Wachler & Associates Health Law Blog

Published on: July 10, 2014

HHS Unveils Statistical Sampling Pilot Program for ALJ Hearings on Medicare Audit Appeals

Last week, the Office of Medicare Hearings and Appeals (OMHA) announced the Statistical Sampling Pilot Program (Pilot Program). The Pilot Program offers Medicare providers an alternative route, along with the Settlement Conference Facilitation Pilot, to reach a final determination for claims pending at the administrative law judge (ALJ) hearing level without enduring the 2-3 year delay for hearing. Although the Pilot Program offers a time-saving and perhaps more efficient option for Medicare providers, engaging in the Pilot Program also comes with risks as Medicare providers may “put all of their eggs in one basket” and rely on a single ALJ to issue a decision that affects a large volume of claims. In some cases, the provider may know the identity of the ALJ prior to agreeing to statistical sampling, but in other cases the provider will not.

The Pilot Program is available to Medicare providers that have requested an ALJ hearing following a Medicare Qualified Independent Contractor (QIC) reconsideration decision. At this time, the ALJ hearing requests must either be assigned to an ALJ or must have been filed between April 1, 2013 and June 30, 2013 and it must meet all jurisdictional requirements, including that it was filed timely. In order to be eligible for the Pilot Program, the Medicare provider must have a minimum of eligible 250 claims and the claims must be one of the following: (1) pre-payment claim denials; (2) post-payment non-RAC claim denials; or (3) post-payment RAC claim denials from one RAC. In addition, claims that are assigned to different ALJs or were requested in different consolidation groups may be incorporated into the request for statistical sampling.

A Medicare provider that meets the eligibility requirements for the Pilot Program may request statistical sampling by submitting a “Request for Statistical Sampling” form that is available on OMHA’s website. The provider must also submit a spreadsheet, a template is also available on OMHA’s website, that provides detailed information about the claims requested to be included in the statistical extrapolation.

Published on: July 9, 2014

HHS Launches Pilot Program for Providers to Settle Medicare Overpayment Demands with CMS

by Wachler & Associates, P.C.

Recently, the Department of Health and Human Services (HHS) announced its new pilot program – Settlement Conference Facilitation (SCF) Pilot – to provide an alternative dispute resolution process for settling appealed Medicare claims denials. Through the SCF program, providers have the opportunity to discuss with the Centers for Medicare and Medicaid Services (CMS) the potential of a mutually agreeable resolution to the claims appealed to an Administrative Law Judge (ALJ) hearing. According to HHS, the settlement conference facilitator, who is an employee of the Office of Medicare Hearings and Appeals (OMHA), will use mediation principles to assist the appellant and CMS in reaching a mutual settlement agreement. If a settlement is reached between the appellant and CMS, the facilitator will draft the settlement document to be signed at the settlement conference by both parties. Once a binding settlement agreement has been executed, any pending ALJ hearing requests for the claims covered by the settlement agreement will be dismissed and no further appeal rights will be attached to those claims. On the other hand, if the parties are unable to reach a settlement agreement and the facilitator believes further efforts to reach an agreement will be unsuccessful, the SCF process will be concluded and the appealed claims will return to the ALJ level of appeal in the order the hearing request was originally received by OMHA.

Initially, HHS is limiting eligibility for the SCF pilot program to claims by Medicare Part B providers who have filed requests for ALJ hearing in 2013 and are not currently assigned to an ALJ. For those eligible providers, the request for SCF must include all of the provider’s pending ALJ appeals for the same item or service (i.e., all claims for the same item or service in which ALJ hearing requests were submitted in 2013). Appellants must include all appeals included in the applicable ALJ hearing requests, and may not request an SCF for some claims and proceed to the ALJ hearing for the remaining claims. Additional SCF eligibility requirements include that at least 20 claims must be at issue or, if fewer than 20 claims are at issue, at least $10,000 must be in controversy. Also, the amount of each individual claim must be less than $100,000. For claims subject to statistical sampling, the extrapolated overpayment amount at issue must be less than $100,000; however, HHS states that it will continue to explore expanding the SCF pilot program for larger extrapolated overpayment cases.

Although the SCF process is only available for a limited group of claims at this time, those providers whose appeals are currently ineligible (e.g., Part A providers) for the SCF pilot program may nonetheless view these developments as a silver lining as countless appealed claims are currently awaiting ALJ hearings to be scheduled – claims in which CMS has likely recouped all of the alleged overpayment amount. With the substantial volume of claims currently backlogged at OMHA causing two to three year delays before the appealed claims are finally adjudicated, appellants may soon be provided a forum to reach mutually agreeable resolutions with CMS and receive the timely payment in which the provider is entitled.

Published on: July 8, 2014

Michigan Passes Law Allowing Direct Access to Physical Therapists

by Wachler & Associates, P.C.

On June 26, 2014, Michigan Governor Rick Snyder signed into law SB 690, allowing a physical therapist or physical therapist assistant to treat a patient without a physician’s referral. Pursuant to the new law, which goes into effect January 1, 2015, physical therapist may now treat self-referring patients without a prescription from a physician under the following circumstances: (1) for up to 21 days or 10 treatments, whichever comes first; or (2) the patient is seeking physical therapy services to prevent injury or promote fitness. With the signing of SB 690, all 50 states, as well as the District of Columbia, now provide for some kind of direct access to physical therapists.

Under the new law, when a physical therapist is treating a patient without a prescription from a physician, the physical therapist must refer the patient to a physician if the physical therapist has reasonable cause to believe that symptoms or conditions are present that require services beyond the physical therapist’s scope of practice. In addition, the law provides that the physical therapist must consult with a physician if the patient does not show reasonable response to treatment in a time period consistent with the standards of practice. The new law also provides that the physical therapist must determine that the patient’s condition requires physical therapy before delegating physical therapy interventions to a physical therapist assistant.

According to the House Committee’s summary of Senate Bill, these rule changes “do not create an open door to [physical therapy] services; a patient would need to obtain a prescription if more than 10 visits or three weeks of treatment were needed.” Moreover, as provided in concurrently adopted Senate Bills (SB691-SB694), an insurer would not be mandated to provide coverage for treatment that was not provided pursuant to a prescription from a physician.

Published on: July 7, 2014

CMS Affirms Physicians May Bill Certain Pharmacy Services as “Incident To” But Highlights Recent Regulatory Amendments Regarding Compliance with State Law

by Wachler & Associates, P.C.

In a March 25, 2014 letter to the American Academy of Family Physicians (AAFP), CMS Administrator Marilyn Tavenner responded to an inquiry from the AAFP asking whether, if all of the “incident to” rules are met, may a physician bill Medicare for a Part B covered service provided by a pharmacist in the physician’s practice.

In its January 2014 letter, AFFP noted the “increasing emphasis on team-based care in family medicine” particularly in the context of a “patient-centered medical home.” Due to such changes, AAFP advised CMS that family medicine practices were employing pharmacists as part of the patient care team. Pursuant to the plan of care developed by the physician, these pharmacists were having and documenting direct, face-to-face encounters with patients where they reviewed “applicable patient history and medications” and counseled patients on the “risks and benefits of pharmaceutical treatment options” and “instructions for improving pharmaceutical treatment compliance and outcomes.” The AAFP took the position with CMS that such encounters would meet the definition of an established patient evaluation and management services (“E/M service”) and would be billed as an E/M service if the physician had provided the service. The AAFP also reviewed applicable Medicare rules on “incident to” billing, specifically section 60 of chapter 15 of the Medicare Benefit Policy Manual and stated that it “found nothing in Section 60 that would exclude pharmacists from this definition.” Accordingly, AAFP requested confirmation that a physician who met all of the “incident to” rules would be permitted to bill Medicare for a Part B covered service provided by a pharmacist in the practice.

In her response, Administrator Tavenner stated that CMS agreed with AAFP’s position that if all the requirements of the “incident to” statute and regulations were met, a physician may be reimbursed under Medicare Part B for services provided by pharmacists in the practice as “incident to” services.

Published on: July 3, 2014

CMS Proposes to Eliminate the Narrative Requirement for Documented Face-to-Face Encounters for Home Health Agencies

by Wachler & Associates, P.C.

In a recently released proposed rule, the Centers for Medicare & Medicaid Services (CMS) proposes to eliminate the narrative requirement from the home health face-to-face encounter documentation requirement. Under the Patient Protection and Affordable Care Act (ACA) and implementing regulations, the certifying physician must document that the physician himself or herself or an allowed nonphysician practitioner conducted a face-to-face encounter with the beneficiary no more than 90 days prior to the home health start of care date or within 30 days of the start of home health care. As part of the home health certification requirements, the documented face-to-face encounter must include a brief narrative of why the clinical findings of the encounter support that the patient is homebound and in need of intermittent skilled nursing services or therapy services.

According to CMS, the narrative requirement was adopted in an effort to achieve greater physician accountability in certifying a patient’s eligibility to receive home health care as well as establishing the patient’s plan of care. However, as CMS noted in the proposed rule, the home health industry is experiencing numerous problems meeting the narrative requirement. Accordingly, since the effective implementation of the face-to-face encounter requirement in April 2011, many home health agencies have seen an increased number of claims denied by Medicare audit contractors due to inadequate narratives supporting the services. In its proposed rule, CMS acknowledges some of the challenges faced by home health agencies in meeting the face-to-face narrative requirement, including:

• A perceived lack established standards for compliance that can be understood and applied by physicians and home health agencies;

Published on: July 2, 2014

OIG Issues Special Fraud Alert Regarding Potentially Unlawful Laboratory Payments to Referring Physicians

by Wachler & Associates, P.C.

On June 25, 2014, the U.S. Department of Health and Human Services Office of Inspector General (OIG) released a Special Fraud Alert (the Alert) regarding two kinds of compensation arrangements between clinical laboratories and referring physicians. The two arrangement types addressed by the Alert involve compensation paid by clinical laboratories to physicians for (1) blood-specimen collection, processing, and packaging and (2) submitting patient data to a registry or database. In the Alert, OIG recognized that these types of arrangements between physicians and labs create a considerable risk of fraud and abuse in violation of the Anti-Kickback Statute.

The specimen processing arrangements involve laboratories paying physicians to collect, process, and package patients’ blood specimens. The OIG noted that these arrangements are typically made on a per-specimen or per-patient-encounter basis. In the Alert, the OIG discussed that physicians are already allowed to bill Medicare a specimen collection fee and for processing and packaging specimens for transport.

As noted by the OIG, the Anti-Kickback Statute prohibits a laboratory from knowingly and willfully paying physicians for services if even one purpose of the payment is to induce or reward referrals. Although the Anti-Kickback Statute is intent-based, the OIG stated, “the probability that a payment is for an illegitimate purpose is increased, however, if a payment exceeds fair market value or it is for a service for which the physician is paid by a third party, including Medicare.”

Published on: June 27, 2014

Beaumont, Botsford, and Oakwood Approve Merger Agreement to Form Region’s Largest Health System

by Wachler & Associates, P.C.

Earlier this week, the boards of Beaumont Health System, Botsford Hospital, and Oakwood Healthcare approved a merger agreement to form a new $3.8 billion nonprofit organization–Beaumont Health. The deal, which still requires state and regulatory approval, would create the region’s largest health system with 8 hospitals, 153 outpatient care sites, 5,000 physicians, 33,093 employees and 3,500 volunteers. Beaumont Health expects to receive approval by the Federal Trade Commission and Michigan Attorney General in time to close the transaction by this fall.

Beaumont Health joins the long list of mergers between hospital systems over the recent years as many hospitals seek to reduce costs and improve patient care through more streamlined operations, increase bargaining power with insurance companies, and take advantage of the cost-saving incentives included in the Affordable Care Act (ACA).

When news of the merger first broke, Fox 2 Detroit interviewed Wachler & Associates partner Andrew Wachler, who explained that the merger could allow patients access to each hospital’s specialization, while allowing the hospitals to share costs. As Mr. Wachler explained, this type of cost sharing typically leads to improved health care quality and reduced costs.

Published on: June 26, 2014

Michigan Supreme Court Issues Ruling on Michigan’s Generic Drug Substitution Statute

by Wachler & Associates, P.C.

On June 11, 2014, the Michigan Supreme Court issued its decision in Michigan ex rel. Gurganus v. CVS Caremark Corp., and ruled that Michigan law requires a pharmacist to pass on the difference in cost between the wholesale cost of a brand-name drug and the wholesale cost of a generic drug to the purchaser when a generic drug is substituted for a brand-name drug (and only then). The case involved two consolidated class actions and a qui tam action against multiple pharmacies alleging that the pharmacies violated MCL 333.17755(2) by failing to pass on the savings to customers when substituting brand-name drugs with generic drugs. The plaintiffs further alleged that the defendant pharmacies necessarily violated the Health Care False Claim Act (HCFCA), MCL 752.1001 et seq, and the Medicaid False Claims Act (MFCA), MCL 400.601 et seq., by violating MCL 333.17755(2) and then submitting claims for reimbursement to the state.

The trial court granted summary disposition to the defendants because it found that the plaintiffs failed to state a claim upon which relief could be granted. The trial court noted that the plaintiffs did not plead with specificity any transactions involving the defendants that purportedly violated MCL 333.17755(2). The plaintiffs relied on a small set of cost data from a single out-of-state pharmacy during a brief time period to support their allegations of systematic fraudulent activity in Michigan by the defendants. The Court of Appeals reversed the trial court’s decision, finding that the plaintiffs’ general allegations were sufficient to avoid summary disposition. The Court of Appeals then reached several issues related to whether the HCFCA and MFCA created private rights of action. The panel also held that MCL 333.17755(2) applied to all transactions in which a generic drug is dispensed – not just to transactions in which a generic drug is substituted for its brand-name equivalent.

In a unanimous decision (with one Justice concurring only in the result), the Michigan Supreme Court reversed the Court of Appeals and reinstated the trial court’s ruling. The Court reversed the Court of Appeals’ construction of MCL 333.17755(2) and its holding that the plaintiffs’ pleadings were sufficient to survive summary disposition. It vacated the remainder of the Court of Appeals’ decision as unnecessary to the resolution of the case.

Published on: June 25, 2014

Federation of State Medical Boards Adopts Model Policy for the Appropriate Use of Telemedicine Technologies

by Wachler & Associates, P.C.

Technological advancements that allow for quicker and more secure electronic communication have encouraged telemedicine. The Federation of State Medical Boards (FSMB) defines telemedicine as “the practice of medicine using electronic communications, information technology or other means between a licensee in one location, and a patient in another location, with or without an intervening healthcare provider.” Telemedicine technologies allow for easier access to health care in rural areas, as well as nearly immediate contact with specialists for individuals involved in an emergency situation. However, widespread usage of telemedicine is still developing and most states have yet to take the appropriate legislative initiative to enact guidelines for state medical boards and health providers to follow when implementing telemedicine systems. As a result, the Federation of State Medical Boards (FSMB), acknowledging the benefits that telemedicine offers, decided to step in.

On April 26, FSMB adopted a Model Policy for the Appropriate Use of Telemedicine Technologies in the Practice of Medicine (Model Policy). The Model Policy comes as a result of the collaborative efforts of the FSMB-appointed State Medical Boards’ Appropriate Regulation of Telemedicine (SMART) Workgroup. The SMART Workgroup, made up of state medical board representatives and telemedicine experts, was tasked with creating uniform guidelines for state medical boards and health providers after:

Conducting a comprehensive literature review of telemedicine services and proposed and/or recommended standards of care;
Identifying and evaluating existing telemedicine standards of care developed and implemented by state medical boards;
Revising the FSMB’s 2002 policy.

In the absence of state legislation, the Model Policy offers a uniform approach to guide state medical boards and health providers in several essential areas.

First, the SMART Workgroup emphasized that the physician-patient relationship is integral in maintaining the integrity of medical care. The Model Policy notes that, before giving any medical advice, physicians utilizing telemedicine should first:

Fully verify and authenticate the location and, to the extent possible, the requesting patient;
Disclose and validate the provider’s identity and applicable credential(s); and
Obtain appropriate consents from requesting patients after disclosures regarding the delivery models and treatment methods or limitations, including any special informed consents regarding the use of telemedicine technologies.

In addition, the Model Policy notes that an appropriate physician-patient relationship has not been established when the physician’s identity is unknown to the patient. Furthermore, a patient must not be randomly assigned to a physician, but rather have a choice, whenever appropriate. So long as the standard of care is met, the physician-patient relationship can be established using telemedicine technologies.

Published on: June 23, 2014

Michigan Physicians Challenge UnitedHealthcare Terminations and Nonrenewals

by Wachler & Associates, P.C.

Healthcare providers across the State of Michigan are continuing to experience terminations and non-renewals from UnitedHealthcare’s Medicaid, MIChild, and Medicare Advantage plans. As previously discussed on this blog, the network exclusions are part of UnitedHealthcare’s nationwide move to narrow networks. Narrow networks limit the amount of physicians available to plan subscribers, which some argue allow plans to better control costs and thus provide premiums that are competitive in the new insurance marketplaces. The real issue, however, is that the manner in which UnitedHealthcare is effectuating its narrow network eliminates patient choice by forcing patient’s to stay with UnitedHealthcare until their anniversary date, despite the fact that they enrolled in UnitedHealthcare with the intent to be treated by their long-term primary care physicians.

In Michigan, providers receiving Terminations Without Cause and Nonrenewals from UnitedHealthcare are granted a limited appeal right via their Participation Agreements. The appeal process, however, is “limited to a review by a UnitedHealthcare panel to determine whether UnitedHealthcare acted in accordance with the provisions of your Participation Agreement.” Accordingly, although an appeal must be filed in order to protect the provider’s appeal rights, the appeal itself may not be effective and providers must look to alternate methods in order to protect physician and patient rights.

Our firm represents multiple primary care physicians facing without cause exclusions from UnitedHealthcare. As the appeal right provided by UnitedHealthcare is insufficient, our firm has contacted the Michigan Department of Community Health (DCH) as well as representative from the State’s Attorney General office in order protect our clients’ and their patients’ rights and achieve a solution that either provides a meaningful appeal process or reinstates patients’ rights to choice of provider.