Last week, a number of health care industry associations sent letters to Congress detailing ways in which the government could relieve them of the burdens associated with “red tape.” The letters are in response to the first stage of a House initiative dubbed the “Medicare Red Tape Relief Project,” which was announced earlier this summer by the House Committee on Ways and Means’ Subcommittee on Health. Continue Reading Hospitals and Others Respond to “Red Tape Relief Project” Requests
The U.S. Centers for Medicare & Medicaid Services (CMS) published a proposed rule last week regarding the cancellation of three bundled payment models and an incentive payment model while also reducing the scope of a third type of payment model. These models were mandatory for hospitals in certain geographic areas. The current administration had delayed the implementation of these models until January 1, 2018. Continue Reading CMS Proposes to Cancel Bundled Payment and Incentive Models
The Trump administration is considering releasing a rule to ease the burden that small practices are facing in trying to comply with the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA), according to a recent report in The Hill.
By way of background, MACRA consolidates a number of existing reporting programs into a two-track system under which eligible clinicians will receive incentive reimbursement payments through either the Merit-Based Incentive Payment Systems (MIPS) or through certain alternative payment models (APMs). Under MIPS, eligible clinicians can receive incentive payment (or penalties) based on their reporting of various measures. (For a detailed discussion of MACRA and these reporting requirements, see our prior post.) Alternatively, clinicians can be reimbursed under the second track if they participate in an “Advanced APM,” which include certain accountable care organizations (ACOs) and patient-centered medical homes. Continue Reading Insiders Say New MACRA Rule Likely as Providers Look to Sec. Price to Ease Burden
The Stark Law has caused angst for many a physician and many a health care lawyer over the years. The Stark Law has also troubled hospital and health system CEOs looking for ways to align incentives with physicians. Some stakeholders say Congress should do away with the myriad statutes and regulations that comprise the strict liability federal law banning physician self-referral. Those stakeholders suggest either repealing it altogether and letting other fraud and abuse laws do the work, or – as its namesake former-Representative Pete Stark has suggested – replace it with a much simpler prohibition on soliciting referrals for kickbacks or other special treatment.
My colleague, Tom Crane, suggests another approach – revamp the Stark Law’s advisory opinion process so the Centers for Medicare and Medicaid Services (“CMS”) can protect arrangements from sanctions, similar to the Office of the Attorney General’s (“OIG’s) Anti-Kickback Statute (“AKS”) advisory opinion process. Continue Reading Changes Needed to Stark Law Advisory Opinion Process
As the healthcare industry moves towards value-based purchasing, pay-for-performance, and other payment reform models, industry leaders have identified federal fraud and abuse laws as a barrier to full implementation of such models. Last month, the Health Care Leadership Council released a White Paper entitled “Health System Transformation: Revisiting the Federal Anti-Kickback Statute and Physician Self-Referral (“Stark”) Law to Foster Integrated Care Delivery and Payment Models” (“HCL White Paper”), identifying current fraud and abuse laws as impeding transformation of the healthcare system. Pharmaceutical and device manufacturers have also taken advantage of the OIG’s Solicitation of New Safe Harbors and Special Fraud Alerts (“OIG Solicitation”) to advocate for more flexible fraud and abuse laws with respect to value-based arrangements. Continue Reading Pharmaceutical Manufacturers and Healthcare Leaders cite Fraud and Abuse Laws as Obstacle to Value-Based Arrangements
Last week, the Medicare Payment Advisory Commission (the “Commission”) debated a package of policy reforms that would change the way Medicare reimburses physicians for Medicare Part B drugs. In the midst of calls to lower drug prices, the Commission has been developing its Part B reform package over the last two years and now, finally, appears poised to move forward with a vote at next month’s meeting.
Medicare Part B drugs are a multi-billion dollar benefit and typically include higher cost specialty drugs that are administered in a physician’s office on an outpatient basis. Drugs covered under Medicare Part B are reimbursed through a so-called “buy and bill” approach. That is, the physician buys the drugs and bills Medicare for their use. Medicare pays the provider the average sales price (“ASP”) of the drug plus a markup of 6% of the ASP. The 6% markup is generally considered compensation to physicians for the storage, handling, and other administrative costs associated with these specialty drugs. Continue Reading Medicare Advisors Debate Part B Drug Payment Reforms
Last week, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services released a report analyzing CMS’ readiness to implement major parts of the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA). The report provides an inside look at the steps CMS is taking to implement MACRA’s Quality Payment Program (QPP), which is an ambitious transformation of the way in which the federal government reimbursements health care providers. The report highlights two key vulnerabilities for the MACRA transition, a process that will hopefully be smoother than the troubled roll out of HealthCare.gov.
The Centers for Medicare & Medicaid Services (CMS) has withdrawn its controversial rule implementing the Medicare Part B payment demonstration. The agency stated that after consideration of the comments, it will not move forward with the demo.
The demonstration was intended to test new reimbursement methods for Medicare Part B drugs and to promote value-based and cost-effective drug purchasing. Despite its intentions, major patient, pharmaceutical, and physician groups criticized the scope of the rule and the speed in which CMS was implementing it. Many worried it would restrict or limit access to certain drugs. It also drew sharp criticism from several members of Congress, including President-elect’s nominee for the Secretary of Health and Human Services, Rep. Tom Price. Continue Reading The Medicare Part B Demo May be Dead, but Drug Pricing Concerns Still Linger
There has been much controversy over the Medicare Part B payment demonstration proposed by the Center for Medicare and Medicaid Innovation (CMMI) in March 2016. As we await the release of the final rule, the fate of this demonstration will be in the hands of a Republican-held Congress and President-Elect Trump. To move forward, not only will CMMI need to finalize the implementing regulations, but the Part B payment demonstration will also need to survive review under the Congressional Review Act (CRA). Continue Reading The Future of the Medicare Part B Payment Demo under a Republican-held Congress
Most of the post-election discussion of the ACA has focused on how promises to repeal the law could impact the newly insured. But one priority area of the ACA that has received very little discussion is the federal government’s strategy to try to reign in health care costs by reducing volume and promoting quality. Complicating the push to fully repeal the ACA is the fact that key elements of the ACA’s cost control strategy have found their way into the Medicare and CHIP Reauthorization Act (MACRA) passed by Congress in 2015.
MACRA was passed on a bipartisan, bicameral basis, creating a two-track system for Medicare provider reimbursement incentive payments. On one track is the more traditional fee-for-service reimbursement structure that will be subject to payment adjustments under a consolidated quality reporting system called the Merit-Based Incentive Payment System (MIPS). The second track, which entails greater incentive payments, addresses reimbursement for providers participating in alternative payment models (APMs) like accountable care organizations (ACOs) and other demonstration programs that have been created under CMS’s Center for Medicare & Medicaid Innovation (CMMI). We discussed these changes at length in our post last month.
While the sweeping Republican election victory portends extensive changes in many areas of health care, MACRA is not likely to see extensive changes–at least not directly. Moving payment policy away from volume and towards quality was a goal for all the Congressional offices participating in the construction of MACRA. However, the implementation of MACRA could still face challenges if Congressional Republicans decide to repeal or constrain the ACA sections that give CMS the authority to operate the CMMI. Such a move would not be outside the realm of possibility; as we previously discussed, the CMMI has been a frequent target of criticism by Congressional Republicans. A full repeal of the ACA, or even limitations to the CMMI’s authority or budget, could cripple the government’s ability to operate the demonstration projects that are the cornerstones of MACRA.
Stakeholders need to engage with CMS moving forward, albeit a CMS under new management, to ensure that changes to the ACA do not have unintended consequences on MACRA’s implementation. CMS may seek to streamline the numerous payment policies that have been proposed under the current Administration. Alternatively, it is possible that CMS will be active in creating its own versions of alternative payment models. One area of potential focus for further reform might be the so-called ACO Track 2 and 3 under the Medicare Shared Savings Program (MSSP), participation in which will now make providers eligible to receive APM incentive payments. Yet CMMI to date has struggled to find the right mix of payment reform, such as requiring two-sided risk, with payment incentives to show significant MSSP savings. In either case, the provider community will be closely watching the developments related to this already complex and daunting transition.