COVID-19 Webinar Series Session 6 – Legislative and Regulatory Roundup

12:00 p.m. – 12:05 p.m.     Welcome and Introductions

Sarah J. Dash, MPH, President and CEO, Alliance for Health Policy, @allhealthpolicy

12:05 p.m. – 12:15 p.m.    Opening Remarks

Andrew M. Rosenberg, J.D., Co-Founder, Thorn Run Partners, @TRPHealthPolicy

Billy Wynne, J.D., Chairman, Wynne Health Group, @billywynne77

12:15 p.m. – 12:30 p.m.    Moderated Discussion

(This is an unedited transcript. For accurate quotes and presentations, please refer to the full-event video.)   0:42 Good afternoon. I am Sarah – president and CEO of the Alliance for Health policy for those who are not familiar with the alliance. We are a non partisan resource for the health policy Community dedicated to advancing knowledge and understanding of Health policy issues. Welcome to the sixth event in our covid-19 webinar series The Alliance for Health policy gratefully acknowledges the National Institute for Healthcare Management foundation, and the Commonwealth fund for supporting today’s webinar. 1:10 You can join today’s conversation on Twitter using the hashtag all help live and follow us at all Health policy. 1:17 We want you all to be active participants in today’s webinar. So please get your questions ready and I’m going to give you some quick technical notes on how you can ask them. You should see a dashboard on the right side of your web browser select the speech bubble icon with the question mark to chat with us about any technical issues. You might be experiencing you can also use that icon to submit questions that you have for the panelists at any time. We will collect these and address them during the broadcast later today. You will also find all of the materials that accompany this webinar. 1:47 a website along with a recording of the webinar as the covid-19 outbreak continues to escalate Congress has been working around the clock to pass legislation to stimulate the economy and support the healthcare system as it responds to the covid-19 outbreak today. Our panelists will review actions that Congress and administration have taken to date and discuss what we can expect in the coming weeks and months now, it is my pleasure to introduce our panelists first. We have Andrew Rosenberg co-founder and partner at store and run a leading bipartisan government affairs. 2:23 Andrew has 25 years of experience as a lobbyist Capitol Hill staffer and health policy lawyer and previously served on the Senate help committee next. I’m pleased to introduce Billy win chairman of the wind Health Group a national public interest Health policy consulting firm previously Billy served as health policy councils to the Senate finance committee Billy Andy. Thank you both for joining us. 2:47 Now you sure have a great Andy. I’m going to hand it off to you first for some opening remarks. 2:56 Fantastic, thank you happy to be here everybody why we get straight to the slides we can jump into the we’ve had three phases. Well, actually we’ve had to covid bills passed so far. There’s so much content here Sarah. I want to sort of get right into it. 3:14 So I’m going to describe the first two phases of the bills of the legislative response, which have already gone through Congress, and then I’m going to talk about the The third one which is literally on the floor of the House of Representatives as we speak and then I’ll talk about plans and prognostications about 1/4 or maybe even a fifth Corona package might look like let me start here with Phase 1. So Phase 1 was an eight point three billion dollar package that was seems like ages ago. It was only a couple weeks ago and it was actually three times what the administration initially asked. 3:55 Or it combined new funding for treatments for covid-19 public health agencies and Community preparedness and had a waiver of restrictions on Medicare Telehealth coverage during the outbreak in included 3.1 billion for vaccines and Therapeutics in a diagnostic Development Fund 300 million in contingency funding for vaccines Therapeutics and Diagnostics 2.2 billion for the CDC. 4:25 A paltry billion dollars for the SBA the Small Business Association and 1.2 billion for the State Department of State Department’s response to the outbreak and for Global health is stability programs. It all seems rather quaint in hindsight just a couple weeks ago. It also included sort of a drug pricing element. This was maybe the most controversial aspect of this first package because it in providing money for funding for that. 4:55 Gnostic I’m sorry for vaccine and treatment therapies. 5:01 There was an effort made to put some restrictions on what companies could charge for those vaccines are cures what Congress decided to come up with where they sort of met in the middle was sort of a statement of existing law, which was that the purchase government purchased a coronavirus Therapeutics and vaccines and Diagnostics must be made according to the well acquisition regulation guidance on fair and reasonable pricing. So nothing terribly controversial came out of it, but it was momentarily a point of some contention. There are also Provisions in that first phase on telemedicine. Like I said authorizing HHS secretary to wave some Telehealth restriction from the Medicare program as well as some language around the Public Health and Social emergency Social Services emergency fund. 5:55 Then came phase two next slide. Please phase two focused on on F map providing states with a 6.2 percent increase on traditional F map for all Medical Services during this Public Health Emergency. It does not apply to expansion or administrative F map. However, there were limitations. It is conditioned on that boost is conditioned on State’s Medicaid programs. 6:25 Is covering covid-19 related at treatment vaccines and Therapeutics at zero cost sharing and on States not making their eligibility standards more restrictive or increasing any cost sharing there was also a technical correction to phase one bill on Medicare Telehealth. 6:43 There were some worker protections it the packaging required employers to provide two weeks of paid sick leave and up to three months of paid family leave for employees that were affected by Virus the cost of which could then be claimed by the employer as a tax credit and then also their social safety net section the package this against Phase 2 provided for 1.25 billion dollars in supplemental assistance for those impacted by the epidemic including 500 million for the wick for the women infants and children program four hundred million dollars for emergency food assistance program. 7:25 A hundred million in nutritional assistance the territories and 250 million for senior nutrition programs. Finally testing. This was a probably the key element of phase 2 the package requires insurers or required insurers to cover covid-19. Testing without cost sharing and it Waves cost sharing for testing under Medicare Medicaid Tricare and the VA it gives States the option to cover testing and related services. 7:55 For their uninsured populations at 100 percent s map. 8:02 Moving now to phase 3 which is the bill that is currently on the floor of the House of Representatives. This is the big one. This is the two trillion dollar package first. I’ll mention that it wrapped the Medicare extenders package which was set to expire on May 22nd into this into this bill to reauthorize the extenders due November 30th of 2020 of this year. So into the lame duck. 8:32 In part that was done because quite frankly Congress doesn’t know for sure when they’re going to be able to get back to Washington after they after they recess a later today. So that hunts the extenders and the bill also places additional require requirements on drug manufacturers with regard to Health Care shortages so that they must be reporting their supply interruptions and to maintain contingency plans to ensure a backup supply of their products. 9:01 There’s also a 100 billion dollar fund for the PHS SEF of Public Health and Social Services emergency fund that is allocated to reimbursing providers for expenses or lost Revenue directly attributable to covid-19. It also included a provision related to over-the-counter OTC reform and you’ve probably heard the big the big stuff on the news about the direct payment. 9:31 If which provides recovery rebates of up to $1200 for individuals $2,400 for married couples and this rebates begin to phase out for incomes of people of $75,000 and above checks would include $500 per dependent child, and then further attacks you 2019 payment deadline has been extended from April to June 15th. Finally. It also includes small business loans. 10:01 That sort of forgivable loans to small businesses with 500 or fewer employees. Those loans are designed to cover payroll mortgage payments rent and debt payments from March through June. So three months and and those are forgivable loans thing essentially grants to small businesses in order to maintain their work their work staff next slide, please. 10:28 This is quickly. They’re the sort of just to remind you of the dates that this was all done. Is it on last couple weeks phase one was signed into law on the 6th of March is to on the 18th of March and then phase 3 literally it’s being on the floor of the House of Representatives this morning right now as we speak literally minutes ago Thomas Massie. 10:49 Oh Renegade Republican of Kentucky demanded a roll call vote of the House of Representatives, and they are Right now scrambling to see if they have enough people to make Quorum, which would be 216 present members of Congress. As of late. Last night Congress was leadership was scrambling to get their members back in done before so they could have a vote and it remains to be seen whether or not they have enough corn to get that done today, or if it needs to be passed tomorrow as a result next slide, please. 11:23 And my final slide is that this is probably not the end of it. There are already conversation there already and to be made for what a phase 4 or possibly a phase 5 could look like this package would include, you know, additional supplemental funding for agencies and Technical correction speaker Pelosi already noted that funding for food Aid stronger worker protections and funding for pensions and state and local governments will be prioritized. 11:52 I Democrats in the next round of covid-19 response legislation so that said I want to leave room for time for questions and for barely win. So Sarah I will hand it back to you great. Thanks Andy for that terrific overview. Let’s jump right into Billy flies. Billy’s going to talk more about the regulatory responsibility take it away. 12:16 It’s very much Sarah and thanks again to the Alliance for Health policy for having me a pleasure to be with you all. Thanks everybody for participating. We move on to the next slide. 12:28 So I just wanted to note a few things that are that are unfolding as we speak and they have changed inside finalized these slides. But the first is that the president had invoked the defense production act which gives the government authority to require private commercial manufacturers to prioritize the manufacturing of products necessary for the National Emergency. 12:57 He had not done so prior to the commencement this call, although there’s been active discussion about doing that president has referred to pursue private negotiations with companies using the DTA invocation as a lever in those negotiations. They have secured a certain degree of protection equipment and masks although Frontline responders with would quickly tell you there are not enough in the in the field. 13:26 Yes, and while they’re not secure an agreement to produce ventilators from private companies seeing just kind of right now that there may be some announcements later today. There’s percent some dispute between the president most notably the governor of your client regarding the number of ventilators that are needed at the moment to meet the healthcare crisis. 13:52 Secondly as I’m sure everyone is observed in is experiencing States and localities have been issuing varying degrees of stay at home or social distancing orders restricting business functions to those deemed essential etcetera. The president has had mixed message on that posture and has recently been openly ruminating on the possibility that some of these restrictions at least in terms of the federal guidance could be relaxed by Sunday April 12. 14:27 But I think I clinical Community including some of his own advisers would would disagree with that prediction and I believe at the end of the day that will see, you know, it’s going to be an ongoing evolution of the decision-making process and I wouldn’t put a lot of invest a lot of certainty into that April 12 date at this point last of all some states have begun issuing or opening special enrollment periods for the Affordable Care Act. 14:56 Change coverage options the federal government had not done. So to be clear loss of employment is a qualifying event. That would enable someone to enroll in an ACA covered plan including to pursue eligibility for Premium cost sharing subsidies. 15:15 So this is really for those who chose not to enroll in the in the regular enrollment period but now may have contracted covid-19 or you know, they fear that they or their family members will contract And would like to get coverage. So that’s what this special enrollment debate is about in about. I don’t know approximately 35 States people need to go through the federal healthcare.gov to access those exchange plans and subsidies. So we are watching closely to see what they do there next slide, please. 15:48 He’s so there has been a host of regulatory guidance and announcements that have come out of the center for Medicare and Medicaid services and others. I’m not going to read through all these I understand these slides will be posted to the Alliance for Health policy website after this call is over. So definitely welcome folks to access them there. I just want to note a few things that for example with regard to the commercial insurance industry CMS initially. 16:18 Regarding the the coverage of covid related diagnosis and therapy as essential health benefits under the Affordable Care Act also pre deductible coverage, for example for high deductible catastrophic plans for these services. So commercial insurers are quickly, you know on the receiving end of implementing this new guidance and I can tell you that there is a good bit of sort of confusion and like everybody else first. 16:48 Sort of working with these adjustments to standard policy in real time. CMS is also issued directives for providers. For example, allowing them to enroll in Medicare temporarily to relax seeing the state restrictions around licensing and trying to minimize the bureaucratic process as providers face and getting waivers of coverage for services for their patients. 17:19 they have also issued a recommendation that non-essential Services Under Central surgeries be postponed unless patients are in very acute need of that type of care and most hospitals as far as we have seen have been complying with that and turning their focus to patients infected with covid or potentially infected next slide, please so I mentioned earlier. I know you had a call earlier about masks and protective gear the CCDC in addition to the the White House LED efforts to procure and distribute those materials. 18:02 The CDC has been issuing guidance to Providers on how to care for patients presenting with covid symptoms and suggesting some Alternatives when the recommended Girls are not available. There have been substantial relaxing of Telehealth requirements Medicare historically as many of you know, I’ve had has had very restrictive rules and restrict guidelines around the use of Telehealth Services primarily out of the fear that it would expand cost and discretionary services within the Medicare program. 18:39 At least the access to that has been greatly expanded temporarily commensurate with the the Timeline for the Declaration of the National Emergency we can get back to that in more detail if folks would like in the QA. Why don’t we move on to the next slide in the interest of time. So I just want to note that clearly access to testing has been a challenge in our country and there have been numerous efforts by the FDA in particular to try to promote the expansion. 19:16 And of approved tests and recommend the test to determine covid infections those processes are ongoing and Commercial companies to are rapidly pursuing potential new approaches, including at-home testing Etc that you know, we’ll see if they can come to the market in the next few months or so. Similarly. There is a lot of effort to pursued both treatment. 19:46 For patients infected and also vaccinations for prophylaxis kept Sarah. For example, you see here on the slide. It’s been used for auto immune deficiencies like room rheumatoid arthritis. So there are some existing therapies that folks are pursuing approval of for application to the coronavirus. There’s also novel therapies that are being developed by some companies and the FDA has been working with them on Fast Track. 20:16 Google where that’s appropriate with regard to States and Medicaid CMS has promoted the use of waivers to relax provider and other restrictions that have been implemented at the Medicare level, but the federal government doesn’t have authority to do at the Medicaid level and several states have begun to pursue those Avenues. 20:42 They can for example again relaxed restrictions around and provider enrollment in the Medicaid Program. They can relax perennial re confirmation of patient eligibility for nursing home access to Services there and home health and a whole host of different services are eligible for eligibility and access relocations. If States choose to apply and many states. I think the number is now more than 13 have done so and received approval of their waivers from the Federal. 21:18 please I think that’s it. I just want to close by noting that we are making all of our covid related analysis free. If you go to win health.com and navigate to our blog you’ll get access to to a range of materials there. So certainly welcome folks to take advantage that if you like. Thanks again for having me. I appreciate it. 21:39 It great. Thanks, Billy. And thanks Andy. So we’ve already gotten a bunch of great questions from the audience. So if you do have a question, please feel free to send it in through the chat bubble. But we’re going to Dive Right In and the 10 minutes or so that we have left. So first, let me let me ask you and E on the extenders deadline which had previously been May 22nd. Now, do you say pushed to the lame duck? There had been aspirations of may be tacking on legislation around drug pricing. 22:09 Around the pie filling. Do you think those gets done in the lame? Duck? What do you think? 22:16 Yeah, great question. I mean there was there was an awful lot riding on or potentially riding on that May 22nd deadline. I mean, I think there were there was a lot of sort of obviously Grassley and proceed to some degree had had sort of I think a shared interest in using that as an opportunity to get some of these things done. 22:39 I’m not sure a short Mitch McConnell saw it the same way, but May 22nd was certainly going to be a bite of The apples are so to speak around some of those and other range of extraneous Healthcare issues that we’re looking to ride on that vehicle. We understand that while Grassley, I think we very much wanted to have another opportunity this calendar year to deal with some of those issues which is why it was printed in November, but actually the request came from the White House to choose November of twenty twenty rather to push it to 2021. 23:16 One to have that deadline extended to which Pelosi and the Democrats were happy to accede to it. Does raise a lot of questions and concerns if you’re in Pharma and you want to avoid a conversation around drug pricing for as long as possible as well as some of these issues on on surprise billing and other related Medicare issues, very possible that it could ride in a lame duck. That’s always sort of been the concern. 23:46 Or been the opportunity to bend you by now you look at it all along that lame duck sort of loomed as that possibility and I think it remains that way. 23:57 Great. Thanks. We have a couple of questions around Telehealth. So I’ll open it up to the belly version and Andrew. If you want to jump in one question is very specific around whether the Telehealth Provisions permitting coverage and HSA plans before the deductible are temporary just through 2021 or permanent and whether they include all Telehealth not just related to covid-19. 24:22 And then there’s a related question which is whether you will feel that there’s Appetite among filmmakers to sort of make any of the health care related Provisions permanent lasting beyond the emergency of specifically mentioning Telehealth. So kind of a couple of compound question, but do you like to take a crack at it? Go ahead sure. This is Billy. So the the with regard to our all services covered. Yes, essentially. I mean, so those that can be performed by Telehealth. It is not restricted to covid relay. 24:57 added services and that is the part of the kind of social distancing strategy, you know, in addition to the to the kind of covid treatment-related strategy my understanding with regard to all of the relaxation of Telehealth standards is that they are temporary and permitted under the president’s Declaration of a national emergency and will be rescinded with the retention of that National Emergency when that day comes having said that to your third part of your Justin Sarah the there’s been a growing interest and movement in the market prior to all of this toward Telehealth. I would be surprised if all of the restrictions and total are rescinded at that point given the the additional traction that will be given to again even on covid related services. So and and I think as in many other aspects of our lives were recognizing that the things we’ve depended on face-to-face encounters to accomplish may not be as necessary. 25:57 Through face-to-face channels as we previously thought I think Telehealth is a great example of that. 26:04 And I would I would agree with everything Billy said I would just say yeah, I mean there’s no question but it covid is providing an opportunity almost a demonstration opportunity in some regard for for some of these ideas and these Technologies and approaches. I think that stakeholders would be wise to tailor their their request to the current emergency. 26:26 So as not to appear to be taking advantage of the situation to further a longer-term But that said looking into the crystal ball. You can’t help but be aware that if there are some good lessons learned from this experience around Telehealth and other remote remote care sort of scenarios that there could be grounds for for further expansion of that. 26:55 Great. Thanks. So we’re going to try to get to as many of the questions as possible. There’s a question around coverage of testing. That’s so in the face three legislation. Was there any provision to make plans cover non-fda-approved test for for Coronavirus? 27:14 And understanding that I still very fresh legislation. 27:20 Not non-fda, Billy. I didn’t see anything that would sort of cover anything. That wasn’t FDA-approved. 27:30 The that enough you if you did you have so sorry. I was mean I agree on nothing, but certainly not mandated, you know, clearly. There’s there’s some kind of ambiguity around off-label use of some of these items but no certainly no mandate to use the approved items. 27:48 Great. So now we have a couple of questions relating to hospitals. There’s a there’s a narrow narrow question and a broad question one is whether there was any mention of permissible Community benefit expense reporting for the not-for-profit hospitals treating covid-19 patients and other public health response. So was there anything around Community benefit reporting and then a much broader question which was an implementation around the hundred billion dollar fund for help. 28:18 Services for Health Systems which was you know a prognostication how quickly do you think that HHS or CMS can turn around guidance and regulations to start making payments from the hundred billion dollar fund sport to hospitals and providers. 28:35 Community benefit and a hundred billion dollars I can do the community. That is typically stride. I have not seen something really. I think it’s an excellent question. 28:43 And I think that there are certainly going to be Community benefits, you know requirement related ramifications of this and how hospitals report their activities under the covid response, but in terms of any formal guidance or new reporting requirements Etc coming from federal government, I have not seen any and my only response on how quickly the hundred billion dollars. 29:07 I mean, I know that or I believe that the Administration has essentially announced it all of these rulemakings that are going to be coming out as a result of and guidance is as a result of these covid 19 bills will not rely on a comment period they will all be expedited that which obviously makes it more important to get in there and try to you know, share your insights as Is possible that said I mean I can’t help but be skeptical and there’s a lot of a lot of these programs that are dependent upon getting money out immediately or very quickly whether it’s you know, suit through small business assistance individual loan individual checks and support or support for the hospitals. And I think that that’s you know to answer that. You have to sort of decide for yourself. How much confidence do you have in the ability of this? 30:03 Trying to get things out quickly. 30:06 All right, great. I want to ask Billy one specific question around Medicare and Medicaid. I mean we’ve seen as you noted a lot of regulations around Medicare some on Medicaid as well. Obviously CMS can kind of take a nationwide approach with Medicare but on the Medicaid front, how do you see that playing out as far as the state response to covid-19? Yeah. I mean, I think it’s kind of the federal regime, you know. 30:37 It is especially with regard to Medicaid and with regard to The state-based Exchange, you know States it really is going to be up to them and therefore kind of the political processes and influences in those states to make those determinations. I think I’m just looking now the recent list I think over half of the states have applied for Medicaid waivers and then granted Medicaid waivers to relax some of those provider and enrollment and eligibility criteria. So we see it. 31:06 Strong Trend and looking just quickly at the state’s. It’s a diverse geographically and politically array of States. So I feel confident, you know the states of respond, but it despite there being, you know, definitely unique approaches taken by each one. 31:22 Great. Thanks for we are just about out of time. What I’d love is for each of you to take about 30 seconds. If there are one two or three things you think we should be looking for in you know, potential future phases of covid legislation. If you if you could prognosticate a little bit and then we’ll go ahead and wrap up and you want to take a first crack at that. 31:47 Great. Well, I’ll just jump real quickly. I think that you know there a lot of people in Washington are just going to size some relief because these last two weeks have just been so incredibly hectic in terms of paste. And as Congress passes the bill they’re going to be sort of hoping that things slow down for a bit, but I don’t think they will I think it’s starting Monday. If not sooner. 32:08 We initially we immediately begin the work on getting the administration to interpret these the New laws the way that your organization hopes. 32:19 They will there’s no doubt going to be some loose language and perhaps drafting errors in what was and what was hastily done meaning an awful lot of authority and responsibility to the administration under very distressed situation to a circumstance to get it right and then we immediately moved to covid for and I think if there’s one thing we’ve seen so far is that this trajectory has just been faster and more dire than we expected. So even though Congress expects to be out of town until April 20th. We imagine that when they return on it at the end of April, there will probably be some urgent needs in Industries and sectors that we can’t even predict right now that they’ll have to get to work on. 33:13 Billy I mean I totally agree with that I think that you will see a lot of legislative development over that that recess period obviously if you’re seeing house Democrats begin to float ideas on what would be in that baseball packages and E has noted I think it is going to be a daily, you know, minute-by-minute stream of implementing regulations and guidance and grant opportunities from the agencies as we try to respond to this. 33:39 I just want to know one Dang, that was I know that there was a question about the the end for our proposal it in the administration had issued before covid the place and this is a restrictions on use of Provider taxes and fees and other things that states were using to draw down the additional federal funds. The status of that regulation is in question. 34:02 I’ve keep an eye out for debate about that in the coming weeks the the Pelosi package from earlier this week included a to Two-year ban on implementation of that regulation but so far the Administration has been mum on whether or not it would proceed. It could have implications on safe ability to do to manage increase Medicaid enrollment. 34:26 Great. Well, that is unfortunately all the time. We have thank you both for enlightening us on a huge array of information over the last 30 minutes, and I’m sure we’ll be back in touch as things continue to develop so for our audience. Thanks for sticking with us. And thank you so much for your participation. And your great questions. Please take the time to complete the brief evaluation survey that you will receive immediately after the broadcast ends as well as I email later today. 34:54 And you can view the full event video and transcript on our website along with all the other videos from the covid-19 webinar series Andy and Billy. Thank you again for joining us. 35:05 Pleasure. Thank you. Thanks everyone. Thanks. Everybody be well.