Case

One of the most widely viewed False Claims Act (FCA) cases filed against a hospital is coming to an end--Florida hospital, Halifax Health, is preparing to pay $1 million to settle a $73 million dollar Medicare overbilling case. Potentially, maximum damages in the trial could have exceeded $200 million, which would then be followed by an $85 million dollar settlement that the health system paid in March to settle the first half of the case. Although the False Claims Act makes it illegal for hospitals to submit inaccurate bills to Medicare, Judge Presell, who presided over this case, ruled that it doesn't necessarily trigger the FCA to bill Medicare for cases in which the medical record lacks enough information to justify admission for inpatient stays.

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July 16, 2014

D.C. Circuit Restores Attorney-Client Privilege Protection for Internal Investigations

Companies doing business in highly-regulated industries, including the health care industry, were left holding their breath after a D.C. district court ruled that the attorney-client privilege doctrine did not attach to a company's internal investigation conducted under the direction of in-house legal counsel. United States ex rel. Barko v. Halliburton Co., No. 05-cv-1276 (D.D.C. Mar. 6, 2014). The decision shattered the previously-held belief that, in most cases, the attorney-client privilege attaches to communications made in the course of an internal investigation led by legal counsel.

However, these industries, and their legal departments in particular, can now breathe easy after the D.C. Circuit Court overturned the district court's decision and restored the attorney-client privilege to its previously-recognized applicability to internal investigations. In Re: Kellogg Brown & Root, Inc., et al., No. 1:05-cv-1276 (D.C. Circuit, May 7, 2014).

Factual Background and District Court's Ruling

Harry Barko, a former employee of defense contractor Kellogg Brown & Root, Inc. ("KBR"), filed a False Claims Act compliant under the qui tam provision alleging that KBR defrauded the federal government by inflating costs and accepting kickbacks while administering military construction contracts in Iraq. During discovery, Barko requested that KBR produce certain documents related to KBR's previously-conducted internal investigations looking into the alleged fraudulent activity. The investigations were conducted at the direction of KBR's in-house legal counsel, and KBR asserted the attorney-client privilege in refusing to produce the documents.

In a potentially groundbreaking decision, the district court held that the attorney-client privilege did not attach to the requested documents because "the communication would not have been made 'but for' the fact that legal advice was sought." The district court concluded that KBR's internal investigation was conducted for a business, not legal, purpose and "undertaken pursuant to regulatory law and corporate policy rather than for the purpose of obtaining legal advice."

In so holding, the district court distinguished the facts in KBR from those in the landmark U.S. Supreme Court case Upjohn Co. v. United States, 449 U.S. 383 (1981), in which the Supreme Court held that the attorney-client privilege applies to corporations. The district court held that Upjohn did not apply because: (i) outside counsel was not involved in KBR's investigation; (ii) non-attorneys conducted many of the interviews; and (iii) KBR did not inform the interviewees that one purpose of the interviews was to assist KBR in obtaining legal advice.

The district court's ruling caught the attention of the health care industry, among others, where internal investigations into fraudulent or illegal activity are common and, in some instances, required by law. Many health care businesses lack the necessary resources to involve outside counsel in every internal investigation or to have an attorney conduct every employee interview, and the district court's ruling threatened the presumed protections of the attorney-client privilege doctrine.

Circuit Court's Ruling

In a much anticipated decision, and to the relief of the health care industry, the circuit court overturned the district court's decision and held that the attorney-client privilege attached to the requested documents.

The circuit court found that the facts of KBR were "materially indistinguishable" from the facts in Upjohn and rejected the reasoning used by the district court to distinguish the two cases. First, the circuit court held that Upjohn does not require the involvement of outside counsel. Rather, the "general rule...is that a lawyer's status as in-house counsel 'does not dilute the privilege.'" Second, the circuit court held that, while the interviews in Upjohn were conducted by attorneys, "communications made by and to non-attorneys serving as agents of attorneys in internal investigations are routinely protected by the attorney-client privilege." Third, the circuit court held that there is no requirement in Upjohn that a company use "magic words" to advise its employees that the investigation is being conducted to assist the company in obtaining legal advice. Nevertheless, the circuit court found that, as in Upjohn, the KBR interviewees "knew that the company's legal department was conducting an investigation of a sensitive nature and that the information they disclosed would be protected."

More importantly, the circuit court rejected the "but for" test applied by the district court as inapplicable to the attorney-client privilege analysis. The circuit court clarified the "primary purpose test" and held that the proper test asks the question: "Was obtaining or providing legal advice a primary purpose of the communication, meaning one of the significant purposes of the communication?" If so, then the attorney-client privilege attaches, regardless of whether the internal investigation was conducted pursuant to company policy, a statute or a regulation.

Implications

The circuit court acknowledged the significance of its decision when it branded the district court's opinion a "novel approach" that "would eradicate the attorney-client privilege for internal investigations conducted by businesses that are required by law to maintain compliance programs, which is now the case in a significant swath of American industries."

In an ever-changing industry where some health care providers are subject to compliance program requirements for Medicare enrollment under the Patient Protection and Affordable Care Act (or are encouraged to implement voluntary compliance programs), health care businesses should take note of both the circuit court's and the district court's opinions. These opinions are a reminder of the importance of having attorneys actively direct the internal investigation and document their involvement. This includes providing written instructions to non-attorneys working on the investigation clarifying that they are working at the direction of the legal department and that a significant purpose of the investigation is to assist the business in obtaining legal advice.

The circuit court's opinion also reminds us that the attorney-client privilege protects against the disclosure of privileged communications, not the underlying facts if the facts can be obtained through non-privileged sources. Additionally, only confidential communications are protected. Therefore, it is important to ask interviewees to keep communications confidential. Also, although "magic words" are not required for the attorney-client privilege to attach, it is prudent to inform the interviewees that the interview is for the purpose of obtaining legal advice for the business. Once conveyed to the interviewee, the interviewer should memorialize in writing that the instructions were conveyed to and understood by the interviewee.

Lastly, it remains to be seen whether other courts will follow the D.C. Circuit's opinion. Therefore, out of an abundance of caution and if the resources are available, businesses should consider having legal counsel conduct employee interviews and should consider engaging outside counsel, if appropriate.

Continue reading "D.C. Circuit Restores Attorney-Client Privilege Protection for Internal Investigations" »

June 20, 2014

HHS Proposed Rules Would Expand Authority to Exclude Providers and Impose Monetary Penalties

On May 9 and May 12, 2014, the United States Department of Health and Human Services ("HHS") published two proposed rules that would significantly expand the authority of the Office of Inspector General ("OIG") to exclude providers from participation in federal health care payor programs and impose civil monetary penalties. The proposed rules are authorized pursuant to the Affordable Care Act of 2010 ("ACA") as the ACA expanded the authority of OIG to protect federal health care programs from fraud and abuse.

The May 9, 2014 proposed rule would expand the OIG's current powers to include permissive exclusion where an individual or entity is convicted of an offense that involves obstruction of an audit. Currently, the OIG's exclusion authority only extends to convictions for obstructing an investigation into any criminal offense described under the mandatory exclusion authorities and certain permissive exclusion authorities.

In addition, the May 9, 2014 proposed rule would expand the OIG's permissive exclusion authority regarding the failure to provide certain payment information. The OIG currently has authority to exclude only entities and individuals who directly provide services and fail to provide required payment information for those services. The proposed rule would expand this authority to include not only the individual or entity directly providing the services, but also any individual or entity ordering, referring, or certifying the need for such services.

The May 9, 2014 proposed rule also adds new exclusion authority for instances where an individual or entity knowingly makes, or causes to be made, a false statement, omission, or misrepresentation of a material fact in any application or contract to participate as a provider in a federal health care program.

HHS also proposes to remove the six-year statute of limitations for exclusions. This means that, under the proposed rule, an individual or entity could be subject to exclusion for actions that occurred at any time, including several years after any alleged wrongdoing has ended or been corrected.

Under the May 14, 2014 proposed rule, the OIG would be granted expanded authority to impose civil monetary penalties on providers and suppliers of federal healthcare. The proposed rule would allow a $10,000 per day penalty on providers and suppliers who fail to timely report and return an identified overpayment. The proposed rule also seeks to add a $15,000 per day penalty for failing to grant timely access to records. False statements, omissions, or misrepresentations of a material fact in any application, bid, or contract to participate or enroll as a provider under a federal health care program would be punishable with a fine up to $50,000 under the proposed rule.

Moreover, the May 14, 2014 proposed rule would also expand existing monetary penalties for arranging or contracting for the provision of services with an excluded individual or entity. A penalty of up to $10,000 is possible under the proposed rule for each separately billable item or service provided, furnished, ordered, or prescribed by an excluded individual, plus an assessment of not more than three times the amount billed for the item or service. If an item or service is not separately billable, the OIG will determine the penalty based on the number of days the excluded person was employed or contracted, and the person's total compensation.

The May 9, 2014 proposed rule can be viewed here. The May 12, 2014 proposed rule can be viewed here. Both proposed rules are open to public comment. The deadline for public comments for the May 9, 2014 proposed rule is July 8, 2014. The deadline for the May 12 2014 proposed rule is July 11, 2014. Public comments can be submitted online at http://www.regulations.gov.

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May 21, 2014

CMS Considering Potential Alternatives to "Two-Midnight Rule"

On May 19, 2014, Centers for Medicare and Medicaid Services ("CMS") announced that it is considering new ways to define and pay for hospital short-stays. In October 2013, CMS implemented the "Two-Midnight Rule" with the goal of bringing clarity to billing for Part A inpatient hospital admissions. However, the Rule has been faced with ongoing criticism and significant pushback from hospitals.

The Two-Midnight Rule was intended to provide clear guidelines regarding when hospitals should bill for inpatient versus outpatient services, such as observation. The rule provides that at the time of admission, the admitting physician must document an expectation that a patient receive 2 midnights or more of hospital care. The medical record must contain sufficient information to support this expectation as a condition of payment. Dr. Ann Sheehy testified at the House Health Subcommittee May 20, 2014 that the rule "does not distinguish between clinical populations because it is a time based policy with no basis in sound clinical judgment."

The distinction between inpatient and outpatient hospital services can significantly impact how much Medicare pays a hospital for the services it provides to beneficiaries. In fact, Medicare has historically paid nearly 3 times more for a short inpatient stay than an observation stay on average. The House Health Subcommittee heard testimony from HHS Regional Inspector General Jodi Nudelman that differing payment rates have resulted in some hospitals admitting short-stay inpatients more than others. In fact, she testified that some hospitals attribute over 70% of their inpatient stays to short stay admissions while others admit short-stay inpatients less than 10% of the time.

Growing confusion surrounding the rule and potential unintended consequences have made it clear that the Two Midnight Rule must be carefully reevaluated. Now CMS is considering new alternatives and is seeking comments on an alternate pay system. According to CMS Deputy Administrator, Sean Cavanaugh, one potential alternative could be modeled after the per-day payment system that is already used for patients who transfer from one hospital to another during an episode of care. Additionally, CMS is soliciting comments on whether reimbursement rates for specific inpatient services should be capped at the outpatient rate for the equivalent service.

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May 21, 2014

2014 PEPPER Guidelines add Target Areas to Identify Improper Billing for Short Stays May 19, 2014

The Program for Evaluating Payment Patterns Electronic Report ("PEPPER") is an electronic data report under contract with the Centers for Medicare & Medicaid Services ("CMS") that helps guide hospital's auditing and monitoring services.

In 2014, PEPPER published new target areas for Short-Term Acute Care hospitals that were identified as prone to improper Medicare payments. Significantly, 6 new target areas related to patient "status" were established (i.e., to determine whether a beneficiary was appropriately admitted as an "inpatient"). Of note, while 4 of these target areas focus on hospital stays that did not cross 2 midnights, two of the target areas focus on 2 day hospital stays. Thus, it is clear that even if a hospital stay crosses 2 midnights, hospitals will be called upon to establish that the hospitalization itself was medically necessary.

Although the Recovery Auditors (i.e., "RACs") presently are prohibited from conducting patient status reviews, Medicare Administrative Contractors ("MACs") have been tasked to conduct "Probe and Educate" medical reviews, for the purposes of determining whether CMS' new 2 midnight rule was satisfied.

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May 16, 2014

90 Individuals Charged with $260 Million False Medicare Billings in National Takedown by Medicare Fraud Strike Force

On Tuesday, May 13, 2014, the Department of Justice ("DOJ") and Department of Health and Human Services ("DHHS") held a joint news conference to announce that the Medicare Fraud Strike Force had conducted a nationwide takedown of 90 individuals involving approximately $260 million in fraudulent Medicare billings. The nationwide takedown marked the seventh such takedown in Medicare Fraud Strike Force history. Since the Strike Force's inception in March 2007, operations in nine locations have charged nearly 1,900 defendants and include allegations of falsely Medicare billings of almost $6 billion. Additionally, CMS, working in conjunction with the DHHS Office of Inspector General, has suspended the enrollments of high-risk providers in five Strike force locations and has removed over 17,000 providers from the Medicare program since 2011.

The Medicare Fraud Strike Force is a multi-agency team of federal, state and local investigators designed to combat Medicare fraud through the use of Medicare data analysis techniques and an increased focus on community policing. Almost 400 law enforcement agents from the FBI, HHS-OIG, multiple Medicaid Fraud Control Units and other federal, state and local law enforcement agencies participated in the takedown.

The recent takedown involved six locations, including Miami, Tampa, Houston, Detroit, Los Angeles, and New York. The charges included allegations that the defendants committed various health care fraud-related crimes, including conspiracy to commit health care fraud, violations of the anti-kickback statute and money laundering. The charges are based on a variety of alleged fraud schemes involving various medical treatments and services, including home health care, mental health services, psychotherapy, physical and occupational therapy, durable medical equipment and pharmacy fraud. Of the 90 individuals charged, 27 were health care professionals, including 16 physicians.

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May 16, 2014

GCI Federal, Inc. Issues Suit against HHS Regarding New RAC Contracts

In December of 2013, the Centers for Medicare & Medicaid Services (CMS) issued a Request for Quotes for new Recovery Auditor (RAC) contracts. The new contracts include significant changes to payment terms. Whereas the current contracts allow payment to RACs after the first level of appeal has been exhausted (120 days), the new contracts do not allow payment until after the second level of appeal has been exhausted (120 - over 400 days).

In opposition of the modification on payment terms, CGI Federal, Inc., the Region B Recovery Auditor, submitted pre-award protests to the federal Government Accountability Office (GAO) asking for a change to the new payment terms. The GAO denied the protests on April 23, 2014.

On May 1, 2014, CGI elevated its case to the Court of Federal Claims. The suit requested the Court to order an injunction against the US Department of Health and Human Services' (HHS) implementation of the new RAC contracts and remove the delay in compensation. GCI argues that the new payment terms are inconsistent with customary commercial practices and unfairly restrict competition for the contract, rendering it "commercially impracticable" for CGI to submit a quote.

The first hearing is scheduled for June 6, 2014. The judge will grant an injunction if he or she determines that irreparable harm would be done if the contracts are awarded. If the judge does not grant injunctive relief, CGI may still proceed with its case. The A/B contract awards were expected in May or June, but could be delayed as a result of the suit.

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May 9, 2014

New York Presbyterian Hospital & Columbia University Pay $4.8 Million to Settle Alleged HIPAA Violations

On May 7, 2014, the Department of Health and Human Services ("HHS"), New York-Presbyterian Hospital ("NYP") and Columbia University ("CU") agreed to collectively pay $4.8 million to settle charges of alleged violations of the HIPAA Privacy and Security Rule marking the largest HIPAA settlement to date.

OCR initiated an investigation of NYP and CU after receiving a joint breach report in September 2010 regarding the disclosure of the electronic protected health information ("ePHI") of 6,800 individuals. Due to a lack of technical safeguards, protected health information including patient status, vital signs, medications, and laboratory results were made publically accessible using Internet search engines.

At the close of the investigation, OCR determined that neither NYP nor CU had conducted an accurate and thorough risk analysis or developed an adequate risk management pan. OCR further determined that NYP failed to implement appropriate policies and procedures for authorizing access to its databases and failed to comply with its own policies on information access management.

In addition the $4.8 million settlement (NYP to pay $3.3 million and CU to pay $1.5 million), both parties will also be required to implement a substantive corrective action plan to correct deficiencies in their HIPAA compliance programs including:

• Undertaking a thorough risk analysis;
• Developing and implementing a risk management plan;
• Reviewing and revising policies and procedures on information access management and device and media controls;
• Training staff that have access to ePHI; and
• Providing progress reports

Notably, this settlement highlights the significance of conducting routine risk and vulnerability assessments, having adequate written policies in place, and conducting workforce training on HIPAA privacy and security policies. It is imperative that all covered entities and business associates proactively review the mandatory requirements under HIPAA and carefully evaluate and monitor to compliance.

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April 9, 2014

NYS Final Budget Out of Network Reform

The final budget bill was recently passed in New York State containing several provisions for Out-of-Network ("OON") reforms. The major changes related to OON reform include: 1) transparency provisions requiring the reestablishment of "usual, customary and reasonable" or "UCR" charges to determine reimbursement rates; 2) adding protections allowing patients to go OON for specialty care; 3) requiring insurers to "make available" OON options reimbursed at 80% UCR; 4) creating a new independent dispute resolution ("IDR") process to resolve disputed claims between insurers and providers; and 5) formation of an OON reimbursement rate workgroup to analyze the effect of the reforms. These reforms not only ensure greater patient choice and access to care, but help protect physician practices that have, for decades, struggled to be adequately reimbursed by insurers for legitimate services provided to patients OON. The following is a brief synopsis of each reform:

Reestablishment of UCR:
Beginning in 2015, insurers must be transparent in regards to their rates of reimbursement for services as a percentage of UCR. UCR will be reestablished and defined as "the 80th percentile of all charges for the particular service in the same or similar specialty and same geographic area as reported in the benchmarking database maintained by FAIR Health."

Increasing OON Access and Coverage: Protections have been added, allowing patients to seek OON physicians when their network does not have providers with proper training and expertise for their treatment. Patients will have the option to purchase UCR-based OON products and may request such options from companies that issue comprehensive policies in the group market that cover OON. Such companies must "make available" at least one option for at least 80% of UCR. If no OON coverage option is available in a particular region in New York State, the Superintendent of the Department of Financial Services ("Superintendent") may require insurers selling in the group market of that region to "make available" a similar option.

Independent Dispute Resolution Process (IDR):
Greater consumer protections will be enacted against "surprise medical bills." An additional "hold harmless" protection will be in place for consumers who receive care from an OON provider as a result of an emergency situation or through no fault of their own and without notice. Instead, insurers and providers will be allowed to utilize the new IDR process to dispute claims. Rulings through IDR are required to be issued within 30 days of receipt of the request for dispute, ensuring expeditious resolution for providers. To determine a reasonable fee, the IDR entity will consider factors including:

• The physician's usual charges for the same or similar services;
• Fees paid by the insurer to reimburse similarly qualified OON physicians for the same services;
• Level of training, education and experience of the physician;
• Circumstances and complexity of the particular case, including time and place of the service; individual patient characteristics; and
• The usual and customary cost of the service.

OON Reimbursement Rate Workgroup:
A workgroup will be formed, aimed at improving access and adequacy of OON services and coverage options. Consisting of two physicians, two insurance representatives, and three consumers and co-chaired by the Superintendent and the Commission of the Department of Health, the workgroup will produce a findings report by January 1, 2016. The workgroup will review and make recommendations regarding the following:

• Current OON reimbursement rates used by insurers and FAIR Health's rate methodology;
• Availability and adequacy of the OON coverage in individual and small group markets in every region; and
• Prevalence of coverage based on UCR or other reimbursement methodologies, such as Medicare.

Continue reading "NYS Final Budget Out of Network Reform" »

April 8, 2014

CMS Establishing a Hospice Quality Reporting Program

The Centers for Medicare & Medicaid Services ("CMS") announced in a Federal Register notice that it is creating a new data-collection program for hospice quality reporting called the Hospice Item Set ("HIS") System.

The HIS System, which is mandated under Section 3004(c) of the Patient Protection and Affordable Care Act of 2010 ("ACA"), establishes a new system of records for patient-level data collection. CMS states that the data will confirm whether the appropriate assessments were made, and whether inquiries and concerns were addressed, for each hospice patient. The data CMS plans to collect for each patient includes:

• Pain,
• Respiratory status,
• Medications,
• Patient preferences, and
• Beliefs and values.

Under the program, which hospices must begin using by July 1, 2014, hospices will submit information to the system at the time of admission (and at the time of discharge if a patient does not die).

CMS plans to use strict time limits regarding submission of the information. Hospices must complete admission forms within 14 days of entry, and where applicable, complete discharge forms within 7 days of discharge. The forms must be submitted to the CMS system within 30 days of admission or discharge. Failure to timely report the information could result in cuts to CMS reimbursements.

Notably, under the new information system, information will be collected on all hospice patients, not just patients who are Medicare beneficiaries.

The hospice quality reporting program announcement can be viewed here.

Continue reading "CMS Establishing a Hospice Quality Reporting Program" »