CMS Proposes CY 2018 Quality Payment Program Policy Changes that Signal Intent to Reduce the Pace and Burdens of MACRA

On June 30, the Centers for Medicare & Medicaid Services (CMS) issued a much anticipated rule outlining proposed payment and policy changes to the new Medicare Part B Quality Payment Program (QPP) that was created by the Medicare Access and Chip Reauthorization Act of 2015 (MACRA). The proposed rule seeks to offer additional flexibility and programmatic support to eligible clinicians, particularly those in small practices, and continues to phase in QPP reporting obligations and payment adjustments.

The proposed rule reiterates MACRA’s goals and continues the core principles of the QPP, including its two pathways for eligible clinicians: (1) the default Merit-based Incentive Payment System (MIPS) path, which includes upward or downward payment adjustments based on scores in four performance categories, and (2) the Advanced Alternative Payment Model (Advanced APM) path for clinicians who meet the criteria of a Qualifying APM Participant (QP) in an Advanced APM. The proposed rule includes key changes impacting both pathways and provides detail on new policies that become effective in and after Year 2 of the QPP. Continue Reading

Capitol Hill Healthcare Update

Delayed Senate Health Vote Boon to GOP or Just Prolonging the Inevitable?

Senate Majority Leader Mitch McConnell’s announcement that he would delay a key procedural vote scheduled for this week on the Republicans’ healthcare overhaul gave the GOP yet more time to find a legislative solution that can pass the Senate.

But given McConnell’s inability so far to cobble together a majority to repeal the Affordable Care Act, the delay may just be prolonging what’s turning into a political nightmare for the GOP. Despite congressional majorities in the House and Senate, Republicans can’t rally around a plan to overturn a law they have campaigned against for seven years.

McConnell was forced to push back a vote on whether to begin debating the GOP health bill, the Better Care Reconciliation Act, after Sen. John McCain underwent surgery for a blood clot Saturday. McCain won’t be back in Washington for at least another week.  Continue Reading

Capitol Hill Healthcare Update

Senate Reconvenes but No Health Votes Expected This Week

The Senate reconvenes today following the Fourth of July recess, but senators are at least a week away – and perhaps even longer – from voting on legislation to replace the Affordable Care Act (ACA).

Familiar divisions continue to frustrate Republicans: how to deal with states that expanded their Medicaid programs (20 GOP senators represent states that did) and how to bring down costs for individual health plans while still covering pre-existing conditions. Majority Leader Mitch McConnell and other GOP leaders personally called rank-and-file senators during the recess, but it doesn’t appear Republicans are closer to resolving thorny policy differences.

Rather than allowing lawmakers to return to the Capitol with renewed optimism for overturning the ACA, the holiday recess appeared to provoke only more intra-party division. Several Republicans announced last week that they opposed the draft legislation McConnell released in June, and at least three other senators refused to publicly back the bill or even its framework. And Sen. John McCain (R-Ariz.) pronounced the current healthcare bill “dead.” Continue Reading

OIG Report Estimates CMS Paid Millions in Erroneous Meaningful Use Incentives

On June 12, 2017 the Department of Health and Human Services Office of Inspector General (OIG) released a report entitled Medicare Paid Hundreds of Millions in Electronic Health Record Incentive Payments That Did Not Comply With Federal Requirements (Report) which estimates that between May 2011 and June 2014, the Centers for Medicare & Medicaid Services (CMS) under the Electronic Health Record Incentive Programs improperly paid over $729 million to providers that did not comply with federal requirements.

Following passage of the Health Information Technology for Economic and Clinical Health Act (HITECH) in 2009, CMS offered significant incentives to health care providers to encourage adoption of EHR systems that satisfied “meaningful use” requirements. To be eligible for EHR incentive payments, providers were required to self-attest that they satisfied federal program requirements and retain all documentation supporting their attestation for a period of six years following the attestation submission. To provide oversight of the program and ensure program integrity, CMS was tasked with conducting risk-based audits of inaccuracies in eligibility, reporting, and payment. Continue Reading

Capitol Hill Healthcare Update

Searching for 50 Votes: Changes to Health Bill, CBO Score Coming This Week

Senate Republican leaders are expected to make a series of changes to the healthcare legislation released Thursday as they scramble to gain the support of at least 50 lawmakers in a showdown vote scheduled for later this week.

GOP leaders are expected to offer additional changes on Medicaid, continuous coverage and opioid addiction funding in an effort to entice senators, including five lawmakers who announced their outright opposition and several others who expressed reservations about the draft bill. The Congressional Budget Office also is expected to release its analysis as soon as today, including estimates on insurance coverage and premiums, and the draft bill’s impact on government spending.

Senate Majority Leader Mitch McConnell (R-Ky.) this week will try to strike just the right balance of legislative changes to woo moderates and conservatives who oppose the current draft, now called the Better Care Reconciliation Act. It’s a tightrope exercise, and it’s not clear whether McConnell can succeed. He can only afford to lose two votes from his 52-seat majority.

The Senate will take a procedural vote Wednesday to bring up the bill and then debate the legislation for up to 20 hours, split evenly between the two parties. After that, senators will begin a “vote-a-rama,” a series of rapid-fire votes on dozens of amendments in a marathon session that likely could stretch for hours.

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

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

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.

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

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

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

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

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