Health Law Advisor

In this episode of the Diagnosing Health Care Podcast:   With the recent midterm elections changing the composition of Congress, and the Biden administration’s first opportunities to advance its policy priorities from the very beginning of the rulemaking process, what are the key health care developments to watch out for in 2023?

Epstein Becker Green attorneys Ted Kennedy, Jr.; Alexis Boaz; and Philo Hall discuss the current landscape of health care policy from both the legislative and regulatory perspectives and analyze which key health care issues may arise.

On November 30, 2018, the Department for Health and Human Services (“HHS”) Health Resources and Services Administration (“HRSA”) will publish its final rule to change the effective date for its 340B Drug Pricing Program ceiling price and manufacturer civil monetary penalty final rule to January 1, 2019.

After two years of proposed rulemaking, HHS published a final rule on January 5, 2017 outlining requirements of manufacturers to calculate the 340B ceiling price for a covered outpatient drug and the process by which HRSA can levy civil monetary penalties on drug ...

On October 15, 2018, the Centers for Medicare and Medicaid Services (CMS) unveiled its proposed rule requiring direct-to-consumer television advertisements for prescription drug and biological products to contain the list price (defined as the Wholesale Acquisition Cost) if the product is reimbursable by Medicare or Medicaid. Medical devices are not included in the proposed rule, although CMS seeks comment on how advertised drugs should be treated if used in combination with a non-advertised device. If finalized, the requirement will be sweeping and only purports to exclude ...

In 2016, the populist trend in American politics was an undeniable factor behind Trump's election victory as well as the ascendancy of Bernie Sanders and Elizabeth Warren within the Democratic Party.  During upcoming months, industry observers will be looking for signs as to whether drug pricing is an area in which both parties can agree on instituting significant legislative action at the state and federal levels.  The nature and shape of any such reforms will be highly consequential for the U.S. pharmaceutical industry, which has served as a prime source of innovation in medicine.  ...

A recent article in Bloomberg BNA's Health Insurance Report will be of interest: "ACA's Employer 'Pay or Play' Mandate Delayed - What Now for Employers?" by Frank C. Morris, Jr., and Adam C. Solander, colleagues of ours, based in Epstein Becker Green's Washington, DC, office. Following is an excerpt:

The past few weeks have changed the way that most employers will prepare for the employer ‘‘shared responsibility'' provisions of the Affordable Care Act (ACA). Over the past year or so, employers have scrambled to understand their obligations with respect to the shared ...

I was recently quoted in an article titled "4th Circuit Upholds ACA's Employer Mandate, Says Insurance Regulation Within Commerce," by Mary Anne Pazanowski, in Bloomberg BNA's Health Care Daily Report. Following is an excerpt:

A unanimous U.S. Court of Appeals for the Fourth Circuit July 11 declared the Affordable Care Act's employer mandate a valid exercise of Congress's power to regulate commerce under the U.S. Constitution's Commerce Clause (Liberty University Inc. v. Lew, 4th Cir., No. 10-2347, 7/11/13).

In an opinion co-authored by Judges Diana Gribbon Motz, James A. Wynn ...

Our colleagues Kara Maciel, Frank C. Morris Jr., Elizabeth Bradley, and Adam Solander have posted a client advisory on the recent ACA employer mandate delay, exploring the ramifications and unresolved issues that employers should consider. Following is an excerpt:

In reaction to employers' concerns about the many difficulties posed in efforts to comply with the Employer Mandate provisions of the Affordable Care Act ("ACA"), the Obama administration ("Administration") announced late yesterday that it is delaying the implementation of the penalty provisions and other ...

By Greta Ravitsky

I wrote the January 2013 edition of Take 5: Views You Can Use, a newsletter published by the Labor and Employment practice of Epstein Becker Green.

In it, I summarize five actions that employers should consider taking in 2013 as the DOL steps up its audit efforts under the leadership of the reenergized Obama administration:

1. Assess the Workforce
2. Choose Whether to “Pay” or to “Play”
3. Evaluate Existing Wellness Programs and/or Implement New Wellness Programs to Enhance Employees’ Health Profiles and to Avoid or Minimize the “Cadillac Tax”
4. Understand and ...

On Friday, November 30, Epstein Becker Green attorneys Frank C. Morris, Jr., and Adam C. Solander offered a one-hour webinar titled “The New Wellness Program Regulations, Part of a Webinar Series on the New ACA Implementation Regulations: Employer Impact.” The webinar discussed:

• the proposed regulations and the impact these regulations could have on your overall wellness strategy
• areas where employer comment is needed
• recent wellness litigation trends
• where EEOC fits in the picture

The audio recording and presentation slides for "The New Wellness Program Regulations" ...

Epstein Becker Green is pleased to announce a webinar series for employers on the forthcoming rules and regulations implementing the Affordable Care Act ("ACA"). We expect the Administration to release a significant number of regulations in the near future which will directly impact employers.

EBG Health Care & Life Sciences and Labor & Employment practitioners, along with outside speakers, will provide in-depth analysis on proposed rules and regulations and how they will impact decisions that must be made by employers. The first webinar will take place on November 30.

Stay tuned ...

Stuart Gerson, a Member of the Firm in the Litigation and Health Care and Life Sciences practices at Epstein Becker Green, authored an article titled "The Supreme Court Has Decided, but Can America Afford the Affordable Care Act?"

Following is an excerpt:

By now, every American who pays any attention to the news is aware that on the last day of its now concluded term, the U.S. Supreme Court, with its June 28 decision in National Federation of Independent Business v. Sebelius, U.S., No. 11-393, 6/28/12, has upheld essentially all of the Obama Administration's Affordable Care Act (ACA ...

On Monday, July 2, 2012, Epstein Becker Green conducted a webinar titled "Decision 2012: What's In, What's Out, and What's Next?" examining the monumental decision (PDF) issued by the Supreme Court of the United States on the Patient Protection and Affordable Care Act.

This webinar analyzed the decision and its implications for the states, the health care and life sciences industry, and employers. It also addressed potential congressional activity and the decision's impact on the presidential election.

Click here to view the recording of this webinar (WMV file)

By Stuart M. Gerson

By now, every American who pays any attention to the news is aware that the Supreme Court of the United States has upheld essentially all of the Obama administration's Affordable Care Act. We have posted a copy of the lengthy opinion, concurrence, and dissent on our website. For now, we should be focusing on what the case of National Federation of Independent Business v. Sebelius actually will cause to occur.

Read the full alert here

by Jay Gerzog, Dale Van Demark, Tamar Rosenberg, and Dawn Welch

Is it possible that the U.S. Department of the Treasury (“Treasury”) knows something we do not about the pending U.S. Supreme Court decision on PPACA?

Probably not, but that has not stopped the Treasury and Internal Revenue Service (“IRS”) from issuing proposed regulations on June 26, 2012, with respect to three of the four new requirements for tax exemption of hospitals imposed by PPACA.

With the adoption of PPACA, Congress took its first concrete step toward toughening the standard for tax exemption in decades ...

by Daniel E. Gospin and Amy F. Lerman

As part of continued efforts to expand the Medicare Recovery Audit Contractor (“RAC”) program, the Centers for Medicare & Medicaid Services announced in November 2011 the implementation of a demonstration project that will allow RACs to conduct prepayment reviews on certain types of Medicare claims that historically have resulted in high rates of improper payments.

The prepayment review demonstration project will focus these efforts in 11 states—seven of which were selected because they have significant populations of fraud- and ...

by Joseph J. Kempf, Jr., and Jackie Selby

Evolving reimbursement models for health care providers (away from “fee for service” and toward “pay for performance” and risk sharing) raise interesting questions as to how such payments will be treated under the new medical loss ratio rules under the Patient Protection and Affordable Care Act. Some of the payments will not qualify as “medical expense” or “quality improvement activities” and will be treated as “administrative expense,” so providers and insurers and health plans may want to take these rules into ...

by Joseph J. Kempf, Jr., and Jane L. Kuesel

On April 12, 2012, Governor Andrew Cuomo issued an Executive Order requiring the State of New York to establish an American Health Benefit Exchange and Small Business Health Options Program in New York (together, the “Health Benefit Exchange”). The Governor’s action was taken in response to the mandate contained in Section 1311 of the Patient Protection and Affordable Care Act, and the New York Legislature’s failure to enact legislation to begin development of the Health Benefit Exchange. Although the Health Benefit Exchange is ...

By Stuart M. Gerson

The three days of arguments about the constitutionality of the Patient Protection and Affordable Care Act are complete. The Justices of the Supreme Court of the United States have conducted their post-argument conference and are now turning their attention to the drafting and the discussions that will lead to a majority opinion and, likely, several dissents and concurrences. The Court's decision should be issued before the end of June. Health care companies and employers, like the rest of the population, await the ultimate decision. However, there are several ...

by Jesse M. Caplan and Serra J. Schlanger

Since November 2011 the Center for Consumer Information & Insurance Oversight (“CCIIO”) in the Centers for Medicare & Medicaid Services has completed 22 reviews of health insurance premium rate increase filings in the individual and small group markets. Under the new federal rate review regulations, CCIIO has determined that six of the reviewed premium rate increases represented “unreasonable” increases while 16 of the rate increases were deemed “not unreasonable.”

This Implementing Health and Insurance Reform alert ...

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 ...

by Shawn M. Gilman and Julia E. Loyd

On February 14, 2012, a final rule implementing Section 2715 of the Public Health Service Act, as added by the Patient Protection and Affordable Care Act, regarding the requirements for group health plans and health insurance issuers to provide a summary of benefits and coverage (“SBC”) to interested parties was published in the Federal Register. As set forth in the final rule, an SBC must be provided upon request or the occurrence of certain events and the content and format of the SBC must be in accordance with the extensive requirements ...

by Kathleen A. Peterson, Benjamin S. Martin, Wendy C. Goldstein, and Constance A. Wilkinson

This issue of Implementing Health & Insurance Reform summarizes and discusses some issues raised by the proposed rule ("Proposed Rule") that the Centers for Medicare & Medicaid Services ("CMS") published on February 2, 2012, to implement changes to the Medicaid Drug Rebate Program ("MDRP") and to reimbursement limits for outpatient drugs covered by Medicaid.

In Part 1, we discuss proposals relating to the MDRP that would change the manner in which pharmaceutical manufacturers calculate ...

by Gretchen Harders, Daly D.E. Temchine, and Joseph J. Kempf, Jr.

On December 7, 2011, final rules on the medical loss ratio (“MLR”) requirements for insured health plans (and an interim final rule for non-federal governmental plans) were issued by the U.S. Department of Health and Human Services and the Centers for Medicare & Medicaid Services under the Patient Protection and Affordable Care Act. The MLR requirements are effective January 1, 2012, and any issuer who does not meet the MLR requirements for the 2011 MLR reporting year must pay rebates by August 1, 2012. This alert ...

by Jesse M. Caplan and Serra J. Schlanger

On November 21, 2011, the Center for Consumer Information & Insurance Oversight, in the Centers for Medicare & Medicaid Services (“CMS”), announced its determination that a health insurance premium rate increase of 11.58 percent in the small group market in Pennsylvania represented an “unreasonable” rate increase, while an 11.10 percent increase in the individual market in Montana did not. These long-awaited determinations represent the first application of CMS’s rate review regulations under federal health reform.

This ...

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 ...

EBG Introduces Interactive National Rate Review Scorecard

by Jesse M. Caplan and Lynn Shapiro Snyder

Shortly after the September 1st effective date for the Centers for Medicare & Medicaid Services (CMS) Rate Review Regulations, the U.S. Department of Health and Human Services published an Amendment to the Final Rule that revises the definitions of “Individual Market” and “Small Group Market” to include insurance policies sold to individuals and small groups through associations, whether or not the applicable state includes association coverage in its own definitions ...

EBG Introduces Interactive National Rate Review Scorecard

by Jesse M. Caplan and Lynn Shapiro Snyder

On May 23, 2011, the Center for Consumer Information & Insurance Oversight (CCIIO), in the Centers for Medicare & Medicaid Services (CMS) of the United States Department of Health and Human Services (HHS) published its Final Rule implementing Section 2794 of the Public Health Service Act (PHSA).  This Section requires HHS to establish a process for the review of “unreasonable” health insurance premium rate increases in the individual and small group markets.  The Final Rule ...

by Lynn Shapiro Snyder,  Shawn M. Gilman,  Adam C. Solander, and Constance A. Wilkinson

On June 16, 2011, the Office of Personnel Management (“OPM”) released the Request for Information (“RFI”) regarding Section 1334 of the Affordable Care Act, which requires OPM to contract with health insurers to offer multi-state qualified health plans (“MSQHPs”). The purpose of the RFI is to provide OPM with information that will allow it to better understand the “interests and capabilities” of health insurance issuers that will offer MSQHPs through Health Insurance ...

by Lynn Shapiro Snyder and Amy F. Lerman

On April 14, 2011, the U.S. Department of Health and Human Services announced several initiatives that will offer states more flexibility to adopt innovative new practices in order to provide better and more coordinated care for Medicare and Medicaid enrollees who are dually eligible under both of these programs. Under one of these initiatives, 15 states have been awarded $1 million contracts to support the design of state demonstration projects that will aim to improve the coordination of care for dual eligibles. The Centers for Medicare ...

by Ross K. Friedberg, Shawn M. Gilman, and Lesley R. Yeung

On March 31, 2011, the Centers for Medicare & Medicaid Services, the Department of Health and Human Services' Office of the Inspector General, the Federal Trade Commission, the Department of Justice, and the Internal Revenue Service released four separate issuances providing the public with the opportunity to comment on the creation of accountable care organizations eligible for participation in the voluntary Medicare Shared Savings Program ("MSSP"). This alert sets forth a listing of each of the places in which the ...

by Wendy C. Goldstein, Kathleen A. Peterson, Benjamin S. Martin, and Constance A. Wilkinson 

On September 3, 2010, the Centers for Medicare & Medicaid Services ("CMS") issued a proposed rule withdrawing regulations governing the determination of "Average Manufacturer Price" ("AMP"), the definition of "Multiple Source Drug," and the application of federal upper reimbursement limits ("FULs") for Multiple Source Drugs (the "Proposed Rule"). This withdrawal would impact the applicable regulations finalized by CMS in 2007 and 2008 but would leave intact other sections of the 2007 ...

Now that we have sweeping new health care legislation, the Patient Protection and Affordable Care Act ("the Act"), let's look at the rollout of the accountable care provisions--i.e., those changes to the payment and delivery system that hold the most long-term promise of improving quality and cost-efficiency. They are discussed in my most recent article: "The Timeline for Accountable Care: The Rollout of the Payment and Delivery Reform Provisions in the Patient Protection and Affordable Care Act and the Implications for Accountable Care Organizations," published last week in ...

With the rejection in the Senate Finance Committee of two separate proposals to create a substantial public health insurance option and, instead, the approval of the relatively weak co-op proposal (which the CBO estimates to be unlikely to establish a meaningful presence and will result in only half the budget amount of $6 billion will be spent) it seemed as though the public option had breathed its last breath.  However, new developments indicate that the public option, in various forms, is still alive. 

Senator Schumer (D-NY), having failed to pass his “level playing ...

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 ...

For the last week or so, the health reform public policy debate has been keyed to the Senate HELP Committee’s draft and thus dominated by whether or not the “Exchange” to be employed in access reform should include a “public plan” and, if so, whether such a plan should have the power to access provider payment rates tied to Medicare and whether Medicare participating providers would be required to contract with it. With this week’s release of the Senate Finance Committee’s draft, it will be interesting to see whether payment reform can similarly capture the ...

In yesterday’s post on The Health Care Blog, Bill Kramer remarks upon a key difference in the health reform discourse this go-round. Simply put, “the Obama Administration is changing the debate in a fundamental way.” As President Obama stated in his opening remarks to last week’s White House Forum on Health Reform, “[h]ealthcare reform is no longer just a moral imperative, it is a fiscal imperative.”

Kramer explains that past attempts at reform suffered from political sticker shock over concerns that health reform would dramatically enlarge the federal deficit ...

Thursday's White House Forum on Health Reform brought together people who have a stake in our health care system with people who have the ability to change it. Prior to his inauguration, President Obama called on Americans to hold community discussions about health care. More than 9,000 Americans signed up to host discussions in all 50 states and more than 30,000 Americans attended these discussions. These community groups submitted reports to the White House that detailed their concerns about the health care system and their suggestions for reform. At the Forum, several of these ...

For health care facilities, and those who invest in them or lend to them, the President’s budget underscored the emerging “shape of things to come” in the delivery system. In short, the Administration intends to compel delivery system modifications through aggressive payment policy changes.

What industry segments are immediately concerned? -- home health agencies, skilled nursing facilities, IRFs, LTCHs, and rehab facilities. In the name of “efficiency and accountability” the President proposes to bleed (Bleeding Edge redux?) $950M over 5 years and $17.8B over ten ...

Many people ask, “can we afford to pay for health care reform?” However, the more pressing question is whether we can afford not to reform our health care system. The collapse of our financial markets and the general deterioration of the economy make fundamental health reform an urgent priority. Investing in our health care system will pay off by helping to keep Americans healthy and economically stable.

On February 10, 2009, Senate Budget Committee Chairman Kent Conrad (D-N.D.) said that health care reform plans cannot add substantial costs to the system, one which already ...