The government is focusing on opioids.  Whether it be program policies, enforcement, or legislation, combating the opioid epidemic continues to be a major focus for government officials.  It is also a major piece of the health care legislation moving in both the House and the Senate.

In the Senate, the Judiciary Committee advanced five bills relating to the opioid crisis, and the HELP Committee advanced the “Opioid Crisis Response Act of 2018,” which has over 40 measures relating to opioids. Most recently (6/12), the Senate Finance Committee unanimously approved the Helping To End Addiction And Lessen (HEAL) Substance Use Disorders Act Of 2018.  That Act includes the expansion of the Physician Payment Sunshine Act to include payments to mid-level providers, as we previously blogged about here.  Click here for a summary of all Senate bills.

On the House side, over the last two weeks, the House passed over 50 bills to combat the opioid crisis and have received bipartisan support. Additional opioid related bills have been introduced and passed out of committee. On June 20, the House voted and passed three additional opioid bills (HR 5925, HR 9797, and HR 6082). Two of these bills were considered controversial. H.R. 5797, The IMD CARE Act, repeals the Medicaid IMD exclusion for individuals with opioid use disorders. H.R. 6082, The Overdose Prevention and Patient Safety Act, amends 42 CFR Part 2 confidentiality protections pertaining to substance use disorder patient records.  Continue Reading Opioids Have Our Attention

Join us in New York on Tuesday, January 24th, for a discussion on FDA priorities in 2017 and the potential impact on companies in the health care and life sciences industries.  In a joint presentation from Mintz Levin and ML Strategies, my colleagues, Bethany Hills, Joanne Hawana, and Rodney Whitlock, will discuss the following topics:

  • President Trump’s plans for FDA reform
  • Expected health care activity in the 115th Congress
  • Changing FDA regulatory priorities
  • Practical implications for industry

We hope you will join us! The program will run from 5:30 – 6:30, with a cocktail reception to follow.  Click here to register.

In the meantime, you can continue to follow our coverage of recent FDA developments here.

Earlier today, my colleagues at ML Strategies published the Washington Outlook for 2016, offering their insights about what we might expect from Capitol Hill and the Administration in the coming year. The Outlook covers a wide range of issues and includes a preview of the US legislative agenda as well as a look at the Obama Administration’s regulatory plans.

Also, check out the Outlook’s Appendix for an election season cheat sheet, including the dates of the US state primaries and lists of the important Senate and House races to watch, as well as the 2016 House and Senate calendars.

With regard to health care, it is likely that the Administration’s signature health care law will continue to be at the forefront of its domestic agenda.  ML Strategies says that we should expect additional activity on targeted bipartisan reform efforts to modify the ACA.  Issues include:

  • The “30-hour work week” fix.
  • The Simplifying Technical Aspects Regarding Seasonality Act, or the “STARS Act,” which would exempt seasonal employees from the definition of “full time employee” of the ACA’s employer mandate.
  • The “Small Business Healthcare Relief Act,” which would allow for small businesses with fewer than 50 employees that do not offer health insurance coverage to establish a health reimbursement arrangement.
  • Efforts to address rising insurance prices in the exchanges, which could include efforts to modify insurance “rating,” or pricing rules.

Continue Reading ML Strategies Publishes Washington Outlook for 2016

On Monday November 2, 2015, ML Strategies released another edition of its Health Care Update.  This publication provides timely information on implementation of the Affordable Care Act, Congressional initiatives affecting the health care industry, and federal and state health regulatory developments. This week’s update focuses on the opening for chair of the Ways & Means Committee and the potential impact of this decision.   Continue Reading ML Strategies: Ways & Means Leadership Changes – Health Policy Implications Looming

Congress returns this week, and ML Strategies has re-launched its weekly Health Care Update.  This publication provides timely information on implementation of the Affordable Care Act, Congressional initiatives affecting the health care industry, and federal and state health regulatory developments.

Policymakers continue to work toward a two-year budget agreement, despite skepticism that a deal can be reached by the December 11, 2015 deadline.  Then, adding another layer of complexity, the Treasury Secretary accelerated his projection for raising the debt limit by moving the deadline for Congress to act to November 3, 2015, giving Congress 10 legislative days to raise the government’s borrowing limit. ML Strategies expects that cuts to mandatory entitlement programs, particularly related to hospital and drug reimbursements, will be at the center of budget negotiations.

This week’s update details a number of health care issues, discussing potential increases in Medicare Part B and Part D premiums, as well as numerous ACA fixes, and other regulatory updates. There are a busy couple of weeks ahead, and ML Strategies will be covering everything from open enrollment season, to the debt limit, to the looming budget negotiations.  Past and future Health Care Updates can be found here.


Earlier this month, my colleague Andy Shin at ML Strategies co-authored an article in the American Journal of Managed Care for a special issue of Evidence–Based Oncology, focusing on personalized medicine.

The article, Alternative Payment Models: Paving the Way of Building a Wall for Personalized Medicine?, highlighted a recent white paper published by the Personalized Medicine Coalition entitled Paying for Personalized Medicine. The authors also discuss how the industry is moving toward value-based payment through alternative payment models (APMs) and how APMs could, if implemented correctly, enhance the main goals of personalized medicine: improving care coordination and managing costs. On the other hand, without appropriate safeguards to ensure high-quality health care services, APMs could limit access to the many advances made in personalized medicine.

The article highlights the three most prominent APMs: Continue Reading Personalized Medicine and Alternative Payment Models

Earlier this week, ML Strategies posted its weekly Health Care Update. This publication provides timely information on implementation of the Affordable Care Act, Congressional initiatives affecting the health care industry, and federal and state health regulatory developments.

This week’s top story focuses on the Center for Medicare & Medicaid Services’ (CMS) release of final 2016 payment rules impacting acute care and long-term care hospitals.  Overall, the rule would increase operating payment by 0.9%; however it includes a $1.2 billion dollar cut in Medicare Disproportionate Share Hospital (DSH) uncompensated care funds for FY 2016.  One of the most controversial provisions in the final rule is that CMS did not extend the delay of the partial enforcement of the two-midnight rule, which is set to expire at the end of this fiscal year.

The update also covers Congresses introduction of the Medicare Post-Acute Care Value-Based Purchasing Act of 2015 (H.R. 3298).  This bill would create a single value-based purchasing (VBP) system for post-acute care that would replace CMS’ mandatory home health VBP pilot that was proposed in the 2016 Home Health proposed rule.

* Lauren is admitted in New Jersey only.  Practicing under the supervision and guidance of Members of the Washington, D.C. office.

Yesterday, ML Strategies posted its Health Care Update and Telehealth Policy Alert. This publication provides timely information for those who are already in, or contemplating entering, the telehealth space.

Key legislative initiatives so far this year include the Sustainable Growth Rate (SGR) repeal, which addressed several aspects of telehealth policy, the 21st Century Cures Initiative, the Telehealth Enhancement Act, and the Senate chronic care working group. Although many of these initiatives do not go as far as some stakeholders would like to address the barriers to widespread implementation of telehealth, the Alert notes that larger legislative efforts appear to be underway that would expand Medicare reimbursement for telehealth.

In addition to legislative initiatives, the Obama Administration has been active in the area of telehealth. In March, CMS unveiled its “Next Generation ACO” program that promises flexibility around Medicare telehealth rules. And the FDA and FTC have provided guidance on the regulation of medical device data systems.

These congressional and administrative initiatives (as well as several others) are discussed in detail in the Alert and highlight current opportunities for stakeholders to consider for shaping the future of telehealth.

Earlier this week, ML Strategies posted its weekly Health Care Update. This publication provides timely information on implementation of the Affordable Care Act, Congressional initiatives affecting the health care industry, and federal and state health regulatory developments.

The top health policy story continues to be the bi-partisan 21st Century Cures legislation, discussed in this post, by my colleague Carrie Roll. The full House Energy and Commerce Committee will begin consideration of the legislation this week, with markup to begin today. A key question that remains for lawmakers is how to pay for the legislation. Stakeholders have been aggressively pushing for additions to the bill since it was introduced, and negotiations reportedly continue over pay-fors.

Other miscellaneous health care legislation moves forward as the Senate Finance Committee closed a request last week for non-controversial health care bills for possible markup during the June work period.

Past Health Care Updates are available here.

ML Strategies has posted its weekly Health Care Update.  This week’s Health Care Update focuses on the latest Congressional developments on the repeal of the Medicare Sustainable Growth Rate (“SGR”), commonly known as the “Doc-Fix” and the Children’s Health Insurance Program (“CHIP”) reauthorization. In a rare showing of bipartisanship, the House passed the SRG replacement and CHIP reauthorization bill, only to have it face contention in the Senate.  The Senate was unable to pass this bill before their Easter break. With the Senate planning to take up this legislation when they return in two weeks, the Centers for Medicare & Medicaid Services (“CMS”) indicated that it will hold Medicare claims for up to 10 business days.

Click here to read this week’s Update.