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April 7, 2016

American Bar Association's Physicians Legal Issues Conference on June 9-10, 2016, in Chicago, IL.

Adrienne Dresevic, Esq., of The Health Law Partners, PC, and Kathleen DeBruhl of DeBruhl Haynes, The Health Law Group, are pleased to announce the American Bar Association Health Law Section's Physicians Legal Issues Conference on June 9-10, 2016, in Chicago, Illinois. This annual conference is attended by both attorneys and physicians and is held in conjunction with the Chicago Medical Society and the American Association for Physician Leadership.

This year's theme is "Thriving in a Time of Change: Attorneys and Physicians Working Together". Physicians continue to face challenging odds in a rapidly evolving healthcare market--whether remaining independent, adapting to "employment" by an integrated system, or addressing consolidated payer markets with little or no negotiating power. This unique conference offers physicians, attorneys and their administrative partners an opportunity to hear how these issues are being addressed by physicians and how physicians can succeed at maintaining viable medical practices that offer quality services at their core.

Physicians and their legal counsel will have access to national speakers and will be educated on key issues affecting employer and hospital relationships, business and industry responses to payer consolidation and market control, and every day "survival" techniques in hospital and private practice settings. Whether you are a physician or entering the field of healthcare law, this conference will provide valuable insight and strategies that can improve your practice.

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April 6, 2016

Adrienne Dresevic and Clinton Mikel Earn the "Pulitzer Prize" of Legal Writing

Please join The Health Law Partners, P.C., in congratulating Adrienne Dresevic (a Founding Shareholder), and Clinton Mikel (a Partner), for earning what has been described as the "Pulitzer Prize of Legal Writing".

The Burton Award for Distinguished Legal Writing, which is run in association with the Library of Congress and co-sponsored by the American Bar Association, is earned each year by 35 exceptional authors nationwide.

Submissions for the Distinguished Legal Writing Award are extremely competitive. The award is generally selected by professors from Harvard Law School, Yale Law School, Stanford Law School, and Columbia Law School, among others.

This year, Adrienne Dresevic and Clinton Mikel join this distinguished group of authors for their journal article titled "Final CY 2016 Stark Law Changes--Welcomed Revisions to Stark". Their article was published in the December issue of the American Bar Association's peer-reviewed Health Lawyer publication (the flagship publication of the ABA's Health Law Section) - it meticulously dissects major revisions to the Physician Self-Referral Law (Stark Law).

The Burton Awards will be held in Washington D.C. on May 23, 2016. U.S. Supreme Court Justice Stephen Breyer will be the featured guest speaker and U.S. Supreme Court Justice Ruth Bader Ginsburg will memorialize Justice Scalia during the program.

March 22, 2016

OCR Launches Phase 2 of HIPAA Audit Program

The HHS Office for Civil Rights ("OCR") has announced that it will begin the 2016 Phase 2 HIPAA Audit Program, the next phase of audits of covered entities and their business associates. In Phase 2, OCR will review the policies and procedures adopted and employed by covered entities and their business associates to satisfy standards and implementation specifications of the Privacy, Security, and Breach Notification Rules. Phase 2 audits will primarily be desk audits, however, some on site audits will occur. OCR will evaluate the results and procedures used in the Phase 2 audits to develop a permanent audit program.
The Phase 2 audit process begins with OCR sending an email to covered entities and business associates requesting verification of an entity's address and contact information. OCR will then send pre-audit questionnaires to obtain information about the size, type, and operations of covered entities and business associates. This information will be used in conjunction with other information to create potential audit subject pools.
If a covered entity or business associate does not respond to OCR's email request to verify contact information or the pre-audit questionnaire, OCR will use publically available information to verify contact information or respond to the questionnaire. Thus, covered entities and business associates should be aware that ignoring OCR's emails will not keep them from being part of potential audit subject pools.
OCR will post updated audit protocols on its website closer to when it will begin to conduct the 2016 audits. The audit protocol will be updated to reflect HIPAA Omnibus Rulemaking.

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March 14, 2016

6th Circuit Court Ruling May Significantly Reduce Recoverable FCA Damages by Feds

In U.S. ex rel. Wall v. Circle C. Construction, Case #14-6150, 2016 WL 423750 (6th Cir. Feb. 4, 2016), the 6th Circuit Court held that damages in false certification cases should be based on the difference between the value of the items or services the government should have received and the value of the items or services the government actually received. The holding, which arose in the non-healthcare context of a construction contract, arguably applies in healthcare matters where medically necessary items or services were furnished pursuant to referrals that violated AKS or Stark laws and thus the government did not sustain any actual damages. A court could then find that the treble damage provision under the False Claims Act is not applicable and the government's damage recovery is limited to the $5,500-11,000 per claim penalty.

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February 9, 2016

Medicare Appeals Delay Case Moves Forward

As many hospitals, as well as other health care providers and suppliers with pending requests for ALJ hearing are acutely aware, lengthy adjudication delays exist within the Medicare appeals process. These delays are most significant at the third level of appeal, i.e., the Administrative Law Judge (ALJ) stage of appeal.

On May 22, 2014, the American Hospital Association (AHA), together with three hospitals, filed suit in the United States District Court for the District of Columbia, requesting mandamus relief, compelling the Secretary of the Department of Health and Human Services (HHS) to act within the statutorily required timeframes. Disappointing appellants nationwide, the District Court entered a decision mandamus relief was not warranted.

However, following an appeal of the lower court's decision, on February 9, 2016, the United States Court of Appeals for the District of Columbia reversed the decision and remanded the case back to the District Court for further consideration. A copy of the February 9, 2016 order is accessible here: http://www.aha.org/advocacy-issues/legal/litigation.shtml.

For an in-depth look at the ALJ appeals adjudication backlog, please see the following articles: http://www.thehealthlawpartners.com/docs/6.6.14.pdf and http://www.thehealthlawpartners.com/docs/5.21.14.pdf.

For more information regarding Recovery Audits, please contact Jessica L. Gustafson, Esq. or Abby Pendleton, Esq. at (248) 996-8510.

December 15, 2015

Broad Cross-Section of Medical Professionals Prescribing Prescription Opioids

Researchers have examined Medicare claims from 2013 to see which doctors prescribed opioids (including OxyContin, morphine and codeine) and how many prescriptions they filled. Research found that these drugs are being prescribed by a broad cross-section of medical professionals, rather than concentrated among a small group of practitioners. While it is not surprising that pain management specialists and anesthesiologists wrote the most prescriptions for opioids when compared to other specialties, primary care physicians such as family practitioners had the highest volume of opioid prescriptions since there are more primary care physicians than specialists. As such, primary care physicians should recognize that future efforts to curb opioid prescribing (including but not limited to state licensing and DEA registration actions) are likely to focus on them. Moreover, the Centers for Disease Control and Prevention has issued new guidelines urging physicians to take a more conservative approach to prescriptions and to closely monitor their patients' use of opioids.

"Broader Strategies Necessary to Counter Painkiller Over Prescribing, Researchers Say" [link]

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December 9, 2015

AFIRM Act Seeks to Improve the Medicare Audit and Appeals Process

On December 9, 2015, Senate Finance Committee Chairman Orrin Hatch (R-Utah) and Ranking Member Ron Wyden (D-Ore.) introduced Senate Bill 2368, the Audit & Appeal Fairness, Integrity, and Reforms in Medicare (AFIRM) Act of 2015. The purpose and goal of AFIRM is to improve the Medicare audit and appeals process by reducing the burden on providers and implement reforms to the Medicare audit and appeals process.
In fiscal year 2014, the Centers for Medicare & Medicaid Services (CMS), conducted audits of more than one billion claims in an effort to curb approximately $60 billion in improper Medicare payments. This many audits has resulted in a corresponding number of appeals leading to a backlog of nearly one million claims causing a near two year backlog.
Among the many ways that AFIRM seeks to resolve this backlog are the following:
 Increase the amount in controversy limits for review by an administrative law judge (ALJ) to $1,500 or more. For cases not meeting this threshold, a Medicare Magistrate program allows senior attorneys with expertise in Medicare law and related policies to adjudicate cases in the same way as ALJs. This is intended to allow ALJs to maintain their focus on complex cases (AFIRM § 1-3).
 Establish a process whereby an ALJ can certify an appeal for expedited access to judicial review (AFIRM § 5).
 Establish a voluntary alternate dispute resolution process allowing multiple claims with similar issues of law or fact to be settled together where they are submitted by the same individual or entity (AFIRM § 6).
 Permit an adjudicator, with the consent of the appellant, to use statistical sampling and extrapolation in reaching a decision (AFIRM § 6).
 Establish a process whereby the Office of Medicare Hearings and Appeals and the Departmental Appeals Board of the Department of Health and Human Services (HHS) can refer cases to law enforcement where there is a credible suspicion of fraudulent activity (AFIRM § 7).
 Publish on the internet appeal information that includes at least the following (AFIRM § 9):
o the percentage of appeals that received fully favorable, partially favorable, and unfavorable decisions;
o the percentage of appeals that received fully favorable, partially favorable, and unfavorable decisions for each ALJ;
o for each type of service, the percentage of appeals that received fully favorable, partially favorable, and unfavorable decisions; and
o the average length of time that has passed between the initial request for review and a final decision.
 Establish alternative resolution dispute processes permitting an individual or entity entitled to a redetermination by a Medicare administrative contractor, or a reconsideration by a qualified independent contractor, to enter into an alternative dispute resolution with CMS (AFIRM § 9).
 Authorize the Secretary to designate a point of contact to oversee and undertake at least the following (AFIRM § 10):
o Develop a strategy for claim review determinations that identifies and reduces claim errors that have the largest impact on improper payment rates and are likely to negatively affect quality of care, in addition to reducing unnecessary burdens on providers of services and suppliers;
o Develop methods to ensure review contractors do not unnecessarily conduct duplicate reviews of individual claims;
o Work with review contractors to develop a uniform, consistent, and transparent review process to reduce the burden on providers of services and suppliers;
o Develop qualification standards for review contractors requiring prepayment and post-payment reviews of claims to be conducted or approved by medical doctors with knowledge of relevant Medicare laws, regulations, and program instruction;
o Verify that decisions by review contractors are consistent with Medicare laws, regulations, and program instruction; and
o Determine whether additional punitive actions against ineffective review contractors could be taken and what, if any, financial incentives or disincentives could be used to promote accuracy of a review contractor's reviews.
 Appoint a Medicare Reviews and Appeals Ombudsman who will (AFIRM § 11):
o identify, investigate and assist in the resolution of complaints and inquiries related to the Medicare audits and appeals process;
o identify trends in complaints and inquiries to provide recommendations for improvements to the claims review and appeals system;
o design a system to measure and evaluate reviewer responsiveness to addressing inquiries from providers of services and suppliers; and
o publish appeal data.
 Establish a compliance incentive program to increase the accuracy of providers of services and suppliers in addition to encouraging consistency with review guidelines, regulations and program instructions for review contractors (AFIRM § 13).
Jessica Gustafson and Abby Pendleton, founding partners of The Health Law Partners, P.C., practice in all areas of healthcare law devoting a substantial portion of their practice on Recovery Audit Contracts and Medicare audit appeals. For more information, please contact Abby Pendleton, Esq. or Jessica Gustafson, Esq., or visit The HLP website.

December 9, 2015

Physician Groups Settle with Anthem Blue Cross and Blue Shield Over "Out-of Network Shenanigans"

Seven physicians groups, including the Connecticut State Medical Society, the American Medical Association, the California Medical Association, the Medical Association of Georgia and others, have reached a settlement with insurance company Anthem Blue Cross and Blue Shield ("Anthem") over allegations of 'out-of network shenanigans'. The suit, which was filed in 2007, accused Anthem of unfair practices when determining reimbursement rates for out-of-network care. Patients were unsure as to which providers were in or out of network and patients were responsible for higher than expected charges due to being misled about how much of the bill for out-of-network care the insurance company would accommodate.

The settlement amount has not been revealed but, according to general counsel for the Connecticut State Medical Society, Anthem will be upgrading their provider finder tool and will also provide a very small monetary reward to the medical societies involved.

"DOCTOR GROUPS SETTLE WITH ANTHEM OVER 'SHENANIGANS'" [LINK]

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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 20, 2015

Per Alabama Court The Government Must Show More Than Difference of Opinion to Prove Falsity in False Claims Act (FCA) Action

After a ten week trial, a federal court in Alabama has granted a hospice care provider, Aseracare Inc.'s motion for a new trial in a False Claims Act (FCA) case. The Government alleged that this hospice care provider knowingly submitted false claims to Medicare for patients who were not terminally ill and thus did not qualify for hospice benefits. However, the Alabama federal court determined that there was reversible error in the jury instructions that left out that the FCA requires proof of an objective falsehood and that a minor difference in opinion is not enough to show falsity. At this time, the court is considering summary judgment given that the government maintains its only evidence for proving falsity is expert testimony and medical records of the patients at issue.

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November 12, 2015

NPDB Revamps its FAQs

Recently, the National Practitioner Data Bank (NPDB) website revised both the content and appearance of its Frequently Asked Questions (FAQs) pages in order to provide more insight and better guidance to its users based upon its call center statistics and other customer feedback. The revised questions and answers are now organized into new categories by audience: Health Care Professionals, Organizations, and Other Topics. There is also a FAQ search bar that allows the user to type in a keyword to search for a topic. See: http://www.npdb.hrsa.gov/faqs/faqs.jsp

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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.

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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.

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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.

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