Ch-Ch-Ch-Ch-Changes: Reporting Requirements for Updating Your CMS Provider Enrollment

By Charlotte Combre and Ernessa McKie on June 22, 2017 Posted in Uncategorized

With the possibility of significant penalties for improperly reported transactions, it is important to understand how certain changes necessitate specific reporting.

Is your organization considering a stock transfer, a merger, a change in control, building a new practice location or updating its board of directors? If these kinds of changes are afoot, it is critical to “turn and face the strain,” making sure that you properly notify the Centers for Medicare & Medicaid Services (CMS) to meet the requirements outlined in the Medicare provider agreement.

There are a variety of transactions that healthcare facilities and practitioners may enter into that could result in either a change of ownership (CHOW) or a change of information (CHOI) to their existing Medicare enrollment information. Because a transaction may start as a CHOI but CMS may ultimately consider it a CHOW, it is important to understand how CMS defines CHOW, CHOI and other changes that require notification to maintain an accurate Medicare enrollment record. Continue Reading

Doc, Can You Hear Me Now? Telehealth Finally Comes of Age in Texas

By Robert M. Wolin on June 20, 2017 Posted in Uncategorized

After many years of heated and contentious debate, and opposition by the Texas Medical Association and the executive director of the Texas Medical Board, Texas has significantly revised its telemedicine statute to permit the routine provision of telemedicine services addressing litigation brought against the Texas Medical Board and reflecting the changing consensus regarding telemedicine services. Historically the Texas Medical Association objected to physicians providing telemedicine services to a patient the physician does not know or has not seen in person and to physician assistants or advanced practice registered nurses being allowed to provide telemedicine services. Under SB 1107, signed into law on May 27, 2017 by Governor Greg Abbott, Texas physicians and practitioners may now provide health or medical services to a patient at a different physical location using telecommunications or information technology.

The Texas Medical Board had required practitioners to use “advanced telecommunications technology” that allowed the practitioner to see and hear the patient in real time. Under the new legislation, a practitioner must:

Use technology that provides synchronous audiovisual interaction between the practitioner and the patient;
Use asynchronous store and forward technology including technology that allows telephonic only interaction provided the practitioner uses certain specified clinical information; and
Otherwise comply with the applicable standard of care.

Exaggerated Diagnosis Codes and Inadequate Provider Networks: Allegations of Medicare Advantage Fraud Settled for $32.5 Million

By Kevin Bradberry on June 20, 2017 Posted in Uncategorized

The latest settlement involving Medicare Advantage (MA) organizations highlights not only the government’s continuing enforcement focus on Medicare Part C but also the vulnerabilities inherent in that program. In United States ex rel. Sewell v. Freedom Health, Inc. et al., two Florida-based MA organizations – Freedom Health and Optimum HealthCare – agreed to pay $32.5 million to resolve allegations that they had fraudulently exaggerated diagnosis codes and misrepresented the adequacy of their provider networks.

According to the complaint, internal coding auditors were instructed by Freedom Health and Optimum to review member medical records for “missing” medical conditions that corresponded to high-value diagnosis codes, regardless of whether the condition or treatment had actually occurred. To circumvent the requirement by the Centers for Medicare & Medicaid Services (CMS) that diagnosis codes must be justified by a face-to-face encounter with a physician each year, the physician whistleblower alleged that the defendants directed doctors to schedule unnecessary office visits for the sole purpose of documenting lucrative diagnosis codes for conditions that had been previously suffered by members but were not treated in the past year. Continue Reading

Capitol Hill Healthcare Update

By Mike Ferguson, Chris Jones, Adam Higgins and Tyler Thompson on June 19, 2017 Posted in Uncategorized

Senate Presses Ahead on Healthcare Talks as Deadline Looms

With only 10 legislative days before Senate Republicans’ self-imposed deadline, GOP lawmakers face growing obstacles in their quest to vote on replacing the Affordable Care Act (ACA) before the beginning of their scheduled Fourth of July recess.

Still, Majority Leader Mitch McConnell (R-Ky.) wants a vote by June 30, in part to clear the chamber’s calendar for other pressing issues this summer, including a fiscal 2018 budget blueprint, legislation to fund the government, and reauthorizing FDA user fees and the children’s health insurance program (CHIP).

Some conservative senators are voicing concern that Sen. McConnell may not be doing enough to curb Medicaid spending in the 31 expansion states. They point to the possibility that the ACA’s Medicaid expansion might last beyond the 2020 cutoff in the House bill as a sign moderate lawmakers are gaining the upper hand as McConnell tries to cobble together 50 votes for an overall package.

But moderate senators worry, too, that conservatives may pick up support for lowering the amount that Washington contributes to state Medicaid programs.

Not content to sit on the sidelines, Democrats are increasingly criticizing Republicans for crafting their bill behind closed doors with no public hearings or input from committees with jurisdiction over healthcare policy (even some rank-and-file GOP senators are voicing the same concern). Democrats this week may try to gum up the Senate with procedural objections in an effort draw attention to their concerns. Continue Reading

Branded Biologic Products Lose 180 Days of Patent Exclusivity in Unanimous Decision From Supreme Court

By Lee H. Rosebush and Lindsay Holmes on June 16, 2017 Posted in Uncategorized

On June 13, 2017, the U.S. Supreme Court issued its opinion in Sandoz v. Amgen. In doing so, it answered two questions raised under the Biologics Price Competition and Innovation Act of 2009 (BPCI). First, is an injunction available under federal law if the biosimilar applicant fails to provide its application and manufacturing information to the manufacturer of the biologic? Second, when does the 180-day notice requirement begin? Both of these questions have serious ramifications for manufacturers, providers and payers moving forward.

Background

BPCI is the biological product counterpart to the Hatch-Waxman Act, which governs the generic drug approval process. BPCI enacted 42 U.S.C., § 262, which governs the biosimilar approval process. Biosimilar biological products that are designated as interchangeable are analogous to generic medications. When a drug is prescribed, a generic is commonly dispensed when available. Generics are usually more cost-effective than brand-name medications. However, as of June 1, 2017, there are only a handful of FDA-approved biosimilar products.

Under BPCI, a biosimilar is defined as a biological product that is “highly similar to the reference product” and has “no clinically meaningful differences between the biological product and the reference product in terms of the safety, purity, and potency of the product.” 42 U.S.C. § 262(i)(2)(A)-(B). However, it should be noted that for payers and providers, there is a difference between a biosimilar and an interchangeable product from a substitution perspective. Specifically, only if the biosimilar is found to be interchangeable, based on the submitted application and testing requirements, may the biosimilar be substituted for the reference product without the intervention of the prescribing healthcare practitioner. Continue Reading

Capitol Hill Healthcare Update

By Mike Ferguson, Chris Jones, Adam Higgins and Tyler Thompson on June 12, 2017 Posted in Uncategorized

Senate GOP Still Talking on Health Bill as Clock Ticks

Senate Republicans continue intra-party discussions on changes to House-passed legislation replacing the Affordable Care Act (ACA), but the lack of consensus is threatening GOP leaders’ pledge to have a bill ready for a vote this month.

Led by Senate Majority Leader Mitch McConnell, key Republican senators held a series of meetings last week to gauge policy options. While the discussions were said to have narrowed some differences, senior staff said senators are not close to resolving the thorny issues that have divided conservative and moderate lawmakers.

The House bill phased out the ACA’s Medicaid expansion after 2020, but Republican senators representing states that added to their Medicaid programs – including Sens. Rob Portman (R-Ohio), Dean Heller (R-Nev.) and Shelly Moore Capito (R-W.Va.) – want to extend it for several more years. A potential solution might be to lengthen the wind-down beyond 2020 but not reduce funding under the per capita cap model as some conservative senators have separately advocated. Continue Reading

Webinar: Medical Device Connectivity: HIPAA, FDA and IP Considerations

By BakerHostetler on June 6, 2017 Posted in Uncategorized

Please join us for this complimentary CLE webinar on Wednesday, June 14, 2017, from 2 -3:30 p.m. EDT

With increasing healthcare costs and the transition to value-based reimbursement, never has the need for connected medical devices been so great – and never have the pitfalls been so daunting. Join us for an overview of the regulatory and intellectual property landscape for this groundbreaking technology.

Our speakers will summarize developments in compliance and security issues, FDA guidelines for premarket and postmarket management of cybersecurity, as well as FDA rules regarding software for medical devices and software as a medical device (SaMD).

In addition, we will cover IP considerations such as claim drafting strategies, design patents for GUIs and recommendations for layered protection of patient monitoring inventions.

Presenters:

Hussein Akhavannik focuses his practice on portfolio management, patent prosecution and IP due diligence. He prosecutes patent applications in technologies related to the electrical, computer, medical and mechanical arts. Hussein spent almost four years at the U.S. Patent and Trademark Office as a patent examiner and as a legal intern for the Patent Trial and Appeal Board and the Office of the Solicitor.

With a background as a defense, regulatory, and registered patent attorney who has also worked as a registered pharmacist, Lee Rosebush provides his clients with legal counsel that is grounded in first-hand experience. Lee is frequently sought out to help expedite corporate deals involving healthcare entities.

CLE Information:

1.5 hrs. of CLE credit is approved for CA and NY and also CO and NJ via reciprocity. Credit has been requested in the following states: FL, GA, IL, MN, OH, TN, TX and VA.

Register Now >>

Capitol Hill Healthcare Update

By Mike Ferguson, Chris Jones, Adam Higgins and Tyler Thompson on June 5, 2017 Posted in Uncategorized

Senate Leaders to Outline ACA Policy Options to GOP Lawmakers

Senate Republicans return to Washington this week after a 10-day recess facing a key inflection point in their effort to repeal and replace the Affordable Care Act (ACA) as GOP leaders will outline policy options they hope can unify their fragmented caucus.

None of the options is a silver bullet, and each effort to appeal to one group of Republicans risks triggering new opposition from another. Majority Leader Mitch McConnell faces the seemingly herculean task of fashioning legislation that can satisfy at least 50 senators, allowing Vice President Pence to cast the tie-breaking vote to pass a repeal-and-replace bill. McConnell’s margin for error is narrow as Republicans hold 52 Senate seats.

Among the policy choices Republicans will begin weighing this week is postponing ACA repeal until 2020 to allow Congress additional time to draft an overhaul of the law. Under that plan, the Senate would provide additional subsidies to try to stabilize individual insurance premiums and to incentivize insurers to return to states they’ve abandoned. Most Republicans would likely view punting for two years as a viable alternative only to doing nothing. Continue Reading

Specificity Sometimes Key; Sometimes Not

By Robert M. Wolin on June 1, 2017 Posted in Uncategorized

Close-up image of contract form on a desk Time spent drafting and negotiating an agreement often pays dividends in assuring that each party gets the benefits they desire through the agreement and incurs obligations no greater than they intended. Two recent cases, discussed below, demonstrate how small drafting oversights resulted in significant litigation costs to the parties and in one case, the party’s loss of the prime benefit they sought from the arrangement.

Arbitration Agreements Signed Under a Power of Attorney

Beverly Wellner and Janis Clark (POA holders) each held a power of attorney (POA) affording her broad authority to manage her family members, Joe Wellner and Olive Clark, respectively. When Wellner and Clark were admitted to a nursing home, the documents to admit them included an agreement to arbitrate any and all claims or controversies arising out of or in any way relating to their stay at the facility. The POA holders signed the arbitration agreements. After Joe and Olive died, their estates sued the nursing home alleging that their deaths were caused by the facility’s negligence. Continue Reading

The DOJ Enters Another FCA Lawsuit Against UnitedHealth

By B. Scott McBride and Jennifer Whitton on May 30, 2017 Posted in Uncategorized

The U.S. Department of Justice (DOJ) recently filed its complaint in intervention in another whistleblower lawsuit brought under the False Claims Act against the nation’s largest owner and operator of Medicare Advantage (MA) organizations, UnitedHealth Group, Inc. (United). The DOJ’s 39-page complaint alleges that United had fraudulently obtained inflated risk adjustment payments by over reporting diagnosis codes for MA beneficiaries since 2005. At the heart of the complaint is the allegation that United “systematically ignored information” in blind audits that revealed both under reporting (i.e., diagnoses that the providers did not report) and over reporting (i.e., invalid diagnoses not supported by medical records). The complaint alleges that by failing to “look both ways,” United “improperly generated and reported skewed data artificially inflating beneficiaries’ risk scores, avoided negative payment adjustments and retained payments to which it was not entitled.” Continue Reading