This morning CMS released a final rule regarding its most popular program for accountable care organizations (ACOs), the Medicare Shared Savings Programs. The final rule is based on the proposed rule for the program that was published in August.  The final rule adopts the major structural overhaul contained in the proposed rule, the reduction of the program to two tracks, Basic and Enhanced, the 1 year limitation for most established (ACOs) to remain in an “upside only” risk model and the 2 year limitation for most new ACOs to remain in an “upside only” risk model. The final rule increased the percentage of savings that will be shared with an ACO in an “upside only” model from 25% as proposed to 40%.  The rule also gives approved ACOs the ability to operate patient incentive programs which include cash payments up to $20 from certain ACO professionals and federally qualified health centers for qualifying primary care services,  provides some ACOs with more flexibility with respect to reimbursement for telehealth services, and includes numerous other detailed changes to the program’s operations. Continue reading…

Word spread quickly Monday (December 20, 2016) about CMS’ issuance of final regulations (to be published in the Federal Register on January 3, 2017) rolling out new mandatory bundled payments models for Acute Miocardial Infarction (AMI), Coronary Artery Bypass Graft (CABG), Surgical Hip and Fracture Treatment (SHFFT), a Cardiac Rehabilitation (CR) incentive model and Track 1+ Accountable Care Organizations. Speculation that President-elect Donald Trump’s nominee for HHS secretary, Rep. Tom Price, would move to roll the regulations back spread just as quickly.

The new regulations mandate bundled payment models (covering the period from admission to ninety days post-discharge) for AMI and CABG in 98 geographies covering 1,120 hospitals; for SHFFT in the 67 geographies where the Comprehensive Joint Replacement (CJR) has already been mandated covering 850 hospitals and for CR in 90 geographies covering 1,320 hospitals. CMS’ chart of geographies covered by each program is set forth here. The AMI, CABG and SHFFT programs give participant clinicians the opportunity to be excluded from Medicare and CHIP Reauthorization Act of 2015’s (MACRA) Medicare Incentive Payment System (MIPS) and to qualify under MACRA’s Advanced Alternative Payment Model (AAPM). Continue reading…

On September 8, 2016, CMS announced in its blog that it will allow physicians to select their level of participation for the first performance year of the Medicare Access and CHIP Reauthorization Act of 2015 (“MACRA”) Quality Payment Program, which begins January 1, 2017. Importantly, during the first performance year (2017), “[c]hoosing one of these options would ensure [physicians] do not receive a negative payment adjustment” under MACRA in 2019.

Under the Quality Payment Program physicians will fall under the Merit-Based Incentive Payment System (“MIPS”) if they do not qualify under the Advanced Alternative Payment Model (“Advanced APM”) option.  In 2019, physicians who are in the MIPS default option could face Medicare rate adjustments of up to 5% based on their performance under four weighted performance categories: quality (50%); resource use (10%); advancing care information (25%); and clinical practice improvement (15%). Advanced APMs include, for example, Track 2 and 3 MSSP ACOs; next generation ACOs; and bundled payment models, and physicians who qualify under the Advanced APM option earn a 5% incentive, are excluded from MIPS adjustments and receive higher fee schedule updates after 2024.

Recognizing that many physicians may face negative payment adjustments under MIPS as a result of participating under the Quality Payment Program, CMS is going to allow eligible physicians to “pick their pace of participation” and ensure they do not receive such negative payment adjustments in 2019 by choosing one of four options for the first performance year:

1. Test the Quality Payment Program;
2. Participate for part of the calendar year;
3. Participate for the full calendar year; or
4. Participate in an Advanced APM in 2017.

The first three options fall under MIPS, while the fourth option falls under the Advanced APM. In the first option, physicians could “submit some data to the Quality Payment Program”, avoid negative payment adjustments and test the waters before broader participation in subsequent years. Under option two, the performance year could begin later than January 1, 2017, a physician practice “could qualify for a small positive payment adjustment”, and a physician would submit Quality Payment Program information for fewer days. The third option is ideal for those physician practices that are ready to participate beginning January 1, 2017 and who are able to submit a full year of quality data. Additionally, physicians “could qualify for a modest positive payment adjustment.” The fourth option would be viable for those physicians or physicians groups who treat enough Medicare beneficiaries and who receive enough of their Medicare payments through an Advanced APM (e.g., MSSP ACOs). Through the Advanced APM option, physicians/physician groups would “qualify for a 5 percent payment in 2019.” It remains unclear what the difference is between a “small” and “modest” payment adjustment. However, CMS may address this in the final rule along with how it will implement MIPS and the Advanced APM. CMS will release the final rule by November 1, 2016.

For more information about MACRA, contact Chris Raphaely, Nicole Martin or a member of Cozen O’Connor’s Health Law team.

Tomorrow, the Centers for Medicare and Medicaid Services (“CMS”) will publish final regulations (“Final Rule”)  for its flagship pay-for-performance program, the Medicare Shared Savings Program, in the Federal Register. The Final Rule generally applies to performance years 2016 and beyond and the second three year “agreement period” for the over 400 accountable care organizations (“ACO”) currently in the program.

Stakeholders watched very closely the development of the Final Rule, so they can now begin sizing up future opportunities with some certainty and determine the longer term complexion of the program itself. The regulations contained in the Final Rule were published in proposed form in December 2014, and, the Final Rule adopts most, but not all, of what CMS initially proposed.  It continues the pattern of easing CMS’ ultimate push towards the two-sided risk model for most, if not all, ACOs and contains adjustments that many will consider to be favorable to ACOs.

Among the most significant developments is one in which, as proposed, ACOs that are currently in their first three year agreement period with CMS for participation in the program’s “upside only” risk model, Track 1, will be permitted to remain under the same model for another three years. This covers the majority of ACOs currently in the program. Significantly, however, CMS declined to institute the 10% cut (from 50% to 40%) to the Maximum Savings Rate for the second term Track 1 ACOs that it proposed last December.  The Final Rule comes none too soon for the first set of Track 1 ACOs who will have to make a decision whether or not to re-up for another three years in the program before the end of 2015.

In the other major structural change to the program, CMS, as it proposed to do, created a third double-sided risk, Track 3, for more highly developed ACOs desiring to trade greater upside opportunity (up to a 75% share of savings generated) for greater risk (up to 75% of losses) with both savings and losses being subject to a cap of 15% and 20% of benchmark, respectively. The new track includes a prospective beneficiary assignment model as opposed to the retrospective model that will continue to be used in Tracks 1 and 2. CMS also gives ACOs who choose the new track the option to waive Medicare’s three day hospital stay requirement for reimbursement of skilled nursing services. CMS stated that it will be considering additional waivers in areas like tele-health for Track 3 ACOs in the future.

CMS also included many technical adjustments to the program, some of which will have a significant impact on how the program and ACOs operate. Among the more significant are the following:

• Adjusting the savings benchmark calculation so second term ACOs that generated savings in their first term are not “penalized” by tougher savings targets in the second term as a result;
• Track 2 and Track 3 ACOs will be given new options for setting Minimum Savings and Loss Rates;
• Greater emphasis on primary care services provided by non-physician practitioners such as licensed nurse practitioners in the beneficiary assignment process;
• Enhanced information in the aggregate data reports supplied to ACOs and the inclusion of patients who had one primary care visit with an ACO in the assignment period even if they were not
  preliminarily assigned to the ACO in the aggregate reports supplied to Track 1 and 2 ACOs; and
• A streamlined data opt-out process in which (i) beneficiaries opt out of data sharing only by notifying CMS directly; and (ii) ACOs no longer have to wait thirty days after notifying beneficiaries of their opt-out rights before requesting detailed claims data on such beneficiaries.

The balance of 2015 and 2016 will be critical to the future of the Medicare Shared Savings Program as ACOs who currently participate in the program and others who are considering participation now have definitive guidance as to what the program will look like at least through 2018.

On January 26, 2015, the Secretary of the United States Department of Health and Human Services (“HHS”), Sylvia Mathews Burwell, announced two important goals for the Department:

1. Increase the percentage of Medicare provider payments that are made through alternative payment models based on how well the providers care for patients, rather than the amount of care provided. The percentage goals for these alternative payment models are 30% by 2016 and 50% by 2018.
2. Tie virtually all Medicare fee-for-service payments (85% in 2016 and 90% in 2018) to quality and value.

This announcement puts hard numbers on the goal to move away from traditional fee-for-service Medicare payments that has been stated generally since at least 2010 when the Affordable Care Act was enacted. By clearly delineating specific figures for alternative payment models, such as accountable care organizations and bundled payment arrangements, from those figures for payment methods, HHS has made it clear that providers should be thinking not just about different forms of payment but different forms of organizations and relationships with other providers. Alternative payment models generally require coordination among different types of providers who may not otherwise be related to each other.

While the announced goals focus on the Medicare fee-for-service system, it is clear that HHS intends the impact of these goals to be far broader. Ms. Burwell also announced the creation of a Health Care Payment Learning and Action Network to facilitate a public-private sector partnership to “continue to build on our work with state Medicaid agencies, private payers, employers, consumers and other partners,” while welcoming the fact that “our partners in the private sector have the opportunity to be even more aggressive” in establishing alternative payment models and pay-for-value compensation systems. On the same day as Ms. Burwell’s announcement, the Centers for Medicare and Medicaid Services released a fact sheet stating that it is taking action with a goal to spend “our health dollars” more wisely, citing the importance of the goal for patients, families, providers, tax payers, employers, states and insurance companies, and making it clear that HHS and CMS fully intend to have their efforts to transform health care delivery and payment systems to reverberate well beyond the Medicare program.

December has been a busy month for CMS with respect to the Medicare Shared Savings Program (“MSSP”). Last week CMS announced that eighty-nine (89) more ACOs would begin participating in the MSSP starting in 2015, bringing the total number of ACOs in the program to four-hundred and five (405). Continue reading…

In early October, the Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) released a proposed rule that included, among other provisions, a proposed gainsharing regulation (“Proposed Rule”), and a specific request for comments on a definition of what it means to “reduce or limit services” under the statutory prohibition against certain “gainsharing” arrangements among hospitals and physicians. The OIG’s goal with this Proposed Rule and subsequent final rule is to “interpret the statutory [gainsharing] prohibition broadly enough to protect beneficiaries and the Federal health care programs, but narrowly enough to allow low risk programs that further the goal of delivering high quality health care at a lower cost.” More specifically, the OIG seeks to implement a “narrower interpretation of the phrase “reduce or limit services.” Industry analysts are touting the final regulation as a potential game changer in the battle to deliver “high quality health care at a lower cost.”

The existing gainsharing civil monetary penalty statute (“Gainsharing CMP”) is a law that broadly “prohibits hospitals and critical access hospitals from knowingly paying a physician to induce the physician to reduce or limit services provided to Medicare or Medicaid beneficiaries who are under the physician’s direct care.” Violation of the Gainsharing CMP by a hospital that makes such payment, and a physician that in turn knowingly accepts the payment, results in CMPs that are no greater than $2,000 per each beneficiary for whom such payment is made.

Determining what does and what does not constitute a payment designed to reduce or limit services can be difficult, particularly because, as HHS has taken pains to point out, the statute technically prohibits payments from hospitals to physicians to limit any services, not just medically necessary services. However, as far back as 2005 the Medicare Payment Advisory Commission and the Chief Counsel to the OIG have supported gainsharing when safeguards are in place to evaluate risks posed by such programs, including “measures that promote accountability, adequate quality controls, and controls on payments that may change referral patterns,” and to date, the OIG has approved 16 gainsharing arrangements through the advisory opinion process.

More recently, under Section 3022 of the Affordable Care Act, the secretary of HHS established  waivers under the Medicare Shared Savings Program (MSSP) with respect to the Gainsharing CMP under certain conditions. These waivers have limited applicability as they apply only to accountable care organizations that participate in the MSSP. The final gainsharing regulations presumably will cover all hospitals and could potentially have a much broader impact upon hospital physician compensation arrangements. Overall, the Proposed Rule and the OIG’s request for comments on what should and should not constitute prohibited payments from hospitals to physicians to reduce or limit services is yet another example of how the regulatory  landscape is changing to adapt to a reimbursement model that is evolving from a fee-for-service dominated model to one in which pay-for-performance will play a much larger role.

The comment period closed under the Proposed Rule in early December, and the final rule is expected in 2015.

It has been a busy summer so far for the Centers for Medicare & Medicaid Services (CMS) with respect to Accountable Care Organizations (ACOs), as the agency has proposed altering the quality reporting measures under the Medicare Shared Savings Program (“MSSP”) for 2015 and beyond.  Expect an even busier fall as other, potentially broader, proposed rule changes for ACOs are analyzed by the Office of Management and Budget (OMB) and both sets of proposals wind their way through the public comment process.

The proposed changes concerning quality reporting would revise and update the measures used to evaluate MSSP ACOs’ performance. Overall, the CMS says it would like to focus more on outcome-based measures (as opposed to process-based measures), reduce duplicative measures, and reflect current clinical practices without increasing ACO’s reporting burden.

More specifically, the CMS proposes to add 12 new measures and remove eight, which would increase the total number of quality measures from 33 to 37. The new measures relate to “avoidable” admissions for patients with multiple chronic conditions, heart failure, and diabetes; depression readmission; readmissions to skilled nursing facilities; patient discussion of prescription costs; and updated composite measures for diabetes and coronary artery disease.

The CMS would like to modify the scoring system to award bonus points toward shared savings to ACOs that make year-over-year improvements on individual measures. Moreover, the agency would like to modify its benchmarking methodology to use flat percentages to establish the benchmark for a measure when the national FSS data results in the 90^th percentile being greater than or equal to 95 percent. And, finally, the CMS proposes several ways to align MSSP reporting requirements with other reporting programs, including Medicare’s Electronic Health Records Incentive Program and the Physician Quality Reporting System.

Fewer details are available about the next set of proposed rules changes, which were submitted to OMB on June 26 and will be printed in the Federal Register after review. It is expected that these regulations will include changes to the MSSP’s payment provisions. The proposed changes would apply to existing ACOs and approved ACO applicants starting January 1, 2016. As soon as the text of the rule becomes publicly available, the Health Law Informer will provide more information.

It has been over three years since the Centers for Medicare and Medicaid Services (CMS) announced its proposed rule and guidance on the development and implementation of Accountable Care Organizations.  About four million Medicare beneficiaries are now in an ACO, and over 400 provider groups are participating in ACOs.  See February 19, 2013 Health Affairs Blog. An estimated 14% of the U.S. population is being treated within an ACO. See April 16, 2014 Kaiser Health News.

By all indications, these numbers will continue to grow as the US health system moves away from the fee-for-service model to pay for value models that reward quality and cost savings and require clinical coordination among different types of providers, in many cases providers who are unrelated other than through an ACO or other similar arrangement.  The seamless sharing of data, patient information and collaboration among large, medium and small physician practices, hospitals, post-acute providers, and even private companies like pharmacy chains is critical to the success of these organizations. Continue reading…