Health Law Advisor Thought Leaders On Laws And Regulations Affecting Health Care And Life Sciences

Tag Archives: Medicare

Stakeholder Agendas in the Washington Transition: 5 Takeaways for Converting Ideas into Technically Effective Proposals

As the transition in Washington moves into high gear this month, it’s not just the new Administration and Congress that are putting in place plans for policy and legislation; stakeholders are busy creating agendas, too.

Many stakeholder agendas will seek to affect how government addresses such prominent health care issues as the Affordable Care Act, Medicare entitlements, fraud-and-abuse policies, FDA user fees, and drug pricing. There will be a myriad of stakeholder ideas, cutting a variety of directions, all framed with an eye to the new political terrain.

But whatever policies a stakeholder advocates, ideas must be translated into a … Continue Reading

Court Issues Nationwide Injunction Prohibiting Enforcement of Section 1557 Provisions Relating to Gender Identity and Termination of Pregnancy – But Other Provisions Still Can Be Enforced

On December 31, 2016, the U.S. District Court for the Northern District of Texas issued a nationwide preliminary injunction that prohibits the U.S. Department of Health and Human Services (HHS) from enforcing certain provisions of its regulations implementing Section 1557 of the Affordable Care Act that prohibit discrimination on the basis of gender identity or termination of pregnancy. This ruling, in Franciscan Alliance v. Burwell (Case No. 7:16-cv-00108-O), a case filed by the Franciscan Alliance (a Catholic hospital system), a Catholic medical group, a Christian medical association, and eight states in which the plaintiffs allege, among other allegations, that … Continue Reading

Top Five Takeaways from MedPAC’s Meeting on Medicare Issues and Policy Developments—December 2016

The Medicare Payment Advisory Commission (“MedPAC”) met in Washington, DC, on December 8-9, 2016. The purpose of this and other public meetings of MedPAC is for the commissioners to review the issues and challenges facing the Medicare program and then make policy recommendations to Congress. MedPAC issues these recommendations in two annual reports, one in March and another in June. MedPAC’s meetings can provide valuable insight into the state of Medicare, the direction of the program moving forward, and the content of MedPAC’s next report to Congress. At the annual December meeting MedPAC reviews draft recommendations to Congress regarding Medicare … Continue Reading

Top Five Takeaways from MedPAC’s Meeting on Medicare Issues and Policy Developments — October 2016

The Medicare Payment Advisory Commission (“MedPAC”) met in Washington, DC, on October 6-7, 2016. The purpose of this and other public meetings of MedPAC is for the commissioners to review the issues and challenges facing the Medicare program and then make policy recommendations to Congress. MedPAC issues these recommendations in two annual reports, one in March and another in June. MedPAC’s meetings can provide valuable insight into the state of Medicare, the direction of the program moving forward, and the content of MedPAC’s next report to Congress.

As thought leaders in health law, Epstein Becker Green monitors MedPAC developments to … Continue Reading

Top Five Takeaways from MedPAC’s Meeting on Medicare Issues and Policy Developments — September 2016

The Medicare Payment Advisory Commission (“MedPAC”) met in Washington, DC, on September 8-9, 2016. The purpose of this and other public meetings of MedPAC is for the commissioners to review the issues and challenges facing the Medicare program and then make policy recommendations to Congress. MedPAC issues these recommendations in two annual reports, one in March and another in June. MedPAC’s meetings can provide valuable insight into the state of Medicare, the direction of the program moving forward, and the content of MedPAC’s next report to Congress.

As thought leaders in health law, Epstein Becker Green monitors MedPAC developments to … Continue Reading

Disruptor Meets Regulator, and Regulator Wins: Lessons Learned from Theranos

On July 7, 2016, the Centers for Medicare and Medicaid Services (“CMS”) imposed several administrative penalties on Theranos, a clinical laboratory company that proposed to revolutionize the clinical laboratory business by performing multiple blood tests using a few drops of blood drawn from a finger rather than from a traditional blood draw that relies on needles and tubes. However, after inspecting the laboratory, CMS concluded that the company failed to comply with federal law and regulations governing clinical laboratories and it posed an immediate jeopardy to patient health and safety. CMS has revoked the CLIA certification of the company’s California … Continue Reading

Network Adequacy: A Multimarket Recap of 2015 and Looking Ahead

2016 is poised to be a major year in network adequacy developments across public and private insurance markets.  Changes are ahead in the Medicare and Medicaid managed care programs, the Exchange markets and the state-regulated group and individual markets, including state-run Exchanges.  The developing standards and enforcement will vary significantly across these markets.

Through 2014 and 2015, major news stories discussed concerns over the growing use of narrow provider networks by issuers on the Affordable Care Act’s insurance exchanges (“Exchanges”).  Others reported on enrollees’ frustration with receipt of unexpected charges from out-of-network practitioners when receiving treatment at in-network facilities (often … Continue Reading

More Time Given To Stakeholders to Respond to CMS’ Request for Information on Physician Payment Reforms

On September 28, 2015, the Centers for Medicare & Medicaid Services (“CMS”) issued a request for information (“RFI”) seeking comments on two key components of the physician payment reform provisions included in the Medicare Access and CHIP Reauthorization Act of 2015 (“MACRA”), the law enacted on April 16, 2015, repealing the sustainable growth rate formula used to update payment rates under the Medicare Physician Fee Schedule.  The RFI was originally open for a 30-comment period.  However, CMS has announced that it is extending the comment period for an additional 15 days.  Comments to the RFI are now due to CMS Continue Reading

CMS Progress Note Template for Home Health Patients: Comments due by October 13

In January 2015, CMS announced that it was considering developing voluntary clinical templates to help physicians adequately document their encounters with Medicare patients who receive home health services.[1] CMS initially proposed a sample paper template progress note and suggested clinical template elements for an electronic progress note. CMS hosted three Special Open Door Forums to solicit feedback on the proposed templates from physicians, home health agencies, and other interested stakeholders to provide feedback on the proposed templates.

On August 12, 2015, CMS announced that a suggested clinical template had been submitted to the Office of Management and Budget (OMB) … Continue Reading

HHS Announces Goals for Moving Medicare from Volume to Value Payments.

By Arthur J. Fried.

In what is being called an historic announcement, Department of Health and Human Services Secretary Sylvia Mathews Burwell announced on Monday the setting of clear goals and timeframes for moving Medicare from volume to value payments.  The stated goals are to tie 30% of all Medicare provider payments to quality and cost of care by 2016, moving to 50% by 2018.   Nearly all fee-for-service payments will be aligned with quality and value – 85% by 2016 and 90% in 2018.  This transformation will be achieved by the expansion of mechanisms already in use – Accountable … Continue Reading

OMHA’s Second Appellant Forum Prompts Opportunity for Stakeholder Comments on Reducing Appeals Backlog

Amy F. LermanOn October 29, 2014, the Office of Medicare Hearings and Appeals (“OMHA”) hosted its second Medicare Appellant Forum (“Forum”) to address the status of the Medicare appeals backlog and related processing delays of Administrative Law Judge (“ALJ”) appeals, which are the third level of the Medicare appeals process that is available to suppliers, providers, and Medicare beneficiaries to challenge denied claims. Last week’s Forum was a follow-up to OMHA’s February 2014 Appellant Forum, which offered few assurances to stakeholders at the time that any effective remedies to the delays in the appeals process … Continue Reading

Medicare’s Proposed Home Health Rule for 2015: Face-to-Face Encounter Documentation Requirements

Our colleagues at Epstein Becker Green released a client alert: “Medicare’s Proposed Home Health Rule for 2015: CMS Suggests Only Limited Relief to the Face-to-Face Encounter Documentation Requirements but Continued Compliance Burdens on Home Health Agencies,” by Emily E. Bajcsi and Serra J. Schlanger.

Following is an excerpt:

On July 7, 2014, the Centers for Medicare & Medicaid Services (“CMS”) published proposed changes to the Medicare Home Health Prospective Payment System (“HH PPS”) for calendar year 2015 (“Proposed Rule”). The Proposed Rule would update the HH PPS payment rates effective January 1, 2015, including continued implementation of the … Continue Reading

CMS Gets the Message – Updated Governance Changes to the Medicare Conditions of Participation

By Arthur J. Fried

The Controversy – 2012 Rulemaking Attempts

Roughly two years ago, the Centers for Medicare and Medicaid Services of the Department of Health and Human Services (“CMS”) published final regulations announcing two controversial rule changes addressing hospital governance.  The industry was taken by surprise, to say  the least, as neither of these requirements had been in the proposed rule.  The changes, promulgated as amendments to the Governing Body Condition of Participation (CoP) included (i) the requirement that a hospital’s board include at least one member of its medical staff; and (ii) a statement in the preamble interpreting … Continue Reading

The ACA Is Constitutional, but What’s Next?

The Supreme Court Has Decided, But Can America Afford the Affordable Care Act? in Bloomberg BNA's Health Law Reporter

Most reasonably-well-informed citizens, and certainly everyone concerned with health care, is well aware that the Supreme Court concluded its most-recent term with the Chief Justice joining the Court’s so called “liberal” wing in National Federation of Independent Business v. Sibelius, in upholding essentially all of the Obama Administration’s Affordable Care Act (“ACA”), including its most controversial provision – the “individual mandate” —  not under the Commerce Clause, as its proponents argued, but under the tax power.  The Court’s majority also upheld, but limited, the controversial Medicaid expansion provision of the ACA. The expansion survives, but if a State declines to … Continue Reading

Medicare ACOs: Financial and Clinical Integration

Back in 1996, the Federal Trade Commission and Department of Justice, in providing antitrust guidance for multi-provider networks, considered financial integration and clinical integration as separate pathways for such networks to avoid per se violations of the antitrust laws and, instead, to be treated under the rule of reason, allowing for an assessment of their procompetitive vs. anticompetitive effects. With 65 organizations now participating in Medicare shared savings initiatives, including the 27 Medicare Shared Savings Program participants announced on April 10 (there are 32 Pioneer Accountable Care Organizations and 6 Physician Group Practice Transition Demonstration organizations), we can see, 16 years … Continue Reading

RAC Roundup: What’s on the Horizon for Medicare Part C and D RACs? Medicaid RAC Implementation Is Underway

by Pamela D. Tyner, Amy Lerman, and Lesley R. Yeung

The Recovery Audit Contractor (“RAC”) program is a national program aimed at identifying Medicare program overpayments and underpayments through a review of individual Medicare claims by contractors paid on a contingency fee basis. Over the next year, the RAC program will expand its reach beyond the current focus on fee-for-service payments under Medicare Parts A and B to include Medicare Part C (Medicare Advantage) and Part D (Prescription Drug Benefit) as well as state Medicaid programs. As Medicaid RAC programs get underway in the states, and private insurers … Continue Reading

Continuing the Spotlight on Medicare Providers and Suppliers: New OIG Report Details Program Integrity Problems with Newly Enrolled Medical Equipment Suppliers

According to a new report released in December 2011 by the Office of Inspector General (“OIG”), more than 25 percent of all durable medical equipment (“DME”) suppliers faced enforcement actions by the Centers for Medicare & Medicaid Services during their first year of participation in the Medicare program. In its report, the OIG reviewed a sample of 229 newly enrolled suppliers and examined multiple data sources in order to assess the extent, if any, that the suppliers in the sample had program integrity issues. According to the report, during the first year of participation in the Medicare program, 26 percent … Continue Reading

Medicare Providers and Suppliers Continue in the Spotlight: Medicare Providers and Suppliers Continue in the Spotlight

Expansion of the DMEPOS Competitive Bidding Program; Legislative Inquiry Related to Fraud and Abuse Enforcement Actions; and Automated Pre-Enrollment Provider Screening

by George B. Breen, Amy F. Lerman, Emily E. Bajcsi, Deepa B. Selvam

In order to be prepared for upcoming changes and to respond to new initiatives, providers and suppliers participating in Medicare must be aware of recent Congressional activity that would hold the federal government accountable for its intended enforcement efforts designed to curb health care fraud, waste, and abuse, as well as an effort by the Centers for Medicare & Medicaid Services (“CMSContinue Reading

Revisiting the Medicare Shared Savings Program: An Interagency Effort to Promote Accountable Care

by Ross K. Friedberg, Shawn M. Gilman, Mark E. Lutes, David E. Matyas, René Y. Quashie, Serra J. Schlanger, Carrie Valiant, Dale C. Van Demark, and Lesley R. Yeung

On October 20, 2011, the Centers for Medicare & Medicaid Services ("CMS") released its final rule ("Final Rule") implementing the voluntary Medicare Shared Savings Program ("Program") for accountable care organizations ("ACOs"). The Program was established by Section 3022 of the Patient Protection and Affordable Care Act. The Final Rule was released in conjunction with revised antitrust guidance from the Federal Trade Commission ("FTC") … Continue Reading

CMS Innovation Center Announces Four Models in Bundled Payments for Care Improvement Initiative

by Lesley R. Yeung, Shawn M. Gilman, and Serra J. Schlanger

On August 23, 2011, the Centers for Medicare & Medicaid Services (“CMS”) Innovation Center announced a new initiative to encourage health care providers to better coordinate patient care. The Bundled Payments for Care Improvement Initiative (“Bundled Payments Initiative”) seeks to align the financial incentives among hospitals, physicians, and non-physician practitioners through the use of a single negotiated payment for all services provided during an episode of care. The use of a bundled payment is expected to encourage hospitals, doctors, and other specialists to coordinate in treating a … Continue Reading

Five Wishes for the Medicare Shared Savings Program Regulations

As the health care world awaits the Medicare Shared Savings Program regulations expected to be issued soon by CMS, below is a wish list for key attributes that I hope the regulations evidence:

 

 

1. Flexibility. 

 

 "Transforming health care everywhere starts with transforming it somewhere." I hope that CMS takes Atul Gawande’s advice and avoids being too proscriptive in launching the Share Savings Program. To me, the biggest risk to the program is being deemed a failure for having gone down too narrow a path that turns out to be unsuccessful.

 

Useful approaches have been suggested for tiering ACOs and … Continue Reading

The Scope of Payment Reform Challenges Congress, Providers and Investors

As the “Three Tenors” (Chairmen Waxman, Miller and Rangel) struggle to finance the access enhancements that are central to the President’s health reform aspirations, the need for meaningful payment reform continues to challenge. This week House Speaker Nancy Pelosi urged the Chairmen to sharpen their pencils in this regard. Moreover, in a letter to the Speaker and Majority Leader Steny Hoyer, the fiscally-conservative “Blue Dog” coalition of House Democrats has now said that the current drafts fail to include sufficient structural reforms likely to succeed in lowering costs and incenting “value” (in purchasing).

These House members would like to see … Continue Reading

Commonwealth Fund and Population Prepayments

Much of the work of the Commonwealth Fund and others seems to presume that payors are a necessary intermediary and should be the entities doling out population prepayment (aka capitation before it was a nasty word). However, it need not work out that way – particularly with House Dems’ concern that Medicare Advantage was profiteering.

It would be a small step for the new public plan likely to be created to make “population prepayments” directly to integrated health systems particularly because the covered lives under such a plan are likely to have the benefit of public reinsurance. Also, since … Continue Reading