DOH Finalizes Temporary Regulations for Clinical Registrants and Academic Clinical Research Centers

The Pennsylvania Department of Health (DOH) published the much anticipated final version of the temporary regulations under the Medical Marijuana Act applicable to Clinical Registrants and Academic Clinical Research Centers (ACRC) in Pennsylvania (“Temporary Regulations”). The Clinical Registrant/ACRC relationship was first developed in Pennsylvania with a specific focus on research.  A Clinical Registrant is a unique category of Medical Marijuana Organization under Pennsylvania law that is granted a permit to act as both a grower/processor and dispensary. An ACRC is “an accredited medical school” in Pennsylvania that “operates or partners with an acute care hospital licensed and operating” in Pennsylvania. The Temporary Regulations require Clinical Registrants and ACRCs to enter into Research Contracts together and provide some broad guidance about the content of those written agreements. Additionally, the Temporary Regulations address certification of ACRCs, capital requirements, approvals for clinical registrants, and the process for Clinical Registrant applicants who wish to convert their already issued grower/processor or dispensary permits to Clinical Registrant permits.

For more information about the Temporary Regulations or the Medical Marijuana Act, contact Chris Raphaely, J. Nicole Martin or another member of Cozen O’Connor’s Cannabis Industry Team.

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CMS Approves Medicaid Waiver Requiring “Community Engagement”

Posted by on January 25, 2018
CMS, Medicaid / No Comments

Medicaid, health concept. Stethoscope, syringe and pills on grey backgroundAs a first in the history of the Medicaid program, the Centers for Medicare & Medicaid Services (CMS) approved, on January 12, 2018, Kentucky’s section 1115 waiver application that imposes on many beneficiaries a “community engagement” requirement as a condition of Medicaid eligibility.  This is commonly referred to as a “work” requirement, given that it can be satisfied through employment.  The prior administration had rejected similar work requirements proposed under an Arkansas waiver requirement as falling outside the boundaries of the Secretary’s statutory authority under Title XIX of the Social Security Act to provide “medical assistance” to designated indigent populations.

The following are some takeaways from the Kentucky HEALTH approved demonstration project.

What must affected beneficiaries do?  Beneficiaries subject to the requirement must demonstrate completion of 80 hours (each month) of community engagement activities.  Otherwise, they will lose Medicaid coverage.  Beneficiaries can fulfill the requirement through a combination of employment, education, job skills training, or community service. Continue reading…

End of 2017 Marked by Scaling Back of Obama Era Nursing Home Financial Penalties under the Trump Administration

Posted by on January 05, 2018
CMS / No Comments

CMS outlined changes to the nursing home survey process in a October 2017 memo to state survey agency directors, which scaled down the use and severity of civil monetary penalties (CMPs) for certain nursing home deficiencies. Shortly thereafter, CMS released a November 2017 memo that among other things, outlined an 18-month moratorium on the imposition of CMPs, discretionary denials of payment for new admissions and discretionary termination by surveyors for survey deficiencies identified by the following eight  “F” tags: Continue reading…

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The Effects of Tax Reform on the Affordable Care Act: An Attempt at Death by a Thousand Cuts

Posted by on December 22, 2017
ACA, Affordable Care Act / No Comments

The sweeping Republican tax reform bill, H.R. 1 (115), was passed by Congress on Wednesday afternoon, and signed by President Trump today. Although the President said on Wednesday that, “ObamaCare has been repealed in this bill,” due to the bill’s elimination of the Individual Mandate, it remains to be seen whether this will truly strike the final blow to ObamaCare (the Affordable Care Act, or “ACA”) as envisioned by the President.

If the ACA manages to survive, it will not be for lack of trying on the Trump administration’s part. On top of the elimination of the Individual Mandate, the Trump administration has removed some subsidies, halved the insurance enrollment period, destroyed the Obamacare marketing campaign, and has permitted skimpy new health plans that will inflict even more damage on the ACA. All together, these add up to an incremental corrosion of the law.

However, although the ACA is weakened, it has so far survived the assault, even if in a diminished form. In fact, numerous polls have found that the ACA is increasingly popular with the American public. And several factors indicate that the ACA may be able to weather the storm. Continue reading…

CMS Waives Medicaid Retroactive Eligibility for Iowa: Is Your State Next?

Posted by on December 01, 2017
Medicaid / No Comments

Medicaid, health concept. Stethoscope, syringe and pills on grey backgroundSince 1973, the Social Security Act has mandated that states provide retroactive Medicaid benefits for three months prior to the individual’s application.  SSA § 1902(a)(34).  Congress enacted this provision to provide coverage to those lacking knowledge about their Medicaid eligibility and to those whose sudden illness prevented them from applying.  Senate Report No. 92-1230, at 209 (Sept. 26, 1972).  Providers benefit from retroactive eligibility through the ability to enroll uninsured patients in Medicaid retroactively, including after discharge, to avoid uncompensated care costs.

Seeking to trim Medicaid expenditures, Iowa’s Governor this year signed a law requiring the State to seek a CMS waiver from the retroactive eligibility requirement.  When the State agency asked the public for comments on its waiver proposal, only one commenter expressed support.  The vast majority expressed concern that many patients—especially trauma patients who might lack the ability to promptly file Medicaid applications—would face new coverage gaps.  The State itself projected that the waiver would shed 3,000 members (monthly) and would slash Medicaid expenditures by $36.8 million (annually).  Providers unsurprisingly voiced concern that the waiver would increase uncompensated care costs. Continue reading…

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Telehealth Report Offers Glimpse Into Variety and Complexity of State Telehealth Laws and Policies

In the recently published fall update of the fifth annual edition of its telehealth report, the Center for Connected Health Policy, the federally designated National Telehealth Policy Resource Center, provides a current summary guide to telehealth-related laws, regulations, and policies for all 50 states and the District of Columbia, and tracks a number of telehealth trends. The report offers a revealing glimpse into the scope and complexity of state laws and policies governing telehealth. The authors conclude, however, that despite the fact that state laws and Medicaid policies “differ significantly” certain trends are coming into relief. Here are some highlights of the report:

  • 48 states and the District of Columbia provide reimbursement for live video consults in their Medicaid fee-for service programs.
  • States alternate between the terms “telemedicine” and “telehealth,” and in some states, both terms are explicitly defined in statute or regulation.
  • 15 state Medicaid programs reimburse for store-and-forward services.
  • 21 Medicaid programs reimburse for remote patient monitoring.
  • 36 states and the District of Columbia have laws governing coverage by private payers of telehealth services.
  • In the 2017 legislative session, 44 states introduced over 200 telehealth-related pieces of legislation addressing issues such as reimbursement and the standard of care.
  • 30 jurisdictions have telehealth informed consent requirements (depending on the state, may apply to Medicaid only, certain specialties, or to all telehealth transactions in the state).
  • 22 states are now part of the Federation of State Medical Boards’ Interstate Medical Licensure Compact facilitating multi-state licensure for physicians in those states.
  • 32 states reimburse a transmission fee, facility fee, or both.
  • 9 state medical/osteopathic medical boards issue special licenses/certificates related to telehealth.

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Hospitals Will Need Psychiatrists and Mental Health Professionals to Satisfy EMTALA

Posted by on November 07, 2017
Hospital, Mental Health, Uncategorized / No Comments

Hospitals that have emergency departments should call upon their “available resources” to screen and stabilize patients with mental health emergencies as required by the Emergency Medical Treatment and Labor Act (“EMTALA”) according to recent statements by an analyst for CMS and an attorney with the Office of Inspector General (“OIG”) for the Department of Health and Human Services.

While speaking at the American College of Emergency Physicians annual meeting in Chicago, the CMS representative noted that EMTALA requires hospitals with emergency departments to provide a medical screening within the capabilities of the hospital by a person who is qualified to do the examination, which, if the hospital offers psychiatric services, would include a psychiatrist.  While the initial screening must be done with medical personnel such as a psychiatrist, the CMS official stated that other mental health professionals may be qualified to assist in those examinations.

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The White House’s One-Two Punch to Obamacare: A Knockout Blow to the ACA?

Posted by on October 16, 2017
ACA, Affordable Care Act / No Comments

Health insurance application form with money and stethoscopeIn moves that stunned and alarmed insurers, providers, and consumers alike, on October 12, the White House issued an announcement and an Executive Order that appear to be purposefully designed to decimate the Exchanges under the ACA:

  1. The White House announced that the government will stop making cost-sharing reduction payments to insurance companies under Obamacare.  According to the White House, there is no appropriation for such payments.  As the Exchange plans will still be obligated to bear the costs of the cost-sharing reductions, premiums for Exchange plans that remain in the market would be expected to rise dramatically.  Many Exchange plans have termination provisions which allow them to terminate their 2018 contracts if the cost-sharing subsidies stop.  On October 13, eighteen states and the District of Columbia sued the administration to restore the funding.
  2. The President also issued an Executive Order requiring the relevant agencies to consider regulations or guidance (1) allowing more employers to form association health plans (AHPs) and (2) expanding the availability of short-term, limited-duration insurance (STLDI).  If the regulations come to fruition, younger and healthier people are expected to be siphoned from Exchange products and into cheaper AHPs and STLDI plans (that potentially offer skimpier coverage), creating adverse selection.  Premiums will rise for those left in the Exchanges.

Is the ultimate goal of these moves the total destruction of the Exchanges?  Are they bargaining chips designed to bring Congress back to the table to fix the “problems” with the ACA?  If the latter, will Medicaid spending cuts sought by many Republicans be part of that discussion?  Stay tuned.

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TELEHEALTH PARITY LAWS: THE REAL STORY

State telehealth parity laws, which generally require private payers (and occasionally Medicaid programs) to cover telehealth services if those services would be covered if provided in-person, have long been trumpeted as a means to increase telehealth acceptance.  The argument is simple: given how the availability of health care services is usually directly tied to whether (and how) payers cover a particular service, laws that require payers to cover telehealth services should drive utilization.  A recently published report, however, questions the impact these laws have on telehealth utilization.

The Center for Connected Health Policy (CCHP), the federally funded national telehealth resource center, conducted a five-month study to analyze state telehealth parity laws and the impact these laws may have on telehealth utilization.  In an interesting twist, the report’s authors also interviewed health plan executives to gain insight into how plans cover and reimburse telehealth services, and the issues preventing greater telehealth utilization.  The report should be required reading for all telehealth stakeholders seeking to understand the telehealth reimbursement landscape.

Here are some key general highlights:

  • As of September 2016, 31 states and the District of Columbia have passed telehealth private payer laws.
  • How a parity law is drafted can determine “the expansiveness of reimbursement and can predict telehealth utilization.”
  • Inclusion/exclusion of certain language may create barriers to telehealth utilization by allowing payers to limit the types of services that may be reimbursed.
  • Only 3 states have laws that explicitly require payment parity (meaning payers in these states have to reimburse for telehealth at the same rate as they pay for in-person services).
  • Live video is the modality most often referenced in the parity statutory definition of telehealth. Approximately 70 percent of state parity laws reference store-and-forward, and about 55 percent include references to remote patient monitoring.
  • Only 4 states and the District of Columbia include a site limitation in their parity laws.
  • Unlike the Medicare program, parity laws usually do not include explicit exclusions regarding types of services, types of providers, and geographic locations.

Payer Interviews

As I mentioned, the report’s authors interviewed commercial plan executives, medical officers, and other plan representatives in six states (CA, MS, MT, OK, TX, and VA), resulting in a compelling look into how commercial payers view telehealth.  For plans not participating in interviews, CCHP conducted research regarding their telehealth policies.  Some points to highlight from the interviews:

  • The majority of selected plans only reimbursed for live video. Some plans provide limited reimbursement for store-and-forward, but only for certain specialties.
  • Remote patient monitoring is not being reimbursed by any of the payers that were part of the study.
  • The majority of interviewees confirmed that their plans reimbursed telehealth services at the same rate as in-person services.

Plan interviewees also noted that, notwithstanding the increase in state parity laws, telehealth utilization is generally low.  Among the reasons provided:

  • Patients are reluctant to use telehealth, although once they try it, many respond positively.
  • Patients have a preference to see physicians and other providers in-person.
  • Providers are reluctant to use telehealth for a number of reasons ranging from lack of training, skepticism regarding telehealth, or concerns that they could lose business by providing telehealth.
  • Lack of education and awareness regarding the availability and efficacy of telehealth.

Medicaid

CCHP also spoke with Medicaid representatives and concluded that private payer laws have little impact on Medicaid telehealth policies unless the laws explicitly include Medicaid.  The Medicaid representatives also noted that providers face significant challenges in implementing telehealth programs, including the cost of equipment and billing issues.

Moving Forward

While the report acknowledges the promise of telehealth, CCHP concludes that many obstacles remain, including what it describes as “a broad misconception that, because telehealth private payer laws are in place in many states around the country, telehealth is achieving its promise of providing the same patient benefit and payment as in-person care.” Specifically, the report warns that parity laws “have been weakened by their lack of clarity and often contain clauses that may negate much of the intent of the legislation.”  The report encourages more careful drafting of laws and a more comprehensive implementation plan.  CCHP concludes by asking policymakers to consider, among other things, the following steps:

  • Using explicit language in private payer laws.
  • Ensuring that payment or reimbursement parity language is included in the language of these laws assuming it is the intent of policymakers to have telehealth reimbursed at the same rate as in-person services.
  • Developing a comprehensive Medicaid telehealth policy.

Conclusion

I believe the report is significant for two reasons.  First, it dispels the notion that the existence of state parity laws alone will drive greater telehealth utilization.  As the report makes clear, some of this is due to poorly drafted laws in some states—but I believe that much of the disconnect between parity laws and telehealth utilization is tied to broader issues regarding telehealth utilization generally. The lack of knowledge and education on the part of consumers regarding telehealth, for example, is as big a stumbling block as any other. Second, it appears that while plans have bought into the benefits of telehealth they are cautious regarding how to drive utilization. The report points out that most plans prefer a slower approach to telehealth expansion and favor using methods such as pilot projects to assess potential expansion.

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2017 Digital Health Funding For Emerging Companies Setting Records

Posted by on July 12, 2017
Healthcare / No Comments

report on table with calculator2017 is setting records for the funding of digital health emerging companies according to two recent reports. Two leading digital health stakeholders StartUp Health and Rock Health published separate reports in the last two weeks highlighting the record number of digital health deals, total investments, and number of deals over $100 million—all great news for the thousands of digital health emerging companies making their way in the health ecosystem. StartUp Health is New York-based organization that brings together a community of innovators, investors, and advisors to help health care-focused companies through various stages of development. Rock Health is a full-service fund based in the Bay Area that supports a wide diversity of digital health emerging companies. Interestingly, while the organizations track funding differently, their reports essentially come to the same conclusion—the funding outlook for digital health emerging companies is as robust as it has ever been.

StartUp Health tracks companies that enable health, wellness and the delivery of care through data/analytics, sensors, mobile, internet-of-things, genomics and personalized medicine. It looks at various levels of funding from accelerator to private equity funding. StartUp Health’s Insights 2017 Mid-Year Report shows that 2017 has surpassed previous years in overall funding and number of new and unique investors focused on digital health. Among the highlights of the report:

  • Q2 2017 had a total $3.8 billion invested—larger than the total annual funding for 2010 and
  • 2011 combined;
  • Mid-year funding stands at a little over $6 billion—setting a record for the most funding by the halfway point of any year;
  • 10 deals over $100 million in the first half of 2017 (tied for most deals in any full year);
  • Approximately 60 percent of deals are considered early-stage (seed and Series A);
  • Mega deals are a trend with 4 deals from 2017 making the top 11 of all deals since StartUp Health began tracking funding in 2010;
  • As expected, funding is most significant in the Bay Area with the Northeast (Boston and New York City) and Chicago also the focus of major deals and funding. Growing digital health hubs include Austin, Minneapolis-St. Paul, Denver, and Seattle;
  • Close to 600 unique investors so far in 2017—almost as many as all of 2015; and
  • No IPOs in the digital health space so far in 2017.

Continue reading…

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